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Drug combination proves effective against myeloma in Phase I trial

BOSTONTwo "new generation" drugs for the bone marrow cancer multiple myeloma may work even better together than they do individually, according to the results of a multicenter Phase I clinical trial to be presented by Dana-Farber Cancer Institute scientists at the annual meeting of the American Society of Hematology in Orlando, Fla.

The trial the first and largest reported to date to test the drugs bortezomib (Velcade) and lenalidomide (Revlimid) in combination involved 38 myeloma patients whose disease had recurred after previous treatment and was progressing despite other therapies.

Participants were divided into groups that received successively higher doses of the drugs. Some also received dexamethasone, a standard myeloma medication which adds to the effects of both bortezomib and lenalidomide, if the combination alone no longer controlled their disease.

The researchers, led by Paul Richardson, MD, and Ken Anderson, MD, of Dana-Farber, found that 58 percent of 36 evaluable patients responded to lenalidomide and bortezomib, including six percent who had complete remission, despite being heavily pre-treated and, in most cases, having received both classes of drug before. The median length of remission was six months, with some patients having disease control for up to two and a half years. The combined therapy also produced only mild fatigue or peripheral neuropathy (nerve damage signaled by tingling or numbness), researchers found. Patients who received dexamethasone because their disease continued to progress on the drug combination found the additional drug tolerable, and it produced a response or disease stabilization in about three quarters of them.

"It is remarkable to see the combination prove both tolerable and engender such durable responses in resistant disease," Richardson says. "We are hopeful that this combination will prove to be a key therapeutic backbone in improving outcomes for our patients, both earl
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Contact: Teresa Herbert
teresa_herbert@dfci.harvard.edu
617-632-4090
Dana-Farber Cancer Institute
11-Dec-2006


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