Isatuximab, Bela Maf, Pom, and Dex in Relapsed/Refractory Multiple Myeloma

Inclusion Criteria

• •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of any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to their future medical care.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. Patients with IgD disease and lower amounts of monoclonal protein may be permitted to enroll with PI approval
• •* ≥ 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
• •* Involved serum free light chain ≥ 100 mg/L (10 mg/dL) and abnormal serum free light chain ratio
• •Previously treated relapsed and refractory multiple myeloma:
• •Patients must have received at least one prior line of therapy;
• •Prior therapy must include at least 2 cycles of lenalidomide and at least 2 cycles of a proteasome inhibitor (either in separate regimens or within the same regimen); and
• •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. Patients with ANC \<1000/µL can be considered for screening on a case-by-case basis with additional monitoring, after discussion with and approval from the PI.
• •Platelet count ≥ 75,000/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 by Modified Diet in Renal Disease (MDRD) formula or Cockcroft-Gault formula
• •Spot urine (albumin/creatinine ratios (spot urine) \< 500 mg/g or urine dipstick negative/trace.
• •Patient has adequate hepatic function, as evidenced by each of the following:
• •Serum bilirubin values \< 1.5 × ULN. Isolated bilirubin ≥ 1.5 × ULN is acceptable if bilirubin is fractionated and direction bilirubin \<35%. Patients with elevated bilirubin due to Gilbert's syndrome may be permitted with PI approval (e.g. total bilirubin \<3 mg/dL and normal direct bilirubin); and
• •Serum aspartate transaminase (ALT) and/or aspartate transaminase (AST) values \< 2.5 × the upper limit of normal (ULN) of the institutional laboratory reference range. Patients with elevated bilirubin due to Gilbert's syndrome may be permitted with PI approval (e.g. total bilirubin \<3 mg/dL and normal direct bilirubin).
• •Must be able to take acetylsalicylic acid (ASA) daily as prophylactic anticoagulation. Patients intolerant to ASA may use low molecular weight heparin, apixaban, rivaroxaban, or equivalent.
• •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.
• •Women of childbearing potential (WOCBP) must adhere to the scheduled pregnancy testing as required in the Pomalyst REMS program and agree to use a highly effective method of contraception during the study for 4 months after the last dose of treatment in the study (see Appendix) and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period). A WOCBP must have a negative highly sensitive serum pregnancy test within 72 hours before the first dose of study intervention and agree to use a highly effective method of contraception during the study and for 4 months after the last dose of belantamab mafodotin. Note: non childbearing potential defined as follows (by other than medical reasons):
• •* ≥ 45 years of age and has not had menses for \> 1 year
• •* Patients who have been amenorrhoeic for \< 2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation
• •* Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.
• •A man who is sexually active with a WOCBP (even if they have undergone a successful vasectomy) must agree to use a barrier method of birth control e.g. either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository for 6 months after receiving the last dose of study drug.
• •Male participants must refrain from donating sperm for 6 months after the last dose of study drug.
• •Able to swallow capsules whole (pomalidomide capsules cannot be crushed, dissolved or broken).