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Lenalidomide (Revlimid) Meets Primary Endpoint in Myeloma Study
A phase III study of lenalidomide (Revlimid, Celgene) in combination with dexamethasone in patients newly diagnosed with multiple myeloma (MM) has met its primary endpoint of progression-free survival (PFS). In the study, a doublet regimen of continuous oral lenalidomide in combination with low-dose dexamethasone demonstrated a statistically significant improvement in PFS compared with patients receiving a comparator arm with a triplet regimen consisting of melphalan, prednisone, and thalidomide.
In the randomized, phase III FIRST (Front-Line Investigation of Revlimid/Dexamethasone vs. Standard Thalidomide) trial, a total of 1,623 patients with MM who were ineligible for autologous stem cell transplantation were randomly assigned to receive continuous oral lenalidomide plus low-dose dexamethasone until disease progression; lenalidomide plus low-dose dexamethasone for eighteen 28-day cycles (72 weeks); or melphalan, prednisone, and thalidomide for up to twelve 42-day cycles (72 weeks).
The study’s primary endpoint was PFS. Secondary endpoints included overall survival, response rate, quality of life, and safety.
The evaluation of efficacy and safety in the treatment arms is ongoing, and the results of the study are planned to be presented at a future medical meeting.
In combination with dexamethasone, Revlimid (lenalidomide) is approved in the U.S. for the treatment of patients with MM who have received at least one prior therapy. As monotherapy, the drug is also approved for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1–risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, and for the treatment of patients with mantle cell lymphoma whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
Source: Celgene; July 11, 2013.