Phase 1b Study of Carfilzomib Administered Once Weekly in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma

Key Inclusion Criteria:

1. Newly diagnosed or relapsed multiple myeloma

2. Measureable disease by Serum M protein, or Urine M protein, or serum free light chain
(SFLC) and an abnormal serum kappa lambda ratio (for subjects without detectable serum
or urine M-protein), or Serum quantitative immunoglobulin A (qlgA) (for immunoglobulin
(Ig) A subjects whose disease can only be reliable measured by qlgA).

3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2

4. Left ventricular ejection fraction (LVEF) ≥ 40%

Key Exclusion Criteria:

1. Waldenström macroglobulinemia

2. For newly diagnosed multiple myeloma: multiple myeloma of IgM subtype

3. For relapsed disease:

1. If treated with a lenalidomide and dexamethasone combination, progression during
the first 3 months after initiating treatment.

2. Any progression during treatment if the lenalidomide and dexamethasone regimen
was the most recent line of therapy.

3. Any prior treatment with carfilzomib

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

5. Plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard
differential)

6. Myelodysplastic syndrome

7. Amyloidosis

8. Prior treatment with carfilzomib or oprozomib