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Forty Percent of Multiple Myeloma Patients Respond to Single Agent Bortezomib: Presented at ASCO

By Ed Susman

ATLANTA, G.A. -- June 5, 2006 -- In a trial of bortezomib (Velcade) monotherapy, 10% of multiple myeloma patients achieved complete remission and another 30% achieved objective response, researchers reported here at the American Society of Clinical Oncology 2006 Annual Meeting (ASCO).

"Emerging data such as these offer real hope that we may continue to improve outcomes for multiple myeloma patients," said Paul Richardson, MD, instructor in medicine, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts. "The data also show we can provide these outcomes with less toxicity than other approaches, such as those involving cytotoxic chemotherapy and/or high-dose dexamethasone."

Dr. Richardson reported the study findings in an oral presentation on June 3^rd. Researchers enrolled 66 patients who had untreated, symptomatic multiple myeloma and received bortezomib monotherapy at 1.3 mg/m² twice a week for 2 weeks during a 21-day cycle for 8 cycles.

"Therapy was well tolerated," Dr. Richardson said. Side effects included peripheral neuropathy, fatigue, and rash. However, he said, the adverse side effects were mild to moderate in almost all cases. Peripheral neuropathy resolved in 75% of cases when the dose was reduced or when the course of treatment was completed.

He said that 36 of 65 evaluable patients reported peripheral neuropathy, but 23 of those patients had grade 1 peripheral neuropathy and 12 others reported grade 2 neuropathy. The single patient with grade 3 neuropathy discontinued treatment.

Multiple myeloma, most frequently a disease that strikes people between the age of 65 and 70, is the second most common hematologic malignancy. Dr. Richardson noted that its incidence appears to be increasing -- about 15,000 new cases are diagnosed each year in the US -- and its onset is becoming more frequent in younger patients.

Dr. Richardson said that the single-agent results in the trial suggest that bortezomib "may provide a strong foundation for combining with other agents in the treatment of newly diagnosed patients."

The study was supported by Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts.


[Presentation title: Single-Agent Bortezomib in Previously Untreated Multiple Myeloma (MM): Results of a Phase II Multicenter Study. Abstract 7504]

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