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.

A well-established safety profile.

The adverse reactions listed from CALGB (Study 1) included events reported post-transplant (completion of high-dose melphalan/auto-HSCT) and the maintenance treatment period. In IFM (Study 2), the adverse reactions were from the maintenance treatment period only.


REVLIMID® + Maintenance Therapy Safety Data
  • All serious treatment-emergent AEs in at least 1% of patients in the Lenalidomide Maintenance group and at least 1% higher frequency (%) than the Placebo Maintenance group.
  • ADRs where at least one was considered to be Life Threatening (if the outcome of the event was death, it is included with death cases).
Full Adverse Events Table
  • The most frequently reported Grade 3 or 4 adverse reactions (>20% in the REVLIMID arm) included neutropenia, thrombocytopenia, and leukopenia
  • In the multiple myeloma maintenance therapy trials, Grade 3 or 4 neutropenia was reported in up to 59% of REVLIMID-treated patients and Grade 3 or 4 thrombocytopenia in up to 38% of REVLIMID-treated patients
  • VTE and ATE are increased in patients treated with REVLIMID
    • Prophylactic medications (aspirin, heparin, or warfarin) could be prescribed for patients at high risk for thrombosis in CALGB
    • Protocol did not include systematic thromboprophylaxis in IFM
  • The serious adverse reactions, lung infection and neutropenia (>4.5%), occurred in the REVLIMID arm

The frequency of ARs was generally highest in the first 6 months of treatment and then decreased or remained stable.

Consider the potential benefit of REVLIMID and risk of SPM

  • Monitor patients for the development of SPM
  • In clinical trials in patients with multiple myeloma receiving REVLIMID, an increase of hematologic plus solid-tumor SPM, notably AML and MDS, has been observed

REVLIMID Maintenance therapy post auto-HSCT

  • In patients receiving REVLIMID Maintenance therapy following high-dose intravenous melphalan and auto-HSCT, hematologic SPM occurred in 7.5% of patients compared with 3.3% of patients receiving placebo
  • The incidence of hematologic plus solid tumor SPM (excluding squamous cell carcinoma and basal cell carcinoma) was 14.9% compared with 8.8% in patients receiving placebo, with a median follow-up of 91.5 months
  • Non-melanoma skin cancer SPM, including squamous cell carcinoma and basal cell carcinoma, occurred in 3.9% of patients receiving REVLIMID Maintenance, compared with 2.6% in the placebo arm


  • The frequency of AML and MDS cases in patients with NDMM treated with REVLIMID + low-dose dex without melphalan was 0.4%

Patients in the FIRST trial who received REVLIMID until disease progression did not show a higher incidence of invasive SPM than those in the fixed duration, REVLIMID-containing arm.

  • AML, acute myeloid leukemia; AR, adverse reaction; ATE, arterial thromboembolism; auto-HSCT, autologous hematopoietic stem cell transplantation; CALGB, Cancer and Leukemia Group B; IFM, Intergroupe Francophone du Myélome; MDS, myelodysplastic syndrome; NDMM, newly diagnosed multiple myeloma; NSCT, non-stem cell transplant; SPM, second primary malignancy; VTE, venous thromboembolism.

Reference: 1. REVLIMID [package insert]. Summit, NJ: Celgene Corp.

View the recommended starting maintenance dose for patients with renal impairment.

View Maintenance Efficacy