A Phase II Study of Elotuzumab in Combination With Pomalidomide, Bortezomib, and Dexamethasone in Relapsed and Refractory Multiple Myeloma
This research study is studying a combination of study drugs as a possible treatment for relapsed and refractory Multiple Myeloma. The interventions involved in this study are elotuzumab, pomalidomide, bortezomib, dexamethasone.
• All laboratory assessments should be performed within 21 days of initiation of protocol therapy unless otherwise specified.
• Participant has given voluntary signed written informed consent before performance of any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see Appendix A).
• Age ≥ 18 years
• Measurable disease of multiple myeloma as defined by at least one of the following
‣ Serum monoclonal protein ≥ 0.5 g/dL
⁃ ≥ 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
⁃ Serum free light chain ≥ 100 mg/L (10 mg/dL) and abnormal serum free kappa to serum free kappa light chain ratio
• Previously treated relapsed and refractory multiple myeloma
‣ Patients must have received at least one prior therapy with at least 2 cycles of lenalidomide and at least 2 cycles of a proteasome inhibitor (either in separate regimens or within the same regimen)
⁃ Disease progression on or within 60 days of completion of last therapy.
• ANC ≥ 1000/μL. G-CSF is not permitted within 14 days of screening.
• Platelet count ≥ 50,000/µL. Platelet transfusion is not permitted within 7 days of screening.
• Hemoglobin ≥ 8 g/dL. Red blood cell transfusions are permitted to meet eligibility criteria.
• Calculated creatinine clearance of ≥ 30 mL/min according to Cockcroft-Gault equation
• Patent has adequate hepatic function, as evidenced by serum bilirubin values \< 2 mg/dL and serum aspartate transaminase (ALT) and/or aspartate transaminase (AST) values \< 3 × the upper limit of normal (ULN) of the local laboratory reference range. Patients with elevated bilirubin due to Gilbert's syndrome may be permitted with PI approval.
• Must be able to take acetylsalicylic acid (ASA) daily as prophylactic anticoagulation. Patients intolerant to ASA may use low molecular weight heparin or equivalent. Warfarin will be allowed provided patient is full anticoagulated, with an INR of 2-3.
• All study participants must be registered into the mandatory POMALYST REMS program, and be willing and able to comply with the requirements of the POMALYST REMS program.
• Able to swallow capsules whole (pomalidomide capsules cannot be crushed, dissolved or broken).