Trial Outcomes & Findings for Lenalidomide Versus Placebo in Myelodysplastic Syndromes With a Deletion 5q[31] Abnormality (NCT NCT00179621)

Last Updated: 2011-04-14

Results Overview

The count of study participants who had no RBC transfusions for 26 consecutive weeks or more during the double-blind period.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

205 participants

Primary outcome timeframe

Up to 52 weeks

Results posted on

2011-04-14

Participant Flow

A total of 263 potential participants were screened. Potentially protocol-eligible participants were then entered into the Pre-Randomization Phase (up to 56 days) to ensure eligibility criteria were met prior to entering the Double-Blind Phase. A total of 205 participants were randomized into the study.

Participant milestones

Participant milestones
Measure	Placebo Placebo matching to active study arms.	Lenalidomide 5 mg Lenalidomide 5 mg daily for 28 days	Lenalidomide 10 mg Lenalidomide 10 mg daily for 21 of 28 days	Placebo Crossover to 5 mg Open-label Period Participants receiving placebo in the Double-Blind phase and Lenalidomide in the Open-Label phase.
Double-Blind Period STARTED	67	69	69	0
Double-Blind Period COMPLETED	3	23	39	0
Double-Blind Period NOT COMPLETED	64	46	30	0
Open-Label Period STARTED	0	42	47	56
Open-Label Period COMPLETED	0	14	19	13
Open-Label Period NOT COMPLETED	0	28	28	43

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo matching to active study arms.	Lenalidomide 5 mg Lenalidomide 5 mg daily for 28 days	Lenalidomide 10 mg Lenalidomide 10 mg daily for 21 of 28 days	Placebo Crossover to 5 mg Open-label Period Participants receiving placebo in the Double-Blind phase and Lenalidomide in the Open-Label phase.
Double-Blind Period Lack of Therapeutic Effect	59	35	19	0
Double-Blind Period Adverse Event	2	7	4	0
Double-Blind Period Withdrawal by Subject	2	1	3	0
Double-Blind Period Death	0	1	2	0
Double-Blind Period Protocol Violation	1	0	0	0
Double-Blind Period Other	0	2	2	0
Open-Label Period Lack of Therapeutic Effect	0	19	19	31
Open-Label Period Adverse Event	0	6	5	6
Open-Label Period Withdrawal by Subject	0	2	2	2
Open-Label Period Death	0	0	1	2
Open-Label Period Other	0	1	1	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=67 Participants Placebo matching to active study arms.	Lenalidomide 5 mg n=69 Participants Lenalidomide 5 mg daily for 28 days	Lenalidomide 10 mg n=69 Participants Lenalidomide 10 mg daily for 21 of 28 days	Total n=205 Participants Total of all reporting groups
Age Continuous	69.9 years n=5 Participants	66.0 years n=7 Participants	68.0 years n=5 Participants	68.0 years n=4 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	53 Participants n=7 Participants	49 Participants n=5 Participants	156 Participants n=4 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	16 Participants n=7 Participants	20 Participants n=5 Participants	49 Participants n=4 Participants
Race/Ethnicity, Customized White	66 participants n=5 Participants	67 participants n=7 Participants	69 participants n=5 Participants	202 participants n=4 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	3 participants n=4 Participants
5q- (31-33) Chromosomal Abnormality Yes	63 Participants n=5 Participants	64 Participants n=7 Participants	64 Participants n=5 Participants	191 Participants n=4 Participants
5q- (31-33) Chromosomal Abnormality No	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
5q- (31-33) Chromosomal Abnormality Missing	3 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
International Prognostic Scoring System (IPSS) Low risk (0)	30 participants n=5 Participants	20 participants n=7 Participants	20 participants n=5 Participants	70 participants n=4 Participants
International Prognostic Scoring System (IPSS) Intermediate-1 (0.5 - 1.0)	22 participants n=5 Participants	29 participants n=7 Participants	23 participants n=5 Participants	74 participants n=4 Participants
International Prognostic Scoring System (IPSS) Intermediate-2 (1.5 - 2.0)	2 participants n=5 Participants	5 participants n=7 Participants	3 participants n=5 Participants	10 participants n=4 Participants
International Prognostic Scoring System (IPSS) High Risk (≥ 2.5)	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants
International Prognostic Scoring System (IPSS) Missing data	13 participants n=5 Participants	15 participants n=7 Participants	22 participants n=5 Participants	50 participants n=4 Participants
French-American-British (FAB) Classification Refractory anemia (RA)	37 participants n=5 Participants	38 participants n=7 Participants	32 participants n=5 Participants	107 participants n=4 Participants
French-American-British (FAB) Classification Refractory anemia with ringed sideroblasts (RARS)	8 participants n=5 Participants	7 participants n=7 Participants	9 participants n=5 Participants	24 participants n=4 Participants
French-American-British (FAB) Classification Refractory anemia with excess blasts (RAEB)	4 participants n=5 Participants	9 participants n=7 Participants	9 participants n=5 Participants	22 participants n=4 Participants
French-American-British (FAB) Classification Chronic myelomonocytic leukemia (CMML)	1 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	3 participants n=4 Participants
French-American-British (FAB) Classification RAEB in transformation	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
French-American-British (FAB) Classification Chronic myelogenous leukemia (CML)	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants
French-American-British (FAB) Classification Specimen not adequate from diagnosis	12 participants n=5 Participants	11 participants n=7 Participants	17 participants n=5 Participants	40 participants n=4 Participants
French-American-British (FAB) Classification Other or missing	4 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	7 participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 52 weeks

The count of study participants who had no RBC transfusions for 26 consecutive weeks or more during the double-blind period.

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Placebo matching to active study arms.	Lenalidomide 5 mg n=47 Participants Lenalidomide 5 mg daily for 28 days	Lenalidomide 10 mg n=41 Participants Lenalidomide 10 mg daily for 21 of 28 days
Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence for >= 26 Weeks (182 Days)	3 Participants	20 Participants	23 Participants

SECONDARY outcome

Timeframe: Up to 52 weeks

Count of study participants who had no RBC transfusions during any 56 or more consecutive study days during the double-blind period.

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Placebo matching to active study arms.	Lenalidomide 5 mg n=47 Participants Lenalidomide 5 mg daily for 28 days	Lenalidomide 10 mg n=41 Participants Lenalidomide 10 mg daily for 21 of 28 days
Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence for 56 Days	4 Participants	24 Participants	25 Participants

SECONDARY outcome

Timeframe: up to 3 years

Population: The modified intent-to-treat (mITT) population included all participants who achieved RBC transfusion independence for at least 182 days.

Mean number of weeks that participants who achieved RBC transfusion independence for at least 182 days were able to maintain RBC transfusion independence. Both double-blind and open-label periods are included.

Outcome measures

Outcome measures
Measure	Placebo n=3 Participants Placebo matching to active study arms.	Lenalidomide 5 mg n=20 Participants Lenalidomide 5 mg daily for 28 days	Lenalidomide 10 mg n=23 Participants Lenalidomide 10 mg daily for 21 of 28 days
Duration of Red Blood Cell (RBC) Transfusion Independence for Participants Who Became RBC Transfusion Independent for at Least 182 Days	61.4 Weeks Standard Deviation 10.93	107.7 Weeks Standard Deviation 52.35	108.6 Weeks Standard Deviation 40.63

SECONDARY outcome

Timeframe: Baseline, up to 52 weeks

Population: The modified intent-to-treat (mITT) population included all participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q\[31\] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug. MITT participants who were transfusion independent for \>= 182 study days are included.

For participants who became RBC transfusion independent for at least 182 days during the double-blind study period, the mean maximum change from baseline in hemoglobin is summarized.

Outcome measures

Outcome measures
Measure	Placebo n=3 Participants Placebo matching to active study arms.	Lenalidomide 5 mg n=20 Participants Lenalidomide 5 mg daily for 28 days	Lenalidomide 10 mg n=23 Participants Lenalidomide 10 mg daily for 21 of 28 days
Maximum Change From Baseline in Hemoglobin During the Double-blind Period for Participants Who Became Red Blood Cell (RBC) Transfusion Independent for at Least 182 Days	2.0 g/dL Standard Deviation 0.61	5.5 g/dL Standard Deviation 1.79	6.0 g/dL Standard Deviation 1.97

SECONDARY outcome

Timeframe: up to 52 weeks

Population: The modified intent-to-treat (mITT) population included all participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q\[31\] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug. Additionally, the participant must have had a baseline platelet count of \<100,000/mm\^3 to be included in the analysis.

The International MDS Working Group (IWG) defines a major platelet response for participants with a pre-treatment platelet count of \<100,000/mm\^3 as an absolute increase of ≥30,000/mm\^3 whereas a minor response is defined as a ≥50% increase in platelet count with a net increase greater than 10,000/mm\^3 but less than 30,000/mm\^3.

Outcome measures

Outcome measures
Measure	Placebo n=3 Participants Placebo matching to active study arms.	Lenalidomide 5 mg n=6 Participants Lenalidomide 5 mg daily for 28 days	Lenalidomide 10 mg n=4 Participants Lenalidomide 10 mg daily for 21 of 28 days
Participants' Response in Platelet Counts as Defined by the International MDS Working Group (IWG 2000) During Double-blind Period Major	0 Participants	1 Participants	1 Participants
Participants' Response in Platelet Counts as Defined by the International MDS Working Group (IWG 2000) During Double-blind Period Minor	0 Participants	0 Participants	0 Participants
Participants' Response in Platelet Counts as Defined by the International MDS Working Group (IWG 2000) During Double-blind Period None	3 Participants	5 Participants	3 Participants

SECONDARY outcome

Timeframe: up to week 52

Population: The modified intent-to-treat (mITT) population included all participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q\[31\] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug. Additionally, the participant must have had a baseline absolute neutrophil counts (ANC) \< 1,000/mm\^3.

A major neutrophil response is defined by the International MDS Working Group (IWG) criteria as at least a 100% increase, or an absolute increase of ≥500/mm\^3 for participants with absolute neutrophil counts (ANC) of less than 1,500/mm\^3 before therapy, whichever is greater. A minor response for such participants is defined as an ANC increase of at least 100%, but absolute increase \<500/mm\^3.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Placebo matching to active study arms.	Lenalidomide 5 mg n=18 Participants Lenalidomide 5 mg daily for 28 days	Lenalidomide 10 mg n=17 Participants Lenalidomide 10 mg daily for 21 of 28 days
Participants' Response in Absolute Neutrophil Counts as Defined by the International MDS Working Group (IWG 2000) During Double-blind Period Major	1 Participants	3 Participants	2 Participants
Participants' Response in Absolute Neutrophil Counts as Defined by the International MDS Working Group (IWG 2000) During Double-blind Period Minor	0 Participants	0 Participants	1 Participants
Participants' Response in Absolute Neutrophil Counts as Defined by the International MDS Working Group (IWG 2000) During Double-blind Period None	9 Participants	15 Participants	14 Participants

SECONDARY outcome

Timeframe: up to 52 weeks

Population: Intent to treat population. Participants represented in the treatment groups to which they were randomized. Placebo response is limited to the double-blind phase. There were 10 responders in the placebo group who achieved their response under lenalidomide treatment after crossover to open-label.

The IWG criteria for bone marrow improvement: a complete remission is bone marrow sampling showing less than 5% myeloblasts with normal maturation of all cell lines, with no evidence for dysplasia. A partial remission is ≥ 50% decrease in blasts over pre-treatment. Bone marrow progression is a ≥ 50% increase in blasts that exceed the top range of the pretreatment percentile range: a) \<5% blasts b) 5-10% blasts c) 10-20% blasts d) 20-30% blasts. For example, a participant with \<5% blasts pretreatment with an on study blast increase of 50% which is now \>5% showed bone marrow progression.

Outcome measures

Outcome measures
Measure	Placebo n=67 Participants Placebo matching to active study arms.	Lenalidomide 5 mg n=69 Participants Lenalidomide 5 mg daily for 28 days	Lenalidomide 10 mg n=69 Participants Lenalidomide 10 mg daily for 21 of 28 days
Participants' Response Based on Bone Marrow Samples by the International MDS Working Group (IWG 2000) During Double-blind Period Complete remission	0 Participants	7 Participants	12 Participants
Participants' Response Based on Bone Marrow Samples by the International MDS Working Group (IWG 2000) During Double-blind Period Partial remission	0 Participants	5 Participants	1 Participants
Participants' Response Based on Bone Marrow Samples by the International MDS Working Group (IWG 2000) During Double-blind Period Stable Disease	37 Participants	35 Participants	33 Participants
Participants' Response Based on Bone Marrow Samples by the International MDS Working Group (IWG 2000) During Double-blind Period Progression	3 Participants	4 Participants	3 Participants

SECONDARY outcome

Timeframe: up to 52 weeks

Population: Modified intent to treat population, which is defined as participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q\[31\] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug. Participants had to have had more than 1 post-baseline assessment in order to be evaluable for cytogenetic response.

The IWG criteria for evaluating cytogenetic response require a minimum of 20 baseline and post-baseline analyzable metaphases using conventional cytogenetic techniques. A major cytogenetic response is defined as no detectable cytogenetic abnormality if preexisting abnormality was present whereas a minor response requires ≥50% reduction in abnormal metaphases. Progression could be concluded based on as few as 3 metaphases if there were additional abnormalities. The best response is represented.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Placebo matching to active study arms.	Lenalidomide 5 mg n=37 Participants Lenalidomide 5 mg daily for 28 days	Lenalidomide 10 mg n=40 Participants Lenalidomide 10 mg daily for 21 of 28 days
Participants Showing Cytogenetic Response by the International MDS Working Group (IWG 2000) During Double-blind Period as Evaluated by Central Review Major response	0 Participants	5 Participants	10 Participants
Participants Showing Cytogenetic Response by the International MDS Working Group (IWG 2000) During Double-blind Period as Evaluated by Central Review Minor response	0 Participants	3 Participants	7 Participants
Participants Showing Cytogenetic Response by the International MDS Working Group (IWG 2000) During Double-blind Period as Evaluated by Central Review Cytogenetic progression	5 Participants	10 Participants	8 Participants
Participants Showing Cytogenetic Response by the International MDS Working Group (IWG 2000) During Double-blind Period as Evaluated by Central Review Not evaluable/data not available	10 Participants	10 Participants	1 Participants

SECONDARY outcome

Timeframe: up to 3 years

Population: Intent to treat population. Participants represented in the treatment groups to which they were randomized.

Number of participants who progressed to acute myeloid leukemia during the study, summarized at three different timepoints: first 16 weeks of the double-blind study, week 52 of the double-blind study, and up to 36 months which includes the double-blind and open-label periods of the study. The counts are cumulative by timeframe.

Outcome measures

Outcome measures
Measure	Placebo n=67 Participants Placebo matching to active study arms.	Lenalidomide 5 mg n=69 Participants Lenalidomide 5 mg daily for 28 days	Lenalidomide 10 mg n=69 Participants Lenalidomide 10 mg daily for 21 of 28 days
Participants Who Progressed to Acute Myeloid Leukemia (AML) During the Study Double-Blind (first 16 weeks)	2 Participants	2 Participants	0 Participants
Participants Who Progressed to Acute Myeloid Leukemia (AML) During the Study Double-Blind (52 weeks)	4 Participants	7 Participants	2 Participants
Participants Who Progressed to Acute Myeloid Leukemia (AML) During the Study Double-Blind + Open-Label	21 Participants	16 Participants	15 Participants

SECONDARY outcome

Timeframe: up to 3 years

Population: Safety population: All randomized participants who received any Lenalidomide or placebo.

Kaplan Meier estimate for median length of survival for study participants as they were randomized at the start of the study.

Outcome measures

Outcome measures
Measure	Placebo n=67 Participants Placebo matching to active study arms.	Lenalidomide 5 mg n=69 Participants Lenalidomide 5 mg daily for 28 days	Lenalidomide 10 mg n=69 Participants Lenalidomide 10 mg daily for 21 of 28 days
Kaplan Meier Estimates of Overall Survival by Randomized Group	42.4 Months Interval 31.9 to The confidence interval cannot be estimated due to not enough number of deaths.	NA Months Interval 24.6 to The confidence interval cannot be estimated due to not enough number of deaths.	44.5 Months Interval 35.5 to The confidence interval cannot be estimated due to not enough number of deaths.

SECONDARY outcome

Timeframe: up to 3 years

Population: Safety Population

Count of participant deaths throughout the entire study and reported by the original treatment assignment.

Outcome measures

Outcome measures
Measure	Placebo n=67 Participants Placebo matching to active study arms.	Lenalidomide 5 mg n=69 Participants Lenalidomide 5 mg daily for 28 days	Lenalidomide 10 mg n=69 Participants Lenalidomide 10 mg daily for 21 of 28 days
Participant Count of Deaths During Double-blind and Open-label by Randomized Group	35 Participants	32 Participants	34 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Participants who had both Baseline and Week 12 FACT-An data.

The Functional Assessment of Cancer Therapy-Anemia (FACT-An) questionnaire (Yellen, 1997) was used to assess health-related quality of life (HRQoL). In addition to general HRQoL, the FACT-An measures the impact of fatigue and other anemia-related symptoms on patient functioning. The overall score range for the FACT-An is 0-188. Higher scores indicate better HRQoL.

Outcome measures

Outcome measures
Measure	Placebo n=52 Participants Placebo matching to active study arms.	Lenalidomide 5 mg n=45 Participants Lenalidomide 5 mg daily for 28 days	Lenalidomide 10 mg n=48 Participants Lenalidomide 10 mg daily for 21 of 28 days
Change From Baseline in the Functional Assessment of Cancer Therapy-Anemia (FACT-An) Endpoints at Week 12	-2.5 units on a scale Standard Deviation 18.50	5.9 units on a scale Standard Deviation 18.26	5.8 units on a scale Standard Deviation 23.17

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Participants who had both Baseline and Week 12 TOI-An data.

The Trial Outcome Index-Anemia (TOI-An) composed of the physical and functional subscales of the FACT-G along with the Anemia subscale was used to assess health-related quality of life (HRQoL). The overall score range for the TOI-An is 0-136. Higher scores indicate better HRQoL.

Outcome measures

Outcome measures
Measure	Placebo n=52 Participants Placebo matching to active study arms.	Lenalidomide 5 mg n=46 Participants Lenalidomide 5 mg daily for 28 days	Lenalidomide 10 mg n=49 Participants Lenalidomide 10 mg daily for 21 of 28 days
Change From Baseline in the Trial Outcome Index-Anemia (TOI-An) Endpoints at Week 12	-1.1 units on a scale Standard Deviation 17.13	5.6 units on a scale Standard Deviation 15.56	4.9 units on a scale Standard Deviation 18.16

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Participants who had both Baseline and Week 12 TOI-F data.

The Trial Outcome Index-Fatigue(TOI-F) composed of the physical and functional subscales of the FACT-G along with the fatigue items from the Anemia subscale was used to assess health-related quality of life (HRQoL). The overall score range for the TOI-F is 0-108. Higher scores indicate better HRQoL.

Outcome measures

Outcome measures
Measure	Placebo n=53 Participants Placebo matching to active study arms.	Lenalidomide 5 mg n=46 Participants Lenalidomide 5 mg daily for 28 days	Lenalidomide 10 mg n=49 Participants Lenalidomide 10 mg daily for 21 of 28 days
Change From Baseline in the Trial Outcome Index-Fatigue (TOI-F) Endpoints at Week 12	-0.8 units on a scale Standard Deviation 14.76	4.8 units on a scale Standard Deviation 14.21	3.9 units on a scale Standard Deviation 15.47

SECONDARY outcome

Timeframe: up to week 52

Population: Safety population.

Counts of study participants who had adverse events (AEs) during the double-blind period by MedDRA System Organ Class (SOC) and preferred term. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. Adverse events were evaluated by the investigator. The National Cancer Institute (NCI)'s Common Terminology Criteria for AEs (CTCAE) was used to grade AE severity. Severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE.

Outcome measures

Outcome measures
Measure	Placebo n=67 Participants Placebo matching to active study arms.	Lenalidomide 5 mg n=69 Participants Lenalidomide 5 mg daily for 28 days	Lenalidomide 10 mg n=69 Participants Lenalidomide 10 mg daily for 21 of 28 days
Summary of Participants Who Had Adverse Events (AE) During the Double-blind Period At least one AE	64 participants	69 participants	69 participants
Summary of Participants Who Had Adverse Events (AE) During the Double-blind Period At least one AE related to study drug	34 participants	68 participants	66 participants
Summary of Participants Who Had Adverse Events (AE) During the Double-blind Period At least one NCI CTCAE grade 3-4 AE	29 participants	62 participants	65 participants
Summary of Participants Who Had Adverse Events (AE) During the Double-blind Period At least one related NCI CTCAE grade 3-4 AE	13 participants	61 participants	61 participants
Summary of Participants Who Had Adverse Events (AE) During the Double-blind Period At least one serious AE	14 participants	31 participants	32 participants
Summary of Participants Who Had Adverse Events (AE) During the Double-blind Period At least one serious AE related to study drug	1 participants	17 participants	13 participants
Summary of Participants Who Had Adverse Events (AE) During the Double-blind Period An AE leading to discontinuation of study drug	3 participants	12 participants	6 participants
Summary of Participants Who Had Adverse Events (AE) During the Double-blind Period An AE leading to dose reduction or interruption	5 participants	44 participants	51 participants
Summary of Participants Who Had Adverse Events (AE) During the Double-blind Period Deaths within 30 days of last dose of study drug	4 participants	2 participants	4 participants

Adverse Events

Placebo

Serious events: 14 serious events

Other events: 64 other events

Deaths: 0 deaths

Lenalidomide 5 mg

Serious events: 42 serious events

Other events: 69 other events

Deaths: 0 deaths

Lenalidomide 10 mg

Serious events: 42 serious events

Other events: 69 other events

Deaths: 0 deaths

Placebo Crossover to 5 mg Open-label Period

Serious events: 33 serious events

Other events: 56 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Associate Director, Clinical Trials Disclosure

Celgene Corporation

Phone: 1-888-260-1599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee * Multicenter publication must include input from investigators and Celgene, agreement to be established before publication. It has priority over subset (single center) publication, for duration of 1 year after study completion. * Individual investigators have publication right after multicenter publication is complete (or 1 year after study completion), whichever is first. In this case, Celgene has the right to comment and right to ask delay of publication for 90 days.
Publication restrictions are in place

Restriction type: OTHER