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.

Rd Continuous prolonged OS vs a non-REVLIMID triplet, MPT.1

(Secondary endpoint)

The FIRST Trial is a randomized, multicenter, open-label, 3-arm study that enrolled more than 1600 newly diagnosed patients who did not receive a stem cell transplant (SCT).

See the FIRST Trial Study Design

10.4-month increase vs MPT in an interim analysis.1


  • OS was a pre-specified secondary endpoint, and the interim analysis did not show a statistically significant difference between these two arms
  • The median follow-up time for all surviving patients in the interim OS analysis was 45.5 months (data cutoff: Mar 3, 2014). In that time, 78% of pre-specified events required for the planned final OS analysis (697 death events) were reported

Rd Continuous extended PFS (primary endpoint).1

  • Median PFS: 25.5 months (95% CI 20.7, 29.4) with Rd Continuous vs 21.2 months (95% CI 19.3, 23.2) with MPT (HR 0.72; 95% CI 0.61, 0.85; P<0.0001)

FIRST Trial.1

FIRST Trial (MM-020) was a randomized, multicenter, open-label, 3-arm study that enrolled over 1600 patients evaluating REVLIMID + dex (Rd) until progression or unacceptable toxicity, in newly diagnosed patients who did not receive an auto-HSCT. Patients were ≥65 years or <65 years and were not a candidate for SCT if the patient refused or did not have access to auto-HSCT. Patients were stratified by age, stage, and country.3


REVLIMID® + dexamethasone FIRST Trial
  • Primary endpoint was PFS
  • The primary comparison for efficacy was between the Rd Continuous and MPT arms
  • Secondary endpoints included OS and response rates
  • All patients received prophylactic anticoagulation, with the most commonly used being aspirin
  • The dose of REVLIMID in the clinical trial was 25 mg orally once daily on Days 1 to 21 of repeated 28-day cycles with low-dose oral dex on Days 1, 8, 15, and 22
    • The dose for dex was 40 mg orally for patients ≤75 years or 20 mg orally for patients >75 years
    • Initial dose and regimens for Rd Continuous and Rd18 were adjusted by age and renal function
  • OS was defined as the time from randomization to death from any cause. NE included patients with no response assessment and those whose only assessment was “response not evaluable.”1
  • PFS was defined as the time from randomization to the first documentation of disease progression as determined by IRAC, based on IMWG response criteria, or death due to any cause, whichever occurred first during the study until the end of the PFS follow-up phase.1 The data cutoff was May 24, 2013.



>75 years of age

Median age of 73 years (range 40-92)


Moderate to severe renal impairment

(CrCl ≤50 mL/min, excluding patients on dialysis)

Demographics and disease-related baseline characteristics of patients were balanced across study arms.1-3

REVLIMID® + dexamethasone Baseline Characteristics

  • auto-HSCT, autologous hematopoietic stem cell transplantation; CI, confidence interval; CrCl, creatinine clearance; ECOG, Eastern Cooperative Oncology Group; HR, hazard ratio; IMWG, International Myeloma Working Group; IRAC, Independent Response Adjudication Committee; ISS, International Staging System; MPT, melphalan + prednisone + thalidomide; NDMM, newly diagnosed multiple myeloma; NE, not evaluable; NSCT, non-stem cell transplant; OS, overall survival; PFS, progression-free survival; Rd, REVLIMID + dexamethasone; SCT, stem cell transplant.

References: 1. REVLIMID [package insert]. Summit, NJ: Celgene Corp. 2. Benboubker L, Dimopoulos MA, Dispenzieri A, et al. Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma. N Engl J Med. 2014;371(10):906-917. 3. Data on file. Celgene Corp; 2020.

Rd safety profile.

View Rd Safety