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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06822972
Phase
PHASE2
Status
Recruiting
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Conditions

  • Multiple Myeloma in Relapse
  • Multiple Myeloma, Refractory

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Selinexor 40 mg — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 22, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Selinexor + bispecific antibody

Primary Outcome Measure

Safety of selinexor given with commercial bispecific antibody as measured by severity of adverse events [ Time Frame: up to 13 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Health SystemDurhamNorth Carolina27705
Jennifer Tichon
[email protected]
+1 919 660 7262

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By research site
Duke University Health System· Durham, NC

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