REVLIMID® (lenalidomide) in combination with dexamethasone (dex) is indicated for the treatment of adult patients with multiple myeloma (MM). REVLIMID is indicated as maintenance therapy in adult patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT). REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

REVLIMID Maintenance therapy post auto-HSCT.1

CALGB (Maintenance Study 1 [US]) and IFM (Maintenance Study 2 [EU]) were randomized, double-blind, placebo-controlled studies conducted in newly diagnosed patients who received an auto-HSCT following induction therapy. Primary endpoint for both studies was PFS.1

See the CALGB and IFM Study Designs

CALGB (STUDY 1): 5.7-year median PFS with REVLIMID Maintenance.1


REVLIMID® Maintenance Therapy Median Progression Free Survival Graph

IFM (Study 2): 1.9-year advantage in median PFS vs placebo.*

  • Median PFS: 3.9 years with REVLIMID Maintenance (95% CI 3.3, 4.7) (n=307) vs 2.0 years with placebo (95% CI 1.8, 2.3) (n=307) (HR 0.53 [95% CI 0.44, 0.64])
  • Updated analysis, March 2015. Based on intent-to-treat (ITT) population.

CALGB (STUDY 1): 9.3-year median OS with REVLIMID Maintenance.1


REVLIMID® Maintenance Therapy Median Overall Survival Graph
  • Descriptive analysis of overall survival data with a cutoff date of February 1, 2016. Median follow-up time was 81.6 months for CALGB and 96.7 months for IFM. Neither CALGB nor IFM was powered to evaluate OS.

The ONLY NCCN Category 1 preferred maintenance therapy post auto-HSCT.2

Explaining the reasons for maintenance post-transplant to your patients may not be easy. Download the REVLIMID Maintenance brochure for patients to help you convey the risks and benefits.

Approved based on 2 large cooperative group trials.1,3

REVLIMID® Maintenance Therapy Trial Design CALGB

Patients in the placebo arm of CALGB were allowed to cross over to receive REVLIMID before disease progression (76 patients [33%] crossed over to REVLIMID). Induction therapy must have occurred within 12 months of diagnosis.

REVLIMID® Maintenance Therapy Trial Design IFM
  • Patients in the placebo arm of IFM were not recommended to cross over. Induction therapy must have occurred within 12 months of diagnosis. Treatment with REVLIMID was stopped at the recommendation of the Data Monitoring Committee in January 2011.
  • REVLIMID was given 25 mg/day on Days 1-21 for 2 cycles.
  • Trial Design: CALGB and IFM were multicenter, randomized, double-blind, parallel-group, placebo-controlled studies conducted in newly diagnosed patients between 18 and 70 years (CALGB) and <65 years at diagnosis (IFM) who received auto-HSCT following induction therapy. Patients were required to achieve at least stable disease following hematologic recovery and CrCl ≥30 mL/min. The primary endpoint for both studies was PFS, defined from randomization to the date of progression or death, whichever occurred first. PFS was based on assessment by investigator. At a preplanned interim analysis, the primary endpoint of PFS was met and both studies were unblinded. After unblinding, patients continued to be followed as before. In both studies, the starting dose of REVLIMID was 10 mg once daily for repeated 28-day cycles. After 3 months, a dose increase to 15 mg once daily occurred in 135 patients (58%) in CALGB, and in 185 patients (60%) in IFM. The dose was reduced, interrupted, and/or discontinued as needed to manage toxicity. Both studies were designed to treat until disease progression, unacceptable toxicity, or patient withdrawal for any reason.

Baseline characteristics in CALGB and IFM.1

REVLIMID® Maintenance Therapy Baseline Characteristics in CALGB & IFM

  • auto-HSCT, autologous hematopoietic stem cell transplantation; CALGB, Cancer and Leukemia Group B; CI, confidence interval; CR, complete response; CrCI, creatinine clearance; HR, hazard ratio; IFM, Intergroupe Francophone du Myélome; MM, multiple myeloma; NCCN, National Comprehensive Cancer Network; NE, not evaluable; OS, overall survival; PD, progressive disease; PFS, progression-free survival; PR, partial response; SD, stable disease; VGPR, very good partial response.

References: 1. REVLIMID [package insert]. Summit, NJ: Celgene Corp. 2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V.3.2022. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed September 9, 2020. To view the most recent and complete version of the guidelines, go online to NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way. 3. Data on file. Celgene Corp; 2018.

Maintenance therapy safety profile.

View Safety