Cyclophosphamide Plus Weekly Carfilzomib and Dexamethasone in Resistant Myeloma
Posted: Tuesday, January 19, 2021
Adding cyclophosphamide to weekly carfilzomib and dexamethasone appears to prolong progression-free survival in patients with relapsed or refractory multiple myeloma, particularly in those who are refractory to lenalidomide, according to the results of a phase II study presented during the 2020 American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract 415). “The administration of carfilzomib at a dose of 70 mg/m2 weekly was safe and more convenient and overall, the toxicity profile was manageable in both arms,” stated Maria-Victoria Mateos, MD, PhD, of the University Hospital of Salamanca, Spain, and colleagues.
In the GEM-KyCyDex study, 198 patients who had received one to three prior lines of therapy were randomly assigned to receive carfilzomib at 70 mg/m2 intravenously on days 1, 8, and 15 plus dexamethasone at 20 mg orally on days 1, 2, 8, 9, 15, and 16, and either cyclophosphamide at 300 mg/m2 intravenously on days 1, 8, and 15 of each 28 days-cycle (n = 97) or no cyclophosphamide (n = 101). Most patients were older than 65 (70%).
After a median follow-up of 15.6 months, the median progression-free survival was 20.7 and 15.2 months in the cyclophosphamide and control arms, respectively (P = .2). The objective response rates were 78% and 73% in the cyclophosphamide and control arms, respectively. In both arms, 20% of patients achieved a complete response. In the lenalidomide-refractory population, adding cyclophosphamide to carfilzomib and dexamethasone resulted in a significant benefit in progression-free survival: 26.2 months versus 7.7 months in the control arm (P = .01).
As for toxicity, neutropenia was the sole hematologic adverse event more frequently reported in the cyclophosphamide arm than the control arm: any grade (24% vs. 11%) and grade 3 or 4 (13% vs. 7%).
Disclosure: For full authors’ disclosures, visit ash.confex.com.
