Selinexor + Bispecific Antibody
A Phase II Safety and Efficacy Study of Selinexor in Combination With Bispecific Antibody in Patients With Relapsed/Refractory Multiple Myeloma
What's the purpose of the trial?
The primary objectives of this study are to determine the safety of single agent Selinexor given with commercial bispecific antibody therapy in patients with Relapsed/Refractory Multiple Myeloma (RRMM) and to determine the MRD negativity rate at 10-5 at 12 months post bispecific antibody therapy.
The investigators will enroll 27 patients with RRMM who are receiving commercial bispecific antibody therapy. Patients will be on treatment for 12 months or until disease progression, and will be followed for 24 months. Study assessments include completing a drug diary, having a safety check in call, and have history, clinical assessments, and labs taken.
Twenty-seven patients will provide 80% power in a one-sample chi square test for a proportion assuming that the rate of negative MRD at 10-5 at 12 months post bispecific antibody therapy is 25% in historical control and 50% in the SEL+bispecific antibody experimental treatment group, under a one-sided 5% significance level.
Trial status
Accepting patients
Phase
Phase 2
Enrollment
27
Last Updated
Participating Centers
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Experimental Treatments
Learn more about the experimental treatments being evaluated in this clinical trial.
- Elranatamab is a B-cell Maturation Antigen (BCMA)-CD3 bispecific antibody being tested in multiple myeloma.
- Talquetamab is a bispecific antibody that binds to both CD3 on T cells and GPRC5D expressed on certain tumor cells.
- Selinexor Selinexor is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. Selinexor is used in the treatment of multiple myeloma.
- Teclistamab is a bispecific antibody that targets BCMA, which is expressed in mature B lymphocytes, and CD3, which is expressed on T-cells.
Arms / Cohorts
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Accepting patients
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