• Michel Attal, Valerie Lauwers-Cances, Gerald Marit, Denis Caillot, Philippe Moreau, Thierry Facon, Anne Marie Stoppa, Cyrille Hulin, Lofti Benboubker, Laurent Garderet, Olivier Decaux, Serge Leyvraz, Marie-Christiane Vekemans, Laurent Voillat, Mauricette Michallet, Brigitte Pegourie, Charles Dumontet, Murielle Roussel, Xavier Leleu, Claire Mathiot, Catherine Payen, Hervé Avet-Loiseau, Jean-Luc Harousseau, and IFM Investigators.
• Department of Hematology, Hôpital Purpan, Toulouse, France. attal.m@chu-toulouse.fr
• N. Engl. J. Med. 2012 May 10; 366 (19): 1782-91.

BackgroundHigh-dose chemotherapy with autologous stem-cell transplantation is a standard treatment for young patients with multiple myeloma. Residual disease is almost always present after transplantation and is responsible for relapse. This phase 3, placebo-controlled trial investigated the efficacy of lenalidomide maintenance therapy after transplantation.MethodsWe randomly assigned 614 patients younger than 65 years of age who had nonprogressive disease after first-line transplantation to maintenance treatment with either lenalidomide (10 mg per day for the first 3 months, increased to 15 mg if tolerated) or placebo until relapse. The primary end point was progression-free survival.ResultsLenalidomide maintenance therapy improved median progression-free survival (41 months, vs. 23 months with placebo; hazard ratio, 0.50; P<0.001). This benefit was observed across all patient subgroups, including those based on the β(2)-microglobulin level, cytogenetic profile, and response after transplantation. With a median follow-up period of 45 months, more than 70% of patients in both groups were alive at 4 years. The rates of grade 3 or 4 peripheral neuropathy were similar in the two groups. The incidence of second primary cancers was 3.1 per 100 patient-years in the lenalidomide group versus 1.2 per 100 patient-years in the placebo group (P=0.002). Median event-free survival (with events that included second primary cancers) was significantly improved with lenalidomide (40 months, vs. 23 months with placebo; P<0.001).ConclusionsLenalidomide maintenance after transplantation significantly prolonged progression-free and event-free survival among patients with multiple myeloma. Four years after randomization, overall survival was similar in the two study groups. (Funded by the Programme Hospitalier de Recherche Clinique and others; ClinicalTrials.gov number, NCT00430365.).

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