"Further, carfilzomib has been generally well tolerated, and the compound's selectivity appears to avoid the off-target effects, such as peripheral neuropathy, associated with currently available proteasome inhibitors."
Adverse events were generally mild and manageable and carfilzomib has been well tolerated for up to one year. Of 31 patients treated, 29 percent have received 12 full cycles of treatment.
These data were reported by Dr. Stewart in an oral presentation, titled "# 0474: Safety and Efficacy Update of PX-171-004, an Open-label Phase II Trial of Carfilzomib in Relapsed Multiple Myeloma," on Saturday, June 6, 2009.
Carfilzomib Combination with Lenalidomide is Well-Tolerated; Achieves Responses in Heavily Pre-treated Patients at Low Doses
Positive preliminary data from an ongoing Phase 1b dose-escalating trial of carfilzomib in combination with lenalidomide and low-dose dexamethasone in relapsed and refractory patients was presented by Michael Wang, M.D., of the University of Texas MD Anderson Cancer Center on Sunday, June 7, 2009. The Phase 1b clinical trial is designed to evaluate safety and to establish a maximum-tolerated dose of carfilzomib in combination with lenalidomide and dexamethasone administered on a 28-day treatment cycle. Lenalidomide in combination with dexamethasone is currently indicated for use in patients with multiple myeloma who have had at least one prior therapy.
To date, the combination of carfilzomib and lenalidomide was well tolerated in heavily pre-treated patients and adverse events were manageable. The most common adverse events reported include anemia and fatigue. No cases of peripheral neuropathy, a common adverse event associated with approved proteasome inhibitors, have been reported. A maximum-tolerated dose has not yet been established and dose-escalation in this trial continues.
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