What is the role of lenalidomide in 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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Patients with MM who are treated with lenalidomide or thalidomide are at significantly increased risk for thrombotic events, and many physicians incorporate anticoagulation strategies in their management. A study by Palumbo et al determined that aspirin and low-dose warfarin had similar efficacy in reducing serious thromboembolic events, acute cardiovascular events, and sudden deaths in patients with myeloma receiving thalidomide-based regimens compared with low-molecular weight heparin, except in elderly patients. [38] In addition, the NCCN recommends that clinicians consider harvesting peripheral blood stem cells before patients have prolonged exposure to lenalidomide. [2]

As monotherapy or in combination, interferon alfa-2b and prednisone modestly prolong the disease-free interval.

A study by the Southwest Oncology Group compared lenalidomide plus dexamethasone to placebo plus dexamethasone in patients with newly diagnosed myeloma. [42] The study determined that lenalidomide plus dexamethasone had superior 1-year progression-free survival, overall response rate, and very good partial response rate, suggesting that it is safe and effective as initial therapy for patients with newly diagnosed myeloma. In February 2015, the US Food and Drug Administration (FDA) expanded the approval of lenalidomide, in combination with dexamethasone, to include newly diagnosed MM. The original indication was for patients who had received at least 1 prior therapy.

A phase III randomized, open-label trial of 119 patients with high-risk smoldering MM found that early treatment with lenalidomide plus dexamethasone, followed by maintenance therapy with lenalidomide, delayed progression to symptomatic disease and increased overall survival. [43, 44]

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