Study of the Pharmacokinetics and Safety of Carfilzomib in Subjects With Multiple Myeloma and Renal Disease

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

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