Lenalidomide after stem-cell transplantation for multiple myeloma

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 MartinMuzaffar 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, Charles Linker

Research output: Contribution to journalArticlepeer-review

785 Scopus citations

Abstract

BACKGROUND: Data are lacking on whether lenalidomide maintenance therapy prolongs the time to disease progression after autologous hematopoietic stem-cell transplantation in patients with multiple myeloma. METHODS: Between 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). RESULTS: The 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%). CONCLUSIONS: Lenalidomide maintenance therapy, initiated at day 100 after hematopoietic stemcell 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.)

Original languageEnglish (US)
Pages (from-to)1770-1781
Number of pages12
JournalNew England Journal of Medicine
Volume366
Issue number19
DOIs
StatePublished - May 10 2012

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