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Trial record 47 of 52 for:    LENALIDOMIDE AND Leukemia AND Acute Myeloid Leukemia (AML)

A Study of Lenalidomide Versus Placebo in Subjects With Transfusion Dependent Anemia in Lower Risk Myelodysplastic Syndrome (MDS) Without Del 5q (MDS-005)

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ClinicalTrials.gov Identifier: NCT01029262
Recruitment Status : Completed
First Posted : December 9, 2009
Results First Posted : June 18, 2015
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Anemia
Interventions Drug: Lenalidomide
Other: Placebo
Enrollment 239
Recruitment Details 239 participants were randomized at sites located in Europe (185), North America (24), Asia/Pacific (13) and the Middle East (17).
Pre-assignment Details Participants must have had transfusion-dependent anemia defined as having an average transfusion need of at least 2 units of packed red blood cells (pRBCs) per 28 days during the 112 days preceding randomization; No consecutive 56-day period that was RBC-transfusion-free during the 112 days preceding randomization; hemoglobin levels ≤ 9.5 g/dL.
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description Participants received 3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.

Participants received lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.

Participants received lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.

Period Title: Overall Study
Started 79 160
Completed 0 0
Not Completed 79 160
Reason Not Completed
Adverse Event             9             52
Lack of therapeutic effect             57             76
Withdrawal by Subject             10             17
Protocol Violation             2             3
Miscellaneous             1             9
Death             0             3
Arm/Group Title Placebo Lenalidomide Total
Hide Arm/Group Description Participants received 3 placebo capsules by mouth daily for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.

Participants receieved lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.

Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.

Total of all reporting groups
Overall Number of Baseline Participants 79 160 239
Hide Baseline Analysis Population Description
The Intent-to-Treat (ITT) population includes all participants who were randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 79 participants 160 participants 239 participants
68.9  (8.26) 70.0  (8.19) 69.6  (8.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 160 participants 239 participants
Female
25
  31.6%
52
  32.5%
77
  32.2%
Male
54
  68.4%
108
  67.5%
162
  67.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 160 participants 239 participants
Asian
1
   1.3%
1
   0.6%
2
   0.8%
Black or African American
0
   0.0%
2
   1.3%
2
   0.8%
White
69
  87.3%
133
  83.1%
202
  84.5%
Japanese
4
   5.1%
8
   5.0%
12
   5.0%
Race Not Disclosed
4
   5.1%
15
   9.4%
19
   7.9%
Other
1
   1.3%
1
   0.6%
2
   0.8%
Packed RBC (pRBC) Transfusion Burden   [1] 
Mean (Standard Deviation)
Unit of measure:  pRBC units/28 days
Number Analyzed 79 participants 160 participants 239 participants
3.4  (1.37) 3.4  (1.23) 3.4  (1.28)
[1]
Measure Description: The baseline transfusion burden is the average number of RBC units/28 days during the 112 days prior to randomization.
International Prognostic Scoring System (IPSS) Investigator Determined   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 160 participants 239 participants
Low
30
  38.0%
85
  53.1%
115
  48.1%
Intermediate 1
49
  62.0%
75
  46.9%
124
  51.9%
[1]
Measure Description: The Myelodysplastic Syndrome (MDS) IPSS score assesses the severity of MDS based on 3 prognostic factors each assigned a score: the percentage of bone marrow blasts, chromosome changes in the marrow cells (karyotype) and the presence of one or more low blood cell counts (cytopenias). The IPSS score is the sum of the bone marrow blast + karyotype + cytopenia score and ranges from 0 (low risk) to 3.5 (high risk). Prognosis is categorized as Low risk (score = 0), Intermediate-1 (score 0.5 to 1.0), Intermediate-2 (score 1.5 to 2.0) or High risk (score ≥ 2.5).
World Health Organization Classification 2008 of MDS by Central Review   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 160 participants 239 participants
Refractory anemia (RA)
1
   1.3%
1
   0.6%
2
   0.8%
Refractory cytopenia unilineage dysplasia (RCUD)
0
   0.0%
5
   3.1%
5
   2.1%
RA with ringed sideroblasts (RARS)
7
   8.9%
12
   7.5%
19
   7.9%
Refractory cytopenia multilineage dysplasia (RCMD)
59
  74.7%
115
  71.9%
174
  72.8%
Refractory anemia with excess blasts-1 (RAEB-1)
12
  15.2%
27
  16.9%
39
  16.3%
[1]
Measure Description: The World Health Organization (WHO) 2008 classification recognizes eight subtypes of MDS that are distinguished by the percentage of myeloblasts, presence or absence of ringed sideroblasts (i.e., erythroid precursors with iron deposits surrounding the nucleus), presence of a monocytosis or a deletion 5q.
Prior Erythropoiesis-stimulating Agent (ESA) Treatment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 160 participants 239 participants
Yes
63
  79.7%
125
  78.1%
188
  78.7%
No
16
  20.3%
35
  21.9%
51
  21.3%
[1]
Measure Description: Erythropoiesis-stimulating agents (ESA) are similar to the cytokine (erythropoietin) that stimulates red blood cell production (erythropoieisis). ESAs, structurally and biologically, are similar to naturally occurring protein erythropoietin. ESAs are used to maintain hemoglobin at the lowest level that both minimizes transfusions and best meets a person's needs
Hemoglobin  
Mean (Standard Deviation)
Unit of measure:  g/dL
Number Analyzed 79 participants 160 participants 239 participants
8.7  (1.37) 8.7  (1.23) 8.7  (1.28)
Gene Expression Signature   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 160 participants 239 participants
3
   3.8%
14
   8.8%
17
   7.1%
[1]
Measure Description: A prespecified subgroup of participants with an erythroid differentiation gene expression signature predictive of lenalidomide response
1.Primary Outcome
Title Percentage of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence for ≥ 56 Days as Determined by an Independent Review Committee (IRC)
Hide Description The percentage of participants who achieved the 56-day RBC transfusion independent (TI) response was defined as the absence of any RBC transfusions during any consecutive “rolling” 56-day interval within the double-blind treatment phase (ie, Days 2 (Day 1 is the first study drug day) to 57, Days 3 to 58, etcetera). The double-blind treatment phase was defined as the period between the 1st dosing up until 28 days after the last study drug dose
Time Frame From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively.
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) population includes all participants who were randomized to either lenalidomide or placebo.
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description:
3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.

Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.

Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.

Overall Number of Participants Analyzed 79 160
Measure Type: Number
Unit of Measure: percentage of participants
2.5 26.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments p-value is from Fisher's exact test to compare lenalidomide treatment group to placebo group
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 10.616
Confidence Interval (2-Sided) 95%
2.639 to 42.702
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants With a Erythroid Gene Signature Who Achieved RBC Transfusion Independence for ≥ 56 Days as Determined by an Independent Review Committee (IRC)
Hide Description The percentage of participants who achieved the 56-day RBC TI response was defined as the absence of any RBC transfusions during any consecutive "rolling" 56-day interval within the double-blind treatment phase (ie, Days 2 (Day 1 is the first study drug day) to 57, Days 3 to 58, etcetera). A participant who achieved at least a 56-day RBC-transfusion-independent response was considered a 56-day RBC-TI responder.
Time Frame From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population includes ITT participants with an erythroid gene expression signature.
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description:
3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.

Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.

Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.

Overall Number of Participants Analyzed 3 14
Measure Type: Number
Unit of Measure: percentage of participants
0.0 7.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments p-value is from Fisher's exact test to compare lenalidomide treatment group to placebo group.
3.Secondary Outcome
Title Percentage of Participants Who Achieved RBC Transfusion Independence With a Duration of ≥ 24 Weeks (168 Days) as Determined by the Sponsor
Hide Description The 168-day RBC-transfusion-independent response was defined as the absence of any RBC transfusion during any consecutive “rolling” 168 days during the treatment period, for example Days 2 (Day 1 is the first study drug day) to 169, Days 3 to 170, Days 4 to 171, etcetera. A responder was defined as a participant who had a ≥ 168 consecutive days of RBC-transfusion-free period after the first dose of study drug in the treatment phase.
Time Frame From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively.
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population includes all participants who were randomized to either lenalidomide or placebo.
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description:
3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.

Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.

Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.

Overall Number of Participants Analyzed 79 160
Measure Type: Number
Unit of Measure: percentage of participants
0.0 17.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments P-value is from Fisher's exact test to compare the lenalidomide arm to the placebo arm.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0
Confidence Interval (2-Sided) 95%
0
NA for risk ratio is due to 0 responder in placebo group.
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Kaplan Meier Estimates of Duration of 56-day RBC Transfusion Independence Response as Determined by the Sponsor
Hide Description

The duration of the first 56-day RBC transfusion-independence response was calculated for those who achieved a response and was dependent on whether a subsequent RBC transfusion was given after the transfusion-free period (response):

  • For those who received a subsequent RBC transfusion after the response starts, the duration of response was not censored, and was calculated as response duration = last day of response – first day of response +1 where the last day of response was defined as 1 day before the first RBC transfusion which was given at 56 days or more after the response starts.
  • For those who did not receive a subsequent RBC transfusion after the response started, the end day of the response was censored and duration of the response was calculated as response duration = date of last RBC transfusion assessment – first day of response+ 1. A responder was a participant who had a ≥ 56 consecutive days of RBC-transfusion-free period after the first study drug treatment period
Time Frame Response was assessed up to the end of treatment; up to the data cut-off date of 17 Mar 2014.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was conducted only for those participants who achieved a 56-day transfusion independence response according to the sponsor's assessment. Responders in the intent to treat population.
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description:
3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.

Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.

Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.

Overall Number of Participants Analyzed 1 41
Median (95% Confidence Interval)
Unit of Measure: weeks
NA [1] 
(NA to NA)
30.9
(20.7 to 59.1)
[1]
Only one placebo participant achieved the response and the response end date was censored
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.639
Comments [Not Specified]
Method Log Rank
Comments p-value from log-rank test to compare lenalidomide and placebo.
5.Secondary Outcome
Title Percentage of Participants Who Achieved an Erythroid Response Based on the Modified International Working Group (IWG) 2006 Criteria
Hide Description

A participant was considered as having achieved an erythroid response if the participant either:

- had a hemoglobin (Hgb) increase ≥1.5 g/dL compared to baseline and confirmed by another central laboratory hemoglobin value at 4 to 8 weeks after the first Hgb measurement that also increased ≥1.5 g/dL. All Hgb values during this time interval must have had a ≥ 1.5 g/dL increase (ie, no central laboratory Hgb increase during this timeframe could be less <1.5 g/dL) OR - had a 50% reduction in the number of the RBC transfusion units over any consecutive 56 days period compared to the baseline transfusion burden.

The baseline transfusion burden is the number of units over 112 days by the randomization divided by 2. Only transfusions given for a pre-transfusion Hgb value of 9 g/dL or less were used in this response assessment.

Time Frame From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively.
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population includes all participants who were randomized to either lenalidomide or placebo.
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description:
3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.

Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.

Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.

Overall Number of Participants Analyzed 79 160
Measure Type: Number
Unit of Measure: percentage of participants
30.4 38.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.252
Comments p-value is from Fisher's exact test to compare the lenalidomide arm to the placebo arm.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.276
Confidence Interval (2-Sided) 95%
0.867 to 1.877
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Time to 56-Day RBC-Transfusion-Independent (TI) Response as Determined by the Sponsor
Hide Description The time to the first 56-day RBC-transfusion-independent response was calculated for participants who achieved a response. The day from the first dose of study drug to the date at which RBC-transfusion-independence starts was achieved and calculated using: Start date of the first response period – the date of the first study drug +1. A responder was defined as a participant who had a ≥ 56 consecutive days of RBC-transfusion-free period after the first dose of study drug in the treatment phase.
Time Frame From first dose of study drug until 28 days after the last dose of study drug, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was conducted only for those participants who achieved a 56-day TI response according to the sponsor's assessment. Responders in the intent to treat population.
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description:
3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.

Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.

Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.

Overall Number of Participants Analyzed 1 41
Median (Full Range)
Unit of Measure: weeks
0.3
(0.3 to 0.3)
10.1
(0.3 to 23.6)
7.Secondary Outcome
Title Kaplan Meier Estimates for Progression to Acute Myeloid Leukemia (AML)
Hide Description Progression to AML is part of the natural course of MDS and is a manifestation of disease progression. The time to progress to AML was calculated from the day of randomization to the first day when AML was diagnosed. Participants who died without AML were censored at the date of death. The participants who were lost to follow-up were censored at the last known day when participants did not have AML. Participants who did not progress to AML at the last follow-up contact were censored at the day of the last follow-up contact.
Time Frame From randomization to final data cut-off date of 03 Jul 2018; median follow up time for progression to AML was 2.3 years (range = 0 to 5.0 years) in the placebo arm and 2.6 years (range = 0 to 6.4 years) in the lenalidomide arm.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population includes all participants who were randomized and received either lenalidomide or placebo. One participant in the placebo arm was diagnosed as having AML before enrollment and was excluded from all analyses of progression to AML.
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description:
3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.

Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.

Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.

Overall Number of Participants Analyzed 78 160
Median (95% Confidence Interval)
Unit of Measure: years
NA [1] 
(NA to NA)
NA [1] 
(5.2 to NA)
[1]
Since only a few patients progressed to AML during the observed time frame, median time of progression to AML could not be estimated.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.864
Comments p-value from log-rank test to compare lenalidomide and placebo.
Method Log Rank
Comments [Not Specified]
8.Secondary Outcome
Title Kaplan Meier Estimate for Overall Survival (OS)
Hide Description Overall survival was assessed using the time between randomization and the date of death or date of censoring. Participants who were alive at a data cutoff date and participants who were lost to follow-up were censored at the last date when participants were known to be alive.
Time Frame From randomization to final data cut-off date of 03 July 2018; maximum survival follow up was 6.4 years
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population includes all participants who were randomized to either lenalidomide or placebo.
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description:
3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.

Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.

Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.

Overall Number of Participants Analyzed 79 160
Median (95% Confidence Interval)
Unit of Measure: years
3.0 [1] 
(2.3 to NA)
3.8
(2.9 to 4.8)
[1]
Placebo upper limit not estimable.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.980
Comments p-value from log-rank test to compare lenalidomide and placebo.
Method Log Rank
Comments [Not Specified]
9.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAE)
Hide Description

A TEAE was defined as an AE that begins or worsens in intensity of frequency on or after the first dose of study drug through 28 days after last dose of study drug.

A serious adverse event (SAE) is any:

  • Death;
  • Life-threatening event;
  • Any inpatient hospitalization or prolongation of existing hospitalization;
  • Persistent or significant disability or incapacity;
  • Congenital anomaly or birth defect;
  • Any other important medical event

The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event. The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 3.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death.

Time Frame From the first dose of study drug through 28 days after discontinuation from the study treatment; up to the final data cut-off date of 03 July 2018; maximum exposure was 2100 days in the lenalidomide arm and 529 days in the placebo arm.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population includes all participants who received at least 1 dose of study drug.
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description:
3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred or intolerable side effects.

Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression or intolerable side effects.

Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance between 40 and 60 mL/min.

.

Overall Number of Participants Analyzed 79 160
Measure Type: Count of Participants
Unit of Measure: Participants
At least 1 TEAE
74
  93.7%
160
 100.0%
≥ 1 Treatment Related AE (TEAE)
42
  53.2%
144
  90.0%
≥ 1 Treatment related TEAE Causing Discontinuation
3
   3.8%
40
  25.0%
≥ 1 TEAE Leading to Dose Reduction
1
   1.3%
10
   6.3%
≥ 1 TEAE Leading to Dose Interruption
11
  13.9%
89
  55.6%
≥ 1 TEAE Leading to Dose Interruption & Reduction
5
   6.3%
68
  42.5%
≥ 1 TEAE Leading to Discontinuation of Study Drug
9
  11.4%
51
  31.9%
≥ 1 Serious TEAE
16
  20.3%
62
  38.8%
≥1 Treatment-Related Serious TEAE
3
   3.8%
25
  15.6%
≥1 Serious TEAE Leading to Dose Reduction
0
   0.0%
1
   0.6%
≥1 serious TEAE leading to dose interruption
4
   5.1%
21
  13.1%
≥1 SAE Causing Dose Interruption & reduction
1
   1.3%
3
   1.9%
≥1 Serious TEAE Leading to Stopping of Study Drug
4
   5.1%
24
  15.0%
≥1 Grade (GR) 3-4 TEAE
35
  44.3%
139
  86.9%
≥ 1 GR 3-4 Related TEAE
16
  20.3%
127
  79.4%
≥ 1 GR 3-4 Leading to Dose Reduction
1
   1.3%
8
   5.0%
≥ 1 GR 3-4 TEAE Leading to Dose Interruption
9
  11.4%
80
  50.0%
≥ 1 GR 3-4 TEAE dose Interruption &reduction
4
   5.1%
64
  40.0%
≥ 1 GR 3-4 TEAE Leading to Stopping of Study Med
6
   7.6%
41
  25.6%
≥ 1 GR 5 TEAE
2
   2.5%
6
   3.8%
≥1 GR Treatment Related 5 TEAE
1
   1.3%
3
   1.9%
10.Secondary Outcome
Title Compliance Rates Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) From Baseline to Week 48
Hide Description The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. A participant was considered compliant at a visit if at least 15 out of the QLQ-C30 items in the questionnaire were checked.
Time Frame Baseline, Week 12, (±3 days), Week 24, (±3 days), Week 36, (±3 days), and Week 48 (±3 days); up to data cut-off of 17 Mar 2014
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed based on the Health Related Quality of Life (HRQoL) evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Data is available up to Week 48 due to small sample after that.
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description:
3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.

Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.

Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.

Overall Number of Participants Analyzed 79 160
Measure Type: Number
Unit of Measure: percentage of participants
Baseline 88.6 90
Week 12 78.5 83.8
Week 24 80.6 85.8
Week 36 100 80.5
Week 48 50 71.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.823
Comments [Not Specified]
Method Fisher Exact
Comments The p-values are calculated based on the Fisher exact test
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 12 (±3 days)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.371
Comments [Not Specified]
Method Fisher Exact
Comments The p-values are calculated based on the Fisher exact test
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 24 (±3 days)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.391
Comments [Not Specified]
Method Fisher Exact
Comments The p-values are calculated based on the Fisher exact test
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 36 (±3 days)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments The p-values are calculated based on the Fisher exact test
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 48 (±3 days)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.508
Comments [Not Specified]
Method Fisher Exact
Comments The p-values are calculated based on the Fisher exact test
11.Secondary Outcome
Title Mean Change From Baseline in the EORTC QLQ-C30 Fatigue Domain at Week 12 and 24
Hide Description The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).
Time Frame Baseline and Week 12, ±3 days and Week 24, ±3 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included.
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description:
3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.

.Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.

Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.

Overall Number of Participants Analyzed 58 131
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 12 Number Analyzed 56 participants 122 participants
0.6  (17.53) 2.4  (28.26)
Week 24 Number Analyzed 47 participants 83 participants
7.6  (20.74) -1.5  (26.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.323
Comments [Not Specified]
Method ANOVA
Comments P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.071
Comments P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.
Method ANOVA
Comments [Not Specified]
12.Secondary Outcome
Title Mean Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain at Week 12 and 24
Hide Description The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).
Time Frame Baseline and Week 12, ±3 days and Week 24, ±3 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed based on the Health Related Quality of Life (HRQoL) evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included.
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description:
3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred or intolerable side effects or withdrawal of consent.

.Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.

Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.

Overall Number of Participants Analyzed 58 131
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 12 Number Analyzed 56 participants 122 participants
0.6  (28.06) 2.2  (29.92)
Week 24 Number Analyzed 47 participants 83 participants
4.3  (26.57) 1.2  (26.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.760
Comments P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.251
Comments P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.
Method ANOVA
Comments [Not Specified]
13.Secondary Outcome
Title Mean Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain at Week 12 and 24
Hide Description The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Physical Functioning Scale was scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Time Frame Baseline and Week 12, ±3 days and Week 24, ±3 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed based on the Health Related Quality of Life (HRQoL) evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included.
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description:
3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.

Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.

Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.

Overall Number of Participants Analyzed 58 131
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 12 Number Analyzed 56 participants 122 participants
-1.4  (15.76) -2.1  (18.09)
Week 24 Number Analyzed 47 participants 83 participants
-5.7  (14.84) -0.4  (18.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.424
Comments P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.116
Comments P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.
Method ANOVA
Comments [Not Specified]
14.Secondary Outcome
Title Mean Change From Baseline in the EORTC QLQ-C30 Global Health Status/Quality of Life (QOL) Domain at Week 12 and 24
Hide Description The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale was scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.
Time Frame Baseline and Week 12, ±3 days and Week 24, ±3 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included.
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description:
3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.

Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.

Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.

Overall Number of Participants Analyzed 58 131
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 12 Number Analyzed 56 participants 122 participants
-2.1  (20.18) -1.4  (24.35)
Week 24 Number Analyzed 47 participants 83 participants
-4.1  (20.25) -2.4  (27.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.746
Comments P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.460
Comments P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.
Method ANOVA
Comments [Not Specified]
15.Secondary Outcome
Title Mean Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain at Week 12 and 24
Hide Description The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Functioning Domain was scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Time Frame Baseline and Week 12, ±3 days and Week 24, ±3 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included.
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description:
3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.

Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.

Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.

.

Overall Number of Participants Analyzed 58 131
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 12 Number Analyzed 56 participants 122 participants
1.2  (18.70) -1.4  (22.39)
Week 24 Number Analyzed 47 participants 83 participants
-7.1  (20.78) 0.8  (20.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.265
Comments P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments 3]: P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.
Method ANOVA
Comments [Not Specified]
16.Secondary Outcome
Title Mean Change From Baseline in Fatigue Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24
Hide Description The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).
Time Frame Baseline, Week 12, ±3 days and Week 24, ±3 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included.
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description:
3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.

Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.

Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.

Overall Number of Participants Analyzed 58 131
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 12 Number Analyzed 56 participants 122 participants
-0.464
(-6.562 to 5.635)
3.497
(-0.631 to 7.624)
Week 24 Number Analyzed 47 participants 83 participants
7.376
(0.990 to 13.762)
0.196
(-4.505 to 4.897)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2909
Comments P-value is based on a two-sample t-test comparing the difference between treatments.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0759
Comments P-value is based on a two-sample t-test comparing the difference between treatments.
Method t-test, 2 sided
Comments [Not Specified]
17.Secondary Outcome
Title Mean Change From Baseline in the Dyspnea Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24
Hide Description The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).
Time Frame Baseline, Week 12, ±3 days and Week 24, ±3 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included.
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description:
3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.

Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.

Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.

.

Overall Number of Participants Analyzed 58 131
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 12 Number Analyzed 56 participants 122 participants
1.696
(-5.313 to 8.706)
3.374
(-1.369 to 8.117)
Week 24 Number Analyzed 47 participants 83 participants
5.998
(-1.174 to 13.171)
-0.206
(-5.557 to 5.146)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6957
Comments P-value is based on a two-sample t-test comparing the difference between treatments
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1729
Comments P-value is based on a two-sample t-test comparing the difference between treatments
Method t-test, 2 sided
Comments [Not Specified]
18.Secondary Outcome
Title Mean Change From Baseline in the Physical Functioning Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24
Hide Description The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). The EORTC QLQ-C30 Physical Functioning was scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.
Time Frame Baseline, Week 12, ±3 days and Week 24, ±3 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included.
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description:
3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.

Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.

Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.

.

Overall Number of Participants Analyzed 58 131
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 12 Number Analyzed 56 participants 122 participants
0.732
(-4.939 to 3.475)
-2.919
(-5.768 to -0.071)
Week 24 Number Analyzed 47 participants 83 participants
-5.451
(-10.046 to -0.85)
-1.484
(-4.861 to 1.892)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3975
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value is based on a two-sample t-test comparing the difference between treatments.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1714
Comments P-value is based on a two-sample t-test comparing the difference between treatments.
Method t-test, 2 sided
Comments [Not Specified]
19.Secondary Outcome
Title Mean Change From Baseline in the Global Health Status/QoL Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24
Hide Description The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). The EORTC QLQ-C30 Global Health Status/QOL scale was scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.
Time Frame Baseline, Week 12, ±3 days and Week 24, ±3 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included.
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description:
3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.

Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.

Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.

.

Overall Number of Participants Analyzed 58 131
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 12 Number Analyzed 56 participants 122 participants
-1.201
(-6.401 to 3.999)
-2.690
(-6.211 to 0.831)
Week 24 Number Analyzed 47 participants 83 participants
-4.502
(-10.330 to 1.326)
-2.441
(-6.761 to 1.880)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6408
Comments P-value is based on a two-sample t-test comparing the difference between treatments.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5750
Comments P-value is based on a two-sample t-test comparing the difference between treatments.
Method t-test, 2 sided
Comments [Not Specified]
20.Secondary Outcome
Title Mean Change From Baseline in the Emotional Functioning Domain Associated With the EORTC QLQ-C30 Scale at Weeks 12 and 24
Hide Description The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Functioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Time Frame Baseline, Week 12, ±3 days and Week 24, ±3 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included.
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description:
3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.

Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.

Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.

.

Overall Number of Participants Analyzed 58 131
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 12 Number Analyzed 56 participants 122 participants
1.458
(-3.621 to 6.536)
-1.876
(-5.307 to 1.556)
Week 24 Number Analyzed 47 participants 83 participants
-6.746
(-12.228 to -1.26)
-1.129
(-5.174 to 2.917)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2848
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value is based on a two-sample t-test comparing the difference between treatments
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1053
Comments P-value is based on a two-sample t-test comparing the difference between treatments
Method t-test, 1 sided
Comments [Not Specified]
21.Secondary Outcome
Title Percentage of Participants With a Clinically Meaningful Improvement in QOL (EORTC QLQ-C-30 Scale) From Baseline in Fatigue Domain at Weeks 12 and 24
Hide Description The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. Improvement means at least 10 points better compared to baseline
Time Frame Baseline, Week 12, ±3 days and Week 24, ±3 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed based on the Health Related Quality of Life (HRQoL) evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included.
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description:
3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.

Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.

Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.

Overall Number of Participants Analyzed 58 131
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 Number Analyzed 56 participants 122 participants
30.4 39.3
Week 24 Number Analyzed 47 participants 83 participants
29.8 38.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.042
Comments The P-values are calculated based on Fisher exact test.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.448
Comments The P-values are calculated based on Fisher exact test.
Method Fisher Exact
Comments [Not Specified]
22.Secondary Outcome
Title Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline in the Dyspnea Domain at Weeks 12 and 24
Hide Description The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom). Improvement means at least 10 points better compared to baseline.
Time Frame Baseline, Week 12, ±3 days and Week 24, ±3 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included.
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description:
3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.

Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.

Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.

.

Overall Number of Participants Analyzed 58 131
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 Number Analyzed 56 participants 122 participants
19.6 21.3
Week 24 Number Analyzed 47 participants 83 participants
12.8 20.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.825
Comments The P-values are calculated based on Fisher exact test.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.568
Comments The P-values are calculated based on Fisher exact test.
Method Fisher Exact
Comments [Not Specified]
23.Secondary Outcome
Title Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline Within the Physical Functioning Domain at Weeks 12 and 24
Hide Description The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. A change of at least 10 points on the standardized domain scores was required for it to be considered clinically meaningful.
Time Frame Baseline, Week 12, ±3 days and Week 24, ±3 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment with the EORTC QLQ-C-30. Only those with available data at baseline and each time point are included.
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description:
3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.

Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.

Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.

.

Overall Number of Participants Analyzed 58 131
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 Number Analyzed 56 participants 122 participants
26.8 16.4
Week 24 Number Analyzed 47 participants 83 participants
12.8 24.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.119
Comments The P-values are calculated based on Fisher exact test.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.172
Comments The P-values are calculated based on Fisher exact test.
Method Fisher Exact
Comments [Not Specified]
24.Secondary Outcome
Title Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline in the Global Health Status/QOL Domain at Weeks 12 and 24
Hide Description The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. A change of at least 10 points on the standardized domain scores was required for it to be considered clinically meaningful.
Time Frame Baseline, Week 12, ±3 days and Week 24, ±3 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment with the EORTC QLQ-C-30. Only those with available data at baseline and each time point are included.
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description:
3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.

Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.

Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.

.

Overall Number of Participants Analyzed 58 131
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 Number Analyzed 56 participants 122 participants
19.6 22.1
Week 24 Number Analyzed 47 participants 83 participants
14.9 26.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.792
Comments The P-values were calculated based on Fisher exact test.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.279
Comments The P-values are calculated based on Fisher exact test.
Method Fisher Exact
Comments [Not Specified]
25.Secondary Outcome
Title Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline in the Emotional Functioning Domain at Weeks 12 and 24
Hide Description The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Functioning Domain was scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Time Frame Baseline, Week 12, ±3 days and Week 24, ±3 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included.
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description:
3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.

Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.

Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.

.

Overall Number of Participants Analyzed 58 131
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 Number Analyzed 56 participants 122 participants
25.0 20.5
Week 24 Number Analyzed 47 participants 83 participants
17.0 21.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.476
Comments The P-values are calculated based on Fisher exact test.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments The P-values are calculated based on Fisher exact test.
Method Fisher Exact
Comments [Not Specified]
26.Secondary Outcome
Title Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Related to Adverse Events Per Person Year
Hide Description Hospitalizations due to adverse events exclude those for transfusions, elective procedures or protocol-driven procedures. HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient.
Time Frame From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population includes all participants who received at least 1 dose of study drug.
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description:
3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.

Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.

Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.

Overall Number of Participants Analyzed 79 160
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Hospitalizations per person-years
0.47
(0.3 to 0.75)
0.77
(0.62 to 0.96)
27.Secondary Outcome
Title Healthcare Resource Utilization (HRU): Duration of Hospitalizations Due to Adverse Events
Hide Description Hospitalizations due to adverse events exclude those for transfusions, elective procedures or protocol-driven procedures. HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient.
Time Frame From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with at least one hospitalization.
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description:
3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.

Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.

Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.

Overall Number of Participants Analyzed 14 57
Median (Full Range)
Unit of Measure: Days
9.0
(1.0 to 66.0)
11.0
(1.0 to 76.0)
28.Secondary Outcome
Title Healthcare Resource Utilization (HRU): Number of Days of Hospitalization Due to Adverse Events Per Person-Years
Hide Description Hospitalizations due to adverse events exclude those for transfusions, elective procedures or protocol-driven procedures. HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient
Time Frame From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population includes all participants who received at least 1 dose of study drug.
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description:
3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.

Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.

Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.

Overall Number of Participants Analyzed 79 160
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Days per person-years
6.37
(4.64 to 8.74)
8.92
(7.35 to 10.82)
29.Post-Hoc Outcome
Title Percentage of Participants Who Achieved an Erythroid Response Based on Original IWG 2006 Criteria
Hide Description

A participant was considered as having achieved an erythroid response when:

- a Hgb increase ≥1.5 g/dL compared to baseline and confirmed by another central laboratory hemoglobin value at 4 to 8 weeks after the first Hgb measurement that had also increased ≥1.5 g/dL for at least 8 weeks. All Hgb values during this time interval must have had a ≥ 1.5 g/dL increase (ie, no central laboratory Hgb increase during this timeframe can be less than a 1.5 g/dL) OR - had an absolute reduction of 4 RBC transfusion units over any consecutive 56 days period compared to the baseline transfusion burden.

The baseline transfusion burden is the number of units over the 112 days prior to randomization divided by 2. Only transfusions given for a pre-transfusion Hgb value of 9.5 g/dL or less may be used in this response assessment.

Time Frame From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population includes all participants who were randomized.
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description:
3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.

Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.

Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.

Overall Number of Participants Analyzed 79 160
Measure Type: Number
Unit of Measure: percentage of participants
20.3 35.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments p-value is from Fisher's exact test to compare lenalidomide treatment group to placebo group.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.759
Confidence Interval (2-Sided) 95%
1.083 to 2.856
Estimation Comments [Not Specified]
Time Frame From the first dose of study drug through 28 days after last dose; up to the final data cut-off date of 03 July 2018; maximum exposure was 2100 days in the lenalidomide treatment group and 529 days in the placebo group
Adverse Event Reporting Description Second primary malignancies were monitored as events of interest and reported as serious adverse events for at least 5 years from randomization unless the participants withdrew consent from the study, died or were lost to follow-up.
 
Arm/Group Title Placebo Lenalidomide
Hide Arm/Group Description Participants received 3 placebo capsules by mouth QD for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent Participants received lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression or intolerable side effects. Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance between 40 and 60 mL/min.
All-Cause Mortality
Placebo Lenalidomide
Affected / at Risk (%) Affected / at Risk (%)
Total   43/79 (54.43%)   94/160 (58.75%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Lenalidomide
Affected / at Risk (%) Affected / at Risk (%)
Total   16/79 (20.25%)   62/160 (38.75%) 
Blood and lymphatic system disorders     
ANAEMIA  1  1/79 (1.27%)  5/160 (3.13%) 
HAEMOLYSIS  1  0/79 (0.00%)  1/160 (0.63%) 
NEUTROPENIA  1  0/79 (0.00%)  3/160 (1.88%) 
PANCYTOPENIA  1  0/79 (0.00%)  1/160 (0.63%) 
THROMBOCYTOPENIA  1  0/79 (0.00%)  1/160 (0.63%) 
Cardiac disorders     
ACUTE MYOCARDIAL INFARCTION  1  1/79 (1.27%)  0/160 (0.00%) 
ATRIAL FIBRILLATION  1  2/79 (2.53%)  1/160 (0.63%) 
ATRIAL FLUTTER  1  1/79 (1.27%)  0/160 (0.00%) 
CARDIAC FAILURE  1  2/79 (2.53%)  3/160 (1.88%) 
CARDIAC FAILURE CONGESTIVE  1  0/79 (0.00%)  1/160 (0.63%) 
MYOCARDIAL INFARCTION  1  1/79 (1.27%)  2/160 (1.25%) 
TACHYARRHYTHMIA  1  0/79 (0.00%)  1/160 (0.63%) 
Eye disorders     
CATARACT  1  0/79 (0.00%)  1/160 (0.63%) 
ULCERATIVE KERATITIS  1  1/79 (1.27%)  0/160 (0.00%) 
Gastrointestinal disorders     
ABDOMINAL PAIN  1  1/79 (1.27%)  0/160 (0.00%) 
ASCITES  1  0/79 (0.00%)  1/160 (0.63%) 
CONSTIPATION  1  1/79 (1.27%)  0/160 (0.00%) 
GASTRITIS  1  0/79 (0.00%)  1/160 (0.63%) 
GASTROINTESTINAL HAEMORRHAGE  1  0/79 (0.00%)  1/160 (0.63%) 
GASTROINTESTINAL NECROSIS  1  0/79 (0.00%)  1/160 (0.63%) 
HAEMATEMESIS  1  0/79 (0.00%)  1/160 (0.63%) 
INGUINAL HERNIA, OBSTRUCTIVE  1  0/79 (0.00%)  1/160 (0.63%) 
PANCREATITIS  1  1/79 (1.27%)  0/160 (0.00%) 
PANCREATITIS NECROTISING  1  1/79 (1.27%)  0/160 (0.00%) 
UPPER GASTROINTESTINAL HAEMORRHAGE  1  0/79 (0.00%)  1/160 (0.63%) 
General disorders     
DISUSE SYNDROME  1  0/79 (0.00%)  1/160 (0.63%) 
GENERAL PHYSICAL HEALTH DETERIORATION  1  0/79 (0.00%)  2/160 (1.25%) 
MALAISE  1  0/79 (0.00%)  1/160 (0.63%) 
MULTI-ORGAN FAILURE  1  0/79 (0.00%)  1/160 (0.63%) 
PYREXIA  1  0/79 (0.00%)  1/160 (0.63%) 
SUDDEN DEATH  1  0/79 (0.00%)  1/160 (0.63%) 
Hepatobiliary disorders     
HEPATIC CIRRHOSIS  1  1/79 (1.27%)  1/160 (0.63%) 
HEPATIC FAILURE  1  0/79 (0.00%)  1/160 (0.63%) 
Infections and infestations     
ATYPICAL PNEUMONIA  1  0/79 (0.00%)  1/160 (0.63%) 
BRONCHITIS  1  2/79 (2.53%)  0/160 (0.00%) 
BRONCHOPNEUMONIA  1  0/79 (0.00%)  1/160 (0.63%) 
BRONCHOPULMONARY ASPERGILLOSIS  1  0/79 (0.00%)  1/160 (0.63%) 
CELLULITIS  1  0/79 (0.00%)  2/160 (1.25%) 
ESCHERICHIA SEPSIS  1  0/79 (0.00%)  1/160 (0.63%) 
INFLUENZA  1  1/79 (1.27%)  0/160 (0.00%) 
LOBAR PNEUMONIA  1  0/79 (0.00%)  1/160 (0.63%) 
LOWER RESPIRATORY TRACT INFECTION  1  0/79 (0.00%)  1/160 (0.63%) 
NEUTROPENIC SEPSIS  1  0/79 (0.00%)  3/160 (1.88%) 
PNEUMONIA  1  2/79 (2.53%)  10/160 (6.25%) 
PNEUMONIA VIRAL  1  0/79 (0.00%)  1/160 (0.63%) 
PSEUDOMONAL SEPSIS  1  0/79 (0.00%)  1/160 (0.63%) 
STAPHYLOCOCCAL INFECTION  1  0/79 (0.00%)  1/160 (0.63%) 
TOOTH ABSCESS  1  0/79 (0.00%)  1/160 (0.63%) 
URINARY TRACT INFECTION  1  0/79 (0.00%)  2/160 (1.25%) 
Injury, poisoning and procedural complications     
FEMORAL NECK FRACTURE  1  0/79 (0.00%)  1/160 (0.63%) 
FEMUR FRACTURE  1  0/79 (0.00%)  2/160 (1.25%) 
HIP FRACTURE  1  0/79 (0.00%)  1/160 (0.63%) 
HUMERUS FRACTURE  1  0/79 (0.00%)  1/160 (0.63%) 
SPINAL FRACTURE  1  0/79 (0.00%)  1/160 (0.63%) 
THORACIC VERTEBRAL FRACTURE  1  0/79 (0.00%)  1/160 (0.63%) 
TRAUMATIC INTRACRANIAL HAEMORRHAGE  1  0/79 (0.00%)  2/160 (1.25%) 
Metabolism and nutrition disorders     
DECREASED APPETITE  1  0/79 (0.00%)  1/160 (0.63%) 
HYPOKALAEMIA  1  0/79 (0.00%)  1/160 (0.63%) 
Musculoskeletal and connective tissue disorders     
INTERVERTEBRAL DISC PROTRUSION  1  0/79 (0.00%)  1/160 (0.63%) 
MYALGIA  1  0/79 (0.00%)  1/160 (0.63%) 
OSTEOARTHRITIS  1  0/79 (0.00%)  1/160 (0.63%) 
RHABDOMYOLYSIS  1  1/79 (1.27%)  0/160 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
ACUTE MYELOID LEUKAEMIA  1  2/79 (2.53%)  0/160 (0.00%) 
ADENOCARCINOMA OF COLON  1  0/79 (0.00%)  1/160 (0.63%) 
CHRONIC MYELOMONOCYTIC LEUKAEMIA  1  1/79 (1.27%)  0/160 (0.00%) 
INVASIVE DUCTAL BREAST CARCINOMA  1  0/79 (0.00%)  1/160 (0.63%) 
LUNG SQUAMOUS CELL CARCINOMA STAGE IV  1  0/79 (0.00%)  1/160 (0.63%) 
MYELODYSPLASTIC SYNDROME  1  0/79 (0.00%)  2/160 (1.25%) 
PROSTATE CANCER  1  1/79 (1.27%)  0/160 (0.00%) 
SQUAMOUS CELL CARCINOMA OF LUNG  1  1/79 (1.27%)  0/160 (0.00%) 
SQUAMOUS CELL CARCINOMA OF THE TONGUE  1  0/79 (0.00%)  1/160 (0.63%) 
Nervous system disorders     
CEREBROVASCULAR ACCIDENT  1  0/79 (0.00%)  1/160 (0.63%) 
DIZZINESS  1  0/79 (0.00%)  1/160 (0.63%) 
DYSKINESIA  1  0/79 (0.00%)  1/160 (0.63%) 
TRANSIENT ISCHAEMIC ATTACK  1  0/79 (0.00%)  2/160 (1.25%) 
Psychiatric disorders     
MENTAL STATUS CHANGES  1  0/79 (0.00%)  2/160 (1.25%) 
Renal and urinary disorders     
NEPHROLITHIASIS  1  0/79 (0.00%)  1/160 (0.63%) 
RENAL COLIC  1  0/79 (0.00%)  1/160 (0.63%) 
RENAL FAILURE ACUTE  1  0/79 (0.00%)  1/160 (0.63%) 
Respiratory, thoracic and mediastinal disorders     
ACUTE RESPIRATORY DISTRESS SYNDROME  1  0/79 (0.00%)  1/160 (0.63%) 
ACUTE RESPIRATORY FAILURE  1  0/79 (0.00%)  1/160 (0.63%) 
ASTHMA  1  0/79 (0.00%)  1/160 (0.63%) 
DYSPNOEA  1  0/79 (0.00%)  1/160 (0.63%) 
LUNG DISORDER  1  0/79 (0.00%)  1/160 (0.63%) 
PLEURAL EFFUSION  1  0/79 (0.00%)  3/160 (1.88%) 
PNEUMONITIS  1  0/79 (0.00%)  1/160 (0.63%) 
PULMONARY OEDEMA  1  1/79 (1.27%)  0/160 (0.00%) 
Skin and subcutaneous tissue disorders     
NEURODERMATITIS  1  0/79 (0.00%)  1/160 (0.63%) 
SKIN ULCER  1  0/79 (0.00%)  2/160 (1.25%) 
Vascular disorders     
CIRCULATORY COLLAPSE  1  0/79 (0.00%)  1/160 (0.63%) 
DEEP VEIN THROMBOSIS  1  0/79 (0.00%)  3/160 (1.88%) 
1
Term from vocabulary, MedDRA 16.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Lenalidomide
Affected / at Risk (%) Affected / at Risk (%)
Total   70/79 (88.61%)   154/160 (96.25%) 
Blood and lymphatic system disorders     
ANAEMIA  1  4/79 (5.06%)  8/160 (5.00%) 
LEUKOPENIA  1  2/79 (2.53%)  22/160 (13.75%) 
NEUTROPENIA  1  9/79 (11.39%)  102/160 (63.75%) 
THROMBOCYTOPENIA  1  6/79 (7.59%)  66/160 (41.25%) 
Eye disorders     
CONJUNCTIVITIS  1  0/79 (0.00%)  8/160 (5.00%) 
Gastrointestinal disorders     
ABDOMINAL PAIN  1  5/79 (6.33%)  10/160 (6.25%) 
ABDOMINAL PAIN UPPER  1  5/79 (6.33%)  12/160 (7.50%) 
CONSTIPATION  1  9/79 (11.39%)  36/160 (22.50%) 
DIARRHOEA  1  18/79 (22.78%)  69/160 (43.13%) 
DYSPEPSIA  1  2/79 (2.53%)  8/160 (5.00%) 
NAUSEA  1  12/79 (15.19%)  19/160 (11.88%) 
VOMITING  1  5/79 (6.33%)  13/160 (8.13%) 
General disorders     
ASTHENIA  1  13/79 (16.46%)  38/160 (23.75%) 
FATIGUE  1  9/79 (11.39%)  36/160 (22.50%) 
OEDEMA PERIPHERAL  1  14/79 (17.72%)  35/160 (21.88%) 
PYREXIA  1  6/79 (7.59%)  20/160 (12.50%) 
Infections and infestations     
INFLUENZA  1  2/79 (2.53%)  10/160 (6.25%) 
NASOPHARYNGITIS  1  9/79 (11.39%)  19/160 (11.88%) 
PNEUMONIA  1  4/79 (5.06%)  4/160 (2.50%) 
UPPER RESPIRATORY TRACT INFECTION  1  5/79 (6.33%)  4/160 (2.50%) 
URINARY TRACT INFECTION  1  6/79 (7.59%)  9/160 (5.63%) 
Injury, poisoning and procedural complications     
OVERDOSE  1  0/79 (0.00%)  15/160 (9.38%) 
Investigations     
ALANINE AMINOTRANSFERASE INCREASED  1  2/79 (2.53%)  13/160 (8.13%) 
SERUM FERRITIN INCREASED  1  4/79 (5.06%)  1/160 (0.63%) 
WEIGHT DECREASED  1  2/79 (2.53%)  17/160 (10.63%) 
Metabolism and nutrition disorders     
DECREASED APPETITE  1  3/79 (3.80%)  19/160 (11.88%) 
HYPOKALAEMIA  1  0/79 (0.00%)  10/160 (6.25%) 
IRON OVERLOAD  1  4/79 (5.06%)  4/160 (2.50%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  5/79 (6.33%)  14/160 (8.75%) 
BACK PAIN  1  9/79 (11.39%)  16/160 (10.00%) 
MUSCLE SPASMS  1  2/79 (2.53%)  19/160 (11.88%) 
MYALGIA  1  1/79 (1.27%)  8/160 (5.00%) 
PAIN IN EXTREMITY  1  3/79 (3.80%)  18/160 (11.25%) 
Nervous system disorders     
DIZZINESS  1  9/79 (11.39%)  13/160 (8.13%) 
HEADACHE  1  8/79 (10.13%)  9/160 (5.63%) 
Psychiatric disorders     
INSOMNIA  1  7/79 (8.86%)  9/160 (5.63%) 
Respiratory, thoracic and mediastinal disorders     
COUGH  1  6/79 (7.59%)  17/160 (10.63%) 
DYSPNOEA  1  9/79 (11.39%)  15/160 (9.38%) 
EPISTAXIS  1  2/79 (2.53%)  10/160 (6.25%) 
Skin and subcutaneous tissue disorders     
DRY SKIN  1  2/79 (2.53%)  12/160 (7.50%) 
NIGHT SWEATS  1  3/79 (3.80%)  8/160 (5.00%) 
PRURITUS  1  9/79 (11.39%)  30/160 (18.75%) 
RASH  1  4/79 (5.06%)  35/160 (21.88%) 
1
Term from vocabulary, MedDRA 16.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results from a center cannot be submitted for publication before results of multicenter study are published unless it is more than 12 months since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 days. Investigator must delete confidential information before submission or defer publication to permit patent applications.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anne McClain, Senior Study Manager
Organization: Celgene Corporation
Phone: 888-260-1588
EMail: clinicaltrialdisclosure@celgene.com
Layout table for additonal information
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01029262     History of Changes
Other Study ID Numbers: CC-5013-MDS-005
First Submitted: December 8, 2009
First Posted: December 9, 2009
Results First Submitted: May 8, 2015
Results First Posted: June 18, 2015
Last Update Posted: June 25, 2019