Phase III data for Revlimid for Multiple Myeloma- Celgene
Celgene Corporation announced that data from FIRST (MM-020/IFM 07-01)�an open-label phase III randomized study of continuous Revlimid (lenalidomide) in combination with dexamethasone in patients newly diagnosed with Multiple Myeloma (NDMM) who are not candidates for stem cell transplant�have been published in the Sept. 4 issue of the New England Journal of Medicine.
Initial findings, including that the trial had met its primary endpoint of progression free survival (PFS), were reported during the plenary session at the 55th American Society of Hematology annual meeting in December 2013 .The findings, as published in the New England Journal of Medicine , demonstrated that at a median follow-up of 37 months among surviving patients, the median progression-free survival was 25.5 months with continuous oral lenalidomide plus low-dose dexamethasone (Rd), 20.7 months with a fixed course of oral lenalidomide plus low-dose dexamethasone (Rd18) and 21.2 months with melphalan, prednisone and thalidomide (MPT). This resulted in a 28% reduction in risk of progression or death for patients treated with continuous Rd compared with those treated with MPT (HR 0.72; 95% CI, 0.61 to 0.85; P < 0.001) and a 30% reduction compared with Rd18 (HR 0.70; 95% CI, 0.60 to 0.82; P < 0.001) in the study.
See "Lenalidomide and Dexamethasone in Transplant-Ineligible Patients with Myeloma"-Lotfi Benboubker, M.D., Meletios A. Dimopoulos, M.D., Angela Dispenzieri, M.D., John Catalano, M.D., Andrew R. Belch, M.D., et al.,N Engl J Med 2014; 371:906-917-September 4, 2014DOI: 10.1056/NEJMoa1402551.
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