Phase 3 Study of Revlimid for Multiple Myeloma

Celgene International Sàrl announced updated data from its Phase 3 study of Revlimid (lenalidomide) for the treatment of multiple myeloma. This controlled, double-blind, multicenter study randomized newly diagnosed multiple myeloma patients who achieved at least stable disease (SD) following autologous stem cell transplant (ASCT) to receive continuous daily treatment with Revlimid 10mg (n=231) or placebo (n=229) until relapse. As of April 2011, a 28-month median follow-up showed patients receiving continuous Revlimid following ASCT demonstrated a statistically significant improvement in overall survival, with an OS rate of 90% (208/231) compared with 83% (190/229) for patients randomized to receive placebo (unadjusted P=0.018; HR 0.51; 95% CI = 0.26–1.014), despite nearly 80% (86/110) of patients crossing over to receive continuous Revlimid at the time of study unblinding. Patients also receiving continuous treatment with Revlimid experienced a 56% reduction in the risk of disease progression or death compared with placebo (P<0.0001).

Revlimid is approved for use, in combination with dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. Revlimid is also approved for treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities. 

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