Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma

Inclusion Criteria:

1. Newly diagnosed symptomatic multiple myeloma (per International Myeloma Working Group [IMWG] diagnostic criteria)

2. Transplant ineligibility

3. Measurable disease, as defined by 1 or more of the following (assessed within 21 daysprior to randomization):

• Serum M-protein ≥ 0.5 g/dL, or

• Urine M-protein ≥ 200 mg/24 hours, or

• In subjects without detectable serum or urine M-protein, serum free light chain (SFLC) > 100 mg/L (involved light chain) and an abnormal kappa lambda ratio (SFLCkappa lambda ratio < 0.26 or > 1.65)

4. No prior treatment for multiple myeloma

5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

1. Multiple myeloma of IgM (immunoglobulin M) subtype

2. Glucocorticoid therapy within 14 days prior to randomization that equals or exceeds acumulative dose of 160 mg of dexamethasone

3. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, andskin changes)

4. Plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standarddifferential)

5. Waldenström macroglobulinemia (WM)

6. Known amyloidosis