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Carfilzomib in multiple myeloma patients with renal impairment: pharmacokinetics and safety.

TitleCarfilzomib in multiple myeloma patients with renal impairment: pharmacokinetics and safety.
Publication TypeJournal Article
Year of Publication2013
AuthorsBadros AZ, Vij R, Martin T, Zonder JA, Kunkel L, Wang Z, Lee S, Wong AF, Niesvizky R
JournalLeukemia
Volume27
Issue8
Pagination1707-14
Date Published2013 Aug
ISSN1476-5551
KeywordsAged, Aged, 80 and over, Antineoplastic Agents, Female, Humans, Kidney Function Tests, Male, Middle Aged, Multiple Myeloma, Oligopeptides, Proteasome Inhibitors, Renal Insufficiency, Treatment Outcome
Abstract

This phase 2 study assessed the safety, pharmacokinetics, pharmacodynamics and efficacy of carfilzomib, a selective proteasome inhibitor, in patients with multiple myeloma and varying degrees of renal impairment, including patients on chronic hemodialysis. Patients were grouped by creatinine clearance: >80 ml/min, 50-80 ml/min, 30-49 ml/min, <30 ml/min and chronic hemodialysis. Carfilzomib was administered on days 1, 2, 8, 9, 15 and 16 in 28-day cycles: 15 mg/m(2) (Cycle 1), 20 mg/m(2) (Cycle 2) and 27 mg/m(2) (Cycles 3+). There were no differences in carfilzomib clearance or exposure among patients with normal renal function and any group with renal impairment. Grade 3/4 adverse events (AEs) included anemia (28.0%), thrombocytopenia (20.0%), lymphopenia (18.0%) and fatigue (14.0%). AEs were similar among groups. At 15 mg/m(2), proteasome inhibition up to 85% was observed and did not differ among groups. Although nearly 50% of patients were refractory to both bortezomib and lenalidomide, end of study partial response or better (overall response rate) was 25.5% with 7.9 months median duration of response. In conclusion, the pharmacokinetics and safety of carfilzomib were not influenced by the degree of baseline renal impairment, including in patients on dialysis, and carfilzomib was well tolerated and demonstrated promising efficacy.

DOI10.1038/leu.2013.29
Alternate JournalLeukemia
PubMed ID23364621
PubMed Central IDPMC3740399