Lenalidomide after stem-cell transplantation for multiple myeloma.
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 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.).
McCarthy, PL; Owzar, K; Hofmeister, CC; Hurd, DD; Hassoun, H; Richardson, PG; Giralt, S; Stadtmauer, EA; Weisdorf, DJ; Vij, R; Moreb, JS; Callander, NS; Van Besien, K; Gentile, T; Isola, L; Maziarz, RT; Gabriel, DA; Bashey, A; Landau, H; Martin, T; Qazilbash, MH; Levitan, D; McClune, B; Schlossman, R; Hars, V; Postiglione, J; Jiang, C; Bennett, E; Barry, S; Bressler, L; Kelly, M; Seiler, M; Rosenbaum, C; Hari, P; Pasquini, MC; Horowitz, MM; Shea, TC; Devine, SM; Anderson, KC; Linker, C
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