What is the efficacy of lenalidomide for the treatment of multiple myeloma (MM)?

Updated: May 11, 2021
  • Author: Dhaval Shah, MD; Chief Editor: Emmanuel C Besa, MD  more...
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In a randomized, double-blind, placebo-controlled trial, lenalidomide plus high-dose dexamethasone proved superior to high-dose dexamethasone alone as treatment for newly diagnosed MM. [51] The overall response rate was 84% in the lenalidomide plus high-dose dexamethasone group versus 53% in the high-dose dexamethasone group, with 22% of patients achieving complete remission in the lenalidomide plus high-dose dexamethasone arm.

PFS and overall survival favored lenalidomide plus high-dose dexamethasone, but 12-month survival for both arms was > 90%. A very important observation, however, was the high incidence of deep venous thrombosis in the lenalidomide plus high-dose dexamethasone arm. [51]

In another randomized trial of lenalidomide plus high-dose dexamethasone (LD) versus lenalidomide plus low-dose dexamethasone (Ld) in newly diagnosed MM, Rajkumar found that although the overall response rate within the first 4 months favored LD, analysis at 1 year, overall survival was 96% in the Ld arm compared with 87% in the LD arm (P=0.0002). As a result, the trial was stopped, and patients on high-dose therapy were crossed over to low-dose therapy. [55]

Another trial assessed the safety and efficacy of the combination regimen clarithromycin (Biaxin), lenalidomide (Revlimid), and dexamethasone (BiRD) as first-line therapy for MM. [56] Of the 72 patients enrolled, 65 had an objective response (90.3%). A combined stringent and conventional complete response rate of 38.9% was achieved, and 73.6% of the patients achieved at least a 90% decrease in M-protein levels. BiRD was found to be an effective regimen with manageable side effects in the treatment of symptomatic, newly diagnosed MM.

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