Carfilzomib: no impact of renal function on treatment in relapsed / refractory myeloma patients


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

XagenaMedicine_2013



Indietro

Altri articoli

The FDA ( U.S. Food and Drug Administration ) has expanded the approval of Mavyret ( Glecaprevir and Pibrentasvir )...


The first non-vitamin K antagonist oral anticoagulant ( NOAC ) introduced to the market in Japan was Dabigatran ( Pradaxa...


The first non-vitamin K antagonist oral anticoagulant ( NOAC ) introduced to the market in Japan was Dabigatran ( Pradaxa...


Vascular calcifications and fractures are major complications of chronic kidney disease. Hemodialysis patients have a high prevalence of atrial fibrillation...


Safety concerns with erythropoietin analogues and intravenous ( IV ) iron for treatment of anemia in chronic kidney disease (...


The results from a multi-arm phase 2 clinical trial evaluating Grazoprevir / Elbasvir ( MK-5172 / MK-8742, the investigational...


There have been postmarketing reports of acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis, in patients taking Januvia...


Contrast-induced acute kidney injury is an adverse outcome resulting from radiocontrast medium exposure during coronary angiography and percutaneous coronary intervention. A...


Abdominal aortic calcification ( AAC ) is reported as a predictor for cardiovascular events in general population and in hemodialysis...


Endothelial dysfunction underlies multiple cardiovascular consequences of chronic kidney disease ( CKD ) and antecedent diabetes or hypertension. Endothelial insults...