An Open-Label, Single-Arm, Phase 1 Study of the Pharmacokinetics (PK) and Safety of Carfilzomib in Patients with Relapsed Multiple Myeloma and End-Stage Renal Disease (ESRD)

Abstract

Abstract Introduction: Renal insufficiency is common in multiple myeloma (MM). Carfilzomib (CFZ), an epoxyketone proteasome inhibitor, is approved in the United States for the treatment of relapsed or refractory MM in patients (pts) who have received 1-3 prior lines of therapy. A previous study (PX-171-005) of pts with MM found no apparent differences in CFZ (15 or 20 mg/m2) clearance, area under the concentration time curve (AUC), and maximum plasma concentration (Cmax) between pts with normal vs those with mild, moderate, or severe renal impairment. The primary objective of this study was to assess the influence of end stage renal disease (ESRD) on the pharmacokinetics (PK) ..