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Trial record 39 of 371 for:    LENALIDOMIDE AND Dexamethasone

A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT00424047
Recruitment Status : Completed
First Posted : January 18, 2007
Results First Posted : March 4, 2015
Last Update Posted : October 19, 2017
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: CC-5013 plus dexamethasone
Drug: Dexamethasone plus Placebo
Enrollment 351
Recruitment Details The study was conducted at 55 sites in Australia, Europe, and Israel. Eligible participants were randomized in a 1:1 ratio to: lenalidomide plus oral pulse high-dose dexamethasone or Placebo plus oral pulse high-dose dexamethasone.
Pre-assignment Details A pre-specified interim analysis revealed a highly significant benefit favoring the lenalidomide/dexamethasone regimen, crossing the pre-specified O'Brien-Fleming superiority boundary. A decision was made to unblind the study allowing those receiving Placebo/dexamethasone to receive the lenalidomide/dexamethasone regimen.
Arm/Group Title Lenalidomide Plus Dexamethasone (Len/Dex) Placebo Plus Dexamethasone
Hide Arm/Group Description

Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.

Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.

Placebo PO daily on Days 1 to 28 of each 28 day cycle.

Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.

Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.

After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression.

Period Title: Blinded Treatment (Up to 03 Aug 2005)
Started 176 175
Safety Population 176 [1] 175 [1]
Evaluable Population 175 [2] 171 [3]
Completed 54 [4] 19 [5]
Not Completed 122 156
Reason Not Completed
Adverse Event             18             12
Progression of disease             67             122
Lack of therapeutic effect             1             3
Withdrawal by Subject             23             8
Death             11             10
Other             2             1
[1]
Includes those who took at least one dose of study medication regimen
[2]
1 participant excluded because they had no baseline M-protein assessment
[3]
4 participants excluded because they had no baseline M-protein assessment
[4]
54 participants ongoing and continuing on lenalidomide/dexamethasone treatment
[5]
Ongoing and includes 15 participants who crossed over to lenalidomide/dexamethasone after unblinding
Period Title: On Study at Time of Unblinding
Started 176 [1] 175
Completed 21 [2] 8 [3]
Not Completed 155 167
Reason Not Completed
Adverse Event             22             12
Progression of disease             92             128
Lack of Efficacy             1             3
Withdrawal by Subject             24             9
Death             11             11
Other             5             4
[1]
Refers to original treatment group assignment in the study.
[2]
Participants completed = those continuing on long term Lenalidomide and dexamethasone
[3]
Participants completed = those continuing on long term dexamethasone
Period Title: Long Term Extension (Up to 25 Jun 2013)
Started 21 8 [1]
Completed 0 0
Not Completed 21 8
Reason Not Completed
Adverse Event             1             0
Death             0             1
Other             12             4
Progression of Disease             7             3
Withdrawal by Subject             1             0
[1]
2 participants opted to receive dex alone, 3 crossed over to Len/Dex and 3 added Len at a later date
Arm/Group Title Lenalidomide Plus Dexamethasone Placebo Plus Dexamethasone Total
Hide Arm/Group Description

Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.

Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.

Placebo PO daily on Days 1 to 28 of each 28 day cycle.

Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.

Total of all reporting groups
Overall Number of Baseline Participants 176 175 351
Hide Baseline Analysis Population Description
Intent to treat population included all participants who were randomized
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 176 participants 175 participants 351 participants
62.2  (10.12) 62.9  (8.80) 62.6  (9.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 176 participants 175 participants 351 participants
Female
72
  40.9%
72
  41.1%
144
  41.0%
Male
104
  59.1%
103
  58.9%
207
  59.0%
Eastern Cooperative Oncology Group Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 176 participants 175 participants 351 participants
0 = (Fully Active) 78 65 143
1 = (Restrictive but Ambulatory) 72 79 151
2 = Ambulatory unable to Work) 23 27 50
3 = (Limited Self-Care) 0 1 1
4 = (Completely Disabled) 0 0 0
Missing 3 3 6
[1]
Measure Description: Eastern Cooperative Oncology Group (ECOG) Performance Status is used by doctors and researchers to assess how a participants' disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis.
Number of Prior Anti-Myeloma Therapies  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 176 participants 175 participants 351 participants
1 Prior anti-myeloma therapy 56 57 113
2 or more prior anti-myeloma therapies 120 118 238
Time from First Pathological Diagnosis  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 176 participants 175 participants 351 participants
3.4
(0.4 to 15.7)
4.0
(0.3 to 26.6)
3.7
(0.3 to 26.6)
Baseline multiple myeloma stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 176 participants 175 participants 351 participants
Stage I 11 8 19
Stage II 50 57 107
Stage III 115 110 225
[1]
Measure Description:

The International Staging System divides myeloma into 3 stages based only on the serum beta-2 microglobulin and serum albumin levels.

Stage I: Serum beta-2 microglobulin is less than 3.5 (mg/L) and the albumin level is above 3.5 (g/L);

Stage II: Neither stage I or III, meaning that either:

  • The beta-2 microglobulin level is between 3.5 and 5.5 (with any albumin level), OR
  • The albumin is below 3.5 while the beta-2 microglobulin is less than 3.5

Stage III: Serum beta-2 microglobulin is greater than 5.5.

1.Primary Outcome
Title Kaplan-Meier Estimate of Time to Tumor Progression (TTP)
Hide Description Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
Time Frame From randomization up to cut-off date of 03 August 2005; up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat included all participants who were randomized.
Arm/Group Title Lenalidomide Plus Dexamethasone Placebo Plus Dexamethasone
Hide Arm/Group Description:

Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.

Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.

Placebo PO daily on Days 1 to 28 of each 28 day cycle.

Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.

Overall Number of Participants Analyzed 176 175
Median (95% Confidence Interval)
Unit of Measure: weeks
52.1 [1] 
(40.9 to NA)
20.1
(16.6 to 20.7)
[1]
Unable to provide as data not yet estimable
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lenalidomide Plus Dexamethasone, Placebo Plus Dexamethasone
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 Log Rank
Comments The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.324
Confidence Interval (2-Sided) 95%
0.240 to 0.438
Estimation Comments Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (Lenalidomide/Dex:Placebo/Dexamethasone)
2.Primary Outcome
Title Kaplan-Meier Estimate of Time to Tumor Progression (TTP) (Later Cut-off Date of 02 Mar 2008)
Hide Description Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
Time Frame From randomization up to cut-off date of 02 March 2008; up to 51 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat included all participants who were randomized.
Arm/Group Title Lenalidomide Plus Dexamethasone Placebo Plus Dexamethasone
Hide Arm/Group Description:

Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.

Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.

Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days.

Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned. After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression.

Overall Number of Participants Analyzed 176 175
Median (95% Confidence Interval)
Unit of Measure: weeks
52.4
(40.9 to 85.6)
20.1
(16.6 to 20.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lenalidomide Plus Dexamethasone, Placebo Plus Dexamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.362
Confidence Interval (2-Sided) 95%
0.27 to 0.478
Estimation Comments Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)
3.Secondary Outcome
Title Kaplan-Meier Estimate of Overall Survival (OS)
Hide Description OS was calculated as the time from randomization to death from any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.
Time Frame Randomization to data cut off of 03 August 2005; up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population includes all participants who were randomized.
Arm/Group Title Lenalidomide Plus Dexamethasone Placebo Plus Dexamethasone
Hide Arm/Group Description:

Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.

Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.

Placebo PO daily on Days 1 to 28 of each 28 day cycle.

Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.

Overall Number of Participants Analyzed 176 175
Median (95% Confidence Interval)
Unit of Measure: weeks
NA [1] 
(NA to NA)
NA [1] 
(71.6 to NA)
[1]
NA: Data not considered materialized or estimable at this time point
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lenalidomide Plus Dexamethasone, Placebo Plus Dexamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.105
Comments [Not Specified]
Method Log Rank
Comments The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.730
Confidence Interval (2-Sided) 95%
0.498 to 1.070
Estimation Comments Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (Lenalidomide/Dexamethasone:Placebo/Dexamethasone)
4.Secondary Outcome
Title Kaplan-Meier Estimate of Overall Survival (OS) (Later Cut-off Date of 02 March 2008)
Hide Description OS was calculated as the time from randomization to death from any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.
Time Frame Randomization to data cut off of 02 March 2008; up to 51 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population includes all participants who were randomized.
Arm/Group Title Lenalidomide Plus Dexamethasone Placebo Plus Dexamethasone
Hide Arm/Group Description:

Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.

Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.

Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days.

Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.

After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression.

Overall Number of Participants Analyzed 176 175
Median (95% Confidence Interval)
Unit of Measure: weeks
161.9
(129.3 to 201.4)
133.3
(101.6 to 174.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lenalidomide Plus Dexamethasone, Placebo Plus Dexamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.302
Comments [Not Specified]
Method Log Rank
Comments The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.863
Confidence Interval (2-Sided) 95%
0.651 to 1.143
Estimation Comments Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)
5.Secondary Outcome
Title Summary of Myeloma Response Rates Based on Best Response Assessment
Hide Description Complete Response (CR): Disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks . Remission Response (RR):75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR): 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD): Criteria for PR or PD have not been met. Plateau Phase: If PR, stable monoclonal paraprotein values (within 25% above or below nadir)/stable soft tissue plasmacytomas maintained for at least 3 months. Progressive Disease (PD): Reappearance of serum or urinary monoclonal paraprotein on immunofixation or electrophoresis on two consecutive occasions at least one week apart. Increase of percentage of plasma cells in bone marrow aspirate or biopsy to ≥ 5%. Development of at least one new lytic bone lesion or soft tissue plasmacytoma.
Time Frame Randomization to 03 August 2005; up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population includes all participants who were randomized
Arm/Group Title Lenalidomide Plus Dexamethasone Placebo Plus Dexamethasone
Hide Arm/Group Description:

Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.

Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.

Placebo PO daily on Days 1 to 28 of each 28 day cycle.

Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.

Overall Number of Participants Analyzed 176 175
Measure Type: Number
Unit of Measure: percentage of participants
Complete Response (CR) 15.3 4.0
Partial Response (PR) 43.8 19.4
Stable Disease (SD) 29.0 56.6
Progressive Disease (PD) 2.8 14.3
Not Evaluable (NE) those without response data 9.1 5.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lenalidomide Plus Dexamethasone, Placebo Plus Dexamethasone
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 Wilcoxon (Mann-Whitney)
Comments Probability from Wilcoxon rank sum test
6.Secondary Outcome
Title Myeloma Response Rates Based on the Reviewers Best Response Assessment (Later Cut-off Date of 02 March 2008)
Hide Description Complete Response (CR): Disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks . Remission Response (RR):75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR): 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD): Criteria for PR or PD have not been met. Plateau Phase: If PR, stable monoclonal paraprotein values (within 25% above or below nadir)/stable soft tissue plasmacytomas maintained for at least 3 months. Progressive Disease (PD): Reappearance of serum or urinary monoclonal paraprotein on immunofixation or electrophoresis on two consecutive occasions at least one week apart. Increase of percentage of plasma cells in bone marrow aspirate or biopsy to ≥ 5%. Development of at least one new lytic bone lesion or soft tissue plasmacytoma.
Time Frame Randomization to data cut-off of 02 Mar 2008; up to 51 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population includes all participants who were randomized
Arm/Group Title Lenalidomide Plus Dexamethasone Placebo Plus Dexamethasone
Hide Arm/Group Description:

Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.

Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.

Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days.

Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.

After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression.

Overall Number of Participants Analyzed 176 175
Measure Type: Number
Unit of Measure: percentage of participants
Complete Response (CR) 17.0 4.0
Partial Response (PR) 42.6 19.4
Stable Disease (SD) 28.4 56.6
Progressive Disease (PD) 3.4 14.3
Not Evaluable (NE) those without response data 8.5 5.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lenalidomide Plus Dexamethasone, Placebo Plus Dexamethasone
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 Wilcoxon (Mann-Whitney)
Comments Probability from Wilcoxon rank sum test
7.Secondary Outcome
Title Number of Participants With Adverse Events (AE)
Hide Description

An AE is any sign, symptom, illness, or diagnosis that appears or worsens during the course of the study. Treatment-emergent AEs (TEAEs) are any AE occurring or worsening on or after the first treatment of the study drug and within 30 days after the last cycle end date of study drug. A serious AE = any AE which results in death; is life-threatening; requires or prolongs existing inpatient hospitalization; results in persistent or significant disability is a congenital anomaly/birth defect; constitutes an important medical event.

The severity of AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE, Version 2.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required); Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death.

Time Frame From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 25 June 2013; up to 90 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all participants who received at least one dose of study drug regimen
Arm/Group Title Lenalidomide Plus Dexamethasone Placebo Plus Dexamethasone
Hide Arm/Group Description:

Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.

Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.

Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days. Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.

After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression.

Overall Number of Participants Analyzed 176 175
Measure Type: Number
Unit of Measure: participants
≥ 1 Adverse Event 176 175
≥ 1 Serious Adverse Event 105 79
≥ 1 AE leading to study drug discontinuation 46 31
≥ 1 AE leading to dose reduction or interruption 137 100
≥ 1 Drug-Related Adverse Event 160 151
≥ 1 Drug-Related Serious Adverse Event 54 30
≥Death within ≤ 30 days of last dose of study drug 17 20
≥ 1 Grade 1 or Higher Adverse Event 176 175
≥ 1 Grade 2 or Higher Adverse Event 168 167
≥ 1 Grade 3 or Higher Adverse Event 146 119
≥ 1 Grade 4 or Higher Adverse Event 52 37
8.Secondary Outcome
Title Time to First Symptomatic Skeletal-related Event (SRE) (Clinical Need for Radiation or Surgery to Bone)
Hide Description Time from randomization to the date of the first occurrence of a symptomatic SRE (clinical need for radiotherapy or surgery to bone).
Time Frame Up to unblinding data cut off of 03 August 2005; up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis not performed due to an insufficient number of participants with SRE
Arm/Group Title Lenalidomide Plus Dexamethasone Placebo Plus Dexamethasone
Hide Arm/Group Description:

Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.

Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.

Placebo PO daily on Days 1 to 28 of each 28 day cycle.

Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.

Overall Number of Participants Analyzed 176 175
Measure Type: Number
Unit of Measure: participants
NA [1]  NA [1] 
[1]
There were an insufficient number of participants with SRE events and no analysis was conducted.
9.Secondary Outcome
Title Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
Hide Description The time to first worsening of the ECOG performance status was calculated as the time from randomization to the date of the first worsening compared with the last ECOG evaluation obtained prior to randomization. Data were censored at the last date that the participant was known to be unchanged or improved from before randomization for the participants who had not had worsened at the time of the analysis and for the patients who were lost to follow-up before worsening in the ECOG performance status was documented.
Time Frame Randomization to cut off date of 03 August 2005; up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat includes all participants who were randomized to study drug; a total of six ECOG scores were missing at the time of the Aug 2005 cut-off.
Arm/Group Title Lenalidomide Plus Dexamethasone Placebo Plus Dexamethasone
Hide Arm/Group Description:

Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.

Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.

Placebo PO daily on Days 1 to 28 of each 28 day cycle.

Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.

Overall Number of Participants Analyzed 173 172
Median (95% Confidence Interval)
Unit of Measure: weeks
10.1
(8.1 to 16.1)
12.3
(10.1 to 24.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lenalidomide Plus Dexamethasone, Placebo Plus Dexamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.271
Comments The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.166
Confidence Interval (2-Sided) 95%
0.887 to 1.532
Estimation Comments Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (lenalidomide/dexamethasone: placebo/dexamethasone)
10.Secondary Outcome
Title Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale (Later Cut-off Date of 02 March 2008)
Hide Description The time to first worsening of the ECOG performance status was calculated as the time from randomization to the date of the first worsening compared with the last ECOG evaluation obtained prior to randomization. Data were censored at the last date that the participant was known to be unchanged or improved from before randomization for the participants who had not had worsened at the time of the analysis and for the patients who were lost to follow-up before worsening in the ECOG performance status was documented.
Time Frame Randomization to cut off date of 02 March 2008; up to 51 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat includes all participants who were randomized to study drug; six ECOG scores were missing at the March 2008 cut-off.
Arm/Group Title Lenalidomide Plus Dexamethasone Placebo Plus Dexamethasone
Hide Arm/Group Description:

Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.

Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.

Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days. Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.

After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression.

Overall Number of Participants Analyzed 173 172
Median (95% Confidence Interval)
Unit of Measure: weeks
10.1
(8.1 to 16.1)
12.3
(10.1 to 24.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lenalidomide Plus Dexamethasone, Placebo Plus Dexamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.359
Comments The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.135
Confidence Interval (2-Sided) 95%
0.866 to 1.486
Estimation Comments Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)
11.Post-Hoc Outcome
Title Kaplan-Meier Estimate of Duration of Response
Hide Description Duration of response was calculated for responders and defined as the time from the first observation of a response (e.g., the first time that the appropriate decrease in M-protein level was observed for confirmed responders) to the first documented progression or relapse. Response duration was censored at the last adequate assessment showing evidence of no progression.
Time Frame Up to data cut off of 03 August 2005; up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population includes all participants who were randomized to study drug.
Arm/Group Title Lenalidomide Plus Dexamethasone Placebo Plus Dexamethasone
Hide Arm/Group Description:

Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.

Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.

Placebo PO daily on Days 1 to 28 of each 28 day cycle.

Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.

Overall Number of Participants Analyzed 104 41
Median (95% Confidence Interval)
Unit of Measure: weeks
67.6 [1] 
(42.1 to NA)
33.3
(22.1 to 51.6)
[1]
NA: Data not considered materialized or estimable at this time point
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lenalidomide Plus Dexamethasone, Placebo Plus Dexamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments [Not Specified]
Method Log Rank
Comments The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.558
Confidence Interval (2-Sided) 95%
0.338 to 0.921
Estimation Comments Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (lenalidomide/dexamethasone : placebo/dexamethasone).
12.Post-Hoc Outcome
Title Kaplan-Meier Estimate of Duration of Response (Cut-off at a Later Date of 03 March 2008)
Hide Description Duration of response was calculated for responders and defined as the time from the first observation of a response (e.g., the first time that the appropriate decrease in M-protein level was observed for confirmed responders) to the first documented progression or relapse. Response duration was censored at the last adequate assessment showing evidence of no progression.
Time Frame Up to data cut off of 03 Mar 2008; up to 51 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population includes all participants who were randomized to study drug.
Arm/Group Title Lenalidomide Plus Dexamethasone Placebo Plus Dexamethasone
Hide Arm/Group Description:

Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.

Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.

Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days. Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.

After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression.

Overall Number of Participants Analyzed 105 41
Median (95% Confidence Interval)
Unit of Measure: weeks
68.1
(42.1 to 105.6)
33.3
(22.1 to 51.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lenalidomide Plus Dexamethasone, Placebo Plus Dexamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.032
Comments [Not Specified]
Method Log Rank
Comments The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.619
Confidence Interval (2-Sided) 95%
0.398 to 0.964
Estimation Comments Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)
Time Frame From first dose of study drug to 30 days after the last visit. Up to 25 Jun 2013 (90 Months).
Adverse Event Reporting Description Includes adverse events for those who received Lenalidomide after unblinding.
 
Arm/Group Title Lenalidomide Plus Dexamethasone Placebo Plus Dexamethasone
Hide Arm/Group Description

Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.

Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.

Placebo PO daily on Days 1 to 28 of each 28 day cycle.

Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.

All-Cause Mortality
Lenalidomide Plus Dexamethasone Placebo Plus Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide Plus Dexamethasone Placebo Plus Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   105/176 (59.66%)   79/175 (45.14%) 
Blood and lymphatic system disorders     
ANAEMIA NOS  2  4/176 (2.27%)  1/175 (0.57%) 
THROMBOCYTOPENIA  2  2/176 (1.14%)  3/175 (1.71%) 
NEUTROPENIA  2  3/176 (1.70%)  1/175 (0.57%) 
FEBRILE NEUTROPENIA  2  4/176 (2.27%)  0/175 (0.00%) 
PANCYTOPENIA  2  0/176 (0.00%)  2/175 (1.14%) 
HYPERVISCOSITY SYNDROME  2  1/176 (0.57%)  0/175 (0.00%) 
THROMBOTIC THROMBOCYTOPENIC PURPURA  2  1/176 (0.57%)  0/175 (0.00%) 
Cardiac disorders     
PULMONARY OEDEMA NOS  2  1/176 (0.57%)  3/175 (1.71%) 
ATRIAL FIBRILLATION  2  2/176 (1.14%)  1/175 (0.57%) 
MYOCARDIAL INFARCTION  2  1/176 (0.57%)  2/175 (1.14%) 
ACUTE CORONARY SYNDROME  2  1/176 (0.57%)  0/175 (0.00%) 
ACUTE MYOCARDIAL INFARCTION  2  1/176 (0.57%)  0/175 (0.00%) 
ANGINA UNSTABLE  2  0/176 (0.00%)  1/175 (0.57%) 
CARDIAC FAILURE ACUTE  2  0/176 (0.00%)  1/175 (0.57%) 
CARDIAC FAILURE CONGESTIVE  2  1/176 (0.57%)  0/175 (0.00%) 
CARDIAC FAILURE NOS  2  0/176 (0.00%)  1/175 (0.57%) 
CARDIO-RESPIRATORY ARREST  2  0/176 (0.00%)  1/175 (0.57%) 
CORONARY ARTERY STENOSIS  2  0/176 (0.00%)  1/175 (0.57%) 
MYOCARDIAL ISCHAEMIA  2  0/176 (0.00%)  1/175 (0.57%) 
VENTRICULAR BIGEMINY  2  0/176 (0.00%)  1/175 (0.57%) 
Endocrine disorders     
ACQUIRED HYPOTHYROIDISM  2  0/176 (0.00%)  1/175 (0.57%) 
ADRENAL INSUFFICIENCY NOS  2  0/176 (0.00%)  1/175 (0.57%) 
Eye disorders     
CORNEAL ULCER  2  1/176 (0.57%)  0/175 (0.00%) 
EXOPHTHALMOS NOS  2  0/176 (0.00%)  1/175 (0.57%) 
Gastrointestinal disorders     
DIARRHOEA NOS  2  2/176 (1.14%)  2/175 (1.14%) 
CONSTIPATION  2  1/176 (0.57%)  1/175 (0.57%) 
MELAENA  2  0/176 (0.00%)  2/175 (1.14%) 
OESOPHAGEAL VARICES HAEMORRHAGE  2  1/176 (0.57%)  1/175 (0.57%) 
OESOPHAGITIS NOS  2  1/176 (0.57%)  1/175 (0.57%) 
UPPER GASTROINTESTINAL HAEMORRHAGE  2  0/176 (0.00%)  2/175 (1.14%) 
ABDOMINAL PAIN NOS  2  1/176 (0.57%)  0/175 (0.00%) 
ABDOMINAL PAIN UPPER  2  0/176 (0.00%)  1/175 (0.57%) 
CAECITIS  2  1/176 (0.57%)  0/175 (0.00%) 
COLOVESICAL FISTULA  2  0/176 (0.00%)  1/175 (0.57%) 
DIVERTICULITIS INTESTINAL  2  0/176 (0.00%)  1/175 (0.57%) 
DIVERTICULITIS NOS  2  1/176 (0.57%)  0/175 (0.00%) 
GASTRIC ULCER  2  0/176 (0.00%)  1/175 (0.57%) 
GASTRITIS NOS  2  1/176 (0.57%)  0/175 (0.00%) 
GASTROENTERITIS NOS  2  1/176 (0.57%)  0/175 (0.00%) 
GASTROINTESTINAL HAEMORRHAGE NOS  2  1/176 (0.57%)  0/175 (0.00%) 
NAUSEA  2  1/176 (0.57%)  0/175 (0.00%) 
OESOPHAGITIS ULCERATIVE  2  0/176 (0.00%)  1/175 (0.57%) 
PEPTIC ULCER HAEMORRHAGE  2  1/176 (0.57%)  0/175 (0.00%) 
VOMITING NOS  2  1/176 (0.57%)  0/175 (0.00%) 
General disorders     
PYREXIA  2  6/176 (3.41%)  7/175 (4.00%) 
GENERAL PHYSICAL HEALTH DETERIORATION  2  4/176 (2.27%)  1/175 (0.57%) 
ASTHENIA  2  2/176 (1.14%)  1/175 (0.57%) 
DIFFICULTY IN WALKING  2  2/176 (1.14%)  0/175 (0.00%) 
MULTI-ORGAN FAILURE  2  2/176 (1.14%)  0/175 (0.00%) 
OEDEMA PERIPHERAL  2  2/176 (1.14%)  0/175 (0.00%) 
PERFORMANCE STATUS DECREASED  2  1/176 (0.57%)  1/175 (0.57%) 
CATHETER SITE INFLAMMATION  2  1/176 (0.57%)  0/175 (0.00%) 
GRANULOMA NOS  2  1/176 (0.57%)  0/175 (0.00%) 
INFLUENZA LIKE ILLNESS  2  0/176 (0.00%)  1/175 (0.57%) 
NECROSIS NOS  2  0/176 (0.00%)  1/175 (0.57%) 
PAIN NOS  2  0/176 (0.00%)  1/175 (0.57%) 
SUDDEN DEATH  2  1/176 (0.57%)  0/175 (0.00%) 
Hepatobiliary disorders     
CHOLELITHIASIS  2  2/176 (1.14%)  0/175 (0.00%) 
CHOLECYSTITIS ACUTE NOS  2  1/176 (0.57%)  0/175 (0.00%) 
HEPATIC FAILURE  2  1/176 (0.57%)  0/175 (0.00%) 
Infections and infestations     
PNEUMONIA NOS  1  11/176 (6.25%)  7/175 (4.00%) 
RESPIRATORY TRACT INFECTION NOS  1  4/176 (2.27%)  7/175 (4.00%) 
SEPSIS NOS  1  3/176 (1.70%)  3/175 (1.71%) 
SEPTIC SHOCK  2  2/176 (1.14%)  2/175 (1.14%) 
UPPER RESPIRATORY TRACT INFECTION NOS  2  4/176 (2.27%)  0/175 (0.00%) 
BRONCHOPNEUMONIA NOS  2  3/176 (1.70%)  0/175 (0.00%) 
CELLULITIS  2  1/176 (0.57%)  2/175 (1.14%) 
ARTHRITIS BACTERIAL  2  2/176 (1.14%)  0/175 (0.00%) 
BRONCHITIS ACUTE NOS  2  2/176 (1.14%)  0/175 (0.00%) 
HERPES ZOSTER  2  2/176 (1.14%)  0/175 (0.00%) 
HERPES ZOSTER OPHTHALMIC  2  1/176 (0.57%)  1/175 (0.57%) 
LOBAR PNEUMONIA NOS  2  2/176 (1.14%)  0/175 (0.00%) 
PNEUMOCYSTIS CARINII PNEUMONIA  2  2/176 (1.14%)  0/175 (0.00%) 
PNEUMONIA PNEUMOCOCCAL  2  1/176 (0.57%)  1/175 (0.57%) 
URINARY TRACT INFECTION NOS  2  1/176 (0.57%)  1/175 (0.57%) 
UROSEPSIS  2  1/176 (0.57%)  1/175 (0.57%) 
BACTERAEMIA  2  0/176 (0.00%)  1/175 (0.57%) 
BACTERIAL SEPSIS  2  1/176 (0.57%)  0/175 (0.00%) 
BRONCHITIS CHRONIC NOS  2  0/176 (0.00%)  1/175 (0.57%) 
BURSITIS INFECTIVE NOS  2  1/176 (0.57%)  0/175 (0.00%) 
CENTRAL LINE INFECTION  2  1/176 (0.57%)  0/175 (0.00%) 
CLOSTRIDIUM DIFFICILE SEPSIS  2  1/176 (0.57%)  0/175 (0.00%) 
ESCHERICHIA URINARY TRACT INFECTION  2  0/176 (0.00%)  1/175 (0.57%) 
GASTROINTESTINAL INFECTION NOS  2  0/176 (0.00%)  1/175 (0.57%) 
LOWER RESPIRATORY TRACT INFECTION NOS  2  1/176 (0.57%)  0/175 (0.00%) 
LUNG INFECTION NOS  2  0/176 (0.00%)  1/175 (0.57%) 
MENINGITIS  2  1/176 (0.57%)  0/175 (0.00%) 
MENINGITIS PNEUMOCOCCAL  2  1/176 (0.57%)  0/175 (0.00%) 
NECROTISING FASCIITIS NOS  2  1/176 (0.57%)  0/175 (0.00%) 
OTITIS MEDIA NOS  2  1/176 (0.57%)  0/175 (0.00%) 
PNEUMONIA BACTERIAL NOS  2  1/176 (0.57%)  0/175 (0.00%) 
PNEUMONIA LEGIONELLA  2  1/176 (0.57%)  0/175 (0.00%) 
PYELONEPHRITIS ACUTE NOS  2  1/176 (0.57%)  0/175 (0.00%) 
RESPIRATORY TRACT INFECTION VIRAL NOS  2  1/176 (0.57%)  0/175 (0.00%) 
SALMONELLA INFECTION NOS  2  1/176 (0.57%)  0/175 (0.00%) 
SINUSITIS NOS  2  1/176 (0.57%)  0/175 (0.00%) 
STAPHYLOCOCCAL INFECTION  2  1/176 (0.57%)  0/175 (0.00%) 
STAPHYLOCOCCAL SEPSIS  2  0/176 (0.00%)  1/175 (0.57%) 
STREPTOCOCCAL SEPSIS  2  1/176 (0.57%)  1/175 (0.57%) 
URINARY TRACT INFECTION BACTERIAL  1  1/176 (0.57%)  0/175 (0.00%) 
Injury, poisoning and procedural complications     
FEMUR FRACTURE  2  2/176 (1.14%)  0/175 (0.00%) 
JOINT DISLOCATION  2  1/176 (0.57%)  0/175 (0.00%) 
POST PROCEDURAL COMPLICATION  2  1/176 (0.57%)  0/175 (0.00%) 
POST PROCEDURAL PAIN  2  1/176 (0.57%)  0/175 (0.00%) 
SPINAL FRACTURE NOS  2  0/176 (0.00%)  1/175 (0.57%) 
THORACIC VERTEBRAL FRACTURE  2  0/176 (0.00%)  1/175 (0.57%) 
Investigations     
BLOOD CREATININE INCREASED  2  0/176 (0.00%)  1/175 (0.57%) 
BODY TEMPERATURE INCREASED  2  0/176 (0.00%)  1/175 (0.57%) 
C-REACTIVE PROTEIN INCREASED  2  0/176 (0.00%)  1/175 (0.57%) 
INTERNATIONAL NORMALISED RATIO DECREASED  2  1/176 (0.57%)  0/175 (0.00%) 
WEIGHT DECREASED  2  1/176 (0.57%)  0/175 (0.00%) 
Metabolism and nutrition disorders     
HYPERGLYCAEMIA NOS  2  3/176 (1.70%)  2/175 (1.14%) 
DEHYDRATION  2  1/176 (0.57%)  1/175 (0.57%) 
ELECTROLYTE IMBALANCE  2  2/176 (1.14%)  0/175 (0.00%) 
HYPERCALCAEMIA  2  0/176 (0.00%)  3/175 (1.71%) 
HYPOCALCAEMIA  2  1/176 (0.57%)  1/175 (0.57%) 
DIABETES MELLITUS INADEQUATE CONTROL  2  1/176 (0.57%)  0/175 (0.00%) 
DIABETES MELLITUS NOS  2  0/176 (0.00%)  1/175 (0.57%) 
Musculoskeletal and connective tissue disorders     
BACK PAIN  2  5/176 (2.84%)  1/175 (0.57%) 
BONE PAIN  2  5/176 (2.84%)  0/175 (0.00%) 
MUSCLE WEAKNESS NOS  2  1/176 (0.57%)  3/175 (1.71%) 
OSTEONECROSIS  2  3/176 (1.70%)  1/175 (0.57%) 
PATHOLOGICAL FRACTURE  2  1/176 (0.57%)  2/175 (1.14%) 
PAIN IN LIMB  2  1/176 (0.57%)  1/175 (0.57%) 
CHEST WALL PAIN  2  1/176 (0.57%)  0/175 (0.00%) 
JOINT SWELLING  2  1/176 (0.57%)  0/175 (0.00%) 
MYALGIA  2  1/176 (0.57%)  0/175 (0.00%) 
MYOPATHY  2  0/176 (0.00%)  1/175 (0.57%) 
MYOPATHY STEROID  2  1/176 (0.57%)  0/175 (0.00%) 
OSTEOPOROSIS NOS  2  0/176 (0.00%)  1/175 (0.57%) 
PAIN IN JAW  2  1/176 (0.57%)  0/175 (0.00%) 
SPONDYLITIS NOS  2  1/176 (0.57%)  0/175 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
BASAL CELL CARCINOMA  2  1/176 (0.57%)  1/175 (0.57%) 
BREAST CANCER IN SITU  2  1/176 (0.57%)  0/175 (0.00%) 
GLIOBLASTOMA MULTIFORME  2  1/176 (0.57%)  0/175 (0.00%) 
LUNG ADENOCARCINOMA NOS  2  1/176 (0.57%)  0/175 (0.00%) 
NEOPLASM NOS  2  1/176 (0.57%)  0/175 (0.00%) 
PROSTATE CANCER NOS  2  1/176 (0.57%)  0/175 (0.00%) 
TRANSITIONAL CELL CARCINOMA  2  1/176 (0.57%)  0/175 (0.00%) 
LUNG SQUAMOUS CELL CARCINOMA, STAGE UNSPECIFIED  2  1/176 (0.57%)  0/175 (0.00%) 
Nervous system disorders     
CEREBROVASCULAR ACCIDENT  2  3/176 (1.70%)  2/175 (1.14%) 
MEMORY IMPAIRMENT  2  1/176 (0.57%)  1/175 (0.57%) 
SPINAL CORD COMPRESSION NOS  2  2/176 (1.14%)  0/175 (0.00%) 
ATAXIA  2  1/176 (0.57%)  0/175 (0.00%) 
BRAIN OEDEMA  2  0/176 (0.00%)  1/175 (0.57%) 
CEREBRAL ISCHAEMIA  2  1/176 (0.57%)  0/175 (0.00%) 
ENCEPHALITIS NOS  2  0/176 (0.00%)  1/175 (0.57%) 
EPIDURITIS  2  0/176 (0.00%)  1/175 (0.57%) 
HYPOAESTHESIA  2  0/176 (0.00%)  1/175 (0.57%) 
INTRACRANIAL PRESSURE INCREASED NOS  2  0/176 (0.00%)  1/175 (0.57%) 
LEUKOENCEPHALOPATHY  2  1/176 (0.57%)  0/175 (0.00%) 
PERIPHERAL MOTOR NEUROPATHY  2  0/176 (0.00%)  1/175 (0.57%) 
PERIPHERAL NEUROPATHY NOS  2  1/176 (0.57%)  0/175 (0.00%) 
POLYNEUROPATHY NOS  2  1/176 (0.57%)  0/175 (0.00%) 
SUBDURAL HAEMATOMA  2  0/176 (0.00%)  1/175 (0.57%) 
TREMOR  2  0/176 (0.00%)  1/175 (0.57%) 
Psychiatric disorders     
DEPRESSION  2  3/176 (1.70%)  1/175 (0.57%) 
CONFUSIONAL STATE  2  1/176 (0.57%)  1/175 (0.57%) 
BIPOLAR DISORDER  2  0/176 (0.00%)  1/175 (0.57%) 
DELIRIUM  2  0/176 (0.00%)  1/175 (0.57%) 
INSOMNIA  2  1/176 (0.57%)  0/175 (0.00%) 
MANIA  2  0/176 (0.00%)  1/175 (0.57%) 
MENTAL DISORDER NOS  2  0/176 (0.00%)  1/175 (0.57%) 
Renal and urinary disorders     
RENAL FAILURE ACUTE  2  4/176 (2.27%)  3/175 (1.71%) 
RENAL FAILURE NOS  2  3/176 (1.70%)  4/175 (2.29%) 
RENAL IMPAIRMENT NOS  2  0/176 (0.00%)  2/175 (1.14%) 
FANCONI SYNDROME ACQUIRED  2  1/176 (0.57%)  0/175 (0.00%) 
OLIGURIA  2  0/176 (0.00%)  1/175 (0.57%) 
RENAL COLIC  2  1/176 (0.57%)  0/175 (0.00%) 
RENAL FAILURE ACUTE ON CHRONIC  2  1/176 (0.57%)  0/175 (0.00%) 
URINARY RETENTION  2  1/176 (0.57%)  0/175 (0.00%) 
Reproductive system and breast disorders     
BREAST MICROCALCIFICATION  2  1/176 (0.57%)  0/175 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
PULMONARY EMBOLISM  2  7/176 (3.98%)  2/175 (1.14%) 
ACUTE RESPIRATORY FAILURE  2  1/176 (0.57%)  1/175 (0.57%) 
BRONCHITIS NOS  2  1/176 (0.57%)  1/175 (0.57%) 
BRONCHOSPASM NOS  2  1/176 (0.57%)  1/175 (0.57%) 
RESPIRATORY FAILURE  2  2/176 (1.14%)  0/175 (0.00%) 
ACUTE RESPIRATORY DISTRESS SYNDROME  2  1/176 (0.57%)  0/175 (0.00%) 
BRONCHOPNEUMOPATHY  2  0/176 (0.00%)  1/175 (0.57%) 
COUGH  2  1/176 (0.57%)  0/175 (0.00%) 
DYSPNOEA NOS  2  0/176 (0.00%)  1/175 (0.57%) 
EPISTAXIS  2  0/176 (0.00%)  1/175 (0.57%) 
LUNG CONSOLIDATION  2  1/176 (0.57%)  0/175 (0.00%) 
MAXILLARY SINUSITIS  2  0/176 (0.00%)  1/175 (0.57%) 
PNEUMONIA ASPIRATION  2  0/176 (0.00%)  1/175 (0.57%) 
PULMONARY CONGESTION  2  1/176 (0.57%)  0/175 (0.00%) 
Skin and subcutaneous tissue disorders     
LEUKOPLAKIA NOS  2  1/176 (0.57%)  0/175 (0.00%) 
Vascular disorders     
DEEP VEIN THROMBOSIS  2  8/176 (4.55%)  6/175 (3.43%) 
HYPOTENSION NOS  2  2/176 (1.14%)  2/175 (1.14%) 
PHLEBITIS NOS  2  1/176 (0.57%)  2/175 (1.14%) 
VENOUS THROMBOSIS NOS LIMB  2  2/176 (1.14%)  1/175 (0.57%) 
PERIPHERAL ISCHAEMIA  2  2/176 (1.14%)  0/175 (0.00%) 
CIRCULATORY COLLAPSE  2  1/176 (0.57%)  0/175 (0.00%) 
PHLEBITIS SUPERFICIAL  2  1/176 (0.57%)  0/175 (0.00%) 
PHLEBOTHROMBOSIS  2  1/176 (0.57%)  0/175 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
2
Term from vocabulary, MedDRA (15.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lenalidomide Plus Dexamethasone Placebo Plus Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   175/176 (99.43%)   173/175 (98.86%) 
Blood and lymphatic system disorders     
NEUTROPENIA  1  71/176 (40.34%)  17/175 (9.71%) 
ANAEMIA  1  52/176 (29.55%)  49/175 (28.00%) 
THROMBOCYTOPENIA  1  33/176 (18.75%)  19/175 (10.86%) 
LEUKOPENIA  1  21/176 (11.93%)  11/175 (6.29%) 
LYMPHOPENIA  1  17/176 (9.66%)  9/175 (5.14%) 
Ear and labyrinth disorders     
VERTIGO  1  12/176 (6.82%)  8/175 (4.57%) 
Endocrine disorders     
CUSHINGOID  1  9/176 (5.11%)  4/175 (2.29%) 
Eye disorders     
VISION BLURRED  1  13/176 (7.39%)  13/175 (7.43%) 
Gastrointestinal disorders     
CONSTIPATION  1  71/176 (40.34%)  41/175 (23.43%) 
DIARRHOEA NOS  1  67/176 (38.07%)  45/175 (25.71%) 
NAUSEA  1  40/176 (22.73%)  20/175 (11.43%) 
DYSPEPSIA  1  23/176 (13.07%)  23/175 (13.14%) 
ABDOMINAL PAIN UPPER  1  22/176 (12.50%)  11/175 (6.29%) 
VOMITING NOS  1  20/176 (11.36%)  12/175 (6.86%) 
ABDOMINAL PAIN NO  1  16/176 (9.09%)  10/175 (5.71%) 
STOMATITIS  1  11/176 (6.25%)  6/175 (3.43%) 
DRY MOUTH  1  10/176 (5.68%)  5/175 (2.86%) 
GASTRITIS NOS  1  9/176 (5.11%)  4/175 (2.29%) 
GASTROENTERITIS NOS  1  9/176 (5.11%)  5/175 (2.86%) 
General disorders     
ASTHENIA  1  64/176 (36.36%)  46/175 (26.29%) 
FATIGUE  1  51/176 (28.98%)  41/175 (23.43%) 
PYREXIA  1  50/176 (28.41%)  40/175 (22.86%) 
OEDEMA PERIPHERAL  1  42/176 (23.86%)  34/175 (19.43%) 
OEDEMA NOS  1  22/176 (12.50%)  15/175 (8.57%) 
LETHARGY  1  15/176 (8.52%)  4/175 (2.29%) 
CHEST PAIN  1  11/176 (6.25%)  7/175 (4.00%) 
Infections and infestations     
UPPER RESPIRATORY TRACT INFECTION NOS  1  29/176 (16.48%)  16/175 (9.14%) 
URINARY TRACT INFECTION NOS  1  15/176 (8.52%)  13/175 (7.43%) 
INFLUENZA  1  10/176 (5.68%)  8/175 (4.57%) 
ORAL CANDIDIASIS  1  10/176 (5.68%)  9/175 (5.14%) 
LOWER RESPIRATORY TRACT INFECTION NOS  1  9/176 (5.11%)  11/175 (6.29%) 
RESPIRATORY TRACT INFECTION NOS  1  9/176 (5.11%)  6/175 (3.43%) 
HERPES SIMPLEX  1  8/176 (4.55%)  12/175 (6.86%) 
SINUSITIS NOS  1  6/176 (3.41%)  9/175 (5.14%) 
Investigations     
WEIGHT DECREASED  1  49/176 (27.84%)  46/175 (26.29%) 
WEIGHT INCREASED  1  17/176 (9.66%)  24/175 (13.71%) 
Metabolism and nutrition disorders     
ANOREXIA  1  25/176 (14.20%)  14/175 (8.00%) 
HYPOKALAEMIA  1  20/176 (11.36%)  10/175 (5.71%) 
HYPERGLYCAEMIA NOS  1  19/176 (10.80%)  22/175 (12.57%) 
HYPOCALCAEMIA  1  16/176 (9.09%)  5/175 (2.86%) 
HYPOPHOSPHATAEMIA  1  11/176 (6.25%)  2/175 (1.14%) 
HYPERURICAEMIA  1  4/176 (2.27%)  10/175 (5.71%) 
Musculoskeletal and connective tissue disorders     
MUSCLE CRAMP  1  56/176 (31.82%)  36/175 (20.57%) 
BACK PAIN  1  45/176 (25.57%)  29/175 (16.57%) 
BONE PAIN  1  34/176 (19.32%)  24/175 (13.71%) 
ARTHRALGIA  1  33/176 (18.75%)  28/175 (16.00%) 
MUSCLE WEAKNESS NOS  1  30/176 (17.05%)  28/175 (16.00%) 
PAIN IN LIMB  1  27/176 (15.34%)  20/175 (11.43%) 
MYALGIA  1  18/176 (10.23%)  16/175 (9.14%) 
CHEST WALL PAIN  1  11/176 (6.25%)  14/175 (8.00%) 
Nervous system disorders     
HEADACHE  1  41/176 (23.30%)  35/175 (20.00%) 
TREMOR  1  39/176 (22.16%)  14/175 (8.00%) 
DIZZINESS  1  36/176 (20.45%)  16/175 (9.14%) 
PARAESTHESIA  1  29/176 (16.48%)  29/175 (16.57%) 
DYSGEUSIA  1  20/176 (11.36%)  16/175 (9.14%) 
HYPOAESTHESIA  1  15/176 (8.52%)  7/175 (4.00%) 
SOMNOLENCE  1  8/176 (4.55%)  10/175 (5.71%) 
Psychiatric disorders     
INSOMNIA  1  51/176 (28.98%)  63/175 (36.00%) 
DEPRESSION  1  19/176 (10.80%)  18/175 (10.29%) 
CONFUSIONAL STATE  1  14/176 (7.95%)  10/175 (5.71%) 
ANXIETY  1  11/176 (6.25%)  14/175 (8.00%) 
MOOD ALTERATION NOS  1  5/176 (2.84%)  10/175 (5.71%) 
Respiratory, thoracic and mediastinal disorders     
COUGH  1  41/176 (23.30%)  41/175 (23.43%) 
DYSPNOEA NOS  1  36/176 (20.45%)  22/175 (12.57%) 
NASOPHARYNGITIS  1  35/176 (19.89%)  23/175 (13.14%) 
BRONCHITIS NOS  1  27/176 (15.34%)  26/175 (14.86%) 
PHARYNGITIS  1  27/176 (15.34%)  16/175 (9.14%) 
EPISTAXIS  1  12/176 (6.82%)  17/175 (9.71%) 
HICCUPS  1  10/176 (5.68%)  8/175 (4.57%) 
RHINITIS NOS  1  5/176 (2.84%)  9/175 (5.14%) 
Skin and subcutaneous tissue disorders     
RASH NOS  1  24/176 (13.64%)  9/175 (5.14%) 
SWEATING INCREASED  1  17/176 (9.66%)  16/175 (9.14%) 
DRY SKIN  1  16/176 (9.09%)  6/175 (3.43%) 
PRURITUS  1  11/176 (6.25%)  9/175 (5.14%) 
ERYTHEMA  1  8/176 (4.55%)  13/175 (7.43%) 
Vascular disorders     
HYPERTENSION NOS  1  17/176 (9.66%)  11/175 (6.29%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.1)
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.
Investigator has the right to publish and/or present study data after multicentric publication or one year has elapsed until completion of this multicentric study provided that he/she (i) furnishes the sponsor a copy of any proposed publication or presentation before its submission, (ii) deletes any sponsor’s confidential data as pointed out by sponsor, and (iii) delays any submission for generally up to ninety (90) days to permit the preparation and filing of intellectual property applications.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anne McClain, Senior Manager
Organization: Celgene Corporation
Phone: 1-866-260-1599
EMail: ClinicalTrialDisclosure@celgene.com
Layout table for additonal information
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT00424047     History of Changes
Other Study ID Numbers: CC-5013-MM-010
First Submitted: January 17, 2007
First Posted: January 18, 2007
Results First Submitted: February 13, 2015
Results First Posted: March 4, 2015
Last Update Posted: October 19, 2017