New phase III trial of Velcade in newly diagnosed myeloma

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Millennium Pharmaceuticals, Inc. has initiated a randomized, multicenter, company-sponsored phase III trial to determine the most effective Velcade (bortezomib)-based combination therapy with approved agents for the treatment of newly diagnosed multiple myeloma patients who are ineligible for stem cell transplantation

CAMBRIDGE, Massachusetts—Millennium Pharmaceuticals, Inc. has initiated a randomized, multicenter, company-sponsored phase III trial to determine the most effective Velcade (bortezomib)-based combination therapy with approved agents for the treatment of newly diagnosed multiple myeloma patients who are ineligible for stem cell transplantation.

The trial, named UPFRONT and conducted primarily at community physician networks nationwide, will compare three Velcade-based therapies. Principal investigator is Ruben Niesvizky, MD, associate professor of medicine, New York-Presbyterian Hospital/Weill Cornell Medical Center. Velcade is currently approved for myeloma patients who have received at least one prior therapy.

UPFRONT will evaluate the safety and efficacy of Velcade and dexamethasone (VD); Velcade, thalidomide (Thalomid), and dexamethasone (VTD); and Velcade, melphalan, and prednisone (VMP). The primary endpoint is progression-free survival, with secondary endpoints including duration of response, overall survival, and overall safety/tolerability. Target enrollment is up to 500 patients, who will be treated for up to 1 year.

UPFRONT has a unique adaptive design, providing the flexibility to modify the therapies (following an interim analysis) should a new standard of care be established. The adaptive design will help ensure that the most effective treatment options are evaluated in the most efficient way, the company said.

For more information, patients and physicians can contact the Millennium Medical Product Information Department at 1-866-835-2233 (1-866-VELCADE). Additional information can also be found at www.velcade.com.

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