Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Multiple Myeloma and Renal Disease
Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Multiple Myeloma and 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.
Key Inclusion Criteria:

 1. Relapsed multiple myeloma

 2. Evaluable disease (serum protein electrophoresis [SPEP]/urine protein electrophoresis
 [UPEP]/serum free light chain [SFLC] criteria)

 3. Received at least 1 prior treatment regimen or line of therapy for multiple myeloma

 4. End-stage renal disease (ESRD) on hemodialysis or CrCl ≥ 75 mL/min

 5. Eastern Cooperative Oncology Group (ECOG) performance status 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. Immunoglobulin M (IgM) multiple myeloma

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

 3. Waldenström Macroglobulinemia

 4. Active congestive heart failure (NYHA Class III-IV) ischemia, conduction abnormalities

 5. Known human immunodeficiency virus (HIV), recent hepatitis B virus (HBV), hepatitis C
 virus (HCV)

 6. Myelodysplastic Syndrome

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

 8. Other investigational drugs