An open label, randomized phase 3 trial of combinations of nivolumab, elotuzumab, pomalidomide and dexamethasone in relapsed and refractory multiple myeloma

• Multiple myeloma
• Refractory (progressed on or within 60 days) to most recent treatment
• Must have received >2 lines of prior therapy which must have included at least 2 consecutive cycles of each immune modulatory drug (IMiD) and a proteasome inhibitor alone or in combination
• Measurable disease at screening defined as one or more of the following:
  • Serum IgG, IgA, or IgM M-protein >0.5 g/dL
  • Urine M-protein >200 mg excreted in 24-hour collection sample
  • Involved serum free light chain >100 mg/L provided the FLC ratio is abnormal
• ECOG PS <2
• No prior treatment with pomalidomide, elotuzumab, or any PD-1/PD-L1 inhibitor
• No MGUS, Smoldering myeloma, Waldenstrom’s, amyloidosis, POEMS syndrome, or active plasma cell leukemia (20% peripheral blood of plasma cells or absolute plasma cell count of 2 x10^9/L)
• No active autoimmune disease
• No active infection or uncontrolled severe CV or pulmonary disease
• No chronic steroid use within 14 days of enrollment
• No known HBV/HCV/HIV
• No Grade >2 peripheral neuropathy
• Auto transplant allowed as long as at least 12 weeks prior
• Allo transplant allowed as long as at least 1 year prior

Primary- ORR, PFS; Secondary- TtR, DoR