| Carfilzomib in multiple myeloma patients with renal impairment: pharmacokinetics and safety. | |
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MedLine Citation:
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PMID: 23364621 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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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, 50-80, 30-49, <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 included anemia (28.0%), thrombocytopenia (20.0%), lymphopenia (18.0%), and fatigue (14.0%). Adverse events 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.Leukemia accepted article preview online, 31 January 2013; doi:10.1038/leu.2013.29. |
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Authors:
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A Z Badros; R Vij; T Martin; J A Zonder; L Kunkel; Z Wang; S Lee; A F Wong; R Niesvizky |
Publication Detail:
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Type: JOURNAL ARTICLE Date: 2013-1-31 |
Journal Detail:
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Title: Leukemia : official journal of the Leukemia Society of America, Leukemia Research Fund, U.K Volume: - ISSN: 1476-5551 ISO Abbreviation: Leukemia Publication Date: 2013 Jan |
Date Detail:
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Created Date: 2013-1-31 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8704895 Medline TA: Leukemia Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Affiliation:
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Greenebaum Cancer Center, University of Maryland, Baltimore, MD, USA. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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