Phase II trial to evaluate four-drug therapy in myeloma

CAMBRIDGE, Massachusetts—Millennium Pharmaceuticals, Inc. has initiated a randomized, multicenter phase II trial to evaluate the efficacy of combining bortezomib (Velcade), lenalidomide (Revlimid) and dexamethasone with or without cyclophosphamide as front-line therapy of multiple myeloma. The trial, named EVOLUTION, is led by Vincent Rajkumar, MD, professor of medicine at the Mayo Clinic.

"The objective of this trial is to evolve the treatment of multiple myeloma by combining these highly active therapies to induce early complete remission and improve long-term survival," said Nancy Simonian, MD, chief medical officer at Millennium. "We are exploring the potential of a new standard of care for patients with newly diagnosed multiple myeloma."

The EVOLUTION trial is expected to enroll approximately 100 patients. The primary endpoint is complete response and very good partial response rates; secondary endpoints include duration or response, overall survival, safety, and tolerability.

For more information about the trial, please contact the Millennium Medical Product Information Department at 1-866-VELCADE (835-2233), or go to www.velcade.com.