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An Open-Label, Single Arm, Phase 1 Study of the Pharmacokinetics and Safety of Carfilzomib in Subjects With Relapsed Multiple Myeloma and End-stage Renal Disease
The purpose of this study is to see how the body and the cancer react to carfilzomib, including measuring the amount of the study drug in the blood at certain times following dosing. This study is being done in people with normal kidney function and those with end-stage renal disease to see if they respond differently to the study drug.
Specifically, the purpose of this study is to assess the influence of end-stage renal disease (ESRD) on area under the curve (both area under the curve, from time 0 to the last concentration measured \[AUC0-last\] and area under the curve, from time 0 extrapolated to infinity \[AUC0-inf\]) of carfilzomib 56 mg/m² at Cycle 2 Day 1 (C2D1) in patients with relapsed multiple myeloma.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Karmanos Cancer Institute
Detroit, Michigan, United States
North Shore-LIJ Health System/Center for Advanced Medicine - North Shore University Hospital
Lake Success, New York, United States
Gabrail Cancer Center
Canton, Ohio, United States
Vanderbilt-Ingram Cancer Center, Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States
Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Monash Health, Monash Medical Centre
Clayton, Victoria, Australia
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Start Date
January 1, 2014
Primary Completion Date
April 1, 2015
Completion Date
January 1, 2017
Last Updated
May 2, 2017
26
ACTUAL participants
Carfilzomib
DRUG
Lead Sponsor
Amgen
NCT04634916
NCT06933472
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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