Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma

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

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    503 Citations (Scopus)

    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
    JournalThe New England Journal of Medicine
    Volume371
    Issue number10
    DOIs
    Publication statusPublished - 2014

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