A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing CC-92480, Bortezomib and Dexamethasone (480Vd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM)

• Subject has documented diagnosis of MM and measurable disease, defined as any of the following:
  • M-protein ≥ 0.5 g/dL by serum protein electrophoresis (sPEP) or 
  • M-protein ≥ 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP) or
  • For subjects without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels > 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio.
• Subject has received 1 to 3 prior lines of antimyeloma therapy. (Note: One line can contain several phases [eg, induction, (with or without) hematopoietic stem cell transplant, (with or without) consolidation, and/or (with or without) maintenance therapy
• Must have received prior treatment with a lenalidomide-containing regimen
• Must have achieved minimal response or better to at least 1 prior antimyeloma therapy
• Must have documented disease progression during or after their last antimyeloma therapy
• ECOG PS 0-2
• May not have had progression during treatment or within 60 days of the last dose of a proteasome inhibitor
• If prior treatment with a bortezomib containing regimen, must have had a best response of minimal response or better and the subject could not have discontinued bortezomib due to toxicity
• No prior allo transplant
• No plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome or clinically significant light-chain amyloidosis
• No known CNS involvement of myeloma
• No grade 2 or higher peripheral neuropathy
• No other malignancy within 5 years
•  

• Primary
  • PFS
• Secondary
  • OS
  • ORR
  • % of patients with Complete response or better
  • % of patients with VGPR
  • TTR
  • DOR
  • Time to progression
  • Time to next treatment
  • PFS-2
  • MRD negativity rate
  • Safety
  • QOL