Study of the Pharmacokinetics and Safety of Carfilzomib in Subjects With Multiple Myeloma and Renal Disease
Conditions
Relapsed Multiple Myeloma - End-stage Renal Disease
Conditions: official terms
Kidney Diseases - Kidney Failure, Chronic - Multiple Myeloma - Neoplasms, Plasma Cell
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label
Intervention
Name: Carfilzomib
Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to see how the body and the cancer react to an investigational drug called 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.
Detailed Description
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 subjects with relapsed multiple myeloma
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Key Inclusion Criteria:

1. Relapsed multiple myeloma

2. Evaluable disease (SPEP/UPEP/SFLC)

3. ≥1 and ≤3 prior lines of treatment

4. ESRD on hemodialysis or CrCl≥90 mL/min

5. ECOG 0-2

6. Adequate organ and bone marrow function

7. Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention or myocardial infarction within the protocol-specified period prior to enrollment

Key Exclusion Criteria:

1. Immunogluobulin M (IgM) multiple myeloma

2. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)

3. Waldenström Macroglobulinemia

4. Active CHF (NYHA Class III-IV) ischemia, conduction abnormalities

5. Known HIV, recent HBV, HCV

6. Myelodysplastic Syndrome

7. Contraindication to test article, constituents, or required concomitant medications

8. Other investigational drugs
Locations
Karmanos Cancer Institute
Detroit, Michigan, United States
Status: Recruiting
North Shore-LIJ Health System/Center for Advanced Medicine - North Shore University Hospital
Lake Success, New York, United States
Status: Recruiting
Gabrail Cancer Center
Canton, Ohio, United States
Status: Recruiting
Vanderbilt-Ingram Cancer Center, Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States
Status: Recruiting
Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Status: Recruiting
UT Southwestern Medical Center
Dallas, Texas, United States
Status: Recruiting
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Status: Recruiting
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Status: Recruiting
Monash Health, Monash Medical Centre
Clayton, Victoria, Australia
Status: Recruiting
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Status: Recruiting
The Alfred Hospital, Malignant Haematology and Stem Cell Transplant Department
Melbourne, Victoria, Australia
Status: Recruiting
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
Status: Recruiting
Sir Mortimer B. Davis-Jewish General Hospital
Montreal, Quebec, Canada
Status: Recruiting
Start Date
October 2013
Completion Date
September 2016
Sponsors
Onyx Therapeutics, Inc.
Source
Onyx Pharmaceuticals
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page