ECOG E3A06 results positive for Revlimid to treat smoldering multiple myeloma.- Celgene

Celgene Corporation announced results from an open-label phase II/III National Clinical Trials Network (NCTN) study led by the ECOG-ACRIN Cancer Research Group and sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health. Revlimid (lenalidomide) was provided by Celgene under a clinical trials agreement with the NCI�s Division of Cancer Treatment and Diagnosis.

ECOG E3A06 is a randomized study evaluating the safety and efficacy of the investigational use of Revlimid monotherapy versus observation in patients with asymptomatic smoldering multiple myeloma . In the study, single-agent Revlimid achieved a statistically significant improvement in the primary endpoint of progression-free survival compared to observation. Based on the preliminary results of the study, safety was consistent with the known safety profile of Revlimid. Revlimid is not approved for use in asymptomatic smoldering multiple myeloma in any geography.