Trial Outcomes & Findings for A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma (NCT NCT00424047)

Last Updated: 2017-10-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

351 participants

Primary outcome timeframe

From randomization up to cut-off date of 03 August 2005; up to 24 months

Results posted on

2017-10-19

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Lenalidomide Plus Dexamethasone (Len/Dex) 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 Plus Dexamethasone 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.
Blinded Treatment (Up to 03 Aug 2005) STARTED	176	175
Blinded Treatment (Up to 03 Aug 2005) Safety Population	176	175
Blinded Treatment (Up to 03 Aug 2005) Evaluable Population	175	171
Blinded Treatment (Up to 03 Aug 2005) COMPLETED	54	19
Blinded Treatment (Up to 03 Aug 2005) NOT COMPLETED	122	156
On Study at Time of Unblinding STARTED	176	175
On Study at Time of Unblinding COMPLETED	21	8
On Study at Time of Unblinding NOT COMPLETED	155	167
Long Term Extension (Up to 25 Jun 2013) STARTED	21	8
Long Term Extension (Up to 25 Jun 2013) COMPLETED	0	0
Long Term Extension (Up to 25 Jun 2013) NOT COMPLETED	21	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Lenalidomide Plus Dexamethasone (Len/Dex) 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 Plus Dexamethasone 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.
Blinded Treatment (Up to 03 Aug 2005) Adverse Event	18	12
Blinded Treatment (Up to 03 Aug 2005) Progression of disease	67	122
Blinded Treatment (Up to 03 Aug 2005) Lack of therapeutic effect	1	3
Blinded Treatment (Up to 03 Aug 2005) Withdrawal by Subject	23	8
Blinded Treatment (Up to 03 Aug 2005) Death	11	10
Blinded Treatment (Up to 03 Aug 2005) Other	2	1
On Study at Time of Unblinding Adverse Event	22	12
On Study at Time of Unblinding Progression of disease	92	128
On Study at Time of Unblinding Lack of Efficacy	1	3
On Study at Time of Unblinding Withdrawal by Subject	24	9
On Study at Time of Unblinding Death	11	11
On Study at Time of Unblinding Other	5	4
Long Term Extension (Up to 25 Jun 2013) Adverse Event	1	0
Long Term Extension (Up to 25 Jun 2013) Death	0	1
Long Term Extension (Up to 25 Jun 2013) Other	12	4
Long Term Extension (Up to 25 Jun 2013) Progression of Disease	7	3
Long Term Extension (Up to 25 Jun 2013) Withdrawal by Subject	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lenalidomide Plus Dexamethasone n=176 Participants 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 Plus Dexamethasone n=175 Participants 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 n=351 Participants Total of all reporting groups
Age, Continuous	62.2 years STANDARD_DEVIATION 10.12 • n=5 Participants	62.9 years STANDARD_DEVIATION 8.80 • n=7 Participants	62.6 years STANDARD_DEVIATION 9.47 • n=5 Participants
Sex: Female, Male Female	72 Participants n=5 Participants	72 Participants n=7 Participants	144 Participants n=5 Participants
Sex: Female, Male Male	104 Participants n=5 Participants	103 Participants n=7 Participants	207 Participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status 0 = (Fully Active)	78 participants n=5 Participants	65 participants n=7 Participants	143 participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status 1 = (Restrictive but Ambulatory)	72 participants n=5 Participants	79 participants n=7 Participants	151 participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status 2 = Ambulatory unable to Work)	23 participants n=5 Participants	27 participants n=7 Participants	50 participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status 3 = (Limited Self-Care)	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status 4 = (Completely Disabled)	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status Missing	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Number of Prior Anti-Myeloma Therapies 1 Prior anti-myeloma therapy	56 participants n=5 Participants	57 participants n=7 Participants	113 participants n=5 Participants
Number of Prior Anti-Myeloma Therapies 2 or more prior anti-myeloma therapies	120 participants n=5 Participants	118 participants n=7 Participants	238 participants n=5 Participants
Time from First Pathological Diagnosis	3.4 years n=5 Participants	4.0 years n=7 Participants	3.7 years n=5 Participants
Baseline multiple myeloma stage Stage I	11 participants n=5 Participants	8 participants n=7 Participants	19 participants n=5 Participants
Baseline multiple myeloma stage Stage II	50 participants n=5 Participants	57 participants n=7 Participants	107 participants n=5 Participants
Baseline multiple myeloma stage Stage III	115 participants n=5 Participants	110 participants n=7 Participants	225 participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization up to cut-off date of 03 August 2005; up to 24 months

Population: Intent to treat included all participants who were randomized.

Outcome measures

Outcome measures
Measure	Lenalidomide Plus Dexamethasone n=176 Participants 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 Plus Dexamethasone n=175 Participants 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.
Kaplan-Meier Estimate of Time to Tumor Progression (TTP)	52.1 weeks Interval 40.9 to Unable to provide as data not yet estimable	20.1 weeks Interval 16.6 to 20.7

PRIMARY outcome

Timeframe: From randomization up to cut-off date of 02 March 2008; up to 51 months

Population: Intent to treat included all participants who were randomized.

Outcome measures

Outcome measures
Measure	Lenalidomide Plus Dexamethasone n=176 Participants 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 Plus Dexamethasone n=175 Participants 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.
Kaplan-Meier Estimate of Time to Tumor Progression (TTP) (Later Cut-off Date of 02 Mar 2008)	52.4 weeks Interval 40.9 to 85.6	20.1 weeks Interval 16.6 to 20.7

SECONDARY outcome

Timeframe: Randomization to data cut off of 03 August 2005; up to 24 months

Population: Intent to Treat population includes all participants who were randomized.

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.

Outcome measures

Outcome measures
Measure	Lenalidomide Plus Dexamethasone n=176 Participants 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 Plus Dexamethasone n=175 Participants 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.
Kaplan-Meier Estimate of Overall Survival (OS)	NA weeks NA: Data not considered materialized or estimable at this time point	NA weeks Interval 71.6 to NA: Data not considered materialized or estimable at this time point

SECONDARY outcome

Timeframe: Randomization to data cut off of 02 March 2008; up to 51 months

Population: Intent to Treat population includes all participants who were randomized.

Outcome measures

Outcome measures
Measure	Lenalidomide Plus Dexamethasone n=176 Participants 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 Plus Dexamethasone n=175 Participants 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.
Kaplan-Meier Estimate of Overall Survival (OS) (Later Cut-off Date of 02 March 2008)	161.9 weeks Interval 129.3 to 201.4	133.3 weeks Interval 101.6 to 174.0

SECONDARY outcome

Timeframe: Randomization to 03 August 2005; up to 24 months

Population: Intent to Treat Population includes all participants who were randomized

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.

Outcome measures

Outcome measures
Measure	Lenalidomide Plus Dexamethasone n=176 Participants 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 Plus Dexamethasone n=175 Participants 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.
Summary of Myeloma Response Rates Based on Best Response Assessment Complete Response (CR)	15.3 percentage of participants	4.0 percentage of participants
Summary of Myeloma Response Rates Based on Best Response Assessment Partial Response (PR)	43.8 percentage of participants	19.4 percentage of participants
Summary of Myeloma Response Rates Based on Best Response Assessment Stable Disease (SD)	29.0 percentage of participants	56.6 percentage of participants
Summary of Myeloma Response Rates Based on Best Response Assessment Progressive Disease (PD)	2.8 percentage of participants	14.3 percentage of participants
Summary of Myeloma Response Rates Based on Best Response Assessment Not Evaluable (NE) those without response data	9.1 percentage of participants	5.7 percentage of participants

SECONDARY outcome

Timeframe: Randomization to data cut-off of 02 Mar 2008; up to 51 months

Population: Intent to Treat Population includes all participants who were randomized

Outcome measures

Outcome measures
Measure	Lenalidomide Plus Dexamethasone n=176 Participants 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 Plus Dexamethasone n=175 Participants 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.
Myeloma Response Rates Based on the Reviewers Best Response Assessment (Later Cut-off Date of 02 March 2008) Complete Response (CR)	17.0 percentage of participants	4.0 percentage of participants
Myeloma Response Rates Based on the Reviewers Best Response Assessment (Later Cut-off Date of 02 March 2008) Partial Response (PR)	42.6 percentage of participants	19.4 percentage of participants
Myeloma Response Rates Based on the Reviewers Best Response Assessment (Later Cut-off Date of 02 March 2008) Stable Disease (SD)	28.4 percentage of participants	56.6 percentage of participants
Myeloma Response Rates Based on the Reviewers Best Response Assessment (Later Cut-off Date of 02 March 2008) Progressive Disease (PD)	3.4 percentage of participants	14.3 percentage of participants
Myeloma Response Rates Based on the Reviewers Best Response Assessment (Later Cut-off Date of 02 March 2008) Not Evaluable (NE) those without response data	8.5 percentage of participants	5.7 percentage of participants

SECONDARY outcome

Timeframe: 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

Population: The safety population includes all participants who received at least one dose of study drug regimen

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.

Outcome measures

Outcome measures
Measure	Lenalidomide Plus Dexamethasone n=176 Participants 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 Plus Dexamethasone n=175 Participants 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.
Number of Participants With Adverse Events (AE) ≥ 1 Adverse Event	176 participants	175 participants
Number of Participants With Adverse Events (AE) ≥ 1 Serious Adverse Event	105 participants	79 participants
Number of Participants With Adverse Events (AE) ≥ 1 AE leading to study drug discontinuation	46 participants	31 participants
Number of Participants With Adverse Events (AE) ≥ 1 AE leading to dose reduction or interruption	137 participants	100 participants
Number of Participants With Adverse Events (AE) ≥ 1 Drug-Related Adverse Event	160 participants	151 participants
Number of Participants With Adverse Events (AE) ≥ 1 Drug-Related Serious Adverse Event	54 participants	30 participants
Number of Participants With Adverse Events (AE) ≥Death within ≤ 30 days of last dose of study drug	17 participants	20 participants
Number of Participants With Adverse Events (AE) ≥ 1 Grade 1 or Higher Adverse Event	176 participants	175 participants
Number of Participants With Adverse Events (AE) ≥ 1 Grade 2 or Higher Adverse Event	168 participants	167 participants
Number of Participants With Adverse Events (AE) ≥ 1 Grade 3 or Higher Adverse Event	146 participants	119 participants
Number of Participants With Adverse Events (AE) ≥ 1 Grade 4 or Higher Adverse Event	52 participants	37 participants

SECONDARY outcome

Timeframe: Up to unblinding data cut off of 03 August 2005; up to 24 months

Population: Analysis not performed due to an insufficient number of participants with SRE

Time from randomization to the date of the first occurrence of a symptomatic SRE (clinical need for radiotherapy or surgery to bone).

Outcome measures

Outcome measures
Measure	Lenalidomide Plus Dexamethasone n=176 Participants 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 Plus Dexamethasone n=175 Participants 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.
Time to First Symptomatic Skeletal-related Event (SRE) (Clinical Need for Radiation or Surgery to Bone)	NA participants There were an insufficient number of participants with SRE events and no analysis was conducted.	NA participants There were an insufficient number of participants with SRE events and no analysis was conducted.

SECONDARY outcome

Timeframe: Randomization to cut off date of 03 August 2005; up to 24 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Lenalidomide Plus Dexamethasone n=173 Participants 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 Plus Dexamethasone n=172 Participants 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.
Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale	10.1 weeks Interval 8.1 to 16.1	12.3 weeks Interval 10.1 to 24.1

SECONDARY outcome

Timeframe: Randomization to cut off date of 02 March 2008; up to 51 months

Population: Intent to Treat includes all participants who were randomized to study drug; six ECOG scores were missing at the March 2008 cut-off.

Outcome measures

Outcome measures
Measure	Lenalidomide Plus Dexamethasone n=173 Participants 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 Plus Dexamethasone n=172 Participants 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.
Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale (Later Cut-off Date of 02 March 2008)	10.1 weeks Interval 8.1 to 16.1	12.3 weeks Interval 10.1 to 24.1

POST_HOC outcome

Timeframe: Up to data cut off of 03 August 2005; up to 24 months

Population: Intent to Treat population includes all participants who were randomized to study drug.

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.

Outcome measures

Outcome measures
Measure	Lenalidomide Plus Dexamethasone n=104 Participants 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 Plus Dexamethasone n=41 Participants 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.
Kaplan-Meier Estimate of Duration of Response	67.6 weeks Interval 42.1 to NA: Data not considered materialized or estimable at this time point	33.3 weeks Interval 22.1 to 51.6

POST_HOC outcome

Timeframe: Up to data cut off of 03 Mar 2008; up to 51 months

Population: Intent to Treat population includes all participants who were randomized to study drug.

Outcome measures

Outcome measures
Measure	Lenalidomide Plus Dexamethasone n=105 Participants 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 Plus Dexamethasone n=41 Participants 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.
Kaplan-Meier Estimate of Duration of Response (Cut-off at a Later Date of 03 March 2008)	68.1 weeks Interval 42.1 to 105.6	33.3 weeks Interval 22.1 to 51.6

Adverse Events

Lenalidomide Plus Dexamethasone

Serious events: 105 serious events

Other events: 175 other events

Deaths: 0 deaths

Placebo Plus Dexamethasone

Serious events: 79 serious events

Other events: 173 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Anne McClain, Senior Manager

Celgene Corporation

Phone: 1-866-260-1599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER