Selinexor + Antibody for Multiple Myeloma

Overseen By Lauren Hill

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Duke University

Must be taking: Bispecific antibodies

Must not be taking: SINE compounds

Disqualifiers: Uncontrolled hypertension, active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

27 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this 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.

Who Is on the Research Team?

Yubin Kang, MD

Principal Investigator

Duke Health

Are You a Good Fit for This Trial?

This trial is for adults with Multiple Myeloma that's come back or hasn't responded to treatment. They must have tried at least four previous treatments including specific inhibitors and antibodies, be in a stable condition (ECOG ≤2), and agree to receive teclistamab, elranatamab, or talquetamab. Patients should not join if they've had severe reactions from bispecific antibody therapy without full recovery.

Inclusion Criteria

I have a detectable tumor outside of my bone marrow.

My blood test shows M protein levels of 1.0 g/dl or more.

My urine test shows more than 200 mg of M protein in 24 hours.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Selinexor in combination with bispecific antibody therapy for 12 months or until disease progression

12 months

Regular safety check-in calls and clinical assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Selinexor

Trial Overview The study tests Selinexor combined with a commercial bispecific antibody therapy in patients with Relapsed/Refractory Multiple Myeloma (RRMM). It aims to assess the safety of this combination and its effectiveness in achieving minimal residual disease negativity after one year of treatment.

How Is the Trial Designed?

Group I: Selinexor + bispecific antibody Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+