The Intergroupe Francophone du My?lome (IFM) has conducted studies of lenalidomid for the treatment of newly diagnosed multiple myeloma . Updated data from the IFM under the sponsorship of the University Hospital of Toulouse were presented at the 52nd Annual Meeting of the American Society of Hematology in Orlando (December 4 ? 7, 2010).

In this international Phase III, controlled, double-blind, multi-centre study, newly diagnosed multiple myeloma patients who achieved at least stable disease (SD) following autologous stem cell transplant (ASCT) were randomized to receive a two-month consolidation regimen of lenalidomid (Revlimid ?, Celgene International S?rl) monotherapy 25 mg per day on 21/28 days, followed by continuous daily treatment with either lenalidomide 10-15 mg (n=307) or placebo (n=307) until relapse.

While thalidomide has changed the treatment paradigm of patients with MM, its efficacy has been compromised by significant side effects. Immunomodulators (IMiDs) such as lenalidomid, a second-generation structural and functional analogs of thalidomide, are specifically designed to enhance anticancer properties and better tolerability profiles. [1]

When compared to thalidomide, lenalidomid exhibits a greatly enhanced potency for immunomodulation and antiangiogenesis. In clinical studies, immunomodulators (IMiDs) appear to have reduced sedative and neurotoxicity effects, which are often associated with long-term thalidomide dosing.[2]

Patients receiving continuous lenalidomide following ASCT had a median progression free survival period of 42 months from randomization compared to 24 months (HR=0.50, p<0.10-8) for patients that received placebo.[3] This represented a 50% reduction in risk of disease progression for patients receiving continuous lenalidomide. Five-year overall survival was 81% for both arms of the study at the time of reporting. According to the study, a longer follow-up is required to appreciate the impact on overall survival.

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Clinically significant improvements in progression free survival were independent of prior induction therapy, depth of response after ASCT, disease volume (expressed by beta-2 microglobulin) or myeloma with high risk cytogenetic features (deletion 13) at entry into the study.

The most common grade 3-4 adverse events experienced by patients receiving lenalidomide or placebo in the study were neutropenia (43% vs. 14%, respectively), thrombocytopenia (12% vs. 6%) and infections (10% vs. 5%). The IFM data are from an investigational study. lenalidomid is not approved as a treatment for patients newly diagnosed with multiple myeloma.

For more information:

[1] Srkalovic G, Hussein M. Immunomodulatory compounds (IMiDs) in the treatment of multiple myeloma. Bosn J Basic Med Sci. 2009 Oct;9 Suppl 1:3-10
[2] Knight R IMiDs: a novel class of immunomodulators. Semin Oncol.2005 Aug;32(4 Suppl 5):S24-30.
[3] Frontline Therapy with Bortezomib, Lenalidomide, and Dexamethasone (VRD) Induction Followed by Autologous Stem Cell Transplantation, VRD Consolidation and Lenalidomide Maintenance In Newly Diagnosed Multiple Myeloma Patients: Primary Results of the IFM 2008 Phase II Study ?[Abstract 624] 52nd Annual Meeting of the American Society of Hematology in Orlando (December 4 ? 7, 2010).

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