Revlimid (Celgene) meets endpoint for Multiple Myeloma
New data from a Phase III study (FIRST) of Revlimid (lenalidomide), from Celgene, in combination with dexamethasone in patients newly diagnosed with Multiple Myeloma, has met its primary endpoint. A total of 1,623 patients either beyond 65 years of age or not candidates for stem cell transplant were randomized into three arms: lenalidomide plus low-dose dexamethasone (Rd) (Arm A); Rd (Arm B); or melphalan, prednisone and thalidomide (Arm C).
After a median follow-up of 37 months, the trial met its primary endpoint (PFS), demonstrating a 28% reduction in risk of progression or death. The preplanned interim analysis of OS demonstrated a 22% reduction in risk of death in favor of Arm A vs. Arm C; however, the pre-specified boundary was not crossed. All other secondary endpoints consistently showed improvement in favour of Arm A vs. Arm C.
Main adverse events in Arm A vs. Arm C were neutropenia (28% vs. 45%), thrombocytopenia (8% vs. 11%), febrile neutropenia (1% vs. 3%) and infection (29% vs. 17%). Data were presented at the American Society of Hematology annual meeting.
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