Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma

Lotfi Benboubker, Meletios A. Dimopoulos, Angela Dispenzieri, John Catalano, Andrew R. Belch, Michele Cavo, Antonello Pinto, Katja Weisel, Heinz Ludwig, Nizar Bahlis, Anne Banos, Mourad Tiab, Michel Delforge, Jamie Cavenagh, Catarina Geraldes, Je Jung Lee, Christine Chen, Albert Oriol, Javier De La Rubia, Lugui QiuDarrell J. White, Daniel Binder, Kenneth Anderson, Jean Paul Fermand, Philippe Moreau, Michel Attal, Robert Knight, Guang Chen, Jason Van Oostendorp, Christian Jacques, Annette Ervin-Haynes, Hervé Avet-Loiseau, Cyrille Hulin, Thierry Facon

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Abstract

Background: The combination melphalan-prednisone-thalidomide (MPT) is considered a standard therapy for patients with myeloma who are ineligible for stem-cell transplantation. However, emerging data on the use of lenalidomide and low-dose dexamethasone warrant a prospective comparison of the two approaches. Methods: We randomly assigned 1623 patients to lenalidomide and dexamethasone in 28-day cycles until disease progression (535 patients), to the same combination for 72 weeks (18 cycles; 541 patients), or to MPT for 72 weeks (547 patients). The primary end point was progression-free survival with continuous lenalidomide-dexamethasone versus MPT. Results: The median progression-free survival was 25.5 months with continuous lenalidomide-dexamethasone, 20.7 months with 18 cycles of lenalidomide-dexamethasone, and 21.2 months with MPT (hazard ratio for the risk of progression or death, 0.72 for continuous lenalidomide-dexamethasone vs. MPT and 0.70 for continuous lenalidomide-dexamethasone vs. 18 cycles of lenalidomide-dexamethasone; P

Original languageEnglish
Pages (from-to)906-917
Number of pages12
JournalNew England Journal of Medicine
Volume371
Issue number10
DOIs
Publication statusPublished - Sep 4 2014

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ASJC Scopus subject areas

  • Medicine(all)

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Benboubker, L., Dimopoulos, M. A., Dispenzieri, A., Catalano, J., Belch, A. R., Cavo, M., Pinto, A., Weisel, K., Ludwig, H., Bahlis, N., Banos, A., Tiab, M., Delforge, M., Cavenagh, J., Geraldes, C., Lee, J. J., Chen, C., Oriol, A., De La Rubia, J., ... Facon, T. (2014). Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma. New England Journal of Medicine, 371(10), 906-917. https://doi.org/10.1056/NEJMoa1402551