HCMT/MM2401: Ph2 Study of Selinexor + Bispecific Antibody for RRMM

Inclusion Criteria

• •1. Age ≥ 18 years old at the time of informed consent.
• •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 of ≤2
• •4. A diagnosis of symptomatic multiple myeloma, with relapsed or refractory disease. Patients must have received at least 4 prior lines of therapy. Prior lines of therapy must include a proteasome inhibitor, an immunomodulatory agent, and an CD38 monoclonal antibody, and may include treatment with BCMA antibody conjugates or BCMA directed chimeric antigen receptor (CAR) T cell therapy.
• •5. All patients must meet criteria for and will receive teclistamab, elranatamab or talquetamab, as per approved label dosing.
• •6. Patients who have had CRS/ICANS from bispecific antibody must have complete resolution of CRS/ICANS before initiation of SEL
• •7. Measurable disease as defined by at least one of the following:
• •* Serum monoclonal (M) protein ≥1.0 g/dl by protein electrophoresis
• •* \>200 mg of M protein in the urine on 24 hour electrophoresis
• •* Serum immunoglobulin free light chain ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
• •* Measurable plasmacytoma
• •8. Adequate hepatic function measured on labs collected within 28 days of C1D1:
• •* 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
• •* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) normal to \<2.5 × ULN.
• •10. Adequate hematopoietic function measured on labs collected within 7 days of C1D1:
• •* Absolute neutrophil count ≥1500/mm3
• •* Hemoglobin ≥8.5 g/dL
• •* Platelet count ≥100,000/mm3 (patients for whom \<50% of bone marrow nucleated cells are plasma cells) or ≥50,000/mm3 (patients for whom ≥50% of bone marrow nucleated cells are plasma cells)
• •* Note 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 (e.g., eltrombopag, romiplostim, interleukin-11) are eligible.
• •* Note 2: Patients must have at least a 1-week interval from the last platelet transfusion prior to the Screening platelet assessment. However, patients may receive RBC and/or platelet transfusions as clinically indicated per institutional guidelines during the study.
• •11. Patients who are able to become pregnant must have a negative serum pregnancy test at screening.
• •12. All patients who could become pregnant or could father a child must use highly effective methods of contraception throughout the study and for 5 months following the last dose of study treatment. Highly effective methods of contraception are listed in Section 9.3.1.
• •13. Female patients must agree not to donate egg during the study treatment period and/or up to 90 days after the last dose of Selinexor. Male patients must agree not to donate sperm during the study treatment period and/or up to 90 days after the last dose of Selinexor.