Dr. Berenson Discusses Results from the CHAMPION-1 Trial
James R. Berenson, MD, founder, President and Medical and Scientific Director of the Institute for Myeloma and Bone Cancer Research, President of Oncotherapeutics, discusses the dose-escalation portion of the phase I/II CHAMPION-1 study looking at weekly carfilzomib in combination with dexamethasone for patients with relapsed or refractory multiple myeloma.
Berenson says the goal of the study was to see if the schedule of carfilzomib could be modified to make it more convenient and possibly more active. Currently, the drug is approved by the FDA to be administered intravenously over 2 to 10 minutes twice weekly on consecutive days each week for 3 weeks of a 28-day cycle.
During this study, the drug was administered once per week starting at 45 mg/m2 and then escalating to 88 mg/m2. The results showed that when administered once per week, the maximum tolerated dose was 70 mg/m2 and the drug was extremely active, Berenson says.
This study also examined weekly dexamethasone at 40 mg/m2.