New lenalidomide phase III study data presented at 13th International Myeloma Workshop

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Updated data from a National Cancer Institute-sponsored clinical trial conducted by the Cancer and Leukemia Group (CALGB) was presented May 5 at the 13th International Myeloma Workshop in Paris, France. The phase III study evaluated the benefits of continuous, or maintenance, treatment with lenalidomide (Revlimid) following an autologous stem-cell transplant in newly diagnosed multiple myeloma patients and found that lenalidomide delays time to disease progression and improves overall survival compared to placebo. Maintenance therapy is an ongoing treatment given after patients achieve response with initial therapy to try to prolong that response.

As of April 2011, patients receiving continuous lenalidomide therapy demonstrated an overall survival rate of 90% at more than two years following transplant, compared to 83% for patients receiving placebo (unadjusted p<0.018). The updated results also further demonstrated that lenalidomide maintenance therapy resulted in longer remissions, delaying disease progression to a median of four years.

"This study answers the important question regarding continuous therapy, and the new survival data further validate long-term maintenance with lenalidomide as an important, and effective, treatment option for patients with multiple myeloma," said Principal Investigator Philip McCarthy, Jr., MD, Professor of Oncology and Director of the Blood & Marrow Transplant Program at Roswell Park Cancer Institute (RPCI). "The updated results from the CALGB trial are important and welcome news for patients, especially because so many will relapse or have progressive disease even after a stem-cell transplant."

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