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Trial record 25 of 179 for:    LENALIDOMIDE AND Leukemia

A Study Being Conducted at Multiple Locations to Compare Safety and Efficacy of Three Different Regimens; (1) High-Dose Lenalidomide; (2) Lenalidomide + Azacitidine; or (3) Azacitidine in Subjects ≥ 65 Years With Newly-Diagnosed Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT01358734
Recruitment Status : Completed
First Posted : May 24, 2011
Results First Posted : July 4, 2016
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: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Myeloid Leukemia
Acute Myelogenous Leukemia
Interventions Drug: Azacitidine
Drug: Lenalidomide
Other: Best Supportive Care (BSC)
Enrollment 88
Recruitment Details Participants were randomized at 25 sites in North America (Canada and the United States).
Pre-assignment Details Participants were centrally randomized 1:1:1 and stratified by the Eastern Cooperative Oncology Group (ECOG) performance score (0 to 1 versus 2) and peripheral blood blast count (<1 versus ≥ 1 x 10^9/L).
Arm/Group Title Lenalidomide Azacitidine Plus Lenalidomide Azacitidine
Hide Arm/Group Description Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion. Participants received azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC
Period Title: Overall Study
Started 15 39 34
Safety Population 14 [1] 38 [1] 32 [1]
Completed 0 0 0
Not Completed 15 39 34
Reason Not Completed
Adverse Event             4             7             3
Lack of Efficacy             0             1             3
Withdrawal by Subject             1             6             3
Death             3             7             2
Progressive Disease             5             13             16
Non-compliance with study drug             0             0             1
Not Specified             2             5             4
Protocol Violation             0             0             2
[1]
The safety population includes all participants who received at least one dose of study drug.
Arm/Group Title Lenalidomide Azacitidine + Lenalidomide Azacitidine Total
Hide Arm/Group Description Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion. Participants received azacitidine 75 mg/m^2/ daily SC on Days 1 through 7 and lenalidomide 50 mg daily PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC Total of all reporting groups
Overall Number of Baseline Participants 15 39 34 88
Hide Baseline Analysis Population Description
Intent To Treat (ITT) includes all randomized participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 39 participants 34 participants 88 participants
77.6  (5.47) 75.5  (5.88) 74.8  (4.96) 75.97  (5.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 39 participants 34 participants 88 participants
Female
3
  20.0%
17
  43.6%
15
  44.1%
35
  39.8%
Male
12
  80.0%
22
  56.4%
19
  55.9%
53
  60.2%
Eastern Cooperative Oncology Group Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 39 participants 34 participants 88 participants
0 = (Fully Active)
4
  26.7%
4
  10.3%
10
  29.4%
18
  20.5%
1 = (Restrictive but ambulatory)
9
  60.0%
28
  71.8%
17
  50.0%
54
  61.4%
(Ambulatory but unable to work)
2
  13.3%
7
  17.9%
6
  17.6%
15
  17.0%
3 = (Limited self care)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4 = (Completely Disabled)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
1
   2.9%
1
   1.1%
[1]
Measure Description: The ECOG Scale of Performance Status is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. It has scores ranging from 0 to 5 and these correlate with scores from Karnofsky Scales 0-100. 0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity)
Peripheral Blast Blood Count  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 39 participants 34 participants 88 participants
<1 X 10^9L
11
  73.3%
31
  79.5%
27
  79.4%
69
  78.4%
≥1 X 10^9L
4
  26.7%
8
  20.5%
7
  20.6%
19
  21.6%
1.Primary Outcome
Title Kaplan Meier Estimates for One Year Survival
Hide Description One-year survival rate was defined as all deaths within one year from the date of randomization. All others censored at the at year 1 or date of discontinuation
Time Frame Up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT included all randomized participants
Arm/Group Title Lenalidomide Azacitidine Plus Lenalidomide Azacitidine
Hide Arm/Group Description:
Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
Participants received azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC
Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC
Overall Number of Participants Analyzed 15 39 34
Median (95% Confidence Interval)
Unit of Measure: months
3.00
(1.18 to 11.93)
9.61
(3.18 to 19.31)
13.67 [1] 
(6.75 to NA)
[1]
The Upper limit of the 95% Confidence Interval could not be estimated due to an insufficient number of participants with events.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lenalidomide, Azacitidine Plus Lenalidomide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.119
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.789
Confidence Interval (2-Sided) 95%
0.861 to 3.718
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lenalidomide, Azacitidine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.659
Confidence Interval (2-Sided) 95%
1.214 to 5.822
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Azacitidine Plus Lenalidomide, Azacitidine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.356
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.367
Confidence Interval (2-Sided) 95%
0.704 to 2.653
Estimation Comments [Not Specified]
2.Primary Outcome
Title Overall Survival
Hide Description Overall Survival reported at the end of the study are for those participants who were alive at the end of the study
Time Frame From date of randomization until the date of the first documented date of progression or date of death of any cause; the overall median follow-up for survivng participants was 4.1 months (range 0.2 to 54.8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were still alive at the end of the study and in safety population.
Arm/Group Title Lenalidomide Azacitidine Plus Lenalidomide Azacitidine
Hide Arm/Group Description:
Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
Participants received azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC
Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC
Overall Number of Participants Analyzed 1 4 3
Median (Full Range)
Unit of Measure: months
0.2
(0.2 to 0.2)
7.1
(1.4 to 53.3)
4.1
(0.2 to 54.8)
3.Secondary Outcome
Title Percentage of Participants With a Complete Response or Morphologic Incomplete Response.
Hide Description

Based on IWG response criteria for AML. Complete remission (CR), morphologic complete remission (CR) was defined as < 5% bone marrow blasts, an absolute neutrophil count ≥ 1 x 10^9/L, platelets ≥100 x 10^9/L, and transfusion independence (no transfusions for 1 week prior to each assessment). No duration of these findings is required for confirmation of this response.

Morphologic CR with incomplete blood count recovery (CRi) was defined as a morphologic complete remission but the ANC count may be <1 x 10^9/L and/or the platelet count may be <100 x 10^9/L. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.

Time Frame Complete Response or Morphologic Incomplete Response data not analyzed.
Hide Outcome Measure Data
Hide Analysis Population Description
Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Arm/Group Title Lenalidomide Azacitidine Plus Lenalidomide Azacitidine
Hide Arm/Group Description:
Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
Participants received azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC
Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Duration of Remission (DoR)
Hide Description Duration of remission was defined as the time from the date of CR or CRi until relapse. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Time Frame Duration of Remission (DoR) time frame not analyzed.
Hide Outcome Measure Data
Hide Analysis Population Description
Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Arm/Group Title Lenalidomide Azacitidine Plus Lenalidomide Azacitidine
Hide Arm/Group Description:
Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
Participants received azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC
Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Cytogenetic Complete Remission Rate (CRc)
Hide Description The CRc response category is comprised of the subset of participants who had abnormal cytogenetics at baseline and subsequently achieved CR during treatment in conjunction with a reversion to a normal karyotype. For the primary definition of CRc, a normal karyotype is defined as no clonal abnormalities after review of at least 10 metaphases using conventional cytogenetic techniques. Cytogenetic complete remission rate (CRc) 1) CR criteria met AND 2) Abnormal karyotype present at baseline AND 3) Reversion to normal karyotype at time of CR (based on ≥ 10 metaphases), where date of cytogenetic sample = date of BM sample used for the CR assessment. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Time Frame Cytogenetic Complete Remission timeframe was not analyzed.
Hide Outcome Measure Data
Hide Analysis Population Description
Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Arm/Group Title Lenalidomide Azacitidine Plus Lenalidomide Azacitidine
Hide Arm/Group Description:
Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
Participants received azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC
Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Percentage of Participants With an Overall Response Rate (CR +CRi+ PR)
Time Frame Overall response rate time frame was not analyzed.
Hide Outcome Measure Data
Hide Analysis Population Description
Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Arm/Group Title Lenalidomide Azacitidine Plus Lenalidomide Azacitidine
Hide Arm/Group Description:
Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
Participants received azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC
Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description PFS is defined as the time from randomization to the first observation of documented disease progression or death from any cause whichever occurred first. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Time Frame Progression-Free survival data and time frame was not analyzed.
Hide Outcome Measure Data
Hide Analysis Population Description
Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Arm/Group Title Lenalidomide Azacitidine Plus Lenalidomide Azacitidine
Hide Arm/Group Description:
Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
Participants received azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC
Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Event-Free Survival (EFS)
Hide Description EFS was defined as the interval from the date of randomization to the date of treatment failure, progressive disease, relapse after CR or CRi, or death from any cause, whichever occurred first. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Time Frame Event-Free survival time was not analyzed.
Hide Outcome Measure Data
Hide Analysis Population Description
Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Arm/Group Title Lenalidomide Azacitidine Plus Lenalidomide Azacitidine
Hide Arm/Group Description:
Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
Participants received azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC
Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Relapse-Free Survival (RFS)
Hide Description RFS is defined only for subjects that achieve CR and CRi and is measured as the interval from that date to the date of disease relapse, death from any cause, whichever occurs first, censoring at the last visit date for subjects alive in continuous CR/CRi. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Time Frame Relapse-Free survival time frame was not analyzed.
Hide Outcome Measure Data
Hide Analysis Population Description
Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Arm/Group Title Lenalidomide Azacitidine Plus Lenalidomide Azacitidine
Hide Arm/Group Description:
Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
Participants received azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC
Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Percentage of Participants With 30-Day Treatment-Related Mortality
Hide Description 30-day mortality rate was defined as death from any cause within 30 days after first dose.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT included all randomized participants.
Arm/Group Title Lenalidomide Azacitidine Plus Lenalidomide Azacitidine
Hide Arm/Group Description:
Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
Participants received azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC
Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC
Overall Number of Participants Analyzed 15 39 34
Measure Type: Number
Unit of Measure: percentage of participants
13.3 17.9 5.9
11.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAE)
Hide Description TEAEs were defined as those events that started on or after the first day of study drug up until 28 days after the last dose of study drug; Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect; constitutes an important medical event. Severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); and according to the scale: Grade (Gr) 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death
Time Frame From the first dose of study drug up to 28 days after the last dose of study drug; up to 15 May 2018
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population includes all participants who have received at least 1 dose of Investigational Product.
Arm/Group Title Lenalidomide Azacitidine Plus Lenalidomide Azacitidine
Hide Arm/Group Description:
Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
Participants received azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC
Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC
Overall Number of Participants Analyzed 14 38 32
Measure Type: Number
Unit of Measure: participants
Any TEAE 14 38 32
≥1 TEAE related to study drug 13 35 30
≥1 TEAE CTCAE Grade 3 or 4 TEAE 14 34 29
≥1 TEAE CTCAE Gr 3 or 4 TEAE related to study drug 11 25 18
≥1 TEAE CTCAE Grade 5 5 10 5
≥1 Serious TEAE 13 29 25
≥1 Serious TEAE related to study drug 10 16 7
≥1TEAE leading to discontinuation of study drug 6 12 4
≥1TEAE leading to dose reduction of study drug 0 8 2
≥1TEAE leading to dose interruption of study drug 8 21 10
12.Secondary Outcome
Title Number of Participants With a Second Primary Malignancy
Hide Description Second primary malignancies were monitored as events of interest and reported as serious adverse events regardless of the treatment arm the participant was enrolled in.
Time Frame From randomization of the last participant up to a minimum of 4 years following discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population includes all participants who received at least one dose of IP
Arm/Group Title Lenalidomide Azacitidine Plus Lenalidomide Azacitidine
Hide Arm/Group Description:
Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
Participants received azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC
Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC
Overall Number of Participants Analyzed 14 38 32
Measure Type: Number
Unit of Measure: Participants
0 0 3
13.Other Pre-specified Outcome
Title Percentage of Participants Alive at One Year
Hide Description Defined as the percentage of participants who survived at one year
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included participants who were randomized.
Arm/Group Title Lenalidomide Azacitidine Plus Lenalidomide Azacitidine
Hide Arm/Group Description:
Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
Participants received azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC
Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC
Overall Number of Participants Analyzed 15 39 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
21.4
(0.0 to 42.9)
43.9
(27.9 to 59.9)
52.3
(34.7 to 69.8)
Time Frame From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018.
Adverse Event Reporting Description Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
 
Arm/Group Title Lenalidomide Azacitidine Plus Lenalidomide Azacitidine
Hide Arm/Group Description Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion. Participants received azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC
All-Cause Mortality
Lenalidomide Azacitidine Plus Lenalidomide Azacitidine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/14 (50.00%)   34/38 (89.47%)   29/32 (90.63%) 
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide Azacitidine Plus Lenalidomide Azacitidine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/14 (92.86%)   29/38 (76.32%)   25/32 (78.13%) 
Blood and lymphatic system disorders       
Febrile neutropenia  1  6/14 (42.86%)  16/38 (42.11%)  8/32 (25.00%) 
Anaemia  1  2/14 (14.29%)  2/38 (5.26%)  2/32 (6.25%) 
Thrombocytopenia  2  2/14 (14.29%)  2/38 (5.26%)  1/32 (3.13%) 
Disseminated intravascular coagulation  2  1/14 (7.14%)  1/38 (2.63%)  0/32 (0.00%) 
Leukocytosis  2  1/14 (7.14%)  0/38 (0.00%)  1/32 (3.13%) 
Heparin-induced thrombocytopenia  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Neutropenia  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Pancytopenia  2  0/14 (0.00%)  1/38 (2.63%)  0/32 (0.00%) 
Cardiac disorders       
Atrial fibrillation  2  1/14 (7.14%)  3/38 (7.89%)  1/32 (3.13%) 
Angina pectoris  1  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Angina unstable  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Atrial flutter  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Cardiac arrest  2  0/14 (0.00%)  1/38 (2.63%)  0/32 (0.00%) 
Cardiac failure  2  0/14 (0.00%)  1/38 (2.63%)  0/32 (0.00%) 
Cardiac failure congestive  2  0/14 (0.00%)  1/38 (2.63%)  0/32 (0.00%) 
Cardio-respiratory arrest  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Ear and labyrinth disorders       
Middle ear inflammation  2  0/14 (0.00%)  1/38 (2.63%)  0/32 (0.00%) 
Gastrointestinal disorders       
Gastrointestinal haemorrhage  2  0/14 (0.00%)  2/38 (5.26%)  1/32 (3.13%) 
Constipation  2  0/14 (0.00%)  2/38 (5.26%)  0/32 (0.00%) 
Diarrhoea  1  0/14 (0.00%)  1/38 (2.63%)  0/32 (0.00%) 
Small intestinal haemorrhage  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
General disorders       
Fatigue  2  2/14 (14.29%)  0/38 (0.00%)  1/32 (3.13%) 
Non-cardiac chest pain  2  1/14 (7.14%)  0/38 (0.00%)  1/32 (3.13%) 
Pyrexia  2  0/14 (0.00%)  0/38 (0.00%)  2/32 (6.25%) 
Asthenia  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Malaise  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Oedema peripheral  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Performance status decreased  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Systemic inflammatory response syndrome  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Infections and infestations       
Pneumonia  2  3/14 (21.43%)  4/38 (10.53%)  7/32 (21.88%) 
Sepsis  2  2/14 (14.29%)  1/38 (2.63%)  2/32 (6.25%) 
Cellulitis  2  0/14 (0.00%)  3/38 (7.89%)  1/32 (3.13%) 
Septic shock  2  2/14 (14.29%)  1/38 (2.63%)  0/32 (0.00%) 
Bronchopulmonary aspergillosis  2  1/14 (7.14%)  1/38 (2.63%)  0/32 (0.00%) 
Clostridium difficile colitis  1  0/14 (0.00%)  0/38 (0.00%)  2/32 (6.25%) 
Klebsiella bacteraemia  2  0/14 (0.00%)  2/38 (5.26%)  0/32 (0.00%) 
Subcutaneous abscess  2  0/14 (0.00%)  1/38 (2.63%)  1/32 (3.13%) 
Breast abscess  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Clostridium difficile infection  1  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Enterobacter bacteraemia  2  0/14 (0.00%)  1/38 (2.63%)  0/32 (0.00%) 
Herpes zoster  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Klebsiella sepsis  2  0/14 (0.00%)  1/38 (2.63%)  0/32 (0.00%) 
Lobar pneumonia  2  0/14 (0.00%)  1/38 (2.63%)  0/32 (0.00%) 
Lung infection  2  0/14 (0.00%)  1/38 (2.63%)  0/32 (0.00%) 
Osteomyelitis  2  0/14 (0.00%)  1/38 (2.63%)  0/32 (0.00%) 
Pneumonia fungal  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Pneumonia staphylococcal  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Postoperative wound infection  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Pseudomonas infection  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Scrotal abscess  2  0/14 (0.00%)  1/38 (2.63%)  0/32 (0.00%) 
Soft tissue infection  2  0/14 (0.00%)  1/38 (2.63%)  0/32 (0.00%) 
Urinary tract infection  2  0/14 (0.00%)  1/38 (2.63%)  0/32 (0.00%) 
Urinary tract infection enterococcal  2  0/14 (0.00%)  1/38 (2.63%)  0/32 (0.00%) 
Viral upper respiratory tract infection  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Injury, poisoning and procedural complications       
Fall  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Femoral neck fracture  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Femur fracture  2  0/14 (0.00%)  1/38 (2.63%)  0/32 (0.00%) 
Head injury  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Subdural haemorrhage  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Investigations       
Blast cell count increased  2  0/14 (0.00%)  1/38 (2.63%)  1/32 (3.13%) 
Blood bilirubin increased  2  0/14 (0.00%)  1/38 (2.63%)  0/32 (0.00%) 
Bone marrow myelogram abnormal  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Megakaryocytes decreased  2  0/14 (0.00%)  1/38 (2.63%)  0/32 (0.00%) 
Metabolism and nutrition disorders       
Dehydration  2  1/14 (7.14%)  1/38 (2.63%)  1/32 (3.13%) 
Decreased appetite  2  1/14 (7.14%)  0/38 (0.00%)  1/32 (3.13%) 
Fluid overload  2  1/14 (7.14%)  0/38 (0.00%)  1/32 (3.13%) 
Hyponatraemia  2  0/14 (0.00%)  2/38 (5.26%)  0/32 (0.00%) 
Tumour lysis syndrome  2  1/14 (7.14%)  0/38 (0.00%)  1/32 (3.13%) 
Failure to thrive  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Hyperglycaemia  2  0/14 (0.00%)  1/38 (2.63%)  0/32 (0.00%) 
Hypoglycaemia  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  2  1/14 (7.14%)  1/38 (2.63%)  1/32 (3.13%) 
Arthritis  2  1/14 (7.14%)  1/38 (2.63%)  0/32 (0.00%) 
Back pain  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Haemarthrosis  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Osteoarthritis  2  0/14 (0.00%)  1/38 (2.63%)  0/32 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Breast cancer metastatic  2  0/14 (0.00%)  1/38 (2.63%)  0/32 (0.00%) 
Leukaemic infiltration extramedullary  2  0/14 (0.00%)  1/38 (2.63%)  0/32 (0.00%) 
Squamous cell carcinoma of skin  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Vulval cancer stage 0  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Nervous system disorders       
Syncope  1  1/14 (7.14%)  0/38 (0.00%)  2/32 (6.25%) 
Central nervous system lesion  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Cerebrovascular accident  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Depressed level of consciousness  2  0/14 (0.00%)  1/38 (2.63%)  0/32 (0.00%) 
Haemorrhage intracranial  2  0/14 (0.00%)  1/38 (2.63%)  0/32 (0.00%) 
Status epilepticus  2  0/14 (0.00%)  1/38 (2.63%)  0/32 (0.00%) 
Subarachnoid haemorrhage  2  0/14 (0.00%)  1/38 (2.63%)  0/32 (0.00%) 
Transient ischaemic attack  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Renal and urinary disorders       
Renal failure acute  2  0/14 (0.00%)  2/38 (5.26%)  0/32 (0.00%) 
Renal failure  2  0/14 (0.00%)  1/38 (2.63%)  0/32 (0.00%) 
Urinary retention  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  2  1/14 (7.14%)  1/38 (2.63%)  1/32 (3.13%) 
Pulmonary haemorrhage  2  2/14 (14.29%)  1/38 (2.63%)  0/32 (0.00%) 
Acute respiratory distress syndrome  2  1/14 (7.14%)  0/38 (0.00%)  1/32 (3.13%) 
Acute respiratory failure  2  1/14 (7.14%)  1/38 (2.63%)  0/32 (0.00%) 
Epistaxis  2  0/14 (0.00%)  1/38 (2.63%)  1/32 (3.13%) 
Hypoxia  2  1/14 (7.14%)  1/38 (2.63%)  0/32 (0.00%) 
Pleural effusion  1  1/14 (7.14%)  0/38 (0.00%)  1/32 (3.13%) 
Pulmonary embolism  1  0/14 (0.00%)  1/38 (2.63%)  1/32 (3.13%) 
Pulmonary infarction  2  2/14 (14.29%)  0/38 (0.00%)  0/32 (0.00%) 
Chronic obstructive pulmonary disease  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Interstitial lung disease  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Pulmonary oedema  2  0/14 (0.00%)  1/38 (2.63%)  0/32 (0.00%) 
Respiratory failure  2  0/14 (0.00%)  0/38 (0.00%)  1/32 (3.13%) 
Skin and subcutaneous tissue disorders       
Angioedema  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Erythema multiforme  2  0/14 (0.00%)  1/38 (2.63%)  0/32 (0.00%) 
Rash maculo-papular  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Vascular disorders       
Deep vein thrombosis  2  1/14 (7.14%)  1/38 (2.63%)  0/32 (0.00%) 
Hypotension  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Orthostatic hypotension  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
1
Term from vocabulary, MedDRA 17.0
2
Term from vocabulary, MedDRA 19.0
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%
Lenalidomide Azacitidine Plus Lenalidomide Azacitidine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/14 (100.00%)   38/38 (100.00%)   32/32 (100.00%) 
Blood and lymphatic system disorders       
Anaemia  2  6/14 (42.86%)  11/38 (28.95%)  10/32 (31.25%) 
Thrombocytopenia  1  3/14 (21.43%)  11/38 (28.95%)  11/32 (34.38%) 
Neutropenia  2  4/14 (28.57%)  6/38 (15.79%)  9/32 (28.13%) 
Febrile neutropenia  2  0/14 (0.00%)  6/38 (15.79%)  2/32 (6.25%) 
Pancytopenia  2  2/14 (14.29%)  2/38 (5.26%)  1/32 (3.13%) 
Leukocytosis  2  2/14 (14.29%)  1/38 (2.63%)  1/32 (3.13%) 
Leukopenia  2  0/14 (0.00%)  0/38 (0.00%)  2/32 (6.25%) 
Autoimmune haemolytic anaemia  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Spleen disorder  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Splenic lesion  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Cardiac disorders       
Atrial fibrillation  1  2/14 (14.29%)  5/38 (13.16%)  1/32 (3.13%) 
Tachycardia  2  1/14 (7.14%)  2/38 (5.26%)  5/32 (15.63%) 
Angina pectoris  2  1/14 (7.14%)  2/38 (5.26%)  1/32 (3.13%) 
Bradycardia  1  0/14 (0.00%)  4/38 (10.53%)  0/32 (0.00%) 
Sinus tachycardia  2  0/14 (0.00%)  2/38 (5.26%)  2/32 (6.25%) 
Atrial flutter  2  1/14 (7.14%)  1/38 (2.63%)  0/32 (0.00%) 
Cardiac failure congestive  2  1/14 (7.14%)  1/38 (2.63%)  0/32 (0.00%) 
Cardiac disorder  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Supraventricular tachycardia  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Ear and labyrinth disorders       
Ear congestion  2  0/14 (0.00%)  2/38 (5.26%)  0/32 (0.00%) 
Ear discomfort  2  0/14 (0.00%)  0/38 (0.00%)  2/32 (6.25%) 
Hypoacusis  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Eye disorders       
Vision blurred  2  2/14 (14.29%)  2/38 (5.26%)  1/32 (3.13%) 
Erythema of eyelid  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Eye inflammation  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Lacrimation increased  1  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Gastrointestinal disorders       
Constipation  1  7/14 (50.00%)  24/38 (63.16%)  17/32 (53.13%) 
Nausea  2  4/14 (28.57%)  19/38 (50.00%)  22/32 (68.75%) 
Diarrhoea  2  5/14 (35.71%)  19/38 (50.00%)  8/32 (25.00%) 
Vomiting  2  3/14 (21.43%)  7/38 (18.42%)  12/32 (37.50%) 
Abdominal pain  2  1/14 (7.14%)  5/38 (13.16%)  6/32 (18.75%) 
Oral disorder  2  3/14 (21.43%)  3/38 (7.89%)  1/32 (3.13%) 
Stomatitis  2  0/14 (0.00%)  4/38 (10.53%)  3/32 (9.38%) 
Dysphagia  2  0/14 (0.00%)  5/38 (13.16%)  1/32 (3.13%) 
Haemorrhoids  2  0/14 (0.00%)  2/38 (5.26%)  3/32 (9.38%) 
Dry mouth  2  0/14 (0.00%)  3/38 (7.89%)  1/32 (3.13%) 
Dyspepsia  2  0/14 (0.00%)  2/38 (5.26%)  2/32 (6.25%) 
Gastrooesophageal reflux disease  2  2/14 (14.29%)  1/38 (2.63%)  1/32 (3.13%) 
Oral pain  2  1/14 (7.14%)  2/38 (5.26%)  1/32 (3.13%) 
Abdominal distension  2  1/14 (7.14%)  1/38 (2.63%)  1/32 (3.13%) 
Mouth haemorrhage  2  1/14 (7.14%)  1/38 (2.63%)  1/32 (3.13%) 
Rectal haemorrhage  2  0/14 (0.00%)  1/38 (2.63%)  2/32 (6.25%) 
Tongue ulceration  2  1/14 (7.14%)  2/38 (5.26%)  0/32 (0.00%) 
Toothache  2  1/14 (7.14%)  2/38 (5.26%)  0/32 (0.00%) 
Faeces discoloured  2  2/14 (14.29%)  0/38 (0.00%)  0/32 (0.00%) 
Flatulence  2  1/14 (7.14%)  0/38 (0.00%)  1/32 (3.13%) 
Gingival bleeding  2  0/14 (0.00%)  0/38 (0.00%)  2/32 (6.25%) 
Abdominal tenderness  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Gastrointestinal haemorrhage  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Odynophagia  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Tongue coated  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
General disorders       
Fatigue  2  8/14 (57.14%)  15/38 (39.47%)  14/32 (43.75%) 
Oedema peripheral  2  6/14 (42.86%)  7/38 (18.42%)  7/32 (21.88%) 
Pyrexia  2  3/14 (21.43%)  9/38 (23.68%)  8/32 (25.00%) 
Asthenia  2  4/14 (28.57%)  7/38 (18.42%)  3/32 (9.38%) 
Chills  2  3/14 (21.43%)  5/38 (13.16%)  2/32 (6.25%) 
Injection site erythema  2  0/14 (0.00%)  4/38 (10.53%)  6/32 (18.75%) 
Injection site reaction  2  0/14 (0.00%)  3/38 (7.89%)  6/32 (18.75%) 
Injection site pain  2  0/14 (0.00%)  7/38 (18.42%)  1/32 (3.13%) 
Pain  2  0/14 (0.00%)  4/38 (10.53%)  3/32 (9.38%) 
Mucosal inflammation  2  1/14 (7.14%)  4/38 (10.53%)  1/32 (3.13%) 
Device occlusion  2  1/14 (7.14%)  1/38 (2.63%)  2/32 (6.25%) 
Injection site bruising  2  0/14 (0.00%)  1/38 (2.63%)  3/32 (9.38%) 
Injection site irritation  2  0/14 (0.00%)  2/38 (5.26%)  2/32 (6.25%) 
Non-cardiac chest pain  2  1/14 (7.14%)  1/38 (2.63%)  2/32 (6.25%) 
Catheter site pain  2  0/14 (0.00%)  0/38 (0.00%)  2/32 (6.25%) 
Face oedema  1  0/14 (0.00%)  2/38 (5.26%)  0/32 (0.00%) 
Facial pain  1  0/14 (0.00%)  2/38 (5.26%)  0/32 (0.00%) 
Gait disturbance  1  0/14 (0.00%)  2/38 (5.26%)  0/32 (0.00%) 
Generalised oedema  2  1/14 (7.14%)  1/38 (2.63%)  0/32 (0.00%) 
Injection site discomfort  2  0/14 (0.00%)  0/38 (0.00%)  2/32 (6.25%) 
Localised oedema  2  1/14 (7.14%)  1/38 (2.63%)  0/32 (0.00%) 
Malaise  2  0/14 (0.00%)  0/38 (0.00%)  2/32 (6.25%) 
Mucosal haemorrhage  2  1/14 (7.14%)  1/38 (2.63%)  0/32 (0.00%) 
Oedema  2  0/14 (0.00%)  0/38 (0.00%)  2/32 (6.25%) 
Feeling abnormal  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Local swelling  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Hepatobiliary disorders       
Hyperbilirubinaemia  2  1/14 (7.14%)  2/38 (5.26%)  0/32 (0.00%) 
Infections and infestations       
Pneumonia  1  3/14 (21.43%)  4/38 (10.53%)  4/32 (12.50%) 
Cellulitis  2  1/14 (7.14%)  5/38 (13.16%)  4/32 (12.50%) 
Urinary tract infection  2  1/14 (7.14%)  3/38 (7.89%)  6/32 (18.75%) 
Upper respiratory tract infection  2  0/14 (0.00%)  6/38 (15.79%)  3/32 (9.38%) 
Herpes simplex  2  2/14 (14.29%)  4/38 (10.53%)  1/32 (3.13%) 
Oral candidiasis  2  2/14 (14.29%)  2/38 (5.26%)  3/32 (9.38%) 
Herpes zoster  2  1/14 (7.14%)  0/38 (0.00%)  3/32 (9.38%) 
Nasopharyngitis  2  0/14 (0.00%)  2/38 (5.26%)  2/32 (6.25%) 
Respiratory tract infection  2  0/14 (0.00%)  4/38 (10.53%)  0/32 (0.00%) 
Sinusitis  2  0/14 (0.00%)  3/38 (7.89%)  1/32 (3.13%) 
Fungal infection  2  1/14 (7.14%)  1/38 (2.63%)  1/32 (3.13%) 
Furuncle  2  0/14 (0.00%)  3/38 (7.89%)  0/32 (0.00%) 
Hordeolum  2  0/14 (0.00%)  2/38 (5.26%)  1/32 (3.13%) 
Oral herpes  2  0/14 (0.00%)  1/38 (2.63%)  2/32 (6.25%) 
Rash pustular  2  1/14 (7.14%)  2/38 (5.26%)  0/32 (0.00%) 
Tooth abscess  2  0/14 (0.00%)  1/38 (2.63%)  2/32 (6.25%) 
Clostridium difficile colitis  2  0/14 (0.00%)  0/38 (0.00%)  2/32 (6.25%) 
Ear infection  2  1/14 (7.14%)  1/38 (2.63%)  0/32 (0.00%) 
Mucosal infection  2  0/14 (0.00%)  2/38 (5.26%)  0/32 (0.00%) 
Osteomyelitis  2  0/14 (0.00%)  2/38 (5.26%)  0/32 (0.00%) 
Tooth infection  2  0/14 (0.00%)  2/38 (5.26%)  0/32 (0.00%) 
Body tinea  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Injury, poisoning and procedural complications       
Contusion  2  1/14 (7.14%)  5/38 (13.16%)  6/32 (18.75%) 
Fall  2  1/14 (7.14%)  3/38 (7.89%)  1/32 (3.13%) 
Procedural pain  2  1/14 (7.14%)  1/38 (2.63%)  2/32 (6.25%) 
Scratch  2  0/14 (0.00%)  1/38 (2.63%)  2/32 (6.25%) 
Transfusion reaction  2  1/14 (7.14%)  0/38 (0.00%)  2/32 (6.25%) 
Wound  2  0/14 (0.00%)  2/38 (5.26%)  0/32 (0.00%) 
Cartilage injury  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Ligament sprain  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Muscle injury  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Muscle rupture  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Upper limb fracture  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Investigations       
Weight decreased  1  5/14 (35.71%)  15/38 (39.47%)  10/32 (31.25%) 
Neutrophil count decreased  2  0/14 (0.00%)  5/38 (13.16%)  4/32 (12.50%) 
White blood cell count decreased  2  0/14 (0.00%)  4/38 (10.53%)  5/32 (15.63%) 
Platelet count decreased  1  0/14 (0.00%)  6/38 (15.79%)  2/32 (6.25%) 
Alanine aminotransferase increased  2  1/14 (7.14%)  5/38 (13.16%)  0/32 (0.00%) 
Aspartate aminotransferase increased  2  0/14 (0.00%)  5/38 (13.16%)  1/32 (3.13%) 
Blood magnesium decreased  2  1/14 (7.14%)  4/38 (10.53%)  0/32 (0.00%) 
Blood creatinine increased  2  1/14 (7.14%)  2/38 (5.26%)  1/32 (3.13%) 
Cardiac murmur  2  3/14 (21.43%)  1/38 (2.63%)  0/32 (0.00%) 
International normalised ratio increased  2  1/14 (7.14%)  3/38 (7.89%)  0/32 (0.00%) 
Lymphocyte count decreased  2  1/14 (7.14%)  2/38 (5.26%)  1/32 (3.13%) 
Blood bilirubin increased  2  0/14 (0.00%)  2/38 (5.26%)  1/32 (3.13%) 
Transaminases increased  2  2/14 (14.29%)  1/38 (2.63%)  0/32 (0.00%) 
Weight increased  2  1/14 (7.14%)  1/38 (2.63%)  1/32 (3.13%) 
Blood alkaline phosphatase increased  2  1/14 (7.14%)  1/38 (2.63%)  0/32 (0.00%) 
Oxygen saturation decreased  2  0/14 (0.00%)  2/38 (5.26%)  0/32 (0.00%) 
Staphylococcus test positive  2  1/14 (7.14%)  1/38 (2.63%)  0/32 (0.00%) 
Vitamin D decreased  2  0/14 (0.00%)  0/38 (0.00%)  2/32 (6.25%) 
Activated partial thromboplastin time abnormal  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Clostridium test positive  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Electrocardiogram QT prolonged  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite  1  4/14 (28.57%)  18/38 (47.37%)  10/32 (31.25%) 
Hypokalaemia  2  7/14 (50.00%)  12/38 (31.58%)  8/32 (25.00%) 
Hypomagnesaemia  2  0/14 (0.00%)  8/38 (21.05%)  2/32 (6.25%) 
Hyponatraemia  2  2/14 (14.29%)  5/38 (13.16%)  2/32 (6.25%) 
Hypocalcaemia  2  2/14 (14.29%)  2/38 (5.26%)  4/32 (12.50%) 
Hypoalbuminaemia  2  4/14 (28.57%)  3/38 (7.89%)  0/32 (0.00%) 
Dehydration  2  1/14 (7.14%)  1/38 (2.63%)  4/32 (12.50%) 
Hypophosphataemia  2  0/14 (0.00%)  5/38 (13.16%)  1/32 (3.13%) 
Hyperglycaemia  2  2/14 (14.29%)  2/38 (5.26%)  1/32 (3.13%) 
Fluid overload  2  0/14 (0.00%)  3/38 (7.89%)  0/32 (0.00%) 
Hypoglycaemia  2  0/14 (0.00%)  1/38 (2.63%)  2/32 (6.25%) 
Hypovolaemia  2  0/14 (0.00%)  0/38 (0.00%)  2/32 (6.25%) 
Failure to thrive  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Glucose tolerance impaired  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Hyperphosphataemia  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Hyperuricaemia  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Vitamin K deficiency  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  2  3/14 (21.43%)  8/38 (21.05%)  11/32 (34.38%) 
Back pain  2  1/14 (7.14%)  3/38 (7.89%)  9/32 (28.13%) 
Pain in extremity  2  1/14 (7.14%)  7/38 (18.42%)  3/32 (9.38%) 
Muscular weakness  2  1/14 (7.14%)  7/38 (18.42%)  0/32 (0.00%) 
Muscle spasms  2  1/14 (7.14%)  3/38 (7.89%)  2/32 (6.25%) 
Neck pain  2  0/14 (0.00%)  2/38 (5.26%)  4/32 (12.50%) 
Arthritis  2  1/14 (7.14%)  3/38 (7.89%)  0/32 (0.00%) 
Musculoskeletal pain  2  0/14 (0.00%)  1/38 (2.63%)  3/32 (9.38%) 
Myalgia  2  0/14 (0.00%)  3/38 (7.89%)  1/32 (3.13%) 
Joint swelling  2  1/14 (7.14%)  1/38 (2.63%)  1/32 (3.13%) 
Arthropathy  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Bursitis  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Osteoarthritis  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Renal neoplasm  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Nervous system disorders       
Dizziness  1  3/14 (21.43%)  12/38 (31.58%)  6/32 (18.75%) 
Headache  2  1/14 (7.14%)  9/38 (23.68%)  4/32 (12.50%) 
Dysgeusia  2  1/14 (7.14%)  6/38 (15.79%)  3/32 (9.38%) 
Syncope  2  2/14 (14.29%)  2/38 (5.26%)  3/32 (9.38%) 
Tremor  2  0/14 (0.00%)  4/38 (10.53%)  0/32 (0.00%) 
Neuropathy peripheral  2  1/14 (7.14%)  1/38 (2.63%)  1/32 (3.13%) 
Balance disorder  2  0/14 (0.00%)  2/38 (5.26%)  0/32 (0.00%) 
Hypoaesthesia  2  0/14 (0.00%)  2/38 (5.26%)  0/32 (0.00%) 
Paraesthesia  2  0/14 (0.00%)  2/38 (5.26%)  0/32 (0.00%) 
Presyncope  2  0/14 (0.00%)  0/38 (0.00%)  2/32 (6.25%) 
Psychiatric disorders       
Insomnia  2  4/14 (28.57%)  8/38 (21.05%)  2/32 (6.25%) 
Anxiety  2  0/14 (0.00%)  10/38 (26.32%)  3/32 (9.38%) 
Depression  2  1/14 (7.14%)  4/38 (10.53%)  4/32 (12.50%) 
Confusional state  1  1/14 (7.14%)  4/38 (10.53%)  2/32 (6.25%) 
Agitation  2  1/14 (7.14%)  2/38 (5.26%)  2/32 (6.25%) 
Mental status changes  2  1/14 (7.14%)  2/38 (5.26%)  2/32 (6.25%) 
Delirium  2  0/14 (0.00%)  3/38 (7.89%)  0/32 (0.00%) 
Renal and urinary disorders       
Dysuria  2  0/14 (0.00%)  3/38 (7.89%)  4/32 (12.50%) 
Haematuria  2  0/14 (0.00%)  5/38 (13.16%)  0/32 (0.00%) 
Renal failure acute  2  0/14 (0.00%)  2/38 (5.26%)  2/32 (6.25%) 
Urinary retention  2  1/14 (7.14%)  1/38 (2.63%)  1/32 (3.13%) 
Pollakiuria  2  0/14 (0.00%)  2/38 (5.26%)  0/32 (0.00%) 
Renal cyst  2  0/14 (0.00%)  2/38 (5.26%)  0/32 (0.00%) 
Renal failure  2  1/14 (7.14%)  1/38 (2.63%)  0/32 (0.00%) 
Azotaemia  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Renal disorder  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Renal tubular necrosis  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  5/14 (35.71%)  12/38 (31.58%)  8/32 (25.00%) 
Dyspnoea  2  3/14 (21.43%)  16/38 (42.11%)  4/32 (12.50%) 
Epistaxis  2  2/14 (14.29%)  6/38 (15.79%)  6/32 (18.75%) 
Oropharyngeal pain  2  1/14 (7.14%)  7/38 (18.42%)  2/32 (6.25%) 
Pleural effusion  2  1/14 (7.14%)  2/38 (5.26%)  5/32 (15.63%) 
Productive cough  2  0/14 (0.00%)  3/38 (7.89%)  3/32 (9.38%) 
Rhinorrhoea  2  1/14 (7.14%)  4/38 (10.53%)  1/32 (3.13%) 
Haemoptysis  2  1/14 (7.14%)  2/38 (5.26%)  2/32 (6.25%) 
Hypoxia  2  1/14 (7.14%)  4/38 (10.53%)  0/32 (0.00%) 
Pulmonary oedema  2  1/14 (7.14%)  4/38 (10.53%)  0/32 (0.00%) 
Chronic obstructive pulmonary disease  2  0/14 (0.00%)  3/38 (7.89%)  1/32 (3.13%) 
Dyspnoea exertional  2  0/14 (0.00%)  1/38 (2.63%)  3/32 (9.38%) 
Acute respiratory failure  2  0/14 (0.00%)  3/38 (7.89%)  0/32 (0.00%) 
Dysphonia  2  0/14 (0.00%)  3/38 (7.89%)  0/32 (0.00%) 
Pleuritic pain  1  1/14 (7.14%)  2/38 (5.26%)  0/32 (0.00%) 
Pulmonary mass  2  0/14 (0.00%)  2/38 (5.26%)  1/32 (3.13%) 
Tachypnoea  2  1/14 (7.14%)  0/38 (0.00%)  2/32 (6.25%) 
Wheezing  2  0/14 (0.00%)  2/38 (5.26%)  1/32 (3.13%) 
Laryngeal inflammation  2  0/14 (0.00%)  2/38 (5.26%)  0/32 (0.00%) 
Lung infiltration  2  2/14 (14.29%)  0/38 (0.00%)  0/32 (0.00%) 
Pneumonitis  2  1/14 (7.14%)  1/38 (2.63%)  0/32 (0.00%) 
Rales  2  2/14 (14.29%)  0/38 (0.00%)  0/32 (0.00%) 
Sinus congestion  2  0/14 (0.00%)  2/38 (5.26%)  0/32 (0.00%) 
Lung disorder  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Pulmonary hypertension  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Respiratory distress  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Skin and subcutaneous tissue disorders       
Pruritus  2  3/14 (21.43%)  14/38 (36.84%)  2/32 (6.25%) 
Rash  2  3/14 (21.43%)  10/38 (26.32%)  6/32 (18.75%) 
Erythema  2  0/14 (0.00%)  7/38 (18.42%)  2/32 (6.25%) 
Petechiae  2  3/14 (21.43%)  4/38 (10.53%)  1/32 (3.13%) 
Rash generalised  2  2/14 (14.29%)  4/38 (10.53%)  2/32 (6.25%) 
Rash maculo-papular  2  0/14 (0.00%)  4/38 (10.53%)  2/32 (6.25%) 
Night sweats  2  0/14 (0.00%)  3/38 (7.89%)  1/32 (3.13%) 
Decubitus ulcer  2  1/14 (7.14%)  1/38 (2.63%)  1/32 (3.13%) 
Hyperhidrosis  2  1/14 (7.14%)  1/38 (2.63%)  1/32 (3.13%) 
Pruritus generalised  2  0/14 (0.00%)  2/38 (5.26%)  1/32 (3.13%) 
Rash erythematous  2  1/14 (7.14%)  2/38 (5.26%)  0/32 (0.00%) 
Blister  2  0/14 (0.00%)  2/38 (5.26%)  0/32 (0.00%) 
Ecchymosis  2  0/14 (0.00%)  2/38 (5.26%)  0/32 (0.00%) 
Rash macular  1  1/14 (7.14%)  0/38 (0.00%)  1/32 (3.13%) 
Skin discolouration  2  0/14 (0.00%)  2/38 (5.26%)  0/32 (0.00%) 
Skin exfoliation  2  1/14 (7.14%)  0/38 (0.00%)  1/32 (3.13%) 
Skin lesion  2  0/14 (0.00%)  0/38 (0.00%)  2/32 (6.25%) 
Skin ulcer  2  1/14 (7.14%)  0/38 (0.00%)  1/32 (3.13%) 
Urticaria  2  1/14 (7.14%)  0/38 (0.00%)  1/32 (3.13%) 
Dermal cyst  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
Vascular disorders       
Hypotension  2  4/14 (28.57%)  6/38 (15.79%)  1/32 (3.13%) 
Hypertension  2  1/14 (7.14%)  3/38 (7.89%)  2/32 (6.25%) 
Deep vein thrombosis  2  1/14 (7.14%)  1/38 (2.63%)  2/32 (6.25%) 
Orthostatic hypotension  2  0/14 (0.00%)  2/38 (5.26%)  0/32 (0.00%) 
Thrombophlebitis superficial  2  1/14 (7.14%)  0/38 (0.00%)  1/32 (3.13%) 
Venous thrombosis limb  2  1/14 (7.14%)  1/38 (2.63%)  0/32 (0.00%) 
Phlebitis  2  1/14 (7.14%)  0/38 (0.00%)  0/32 (0.00%) 
1
Term from vocabulary, MedDRA 17.0
2
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Accrual to the lenalidomide arm was stopped before ending accrual to the 2 other arms because of poor tolerability and no comparison of outcomes was planned.
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 1 year 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 Manager, Clinical Trial Disclosure
Organization: Celgene Corporation
Phone: 888-260-1599
EMail: ClinicalTrialDisclosure@celgene.com
Layout table for additonal information
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01358734     History of Changes
Other Study ID Numbers: CC-5013-AML-001
First Submitted: May 19, 2011
First Posted: May 24, 2011
Results First Submitted: April 4, 2016
Results First Posted: July 4, 2016
Last Update Posted: June 25, 2019