Successsful Phase III study of Actimid in Multiple Myeloma

A phase III, multi-center, randomized, open-label study (MM-003) of Actimid (pomalidomide) plus low-dose dexamethasone compared to high-dose dexamethasone in patients with relapsed and/or refractory Multiple Myeloma was reviewed by a data safety monitoring board (DSMB). The DSMB determined MM-003 met the primary endpoint of improvement in progression-free survival (PFS) at the PFS final analysis. Additionally, at the OS interim analysis, the study crossed the superiority boundary for overall survival (OS), a key secondary endpoint that the study was also powered to evaluate. Improvements in PFS and OS were both highly statistically significant and clinically meaningful. As a result, the DSMB recommended that patients who had not yet progressed in the high-dose dexamethasone arm should be crossed-over to the pomalidomide plus low-dose dexamethasone arm.