Phase III study of Revlimid (Celgene) meets primary endpoint for Multiple Myeloma
A Phase III study (MM-020/IFM 07-01) of Revlimid (lenalidomide), from Celgene, in combination with dexamethasone in patients newly diagnosed with Multiple Myeloma has met its primary endpoint of progression-free survival (PFS). One of the largest randomized, international studies ever conducted in newly-diagnosed Multiple Myeloma, MM-020/IFM 07-01 is also known as the FIRST trial. In the study, a doublet regimen of continuous oral lenalidomide in combination with low-dose dexamethasone (Rd) demonstrated a statistically significant improvement in PFS compared to patients receiving a comparator arm with a triplet regimen consisting of melphalan, prednisone and thalidomide (MPT).
The evaluation of safety and efficacy in the treatment arms is ongoing and the results of the study are planned to be presented at an upcoming medical meeting. Based on the results, the Company will commence discussions with regulatory authorities and plans to submit dossiers for registration in the US, Europe and other markets.
Learning Zones
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