RecruitingPhase 2NCT06822972

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

A Phase II Safety and Efficacy Study of Selinexor in Combination With Bispecific Antibody in Patients With Relapsed/Refractory Multiple Myeloma

Sponsor

Duke University

Enrollment

27 participants

Start Date

Aug 22, 2025

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma in Relapse Multiple Myeloma, Refractory

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug called selinexor to a type of immunotherapy (bispecific antibody) works better for people with multiple myeloma (a blood cancer affecting plasma cells) that has relapsed or stopped responding to previous therapies. **You may be eligible if...** - You are 18 or older - You have multiple myeloma that has come back or stopped responding to treatment - You have already tried at least 4 prior treatments, including drugs that target the immune system and a CD38 antibody - Your blood counts, kidney function, and liver function are within acceptable ranges - You are willing to use contraception throughout the study and for 5 months after **You may NOT be eligible if...** - You previously took selinexor or a similar drug and your cancer stopped responding to it - You have uncontrolled high blood pressure or other serious medical conditions - You are pregnant or trying to become pregnant - You have active serious infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSelinexor 40 mg

Patients will receive 40mg of oral SEL, weekly, beginning after they have completed step-up dosing and are 5 (± 2) days out from administration of the first full treatment dose of bispecific antibody therapy for 12 months or until disease progression.