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Trial record 40 of 53 for:    LENALIDOMIDE AND Leukemia AND Acute Myeloid Leukemia (AML)

Lenalidomide Versus Placebo in Myelodysplastic Syndromes With a Deletion 5q[31] Abnormality

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00179621
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : March 17, 2011
Last Update Posted : April 14, 2011
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by:
Celgene

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Myelodysplastic Syndromes
Interventions Drug: Lenalidomide 5 mg
Drug: Lenalidomide 10 mg
Drug: Placebo
Enrollment 205
Recruitment Details  
Pre-assignment Details A total of 263 potential participants were screened. Potentially protocol-eligible participants were then entered into the Pre-Randomization Phase (up to 56 days) to ensure eligibility criteria were met prior to entering the Double-Blind Phase. A total of 205 participants were randomized into the study.
Arm/Group Title Placebo Lenalidomide 5 mg Lenalidomide 10 mg Placebo Crossover to 5 mg Open-label Period
Hide Arm/Group Description Placebo matching to active study arms. Lenalidomide 5 mg daily for 28 days Lenalidomide 10 mg daily for 21 of 28 days Participants receiving placebo in the Double-Blind phase and Lenalidomide in the Open-Label phase.
Period Title: Double-Blind Period
Started 67 69 69 0
Completed 3 23 39 0
Not Completed 64 46 30 0
Reason Not Completed
Lack of Therapeutic Effect             59             35             19             0
Adverse Event             2             7             4             0
Withdrawal by Subject             2             1             3             0
Death             0             1             2             0
Protocol Violation             1             0             0             0
Other             0             2             2             0
Period Title: Open-Label Period
Started 0 42 [1] 47 [2] 56 [3]
Completed 0 14 19 13
Not Completed 0 28 28 43
Reason Not Completed
Lack of Therapeutic Effect             0             19             19             31
Adverse Event             0             6             5             6
Withdrawal by Subject             0             2             2             2
Death             0             0             1             2
Other             0             1             1             2
[1]
'Started' includes 23 participants who completed double-blind and 19 who discontinued double-blind.
[2]
'Started' includes 39 participants who completed double-blind and 8 who discontinued double-blind.
[3]
'Started' includes 1 participant who completed double-blind and 55 who discontinued double-blind.
Arm/Group Title Placebo Lenalidomide 5 mg Lenalidomide 10 mg Total
Hide Arm/Group Description Placebo matching to active study arms. Lenalidomide 5 mg daily for 28 days Lenalidomide 10 mg daily for 21 of 28 days Total of all reporting groups
Overall Number of Baseline Participants 67 69 69 205
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 67 participants 69 participants 69 participants 205 participants
69.9
(39.0 to 85.0)
66.0
(40.0 to 86.0)
68.0
(36.0 to 84.0)
68.0
(36.0 to 86.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 69 participants 69 participants 205 participants
Female
54
  80.6%
53
  76.8%
49
  71.0%
156
  76.1%
Male
13
  19.4%
16
  23.2%
20
  29.0%
49
  23.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 67 participants 69 participants 69 participants 205 participants
White 66 67 69 202
Other 1 2 0 3
5q- (31-33) Chromosomal Abnormality  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 67 participants 69 participants 69 participants 205 participants
Yes 63 64 64 191
No 1 2 1 4
Missing 3 3 4 10
International Prognostic Scoring System (IPSS)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 67 participants 69 participants 69 participants 205 participants
Low risk (0) 30 20 20 70
Intermediate-1 (0.5 - 1.0) 22 29 23 74
Intermediate-2 (1.5 - 2.0) 2 5 3 10
High Risk (≥ 2.5) 0 0 1 1
Missing data 13 15 22 50
[1]
Measure Description: The international prognostic scoring system (IPSS) is a standard for risk assessment in primary myelodysplastic syndromes (MDS) that categorizes prognoses taking into account cytogenetics, cytopenias, blasts and blood counts. The IPSS prognostic subgroups consist of low-, intermediate-1-, intermediate-2-, and high-risk groups. The scale is 0-3.5 at 0.5 increments. Scores of 0=Low; 0.5-1.0=Int-1; 1.5-2.0=Int-2; 2.5-3.5=High risk which corresponds to poorer prognosis. The assessment was performed by the Central Reviewer.
French-American-British (FAB) Classification   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 67 participants 69 participants 69 participants 205 participants
Refractory anemia (RA) 37 38 32 107
Refractory anemia with ringed sideroblasts (RARS) 8 7 9 24
Refractory anemia with excess blasts (RAEB) 4 9 9 22
Chronic myelomonocytic leukemia (CMML) 1 2 0 3
RAEB in transformation 1 0 0 1
Chronic myelogenous leukemia (CML) 0 0 1 1
Specimen not adequate from diagnosis 12 11 17 40
Other or missing 4 2 1 7
[1]
Measure Description: FAB is a classification system for five (5) subtypes of myelodysplastic syndrome that are distinguished by the percentage of myeloblasts, presence or absence of ringed sideroblasts or a monocytosis. Classification was made by the Central Reviewer.
1.Primary Outcome
Title Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence for >= 26 Weeks (182 Days)
Hide Description The count of study participants who had no RBC transfusions for 26 consecutive weeks or more during the double-blind period.
Time Frame Up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population included all participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q[31] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug.
Arm/Group Title Placebo Lenalidomide 5 mg Lenalidomide 10 mg
Hide Arm/Group Description:
Placebo matching to active study arms.
Lenalidomide 5 mg daily for 28 days
Lenalidomide 10 mg daily for 21 of 28 days
Overall Number of Participants Analyzed 51 47 41
Measure Type: Number
Unit of Measure: Participants
3 20 23
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide 5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments To compare the response rates of Lenalidomide 5 mg QD vs. placebo, the Hochberg procedure was used to control the familywise error rate of 0.05.
Method Cochran-Mantel-Haenszel
Comments Stratified by International Prognostic Scoring System (IPSS) score (IPSS combined score =0 versus >0) to compare lenalidomide treatment with placebo.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments To compare the response rates of Lenalidomide 10 mg QD vs. placebo, the Hochberg procedure was used to control the familywise error rate of 0.05.
Method Cochran-Mantel-Haenszel
Comments Stratified by International Prognostic Scoring System (IPSS) score (IPSS combined score =0 versus >0) to compare lenalidomide treatment with placebo.
2.Secondary Outcome
Title Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence for 56 Days
Hide Description Count of study participants who had no RBC transfusions during any 56 or more consecutive study days during the double-blind period.
Time Frame Up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population included all participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q[31] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug.
Arm/Group Title Placebo Lenalidomide 5 mg Lenalidomide 10 mg
Hide Arm/Group Description:
Placebo matching to active study arms.
Lenalidomide 5 mg daily for 28 days
Lenalidomide 10 mg daily for 21 of 28 days
Overall Number of Participants Analyzed 51 47 41
Measure Type: Number
Unit of Measure: Participants
4 24 25
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide 5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by International Prognostic Scoring System (IPSS) score (IPSS combined score =0 versus >0) to compare lenalidomide treatment with placebo.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by International Prognostic Scoring System (IPSS) score (IPSS combined score =0 versus >0) to compare lenalidomide treatment with placebo.
3.Secondary Outcome
Title Duration of Red Blood Cell (RBC) Transfusion Independence for Participants Who Became RBC Transfusion Independent for at Least 182 Days
Hide Description Mean number of weeks that participants who achieved RBC transfusion independence for at least 182 days were able to maintain RBC transfusion independence. Both double-blind and open-label periods are included.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population included all participants who achieved RBC transfusion independence for at least 182 days.
Arm/Group Title Placebo Lenalidomide 5 mg Lenalidomide 10 mg
Hide Arm/Group Description:
Placebo matching to active study arms.
Lenalidomide 5 mg daily for 28 days
Lenalidomide 10 mg daily for 21 of 28 days
Overall Number of Participants Analyzed 3 20 23
Mean (Standard Deviation)
Unit of Measure: Weeks
61.4  (10.93) 107.7  (52.35) 108.6  (40.63)
4.Secondary Outcome
Title Maximum Change From Baseline in Hemoglobin During the Double-blind Period for Participants Who Became Red Blood Cell (RBC) Transfusion Independent for at Least 182 Days
Hide Description For participants who became RBC transfusion independent for at least 182 days during the double-blind study period, the mean maximum change from baseline in hemoglobin is summarized.
Time Frame Baseline, up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population included all participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q[31] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug. MITT participants who were transfusion independent for >= 182 study days are included.
Arm/Group Title Placebo Lenalidomide 5 mg Lenalidomide 10 mg
Hide Arm/Group Description:
Placebo matching to active study arms.
Lenalidomide 5 mg daily for 28 days
Lenalidomide 10 mg daily for 21 of 28 days
Overall Number of Participants Analyzed 3 20 23
Mean (Standard Deviation)
Unit of Measure: g/dL
2.0  (0.61) 5.5  (1.79) 6.0  (1.97)
5.Secondary Outcome
Title Participants' Response in Platelet Counts as Defined by the International MDS Working Group (IWG 2000) During Double-blind Period
Hide Description The International MDS Working Group (IWG) defines a major platelet response for participants with a pre-treatment platelet count of <100,000/mm^3 as an absolute increase of ≥30,000/mm^3 whereas a minor response is defined as a ≥50% increase in platelet count with a net increase greater than 10,000/mm^3 but less than 30,000/mm^3.
Time Frame up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population included all participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q[31] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug. Additionally, the participant must have had a baseline platelet count of <100,000/mm^3 to be included in the analysis.
Arm/Group Title Placebo Lenalidomide 5 mg Lenalidomide 10 mg
Hide Arm/Group Description:
Placebo matching to active study arms.
Lenalidomide 5 mg daily for 28 days
Lenalidomide 10 mg daily for 21 of 28 days
Overall Number of Participants Analyzed 3 6 4
Measure Type: Number
Unit of Measure: Participants
Major 0 1 1
Minor 0 0 0
None 3 5 3
6.Secondary Outcome
Title Participants' Response in Absolute Neutrophil Counts as Defined by the International MDS Working Group (IWG 2000) During Double-blind Period
Hide Description A major neutrophil response is defined by the International MDS Working Group (IWG) criteria as at least a 100% increase, or an absolute increase of ≥500/mm^3 for participants with absolute neutrophil counts (ANC) of less than 1,500/mm^3 before therapy, whichever is greater. A minor response for such participants is defined as an ANC increase of at least 100%, but absolute increase <500/mm^3.
Time Frame up to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population included all participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q[31] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug. Additionally, the participant must have had a baseline absolute neutrophil counts (ANC) < 1,000/mm^3.
Arm/Group Title Placebo Lenalidomide 5 mg Lenalidomide 10 mg
Hide Arm/Group Description:
Placebo matching to active study arms.
Lenalidomide 5 mg daily for 28 days
Lenalidomide 10 mg daily for 21 of 28 days
Overall Number of Participants Analyzed 10 18 17
Measure Type: Number
Unit of Measure: Participants
Major 1 3 2
Minor 0 0 1
None 9 15 14
7.Secondary Outcome
Title Participants' Response Based on Bone Marrow Samples by the International MDS Working Group (IWG 2000) During Double-blind Period
Hide Description The IWG criteria for bone marrow improvement: a complete remission is bone marrow sampling showing less than 5% myeloblasts with normal maturation of all cell lines, with no evidence for dysplasia. A partial remission is ≥ 50% decrease in blasts over pre-treatment. Bone marrow progression is a ≥ 50% increase in blasts that exceed the top range of the pretreatment percentile range: a) <5% blasts b) 5-10% blasts c) 10-20% blasts d) 20-30% blasts. For example, a participant with <5% blasts pretreatment with an on study blast increase of 50% which is now >5% showed bone marrow progression.
Time Frame up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. Participants represented in the treatment groups to which they were randomized. Placebo response is limited to the double-blind phase. There were 10 responders in the placebo group who achieved their response under lenalidomide treatment after crossover to open-label.
Arm/Group Title Placebo Lenalidomide 5 mg Lenalidomide 10 mg
Hide Arm/Group Description:
Placebo matching to active study arms.
Lenalidomide 5 mg daily for 28 days
Lenalidomide 10 mg daily for 21 of 28 days
Overall Number of Participants Analyzed 67 69 69
Measure Type: Number
Unit of Measure: Participants
Complete remission 0 7 12
Partial remission 0 5 1
Stable Disease 37 35 33
Progression 3 4 3
8.Secondary Outcome
Title Participants Showing Cytogenetic Response by the International MDS Working Group (IWG 2000) During Double-blind Period as Evaluated by Central Review
Hide Description The IWG criteria for evaluating cytogenetic response require a minimum of 20 baseline and post-baseline analyzable metaphases using conventional cytogenetic techniques. A major cytogenetic response is defined as no detectable cytogenetic abnormality if preexisting abnormality was present whereas a minor response requires ≥50% reduction in abnormal metaphases. Progression could be concluded based on as few as 3 metaphases if there were additional abnormalities. The best response is represented.
Time Frame up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat population, which is defined as participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q[31] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug. Participants had to have had more than 1 post-baseline assessment in order to be evaluable for cytogenetic response.
Arm/Group Title Placebo Lenalidomide 5 mg Lenalidomide 10 mg
Hide Arm/Group Description:
Placebo matching to active study arms.
Lenalidomide 5 mg daily for 28 days
Lenalidomide 10 mg daily for 21 of 28 days
Overall Number of Participants Analyzed 41 37 40
Measure Type: Number
Unit of Measure: Participants
Major response 0 5 10
Minor response 0 3 7
Cytogenetic progression 5 10 8
Not evaluable/data not available 10 10 1
9.Secondary Outcome
Title Participants Who Progressed to Acute Myeloid Leukemia (AML) During the Study
Hide Description Number of participants who progressed to acute myeloid leukemia during the study, summarized at three different timepoints: first 16 weeks of the double-blind study, week 52 of the double-blind study, and up to 36 months which includes the double-blind and open-label periods of the study. The counts are cumulative by timeframe.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. Participants represented in the treatment groups to which they were randomized.
Arm/Group Title Placebo Lenalidomide 5 mg Lenalidomide 10 mg
Hide Arm/Group Description:
Placebo matching to active study arms.
Lenalidomide 5 mg daily for 28 days
Lenalidomide 10 mg daily for 21 of 28 days
Overall Number of Participants Analyzed 67 69 69
Measure Type: Number
Unit of Measure: Participants
Double-Blind (first 16 weeks) 2 2 0
Double-Blind (52 weeks) 4 7 2
Double-Blind + Open-Label 21 16 15
10.Secondary Outcome
Title Kaplan Meier Estimates of Overall Survival by Randomized Group
Hide Description Kaplan Meier estimate for median length of survival for study participants as they were randomized at the start of the study.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All randomized participants who received any Lenalidomide or placebo.
Arm/Group Title Placebo Lenalidomide 5 mg Lenalidomide 10 mg
Hide Arm/Group Description:
Placebo matching to active study arms.
Lenalidomide 5 mg daily for 28 days
Lenalidomide 10 mg daily for 21 of 28 days
Overall Number of Participants Analyzed 67 69 69
Median (95% Confidence Interval)
Unit of Measure: Months
42.4 [1] 
(31.9 to NA)
NA [1] 
(24.6 to NA)
44.5 [1] 
(35.5 to NA)
[1]
The confidence interval cannot be estimated due to not enough number of deaths.
11.Secondary Outcome
Title Participant Count of Deaths During Double-blind and Open-label by Randomized Group
Hide Description Count of participant deaths throughout the entire study and reported by the original treatment assignment.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Lenalidomide 5 mg Lenalidomide 10 mg
Hide Arm/Group Description:
Placebo matching to active study arms.
Lenalidomide 5 mg daily for 28 days
Lenalidomide 10 mg daily for 21 of 28 days
Overall Number of Participants Analyzed 67 69 69
Measure Type: Number
Unit of Measure: Participants
35 32 34
12.Secondary Outcome
Title Change From Baseline in the Functional Assessment of Cancer Therapy-Anemia (FACT-An) Endpoints at Week 12
Hide Description

The Functional Assessment of Cancer Therapy-Anemia (FACT-An) questionnaire (Yellen, 1997) was used to assess health-related quality of life (HRQoL).

In addition to general HRQoL, the FACT-An measures the impact of fatigue and other anemia-related symptoms on patient functioning. The overall score range for the FACT-An is 0-188. Higher scores indicate better HRQoL.

Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both Baseline and Week 12 FACT-An data.
Arm/Group Title Placebo Lenalidomide 5 mg Lenalidomide 10 mg
Hide Arm/Group Description:
Placebo matching to active study arms.
Lenalidomide 5 mg daily for 28 days
Lenalidomide 10 mg daily for 21 of 28 days
Overall Number of Participants Analyzed 52 45 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.5  (18.50) 5.9  (18.26) 5.8  (23.17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide 5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in the Trial Outcome Index-Anemia (TOI-An) Endpoints at Week 12
Hide Description The Trial Outcome Index-Anemia (TOI-An) composed of the physical and functional subscales of the FACT-G along with the Anemia subscale was used to assess health-related quality of life (HRQoL). The overall score range for the TOI-An is 0-136. Higher scores indicate better HRQoL.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both Baseline and Week 12 TOI-An data.
Arm/Group Title Placebo Lenalidomide 5 mg Lenalidomide 10 mg
Hide Arm/Group Description:
Placebo matching to active study arms.
Lenalidomide 5 mg daily for 28 days
Lenalidomide 10 mg daily for 21 of 28 days
Overall Number of Participants Analyzed 52 46 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.1  (17.13) 5.6  (15.56) 4.9  (18.16)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide 5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.054
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.080
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in the Trial Outcome Index-Fatigue (TOI-F) Endpoints at Week 12
Hide Description The Trial Outcome Index-Fatigue(TOI-F) composed of the physical and functional subscales of the FACT-G along with the fatigue items from the Anemia subscale was used to assess health-related quality of life (HRQoL). The overall score range for the TOI-F is 0-108. Higher scores indicate better HRQoL.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both Baseline and Week 12 TOI-F data.
Arm/Group Title Placebo Lenalidomide 5 mg Lenalidomide 10 mg
Hide Arm/Group Description:
Placebo matching to active study arms.
Lenalidomide 5 mg daily for 28 days
Lenalidomide 10 mg daily for 21 of 28 days
Overall Number of Participants Analyzed 53 46 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.8  (14.76) 4.8  (14.21) 3.9  (15.47)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide 5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.062
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lenalidomide 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.113
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
15.Secondary Outcome
Title Summary of Participants Who Had Adverse Events (AE) During the Double-blind Period
Hide Description

Counts of study participants who had adverse events (AEs) during the double-blind period by MedDRA System Organ Class (SOC) and preferred term. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. Adverse events were evaluated by the investigator.

The National Cancer Institute (NCI)'s Common Terminology Criteria for AEs (CTCAE) was used to grade AE severity. Severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE.

Time Frame up to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population.
Arm/Group Title Placebo Lenalidomide 5 mg Lenalidomide 10 mg
Hide Arm/Group Description:
Placebo matching to active study arms.
Lenalidomide 5 mg daily for 28 days
Lenalidomide 10 mg daily for 21 of 28 days
Overall Number of Participants Analyzed 67 69 69
Measure Type: Number
Unit of Measure: participants
At least one AE 64 69 69
At least one AE related to study drug 34 68 66
At least one NCI CTCAE grade 3-4 AE 29 62 65
At least one related NCI CTCAE grade 3-4 AE 13 61 61
At least one serious AE 14 31 32
At least one serious AE related to study drug 1 17 13
An AE leading to discontinuation of study drug 3 12 6
An AE leading to dose reduction or interruption 5 44 51
Deaths within 30 days of last dose of study drug 4 2 4
Time Frame Placebo arm is limited to the double-blind period. Lenalidomide 5 mg and 10 mg treatment arms cover both double-blind and open-label periods. The Placebo Crossover to 5 mg Open-label Period arm is limited to the open-label period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Lenalidomide 5 mg Lenalidomide 10 mg Placebo Crossover to 5 mg Open-label Period
Hide Arm/Group Description Placebo matching to active study arms. Lenalidomide 5 mg daily for 28 days Lenalidomide 10 mg daily for 21 of 28 days Participants receiving placebo in the Double-Blind phase and Lenalidomide in the Open-Label phase.
All-Cause Mortality
Placebo Lenalidomide 5 mg Lenalidomide 10 mg Placebo Crossover to 5 mg Open-label Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo Lenalidomide 5 mg Lenalidomide 10 mg Placebo Crossover to 5 mg Open-label Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/67 (20.90%)   42/69 (60.87%)   42/69 (60.87%)   33/56 (58.93%) 
Blood and lymphatic system disorders         
Anaemia  1  0/67 (0.00%)  4/69 (5.80%)  1/69 (1.45%)  1/56 (1.79%) 
Amaemia Haemolytic Autoimmune  1  0/67 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/56 (1.79%) 
Autoimmune Thrombocytopenia  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Bone Marrow Failure  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Coagulopathy  1  0/67 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/56 (1.79%) 
Febrile Neutropenia  1  0/67 (0.00%)  2/69 (2.90%)  2/69 (2.90%)  3/56 (5.36%) 
Haemolysis  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Neutropenia  1  0/67 (0.00%)  5/69 (7.25%)  5/69 (7.25%)  5/56 (8.93%) 
Pancytopenia  1  0/67 (0.00%)  1/69 (1.45%)  1/69 (1.45%)  0/56 (0.00%) 
Splenomegaly  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Thrombocytopenia  1  0/67 (0.00%)  6/69 (8.70%)  3/69 (4.35%)  3/56 (5.36%) 
Cardiac disorders         
Atrial Flutter  1  1/67 (1.49%)  0/69 (0.00%)  0/69 (0.00%)  0/56 (0.00%) 
Acute Myocardial Infarction  1  0/67 (0.00%)  0/69 (0.00%)  2/69 (2.90%)  1/56 (1.79%) 
Angina unstable  1  0/67 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/56 (1.79%) 
Atrial Fibrillation  1  0/67 (0.00%)  2/69 (2.90%)  0/69 (0.00%)  2/56 (3.57%) 
Cardiac Arrest  1  0/67 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/56 (1.79%) 
Cardiac Failure  1  0/67 (0.00%)  2/69 (2.90%)  1/69 (1.45%)  3/56 (5.36%) 
Myocardial Infarction  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Sinus Bradycardia  1  0/67 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/56 (1.79%) 
Tachyarrhythmia  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Congenital, familial and genetic disorders         
Cytogenetic Abnormality  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Ear and labyrinth disorders         
Vertigo  1  0/67 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/56 (1.79%) 
Eye disorders         
Cataract  1  1/67 (1.49%)  0/69 (0.00%)  0/69 (0.00%)  0/56 (0.00%) 
Gastrointestinal disorders         
Gastrointestinal Haemorrhage  1  1/67 (1.49%)  0/69 (0.00%)  0/69 (0.00%)  1/56 (1.79%) 
Abdominal Pain  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Abdominal Pain Upper  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Colitis  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  1/56 (1.79%) 
Constipation  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Diarrhoea  1  0/67 (0.00%)  1/69 (1.45%)  3/69 (4.35%)  1/56 (1.79%) 
Food Poisoning  1  0/67 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/56 (1.79%) 
Haemorrhoidal Haemorrhage  1  0/67 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/56 (1.79%) 
Intestinal Obstruction  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Intestinal Perforation  1  0/67 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/56 (1.79%) 
Intussusception  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Tooth Disorder  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Vomiting  1  0/67 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/56 (1.79%) 
General disorders         
Pyrexia  1  2/67 (2.99%)  5/69 (7.25%)  2/69 (2.90%)  3/56 (5.36%) 
Asthenia  1  1/67 (1.49%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Chest Pain  1  0/67 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/56 (1.79%) 
Fatigue  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
General Physical Health Deterioration  1  0/67 (0.00%)  0/69 (0.00%)  2/69 (2.90%)  0/56 (0.00%) 
Generalised Oedema  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Mucosal Inflammation  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Multi-Organ Failure  1  0/67 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/56 (1.79%) 
Non-cardiac Chest Pain  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Infections and infestations         
Arthritis Bacterial  1  1/67 (1.49%)  0/69 (0.00%)  0/69 (0.00%)  0/56 (0.00%) 
Bronchopneumonia  1  1/67 (1.49%)  0/69 (0.00%)  1/69 (1.45%)  1/56 (1.79%) 
Pneumonia  1  1/67 (1.49%)  5/69 (7.25%)  3/69 (4.35%)  1/56 (1.79%) 
Anal Abscess  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Bacteraemia  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Bronchitis  1  0/67 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/56 (1.79%) 
Cellulitis  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Erysipelas  1  0/67 (0.00%)  1/69 (1.45%)  1/69 (1.45%)  0/56 (0.00%) 
Febrile Infection  1  0/67 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/56 (1.79%) 
Gastroenteritis  1  0/67 (0.00%)  1/69 (1.45%)  1/69 (1.45%)  0/56 (0.00%) 
Infection  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Lower Respiratory Tract Infection  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Neutropenic Sepsis  1  0/67 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/56 (1.79%) 
Pneumonia Legionella  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Pyelonephritis  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Respiratory Tract Infection  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Septic Shock  1  0/67 (0.00%)  0/69 (0.00%)  2/69 (2.90%)  0/56 (0.00%) 
Sinusitis  1  0/67 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/56 (1.79%) 
Staphylococcal Sepsis  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Urinary Tract Infection  1  0/67 (0.00%)  3/69 (4.35%)  1/69 (1.45%)  0/56 (0.00%) 
Urosepsis  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Injury, poisoning and procedural complications         
Spinal Fracture  1  1/67 (1.49%)  0/69 (0.00%)  0/69 (0.00%)  0/56 (0.00%) 
Fall  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Femoral Neck Fracture  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Humerus Fracture  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Injury  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Meniscus Lesion  1  0/67 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/56 (1.79%) 
Spinal Compression Fracture  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Subdural Haematoma  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Synovial Rupture  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Transfusion Reaction  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Investigations         
International normalised Ratio Increased  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Urine Human Chorionic Gonadotropin Abnormal  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Metabolism and nutrition disorders         
Malnutrition  1  1/67 (1.49%)  0/69 (0.00%)  0/69 (0.00%)  0/56 (0.00%) 
Diabetes Mellitus Inadequate Control  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Hyperglycaemia  1  0/67 (0.00%)  1/69 (1.45%)  1/69 (1.45%)  0/56 (0.00%) 
Hypoglycaemia  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthritis  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  1/56 (1.79%) 
Back Pain  1  0/67 (0.00%)  0/69 (0.00%)  2/69 (2.90%)  0/56 (0.00%) 
Chondropathy  1  0/67 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/56 (1.79%) 
Fibromyalgia  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Gouty Arthritis  1  0/67 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/56 (1.79%) 
Joint Range of Motion Decreased  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Muscle Spasms  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Musculoskeletal Pain  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Myalgia  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Osteoarthritis  1  0/67 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  2/56 (3.57%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Acute Myeloid Leukaemia  1  2/67 (2.99%)  8/69 (11.59%)  8/69 (11.59%)  5/56 (8.93%) 
Acute Leukaemia  1  0/67 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/56 (1.79%) 
Bladder Cancer  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Breast Cancer  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Colon Cancer  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Colorectal Cancer  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Histiocytosis Haematophagic  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Leukaemia  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  2/56 (3.57%) 
Lung Cancer Metastatic  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Myelodysplastic syndrome  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Refractory Anaemia with an excess of blasts  1  0/67 (0.00%)  1/69 (1.45%)  2/69 (2.90%)  1/56 (1.79%) 
Nervous system disorders         
Sciatica  1  1/67 (1.49%)  0/69 (0.00%)  0/69 (0.00%)  0/56 (0.00%) 
Cerebral Haemorrhage  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Cerebrovascular Accident  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Coma  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Dizziness  1  0/67 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/56 (1.79%) 
Headache  1  0/67 (0.00%)  1/69 (1.45%)  1/69 (1.45%)  0/56 (0.00%) 
Psychiatric disorders         
Cotard's Syndrome  1  1/67 (1.49%)  0/69 (0.00%)  0/69 (0.00%)  0/56 (0.00%) 
Suicide Attempt  1  1/67 (1.49%)  0/69 (0.00%)  0/69 (0.00%)  0/56 (0.00%) 
Anxiety Disorder  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Confusional State  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  1/56 (1.79%) 
Delirium  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Depression  1  0/67 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/56 (1.79%) 
Mood Altered  1  0/67 (0.00%)  1/69 (1.45%)  1/69 (1.45%)  0/56 (0.00%) 
Renal and urinary disorders         
Urethral caruncle  1  1/67 (1.49%)  0/69 (0.00%)  0/69 (0.00%)  0/56 (0.00%) 
Renal Colic  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Renal Failure  1  0/67 (0.00%)  1/69 (1.45%)  1/69 (1.45%)  0/56 (0.00%) 
Stress Urinary Incontinence  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Urinary Incontinence  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Reproductive system and breast disorders         
Acute Respiratory Distress Syndrome  1  1/67 (1.49%)  0/69 (0.00%)  0/69 (0.00%)  1/56 (1.79%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  1  1/67 (1.49%)  1/69 (1.45%)  1/69 (1.45%)  1/56 (1.79%) 
Pleural Effusion  1  1/67 (1.49%)  0/69 (0.00%)  0/69 (0.00%)  0/56 (0.00%) 
Pulmonary Fibrosis  1  1/67 (1.49%)  0/69 (0.00%)  0/69 (0.00%)  0/56 (0.00%) 
Chronic Obstructive Pulmonary Disease  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Epistaxis  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  1/56 (1.79%) 
Haemoptysis  1  0/67 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/56 (1.79%) 
Hypoxia  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  1/56 (1.79%) 
Interstitial Lung Disease  1  0/67 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/56 (1.79%) 
Lung Disorder  1  0/67 (0.00%)  1/69 (1.45%)  1/69 (1.45%)  0/56 (0.00%) 
Pneumonia Aspiration  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Pulmonary Embolism  1  0/67 (0.00%)  3/69 (4.35%)  2/69 (2.90%)  0/56 (0.00%) 
Pulmonary Haemorrhage  1  0/67 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/56 (1.79%) 
Respiratory Failure  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Skin and subcutaneous tissue disorders         
Pyoderma Gangrenosum  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Skin Ulcer  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Urticaria  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Vascular disorders         
Deep Vein Thrombosis  1  1/67 (1.49%)  1/69 (1.45%)  4/69 (5.80%)  3/56 (5.36%) 
Arterial Occlusive Disease  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Hypotension  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Orthostatic Hypotension  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/56 (0.00%) 
Phlebitis  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Thrombophlebitis Superficial  1  0/67 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/56 (1.79%) 
Venous Thrombosis  1  0/67 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/56 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Lenalidomide 5 mg Lenalidomide 10 mg Placebo Crossover to 5 mg Open-label Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   64/67 (95.52%)   69/69 (100.00%)   69/69 (100.00%)   56/56 (100.00%) 
Blood and lymphatic system disorders         
Neutropenia  1  12/67 (17.91%)  55/69 (79.71%)  57/69 (82.61%)  45/56 (80.36%) 
Anaemia  1  6/67 (8.96%)  10/69 (14.49%)  6/69 (8.70%)  13/56 (23.21%) 
Leukopenia  1  3/67 (4.48%)  12/69 (17.39%)  8/69 (11.59%)  5/56 (8.93%) 
Thrombocytopenia  1  2/67 (2.99%)  38/69 (55.07%)  36/69 (52.17%)  26/56 (46.43%) 
Cardiac disorders         
Atrial Fibrillation  1  2/67 (2.99%)  0/69 (0.00%)  1/69 (1.45%)  4/56 (7.14%) 
Tachycardia  1  1/67 (1.49%)  0/69 (0.00%)  0/69 (0.00%)  4/56 (7.14%) 
Ear and labyrinth disorders         
Vertigo  1  1/67 (1.49%)  8/69 (11.59%)  3/69 (4.35%)  2/56 (3.57%) 
Eye disorders         
Cataract  1  0/67 (0.00%)  1/69 (1.45%)  5/69 (7.25%)  2/56 (3.57%) 
Conjunctivitis  1  0/67 (0.00%)  0/69 (0.00%)  5/69 (7.25%)  2/56 (3.57%) 
Gastrointestinal disorders         
Diarrhoea  1  12/67 (17.91%)  32/69 (46.38%)  37/69 (53.62%)  26/56 (46.43%) 
Nausea  1  6/67 (8.96%)  16/69 (23.19%)  21/69 (30.43%)  11/56 (19.64%) 
Constipation  1  5/67 (7.46%)  18/69 (26.09%)  19/69 (27.54%)  17/56 (30.36%) 
Abdominal Pain  1  4/67 (5.97%)  7/69 (10.14%)  14/69 (20.29%)  10/56 (17.86%) 
Vomiting  1  4/67 (5.97%)  8/69 (11.59%)  9/69 (13.04%)  3/56 (5.36%) 
Dry Mouth  1  2/67 (2.99%)  4/69 (5.80%)  5/69 (7.25%)  5/56 (8.93%) 
Abdominal Pain Upper  1  1/67 (1.49%)  8/69 (11.59%)  8/69 (11.59%)  2/56 (3.57%) 
Dyspepsia  1  1/67 (1.49%)  4/69 (5.80%)  5/69 (7.25%)  4/56 (7.14%) 
Flatulence  1  0/67 (0.00%)  2/69 (2.90%)  1/69 (1.45%)  4/56 (7.14%) 
General disorders         
Asthenia  1  10/67 (14.93%)  10/69 (14.49%)  10/69 (14.49%)  9/56 (16.07%) 
Fatigue  1  5/67 (7.46%)  17/69 (24.64%)  17/69 (24.64%)  11/56 (19.64%) 
Oedema Peripheral  1  5/67 (7.46%)  15/69 (21.74%)  13/69 (18.84%)  10/56 (17.86%) 
Chest Pain  1  4/67 (5.97%)  1/69 (1.45%)  0/69 (0.00%)  1/56 (1.79%) 
Pyrexia  1  3/67 (4.48%)  11/69 (15.94%)  16/69 (23.19%)  9/56 (16.07%) 
Non-Cardiac Chest Pain  1  1/67 (1.49%)  5/69 (7.25%)  1/69 (1.45%)  2/56 (3.57%) 
Influenza Like Illness  1  0/67 (0.00%)  5/69 (7.25%)  5/69 (7.25%)  1/56 (1.79%) 
Oedema  1  0/67 (0.00%)  3/69 (4.35%)  4/69 (5.80%)  1/56 (1.79%) 
Pain  1  0/67 (0.00%)  1/69 (1.45%)  4/69 (5.80%)  0/56 (0.00%) 
Infections and infestations         
Nasopharyngitis  1  5/67 (7.46%)  15/69 (21.74%)  16/69 (23.19%)  8/56 (14.29%) 
Upper Respiratory Tract Infection  1  4/67 (5.97%)  11/69 (15.94%)  12/69 (17.39%)  8/56 (14.29%) 
Urinary Tract Infection  1  4/67 (5.97%)  6/69 (8.70%)  12/69 (17.39%)  8/56 (14.29%) 
Bronchitis  1  3/67 (4.48%)  7/69 (10.14%)  14/69 (20.29%)  8/56 (14.29%) 
Cystitis  1  1/67 (1.49%)  2/69 (2.90%)  4/69 (5.80%)  4/56 (7.14%) 
Lower Respiratory Tract Infection  1  1/67 (1.49%)  2/69 (2.90%)  5/69 (7.25%)  2/56 (3.57%) 
Respiratory Tract Infection  1  1/67 (1.49%)  9/69 (13.04%)  3/69 (4.35%)  6/56 (10.71%) 
Sinusitis  1  1/67 (1.49%)  1/69 (1.45%)  6/69 (8.70%)  4/56 (7.14%) 
Gastroenteritis  1  0/67 (0.00%)  7/69 (10.14%)  6/69 (8.70%)  2/56 (3.57%) 
Gastroenteritis Viral  1  0/67 (0.00%)  4/69 (5.80%)  0/69 (0.00%)  0/56 (0.00%) 
Influenza  1  0/67 (0.00%)  5/69 (7.25%)  5/69 (7.25%)  3/56 (5.36%) 
Oral Herpes  1  0/67 (0.00%)  6/69 (8.70%)  0/69 (0.00%)  2/56 (3.57%) 
Pharyngitis  1  0/67 (0.00%)  3/69 (4.35%)  4/69 (5.80%)  0/56 (0.00%) 
Rhinitis  1  0/67 (0.00%)  4/69 (5.80%)  3/69 (4.35%)  4/56 (7.14%) 
Pneumonia  1  2/67 (2.99%)  2/69 (2.90%)  2/69 (2.90%)  5/56 (8.93%) 
Injury, poisoning and procedural complications         
Contusion  1  1/67 (1.49%)  3/69 (4.35%)  4/69 (5.80%)  1/56 (1.79%) 
Fall  1  0/67 (0.00%)  2/69 (2.90%)  4/69 (5.80%)  2/56 (3.57%) 
Joint Sprain  1  0/67 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  3/56 (5.36%) 
Wound  1  0/67 (0.00%)  2/69 (2.90%)  4/69 (5.80%)  1/56 (1.79%) 
Investigations         
Alanine Aminotransferase Increased  1  2/67 (2.99%)  7/69 (10.14%)  5/69 (7.25%)  4/56 (7.14%) 
Weight Decreased  1  1/67 (1.49%)  6/69 (8.70%)  5/69 (7.25%)  12/56 (21.43%) 
Metabolism and nutrition disorders         
Decreased Appetite  1  2/67 (2.99%)  8/69 (11.59%)  8/69 (11.59%)  8/56 (14.29%) 
Iron Overload  1  2/67 (2.99%)  4/69 (5.80%)  5/69 (7.25%)  2/56 (3.57%) 
Hypoalbuminaemia  1  0/67 (0.00%)  4/69 (5.80%)  1/69 (1.45%)  0/56 (0.00%) 
Hypokalaemia  1  0/67 (0.00%)  7/69 (10.14%)  3/69 (4.35%)  1/56 (1.79%) 
Hypomagnesaemia  1  0/67 (0.00%)  3/69 (4.35%)  3/69 (4.35%)  4/56 (7.14%) 
Musculoskeletal and connective tissue disorders         
Muscle Spasms  1  6/67 (8.96%)  12/69 (17.39%)  15/69 (21.74%)  13/56 (23.21%) 
Back Pain  1  4/67 (5.97%)  12/69 (17.39%)  8/69 (11.59%)  10/56 (17.86%) 
Myalgia  1  2/67 (2.99%)  4/69 (5.80%)  6/69 (8.70%)  3/56 (5.36%) 
Arthralgia  1  1/67 (1.49%)  6/69 (8.70%)  5/69 (7.25%)  5/56 (8.93%) 
Pain in Extremity  1  1/67 (1.49%)  5/69 (7.25%)  10/69 (14.49%)  9/56 (16.07%) 
Musculoskeletal Chest Pain  1  0/67 (0.00%)  1/69 (1.45%)  5/69 (7.25%)  1/56 (1.79%) 
Neck Pain  1  0/67 (0.00%)  3/69 (4.35%)  3/69 (4.35%)  3/56 (5.36%) 
Musculoskeletal Pain  1  3/67 (4.48%)  5/69 (7.25%)  11/69 (15.94%)  9/56 (16.07%) 
Nervous system disorders         
Headache  1  6/67 (8.96%)  12/69 (17.39%)  14/69 (20.29%)  5/56 (8.93%) 
Dizziness  1  3/67 (4.48%)  8/69 (11.59%)  10/69 (14.49%)  8/56 (14.29%) 
Paraesthesia  1  3/67 (4.48%)  8/69 (11.59%)  3/69 (4.35%)  6/56 (10.71%) 
Sciatica  1  2/67 (2.99%)  2/69 (2.90%)  4/69 (5.80%)  0/56 (0.00%) 
Balance Disorder  1  0/67 (0.00%)  0/69 (0.00%)  4/69 (5.80%)  0/56 (0.00%) 
Peripheral Sensory Neuropathy  1  0/67 (0.00%)  4/69 (5.80%)  1/69 (1.45%)  2/56 (3.57%) 
Psychiatric disorders         
Insomnia  1  5/67 (7.46%)  6/69 (8.70%)  9/69 (13.04%)  6/56 (10.71%) 
Depression  1  3/67 (4.48%)  4/69 (5.80%)  2/69 (2.90%)  2/56 (3.57%) 
Anxiety  1  2/67 (2.99%)  3/69 (4.35%)  5/69 (7.25%)  4/56 (7.14%) 
Renal and urinary disorders         
Dysuria  1  2/67 (2.99%)  1/69 (1.45%)  3/69 (4.35%)  3/56 (5.36%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  4/67 (5.97%)  12/69 (17.39%)  10/69 (14.49%)  9/56 (16.07%) 
Dyspnoea  1  4/67 (5.97%)  12/69 (17.39%)  9/69 (13.04%)  5/56 (8.93%) 
Epistaxis  1  2/67 (2.99%)  3/69 (4.35%)  4/69 (5.80%)  3/56 (5.36%) 
Dyspnoea Exertional  1  1/67 (1.49%)  4/69 (5.80%)  3/69 (4.35%)  1/56 (1.79%) 
Oropharyngeal Pain  1  1/67 (1.49%)  7/69 (10.14%)  6/69 (8.70%)  3/56 (5.36%) 
Skin and subcutaneous tissue disorders         
Pruritus  1  3/67 (4.48%)  16/69 (23.19%)  20/69 (28.99%)  7/56 (12.50%) 
Dry Skin  1  1/67 (1.49%)  10/69 (14.49%)  10/69 (14.49%)  6/56 (10.71%) 
Rash  1  1/67 (1.49%)  18/69 (26.09%)  12/69 (17.39%)  8/56 (14.29%) 
Alopecia  1  0/67 (0.00%)  0/69 (0.00%)  4/69 (5.80%)  1/56 (1.79%) 
Hyperhidrosis  1  0/67 (0.00%)  2/69 (2.90%)  4/69 (5.80%)  1/56 (1.79%) 
Petechiae  1  0/67 (0.00%)  3/69 (4.35%)  4/69 (5.80%)  3/56 (5.36%) 
Vascular disorders         
Haematoma  1  2/67 (2.99%)  6/69 (8.70%)  6/69 (8.70%)  5/56 (8.93%) 
Phlebitis  1  1/67 (1.49%)  1/69 (1.45%)  4/69 (5.80%)  2/56 (3.57%) 
Hypertension  1  0/67 (0.00%)  7/69 (10.14%)  9/69 (13.04%)  5/56 (8.93%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
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.
  • Multicenter publication must include input from investigators and Celgene, agreement to be established before publication. It has priority over subset (single center) publication, for duration of 1 year after study completion.
  • Individual investigators have publication right after multicenter publication is complete (or 1 year after study completion), whichever is first. In this case, Celgene has the right to comment and right to ask delay of publication for 90 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Associate Director, Clinical Trials Disclosure
Organization: Celgene Corporation
Phone: 1-888-260-1599
EMail: clinicaltrialdisclosure@celgene.com
Publications of Results:
Fenaux, Pierre, Giagounidis, Aristotle, Selleslag, Dominik, Beyne-Rauzy, Odile, Mufti, Ghulam J, Mittelman, Moshe, Muus, Petra, te Boekhorst, Peter, Sanz, Guillermo, del Canizo, Consuelo, Guerci-Bresler, Agnes, Schlegelberger, Brigitte, Aul, Carlo, Kreipe, Hans, Goehring, Gudrun, Knight, Robert, Francis, John, Fu, Tommy, Hellstrom-Lindberg, Eva. RBC Transfusion Independence and Safety Profile of Lenalidomide 5 or 10 mg in Pts with Low- or Int-1-Risk MDS with Del5q: Results From a Randomized Phase III Trial (MDS-004). ASH Annual Meeting Abstracts 2009 114: 944.
Fenaux, P., Giagounidis, A., Selleslag, D. L., Beyne-Rauzy, O., Mittelman, M., Muus, P., Knight, R. D., Fu, T., Hellstrom-Lindberg, E., The MDS-004 Len del(5q) Study Group. Safety of lenalidomide (LEN) from a randomized phase III trial (MDS-004) in low-/int-1-risk myelodysplastic syndromes (MDS) with a del(5q) abnormality. J Clin Oncol (Meeting Abstracts) 2010 28: 6598
Fenaux, P., Giagounidis, A., Selleslag, D., Knight, R., Fu, T., Hellström-Lindberg, E. Effect of baseline EPO and prior erythropoiesis stimulating agents on RBC transfusion independence in Low-/Int-1-Risk MDS with del 5q treated with lenalidomide: A randomized phase 3 study (MDS-004). Haematologica 2010; 95[suppl.2]:125, abs. 0311.
Brandenburg, N., Fu, T., Revicki, D., Knight, R., Muus, P., Fenaux, P. Impact of lenalidomide on health-related quality of life in patients with RBC transfusion-dependent low- or int-1-risk myelodysplastic syndromes with del 5q: a randomized Phase 3 study (MDS-004). Haematologica 2010; 95[suppl.2]:127, abs. 0316
Fenaux, P., Giagounidis, A., Beyne-Rauzy, O., Mufti, G., Mittelman, M., Muus, P., te Boekhorst, P., Sanz, G., Cazzola, M., Backstrom, J., Fu, T., Hellström-Lindberg, E. Prognostic Factors of Long-Term Outcomes In Low- or Int-1-Risk MDS with del5q Treated with Lenalidomide (LEN): Results From a Randomized Phase 3 Trial (MDS-004). Blood ASH Annual Meeting Abstracts 2010 116:21 abs. 4027.
Brandenburg, N., Yu, R., Revicki, D. Reliability and Validity of the FACT-AN In Patients with Low or Int-1-Risk Myelodysplastic Syndromes with Deletion 5q. Blood ASH Annual Meeting Abstracts 2010 116:21 abs. 3827.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jay Backstrom, MD, Vice President, Clinical Development MDS, Celgene Corporation
ClinicalTrials.gov Identifier: NCT00179621    
Other Study ID Numbers: CC-5013-MDS-004
2005-000454-73 ( EudraCT Number )
First Submitted: September 10, 2005
First Posted: September 16, 2005
Results First Submitted: February 9, 2011
Results First Posted: March 17, 2011
Last Update Posted: April 14, 2011