Lenalidomide after stem-cell transplantation for multiple myeloma Journal Article
| Authors: | McCarthy, P. L.; Owzar, K.; Hofmeister, C. C.; Hurd, D. D.; Hassoun, H.; Richardson, P. G.; Giralt, S.; Stadtmauer, E. A.; Weisdorf, D. J.; Vij, R.; Moreb, J. S.; Callander, N. S.; van Besien, K.; Gentile, T.; Isola, L.; Maziarz, R. T.; Gabriel, D. A.; Bashey, A.; Landau, H.; Martin, T.; Qazilbash, M. H.; 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, M. C.; Horowitz, M. M.; Shea, T. C.; Devine, S. M.; Anderson, K. C.; Linker, C. |
| Article Title: | Lenalidomide after stem-cell transplantation for multiple myeloma |
| 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.) Copyright © 2012 Massachusetts Medical Society. |
| Journal Title: | New England Journal of Medicine |
| Volume: | 366 |
| Issue: | 19 |
| ISSN: | 0028-4793 |
| Publisher: | Massachusetts Medical Society |
| Date Published: | 2012-05-10 |
| Start Page: | 1770 |
| End Page: | 1781 |
| Language: | English |
| DOI: | 10.1056/NEJMoa1114083 |
| PROVIDER: | scopus |
| PUBMED: | 22571201 |
| PMCID: | PMC3744390 |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 2" - "Export Date: 4 June 2012" - "CODEN: NEJMA" - "Source: Scopus" |
Altmetric
Citation Impact
BMJ Impact Analytics
Related MSK Work