Phase 2 Study of Oral Selinexor Combined with Commercial Bispecific Antibody Therapy for Adults with Relapsed or Refractory Multiple Myeloma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the drug Selinexor combined with commercial bispecific antibody therapy in patients with relapsed or refractory multiple myeloma. This Phase II study aims to determine the safety profile of Selinexor given with bispecific antibody therapy and to assess the rate of minimal residual disease MRD negativity at a sensitivity of 10-5 twelve months after bispecific antibody treatment. The study is sponsored by Duke University and plans to enroll 27 participants. Participants will receive 40 mg of oral Selinexor weekly, starting about 5 days after the first full dose of bispecific antibody therapy. Treatment will continue for up to 12 months or until the disease progresses. During this period, patients will be monitored closely through safety check calls and required to keep a drug diary. The study focuses on patients who have already received multiple prior therapies including proteasome inhibitors, immunomodulatory agents, and CD38 monoclonal antibodies, and who are planned to receive teclistamab, elranatamab, or talquetamab as the bispecific antibody therapy. Participants will undergo regular clinical assessments, history reviews, and laboratory tests during the treatment and follow-up periods. The study will track safety by measuring the severity of adverse events up to 13 months, and evaluate the MRD negativity rate at 12 months after treatment. Additional outcomes include response rates, progression-free survival, and monitoring for immune-related side effects such as cytokine release syndrome and neurotoxicity. Follow-up will continue for 24 months to observe long-term outcomes and safety.

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