Phase III Study Evaluating REVLIMID in Patients with High-Risk Smoldering Multiple Myeloma Presented at ASH

Three Year Overall Survival from Inclusion Was 93% for Patients Treated with REVLIMID® and Dexamethasone Compared to 76% for Patients under Observation Only Celgene International Sàrl, a subsidiary of Celgene Corporation

, announced that updated data evaluating continuous treatment with REVLIMID® (lenalidomide) in patients with high-risk asymptomatic smoldering multiple myeloma were presented at the 53rd Annual Meeting of the American Society of Hematology. The study demonstrated that early treatment with lenalidomide and dexamethasone followed by continuous lenalidomide delayed time to symptomatic disease and demonstrated a projected survival advantage compared with observation. The Phase III, randomized, multicenter, open-label study evaluated whether continuous treatment with lenalidomide in high-risk asymptomatic smoldering multiple myeloma patients prolonged time to progression to symptomatic disease compared with patients who did not receive treatment and were just observed, which is the current standard of care for smoldering multiple myeloma. Of 119 evaluable patients, 57 were treated with lenalidomide (25 mg daily on days 1-21 of a 28-day cycle) and dexamethasone (20 mg on days 1-4 and 12-15 of a 28-day cycle) for nine four-week cycles and then continued treatment with a lower dose of lenalidomide (10 mg daily on days 1-21 of a 28-day cycle) until disease progression, while there were 62 patients in the therapeutic abstention arm.