Phase II 004 Clinical Trial Results for Advanced Myeloma
Dr. Siegel and Dr. Vesole served as co-investigators on an 18-center, phase II open-label efficacy and safety clinical trial, also known as 004, of carfilzomib in combination with Bortezomib, another proteasome inhibitor. The study was published in the June 14th issue of Blood.
"We saw significant responses in patients considered more difficult to treat, including those with more advanced disease and poor prognoses," said Dr. Siegel, the senior author of the study. "Our results support the potential use of carfilzomib in this patient population."
The researchers enrolled 129 patients with multiple myeloma who had relapsed following one to three previous courses of treatment. Patients treated with bortezomib were excluded, as it is in the same drug class as carfilzomib and its use might make the effect of carfilzomib more difficult to determine. The study's primary endpoint was overall response rate. Researchers also measured patients' responses at various intervals as well as time to disease progression, and recorded reactions (adverse events) to treatment.
The most common adverse events in the study were fatigue (62 percent) and nausea (48.8 percent), while 17.1 percent of patients developed peripheral neuropathy, mostly Grades 1 and 2. Peripheral neuropathy, damage to nerves that fan out across the body from the brain and spinal cord, causes pain and other symptoms; lower grades have less severe symptoms. Peripheral neuropathy has been reported in 37-70 percent of myeloma patients receiving other commonly used drug therapies.
"Our myeloma team is leading the way in innovative research that makes promising therapies available to our patients, while also continually testing new
|Contact: Amy Leahing|
John Theurer Cancer Center