A new proteasome inhibitor may hold hope for patients with multiple myeloma who have been treated unsuccessfully with other drugs. Dr. Siegel and colleagues conducted an open-label single-arm phase 2b study of carfilzomib, a novel drug in development for treating multiple myeloma. The medication has already demonstrated antitumor activity in phase 1 and 2 studies in patients with relapsed or refractory myeloma.
The current study enrolled 266 patients (257 of whom could be evaluated), who had myeloma for a median of 5.4 years. Patients in the study must have received at least two prior treatments with other medications or stem cell transplantation, with a median pre-study rate of five prior courses of treatment. Eighty-three percent had disease that progressed within 60 days of their last previous treatment, and 17 percent had achieved less than a 25 percent response to their treatment regimen that immediately preceded the study. Patients received the carfilzomib in increasing doses for up to 12 treatments, and some also entered an extension study.
Thirty-six percent of study participants responded to carfilzomib, with a median response duration of 6.3 months in those with some response.
"This study demonstrates that carfilzomib has the potential to offer substantial clinical benefit to patients with relapsed or refractory myeloma," said Dr. Siegel. "We did not see cumulative side effects, indicating the medication may be appropriate for prolonged single-agent dosing for chronic disease."
This research was presented at the annual meeting of the American Society of Hematology (ASH) taking place December 4-7, 2010 in Orlando, Florida.
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