TY - JOUR
T1 - Lenalidomide after stem-cell transplantation for multiple myeloma
AU - McCarthy, Philip L.
AU - Owzar, Kouros
AU - Hofmeister, Craig C.
AU - Hurd, David D.
AU - Hassoun, Hani
AU - Richardson, Paul G.
AU - Giralt, Sergio
AU - Stadtmauer, Edward A.
AU - Weisdorf, Daniel J.
AU - Vij, Ravi
AU - Moreb, Jan S.
AU - Callander, Natalie Scott
AU - Van Besien, Koen
AU - Gentile, Teresa
AU - Isola, Luis
AU - Maziarz, Richard T.
AU - Gabriel, Don A.
AU - Bashey, Asad
AU - Landau, Heather
AU - Martin, Thomas
AU - Qazilbash, Muzaffar H.
AU - Levitan, Denise
AU - McClune, Brian
AU - Schlossman, Robert
AU - Hars, Vera
AU - Postiglione, John
AU - Jiang, Chen
AU - Bennett, Elizabeth
AU - Barry, Susan
AU - Bressler, Linda
AU - Kelly, Michael
AU - Seiler, Michele
AU - Rosenbaum, Cara
AU - Hari, Parameswaran
AU - Pasquini, Marcelo C.
AU - Horowitz, Mary M.
AU - Shea, Thomas C.
AU - Devine, Steven M.
AU - Anderson, Kenneth C.
AU - Linker, Charles
PY - 2012/5/10
Y1 - 2012/5/10
N2 - 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.)
AB - 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.)
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U2 - 10.1056/NEJMoa1114083
DO - 10.1056/NEJMoa1114083
M3 - Article
C2 - 22571201
AN - SCOPUS:84860741191
SN - 0028-4793
VL - 366
SP - 1770
EP - 1781
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 19
ER -