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Study finds Velcade major improvement over standard therapy for relapsed multiple myeloma patients

NEW ORLEANSEarly results from a major, international Phase III clinical trial decisively show that recurrent multiple myeloma is more effectively treated with the drug bortezomib (trade name: Velcade TM) than with dexamethasone, a drug that for decades has been the standard therapy for relapsed disease, researchers at Dana-Farber Cancer Institute report.

The findings, which will be presented at the annual meeting of the American Society of Clinical Oncology (Sunday, June 6, 2 p.m. Room 283) were sufficiently striking that the trial was stopped early so that patients who had been randomly assigned to receive dexamethasone could switch to bortezomib.

The study, which involved 669 patients in 92 treatment centers around the world, was the first head-to-head comparison of bortezomib and dexamethasone in a Phase III trial of patients who had relapsed after treatment for multiple myeloma. (Phase III trials test new treatments against standard ones to determine which is safer and more effective.)

"This trial represents the largest, most broad-based assessment to date of bortezomib and dexamethasone in this group of patients," says the study's lead author, Paul Richardson, MD, of Dana-Farber. "The finding that bortezomib significantly lengthened the time to disease progression and improved survival when compared with dexamethasone, with a similar level of safety, is important confirmatory evidence of bortezomib's effectiveness for patients with relapsed multiple myeloma."

Multiple myeloma is a currently incurable cancer of the bone marrow that causes a plunge in the production of vital red and white blood cells. Although relatively rare, it is the second most common type of blood cancer and accounts for 11,000 deaths annually in the United States. It is the fourth fastest-growing cancer in terms of mortality and is among the top 10 causes of death among African Americans.

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Contact: Bill Schaller
janet_haley@dfci.harvard.edu
617-233-5507
Dana-Farber Cancer Institute
5-Jun-2004


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