A study of carfilzomib and dexamethasone in patients with relapsed and refractory multiple myeloma in China

Abstract

The second-generation proteasome inhibitor carfilzomib produces superior outcomes in relapsed or refractory multiple myeloma (MM). We conducted a single-arm trial of twice-weekly carfilzomib (27\xa0mg/m 2 )-dexamethasone (Kd27) for relapsed and refractory MM in China. Kd27 was administered in 28-day cycles to 123 patients previously treated with\u2009≥\u20092 other regimens, including treatment with bortezomib and an immunomodulatory drug, and refractory to their most recent therapy. Overall response rate (ORR) was the primary endpoint; progression-free survival (PFS) and overall survival (OS) were key secondary endpoints. Primary analysis was conducted when all patients received\u2009≥\u20096 cycles of Kd27 or discontinued Kd27. Median age was 60\xa0years; median number of prior regimens was 4; 74% were refractory to proteasome inhibitors and immunomodulatory drugs. ORR was 35.8% (95% CI 27.3–44.9), median PFS was 5.6 (95% CI 4.6–6.5) months, and median OS was 16.6 (95% CI 12.2–NE) months. Grade\u2009≥\u20093 adverse events (AEs) occurred in 76.4% of patients. Grade\u2009≥\u20093 AEs of interest included hypertension (13.8%), acute renal failure (3.3%), cardiac failure (0.8%), ischemic heart disease (0.0%), and peripheral neuropathy (0.0%); 5.7% of patients discontinued carfilzomib due to AEs. Carfilzomib–dexamethasone produced a clinically meaningful response without new safety findings in Chinese patients with previously treated MM. Trial registration : NCT03029234.