According to final results from the phase 3 FIRST study published in the New England Journal of Medicine, continuous lenalidomide (Revlimid) plus dexamethasone was safe and effective for the treatment of patients with newly diagnosed multiple myeloma who are not eligible to receive stem cell transplantation.
In the study, researchers found that those treated with continuous oral lenalidomide in combination with low-dose dexamethasone (Rd) had a progression-free survival (PFS) of 25.5 months while those treated with a fixed course of lenalidomide plus low-dose dexamethasone (Rd18) had a PFS of 20.7 months. Those treated with melphalan, prednisone, and thalidomide (MPT) had a PFS of 21.2 months.
Therefore, those treated with Rd had a 28% decrease in risk of progression of disease or death compared with those treated with Rd18 (P<0.001) and a 30% reduction compared with those treated with Rd18 (P<0.001).
The most common adverse effects observed with Rd therapy were infection, neutropenia, anemia, thrombocytopenia, and deep vein thrombosis/pulmonary embolism. Based on the results of the FIRST study, Celgene Corporation has submitted Revlimid plus dexamethasone to the U.S. Food and Drug Administration for approval for the treatment of patients with NDMM.
Celgene Corporation has announced that data from FIRST (MM-020/IFM 07-01) – an open-label phase III randomized study of continuous REVLIMID (lenalidomide) in combination with dexamethasone in patients newly diagnosed with multiple myeloma (NDMM) who are not candidates for stem cell transplant – have been published in the New England Journal of Medicine.
Initial findings, including that the trial had met its primary endpoint of progression free survival (PFS), were reported during the plenary session at the 55th American Society of Hematology annual meeting in December 2013.