The medical journal Leukemia has published results from the Phase 2 trial known as PX-171-005, an open-label, multicenter clinical trial evaluating Kyprolis ( Carfilzomib ) for injection in patients with relapsed and refractory multiple myeloma and varying degrees of renal insufficiency.
The article is titled, Carfilzomib in Multiple Myeloma Patients With Renal Impairment: Pharmacokinetics and Safety.
Renal impairment is a frequent and severe complication in patients with multiple myeloma, and presents challenges in the utilization of some anti-myeloma therapies.
This prospective study provides data for Carfilzomib use across the spectrum of renal impairment, from patients presenting with minimal impairment to those on chronic hemodialysis.
Fifty patients with relapsed, refractory and/or progressive multiple myeloma who had received at least two prior therapeutic regimens were enrolled in the open-label, single-agent, multicenter phase 2 PX-171-005 trial, and 47 were evaluable for response.
The primary endpoint was the influence of renal impairment on the pharmacokinetics of Carfilzomib. Statistical comparisons showed no differences between renal function status and the dose-adjusted pharmacokinetics parameters including apparent plasma clearance, dose-normalized AUCinf ( total exposure ), and the dose-normalized Cmax.
Secondary outcomes included safety, tolerability, pharmacodynamic measures, and efficacy.
The most common treatment-emergent adverse events reported in this study were fatigue ( 56% ) and anemia ( 50% ), and the most common grade 3/4 adverse events were anemia ( 28% ), thrombocytopenia ( 20% ).
The most common adverse reactions of any grade possibly related to Carfilzomib were fatigue ( 56% ), anemia ( 50% ), nausea ( 36% ), and diarrhea ( 36% ). ( Xagena )
Source: Onyx, 2013