• Philip L McCarthy, Kouros Owzar, Craig C Hofmeister, David D Hurd, Hani Hassoun, Paul G Richardson, Sergio Giralt, Edward A Stadtmauer, Daniel J Weisdorf, Ravi Vij, Jan S Moreb, Natalie Scott Callander, Koen Van Besien, Teresa Gentile, Luis Isola, Richard T Maziarz, Don A Gabriel, Asad Bashey, Heather Landau, Thomas Martin, Muzaffar H Qazilbash, Denise Levitan, Brian McClune, Robert Schlossman, Vera Hars, John Postiglione, Chen Jiang, Elizabeth Bennett, Susan Barry, Linda Bressler, Michael Kelly, Michele Seiler, Cara Rosenbaum, Parameswaran Hari, Marcelo C Pasquini, Mary M Horowitz, Thomas C Shea, Steven M Devine, Kenneth C Anderson, and Charles Linker.
• Blood and Marrow Transplant Program, Roswell Park Cancer Institute, Buffalo, NY 14263, USA. philip.mccarthy@roswellpark.org
• N. Engl. J. Med. 2012 May 10; 366 (19): 177017811770-81.

BackgroundData are lacking on whether lenalidomide maintenance therapy prolongs the time to disease progression after autologous hematopoietic stem-cell transplantation in patients with multiple myeloma.MethodsBetween April 2005 and July 2009, we randomly assigned 460 patients who were younger than 71 years of age and had stable disease or a marginal, partial, or complete response 100 days after undergoing stem-cell transplantation to lenalidomide or placebo, which was administered until disease progression. The starting dose of lenalidomide was 10 mg per day (range, 5 to 15).ResultsThe study-drug assignments were unblinded in 2009, when a planned interim analysis showed a significantly longer time to disease progression in the lenalidomide group. At unblinding, 20% of patients who received lenalidomide and 44% of patients who received placebo had progressive disease or had died (P<0.001); of the remaining 128 patients who received placebo and who did not have progressive disease, 86 crossed over to lenalidomide. At a median follow-up of 34 months, 86 of 231 patients who received lenalidomide (37%) and 132 of 229 patients who received placebo (58%) had disease progression or had died. The median time to progression was 46 months in the lenalidomide group and 27 months in the placebo group (P<0.001). A total of 35 patients who received lenalidomide (15%) and 53 patients who received placebo (23%) died (P=0.03). More grade 3 or 4 hematologic adverse events and grade 3 nonhematologic adverse events occurred in patients who received lenalidomide (P<0.001 for both comparisons). Second primary cancers occurred in 18 patients who received lenalidomide (8%) and 6 patients who received placebo (3%).ConclusionsLenalidomide maintenance therapy, initiated at day 100 after hematopoietic stem-cell transplantation, was associated with more toxicity and second cancers but a significantly longer time to disease progression and significantly improved overall survival among patients with myeloma. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT00114101.).

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