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Celgene International Sàrl announced that data from the planned second interim analysis (median follow-up of 21 months) of a phase III, randomised, double-blind study of continuous REVLIMID (lenalidomide) for the treatment of elderly patients with newly diagnosed multiple myeloma show improvement in progression-free survival (PFS), the primary endpoint of the study. The data were presented during the European Haematology Association’s annual congress in Barcelona, Spain.
The study of 459 patients 65 years or older evaluated patients receiving lenalidomide in combination with melphalan and prednisone, followed by lenalidomide alone (MPR-R) (n=152); patients receiving lenalidomide in combination with melphalan and prednisone, followed by placebo (MPR) (n=153); and patients receiving placebo, melphalan and prednisone, followed by placebo (MP) (n=154).
Median PFS of the MPR-R arm has yet to be reached, while the MP arm had a median PFS of 13 months (p<0.001). Patients treated with MPR-R had a 58% reduction in the risk of disease progression compared to MP, an improvement over the reduction in risk of disease progression reported at the first interim analysis in December 2009. At the time of the second analysis, it was estimated that 55% of all patients receiving MPR-R would remain progression free after two years compared to only 16% of patients receiving MP.
In the safety population (the patients who received at least one dose of therapy on study), the most common grade 3 or 4 hematological adverse events included neutropenia (71%, MPR-R vs. 30%, MP), thrombocytopenia (39%, MPR-R vs. 14%, MP) and febrile neutropenia (7%, vs. 0%, MP). Grade 3 or 4 non-hematological adverse events included fatigue (6%, MPR-R vs. 3%, MP), deep-vein thrombosis/pulmonary embolism (4%, MPR-R vs. 1%, MP), and rash (5%, MPR-R vs. 1%, MP). No grade 3 or 4 peripheral neuropathy was experienced by patients in this study.
These data are from an investigational study. REVLIMID is not approved as an initial treatment for patients with multiple myeloma.