Elotuzumab, Selinexor, and Dexamethasone for Relapsed Refractory Multiple Myeloma

Inclusion Criteria

• •1. Age ≥ 18 years
• •2. Willing and able to provide written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure
• •3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of ≤ 2
• •4. Having measurable MM based on the modified International Myeloma Working Group (IMWG) guidelines, defined by at least one of the following: Serum M-protein
• •≥ 0.5 g/dL by serum electrophoresis (SPEP), urinary M-protein excretion ≥ 200 mg/24 hours by urine electrophoresis (UPEP), and free light chain (FLC) ≥ 100 mg/L, provided that the FLC ratio is abnormal.
• •5. Patients with non-secretory multiple myeloma will be included if they have 25% or more of plasmacytoma size progression or appearance of new plasmacytoma lesions.
• •6. Must have at least previously received ≥ 1 anti-MM regimens
• •7. More than 6 months have passed since an allogeneic transplant or 100 days since an autologous stem cell transplant, if patients had any
• •8. Adequate hepatic function within 28 days prior to C1D1:
• •1. Total bilirubin \< 1.5 × upper limit of normal (ULN) (except patients with Gilbert's syndrome who must have a total bilirubin of \< 3 × ULN), and
• •2. Aspartate aminotransferase (AST) and alanine aminotransferase (3) normal to\<2 × ULN.
• •9. Calculated creatinine clearance (CrCl) \>15 mL/min based on the Cockcroft and Gault formula.
• •10. Adequate hematopoietic function within 7 days prior to C1D1: total white blood cell (WBC) count ≥1500/mm3, absolute neutrophil count ≥1000/mm3, hemoglobin
• •≥8.5 g/dL and platelet count ≥75,000/mm3
• •1. Patients receiving hematopoietic growth factor support, including erythropoietin, darbepoetin, granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), and platelet stimulators (eg, eltrombopag, romiplostim, or interleukin-11) must have at least a 2-week interval between growth factor support and the Screening assessments, but they may receive growth factor support during the study.
• •2. Patients must have:
• •* At least a 2-week interval from the last red blood cell (RBC) transfusion prior to the Screening hemoglobin assessment, and
• •* At least a 1-week interval from the last platelet transfusion prior to the Screening platelet assessment.
• •11. Female patients of childbearing potential must have a negative serum pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly
• •12. Effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.
• •11. Any active gastrointestinal dysfunction interfering with the patient's ability to swallow tablets, or any active gastrointestinal dysfunction that could interfere with absorption of study treatment.
• •12. Inability or unwillingness to take supportive medications such as anti-nausea and anti-anorexia agents as recommended by the National Cancer Comprehensive Network (NCCN) for antiemesis and anorexia/cachexia (palliative care).
• •13. Any active, serious psychiatric, medical, or other conditions/situations that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give informed consent.
• •14. Contraindication to any of the required concomitant drugs or supportive treatments.
• •15. Patients unwilling or unable to comply with the protocol including providing 24-hour urine samples for urine protein electrophoresis at the required time points.