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

Inclusion Criteria

• Newly diagnosed or relapsed multiple myeloma
• 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 (glgA) (for immunoglobulin (Ig) A subjects whose disease can only be reliable measured by qlgA).
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2
• Left ventricular ejection fraction (LVEF) ≥ 40% Key

Exclusion Criteria

• Waldenström macroglobulinemia
• For newly diagnosed multiple myeloma: multiple myeloma of IgM subtype
• For relapsed disease:
• If treated with a lenalidomide and dexamethasone combination, progression during the first 3 months after initiating treatment.
• Any progression during treatment if the lenalidomide and dexamethasone regimen was the most recent line of therapy.
• Any prior treatment with carfilzomib
• POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
• Plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard differential)
• Myelodysplastic syndrome
• Amyloidosis
• Prior treatment with carfilzomib or oprozomib