Celgene announced that analyses of both Phase III Special Protocol Assessment (SPA) multiple myeloma trials exceeded the pre-specified value for stopping the trials.
The IDMC found a statistically significant improvement in time to disease progression — the primary endpoint of these Phase III trials — in patients receiving REVLIMID plus dexamethasone compared to patients receiving dexamethasone alone. Celgene has initiated discussions with the FDA and international regulatory authorities regarding the submission of this data for potential approval. Treatment assignments for patients currently on the trials will be unblinded and those currently not on REVLIMID will have the opportunity to add REVLIMID to their dexamethasone regimen.
“Following preliminary analysis we plan to use this data as the basis of a regulatory submission to the FDA and international regulatory agencies for REVLIMID in previously treated multiple myeloma patients,” said Jerome B. Zeldis, M.D., Ph.D., Chief Medical Officer and VP, Medical Affairs of Celgene Corporation.
The REVLIMID Phase III trials included patients with relapsed or refractory multiple myeloma. Patients were randomized to receive REVLIMID plus dexamethasone or dexamethasone alone. The trials enrolled 705 patients and are being conducted in 97 sites internationally, including: U.S., Europe and Australia. The trial design included a primary endpoint of time to disease progression calculated as the time from randomization to the first documentation of progressive disease based on Blade myeloma response criteria.
In addition to the initial positive efficacy profile, the preliminary safety profile was favorable. All data are being analyzed further for the regulatory submissions.
Murdok | Breaking eBusiness News
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