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Published on 28 June 2010

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Phase III studies demonstrate significantly superior progression free survival with continuous revlimid therapy in diagnosed multiple myeloma

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Data presented at the European Haematology Association’s annual congress in Barcelona, Spain, from the planned second interim analysis (median follow-up of 21 months) of a phase III, randomised, double-blind study of continuous REVLIMID (lenalidomide) (MM-015) for the treatment of elderly patients with newly diagnosed multiple myeloma showed improvement in progression free survival (PFS).

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). Patients were also offered lenalidomide therapy if they progressed while participating in the study. The primary endpoint of the study was to determine the improvement of progression free survival (PFS) in patients who received MPR-R versus patients who received
MP.

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.

“Over the past decade, the treatment landscape for myeloma has evolved dramatically with the advent of novel therapies, such as REVLIMID. Initially used for relapsed or difficult-to-treat cases, these results demonstrate for the first time that a more effective use of REVLIMID is to treat patients early and continuously,” commented Professor Gareth Morgan, Head of the Haemato-Oncology Unit at The Royal Marsden Hospital, London.

“Patients can now live longer with a tolerable treatment. I hope this latest evidence will contribute to a change in the standard of care for newly diagnosed elderly myeloma patients.”

Celgene



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