Trial Outcomes & Findings for Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma) (NCT NCT01938001)

NCT ID: NCT01938001

Last Updated: 2023-02-22

Results Overview

Progression-free survival (PFS) was defined as the time from date of randomization into the study to the first observation of documented disease progression or death due to any cause, whichever occurred first. PFS was based on the data from the IRC review using the modified 2007 International Working Group Response Criteria (IWGRC) using FDA censoring rules.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

358 participants

Primary outcome timeframe

From randomization of study drug up to disease progression or death, which occurred first; up to the data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months).

Results posted on

2023-02-22

Participant Flow

Participant milestones

Participant milestones
Measure	Rituximab + Lenalidomide (R^2) Participants received rituximab 375 mg/m\^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but \< 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.	Rituximab + Placebo Participants received rituximab 375 mg/m\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Pre-Treatment STARTED	178	180
Pre-Treatment COMPLETED	176	180
Pre-Treatment NOT COMPLETED	2	0
Treatment STARTED	176	180
Treatment COMPLETED	124	110
Treatment NOT COMPLETED	52	70

Reasons for withdrawal

Reasons for withdrawal
Measure	Rituximab + Lenalidomide (R^2) Participants received rituximab 375 mg/m\^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but \< 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.	Rituximab + Placebo Participants received rituximab 375 mg/m\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Pre-Treatment Adverse Event unrelated to Study Drug	1	0
Pre-Treatment Death	1	0
Treatment Death	2	0
Treatment Adverse Event	14	8
Treatment Progressive Disease	21	54
Treatment Withdrawal by Subject	13	7
Treatment Other reasons	2	1

Baseline Characteristics

Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rituximab + Lenalidomide (R^2) n=178 Participants Participants received rituximab 375 mg/m\^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but \< 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.	Rituximab + Placebo n=180 Participants Participants received rituximab 375 mg/m\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.	Total n=358 Participants Total of all reporting groups
Age, Continuous	62.30 Years STANDARD_DEVIATION 11.227 • n=5 Participants	61.48 Years STANDARD_DEVIATION 11.160 • n=7 Participants	61.89 Years STANDARD_DEVIATION 11.186 • n=5 Participants
Sex: Female, Male Female	103 Participants n=5 Participants	83 Participants n=7 Participants	186 Participants n=5 Participants
Sex: Female, Male Male	75 Participants n=5 Participants	97 Participants n=7 Participants	172 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	24 Participants n=5 Participants	20 Participants n=7 Participants	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	147 Participants n=5 Participants	158 Participants n=7 Participants	305 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized White	118 Participants n=5 Participants	115 Participants n=7 Participants	233 Participants n=5 Participants
Race/Ethnicity, Customized Other Races	54 Participants n=5 Participants	64 Participants n=7 Participants	118 Participants n=5 Participants
Race/Ethnicity, Customized Not Collected or Reported	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization of study drug up to disease progression or death, which occurred first; up to the data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months).

Population: The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.

Outcome measures

Outcome measures
Measure	Rituximab + Lenalidomide (R^2) n=178 Participants Participants received rituximab 375 mg/m\^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but \< 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.	Rituximab + Placebo n=180 Participants Participants received rituximab 375 mg/m\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Kaplan Meier Estimate of Progression Free Survival Assessed by the Independent Review Committee (IRC) According to the 2007 International Working Group Response Criteria (IWGRC)	39.4 months Interval 22.9 to NA =Not enough events had occurred at the time of the data cut-off date	14.1 months Interval 11.4 to 16.7

SECONDARY outcome

Timeframe: From first dose of investigational product (IP) to data cut-off date of 22 June 2018; the median treatment duration was 11.19 months in the rituximab/lenalidomiade arm and 11.04 months in the rituximab/placebo arm

Population: The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.

DCCR was defined as the percentage of participants with a best response of complete response (CR) that lasted no less than one year (≥ 48 weeks) during the study prior to administration of new anti-lymphoma therapy. A CR is defined as a complete disappearance of any disease-related symptoms and normalization of biochemical abnormalities.

Outcome measures

Outcome measures
Measure	Rituximab + Lenalidomide (R^2) n=178 Participants Participants received rituximab 375 mg/m\^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but \< 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.	Rituximab + Placebo n=180 Participants Participants received rituximab 375 mg/m\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Durable Complete Response Rate (DCCR) as Assessed by the IRC According to the 2007 IWGRC	25.3 Percentage of Participants Interval 19.1 to 32.3	11.1 Percentage of Participants Interval 6.9 to 16.6

SECONDARY outcome

Timeframe: From date of randomization to death due to any cause (Average of 55.71 months and a maximum up to 95.2 months)

Population: The ITT population is defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.

Overall survival was defined as the time from randomization to death from any cause. Overall survival 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	Rituximab + Lenalidomide (R^2) n=178 Participants Participants received rituximab 375 mg/m\^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but \< 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.	Rituximab + Placebo n=180 Participants Participants received rituximab 375 mg/m\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Kaplan-Meier Estimate of Overall Survival (OS)	NA Months insufficient number of participants with events	NA Months insufficient number of participants with events

SECONDARY outcome

Timeframe: From date of first dose to data cut-off date of 22 June 2018; the median treatment duration was 11.19 months in the rituximab/lenalidomide arm and 11.04 months in the rituximab/placebo arm

Population: The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.

Percentage of participants with an objective response is defined as having a response of at least a PR during the study without administration of new anti-lymphoma therapy. A complete response = a complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities; a partial response (PR) = 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD.

Outcome measures

Outcome measures
Measure	Rituximab + Lenalidomide (R^2) n=178 Participants Participants received rituximab 375 mg/m\^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but \< 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.	Rituximab + Placebo n=180 Participants Participants received rituximab 375 mg/m\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Percentage of Participants With an Objective Response as Assessed by the IRC According to the 2007 IWGRC	77.5 Percentage of Participants Interval 70.7 to 83.4	53.3 Percentage of Participants Interval 45.8 to 60.8

SECONDARY outcome

Timeframe: From date of first dose up to data cut-off date of 22 June 2018; the median treatment duration was 11.19 months in the rituximab/lenalidomide arm and 11.04 months in the rituximab/placebo arm

Population: The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.

Percentage of participants with a best response of at CR during the study without administration of new anti-lymphoma therapy. A CR = Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities.

Outcome measures

Outcome measures
Measure	Rituximab + Lenalidomide (R^2) n=178 Participants Participants received rituximab 375 mg/m\^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but \< 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.	Rituximab + Placebo n=180 Participants Participants received rituximab 375 mg/m\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Percentage of Participants With a Best Response of Complete Response as Assessed by the IRC According to the 2007 IWGRC	33.7 Percentage of Participants Interval 26.8 to 41.2	18.3 Percentage of Participants Interval 13.0 to 24.8

SECONDARY outcome

Timeframe: From randomization up to data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months).

Population: Participants who achieved an objective response in the ITT population.

Duration of response (DOR) was defined as the time from initial response (at least PR) until documented progressive disease (PD) or death. Participants who had not progressed at the time of analysis were censored at the last assessment date that the participant was known to be progression free. Participants who received a new treatment without documented progression were censored at the last assessment date that the participants was known to be progression free.

Outcome measures

Outcome measures
Measure	Rituximab + Lenalidomide (R^2) n=138 Participants Participants received rituximab 375 mg/m\^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but \< 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.	Rituximab + Placebo n=96 Participants Participants received rituximab 375 mg/m\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Kaplan-Meier Estimate of Duration of Objective Response as Assessed by the IRC According to the 2007 IWGRC	36.6 months Interval 22.9 to Not estimable as not enough events had occurred at the time of the data cut-off date	21.7 months Interval 12.8 to 27.6

SECONDARY outcome

Timeframe: From randomization up to data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months).

Population: Participants who achieved a complete response in the ITT population.

DOCR was defined as the time from initial CR until documented PD or death. Participants who had not progressed at the time of analysis were censored at the last assessment date that the participant was known to be progression free. Participants who received a new treatment without documented progression were censored at the last assessment date that the participants was known to be progression free.

Outcome measures

Outcome measures
Measure	Rituximab + Lenalidomide (R^2) n=60 Participants Participants received rituximab 375 mg/m\^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but \< 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.	Rituximab + Placebo n=33 Participants Participants received rituximab 375 mg/m\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Kaplan-Meier Estimate of Duration of Complete Response (DOCR) as Assessed by the IRC According to the 2007 IWGRC	NA months Interval 25.3 to Not enough events had occurred at the time of the data cut-off date	NA months Interval 13.8 to Not enough events had occurred at the time of the data cut-off date

SECONDARY outcome

Timeframe: From date of randomization to data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months).

Population: The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.

Event-free survival (EFS) was defined as the time from date of randomization to date of first documented progression, relapse, institution of new anti-lymphoma treatment (chemotherapy, radiotherapy or immunotherapy) or death from any cause. Responding participants and those who were lost to follow up were censored at their last tumor assessment date.

Outcome measures

Outcome measures
Measure	Rituximab + Lenalidomide (R^2) n=178 Participants Participants received rituximab 375 mg/m\^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but \< 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.	Rituximab + Placebo n=180 Participants Participants received rituximab 375 mg/m\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Kaplan Meier Estimate of Event Free Survival as Assessed by the IRC According to the 2007 IWGRC	27.6 months Interval 22.1 to Not enough events had occurred at the time of the data cut-off date	13.9 months Interval 11.4 to 16.7

SECONDARY outcome

Timeframe: From date of randomization to date of first documented administration of a new anti-lymphoma treatment (Average of 55.71 months and a maximum up to 95.2 months)

Population: The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.

Time to next anti-lymphoma treatment (TTNLT) was defined as the time from date of randomization to date of first documented administration of a new anti-lymphoma treatment (including chemotherapy, radiotherapy, radioimmunotherapy or immunotherapy). The time to the next anti-lymphoma treatment was of special interest to the study.

Outcome measures

Outcome measures
Measure	Rituximab + Lenalidomide (R^2) n=178 Participants Participants received rituximab 375 mg/m\^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but \< 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.	Rituximab + Placebo n=180 Participants Participants received rituximab 375 mg/m\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Kaplan Meier Estimate of Time to Next Anti-Lymphoma Treatment (TTNLT)	73.1 Months Interval 43.0 to upper limit not available due to insufficient number of participants with events	31.8 Months Interval 22.2 to 39.4

SECONDARY outcome

Timeframe: From first dose to 28 days post last dose (Average of 55.71 months and a maximum up to 95.2 months)

Population: The safety population was defined as all participants who have received at least one dose of study medication.

TEAEs include AEs that started or worsened between the date of the first dose and 28 days after the date of the last dose. A serious adverse event (SAE) is any: • Death; • Life-threatening event; • Any inpatient hospitalization or prolongation of existing hospitalization; • Persistent or significant disability or incapacity; • Congenital anomaly or birth defect; • Any other important medical event. The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event. The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 4.03) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death

Outcome measures

Outcome measures
Measure	Rituximab + Lenalidomide (R^2) n=176 Participants Participants received rituximab 375 mg/m\^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but \< 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.	Rituximab + Placebo n=180 Participants Participants received rituximab 375 mg/m\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any TEAE	174 Participants	173 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any TEAE Related to Lenalidomide/Placebo (LEN/PBO)	159 Participants	118 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any TEAE Related to Rituximab (RIT)	134 Participants	105 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any Serious TEAE	45 Participants	25 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any Serious TEAE Related to LEN/PBO	23 Participants	8 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any Serious TEAE Related to RIT	13 Participants	4 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any CTCAE Grade (GR) 3/4 TEAE	121 Participants	58 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any CTCAE GR 3/4 TEAE Related to LEN/PBO	101 Participants	38 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any CTCAE GR 3/4 TEAE Related to RIT	57 Participants	20 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any GR 5 TEAE	2 Participants	2 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any TEAE Leading to Dose Reduction LEN/PBO	46 Participants	6 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any TEAE Leading to Dose Interruption LEN/PBO	113 Participants	47 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any TEAE Leading to Dose Interruption RIT	59 Participants	38 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any TEAE Leading to Discontinuation of LEN/PBO	15 Participants	9 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any TEAE Leading to Discontinuation of RIT	6 Participants	2 Participants

Adverse Events

Rituximab + Lenalidomide (R^2)

Serious events: 45 serious events

Other events: 170 other events

Deaths: 27 deaths

Rituximab + Placebo

Serious events: 25 serious events

Other events: 158 other events

Deaths: 47 deaths

Serious adverse events

Other adverse events

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please Email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER