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RECRUITINGPHASE2

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

NCT06822972•Duke University

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 years old at the time of informed consent.
•2. Willing and able to provide written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure.
•3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
•4. A diagnosis of symptomatic multiple myeloma, with relapsed or refractory disease. Patients must have received at least 4 prior lines of therapy. Prior lines of therapy must include a proteasome inhibitor, an immunomodulatory agent, and an CD38 monoclonal antibody, and may include treatment with BCMA antibody conjugates or BCMA directed chimeric antigen receptor (CAR) T cell therapy.
•5. All patients must meet criteria for and will receive teclistamab, elranatamab or talquetamab, as per approved label dosing.
•6. Patients who have had CRS/ICANS from bispecific antibody must have complete resolution of CRS/ICANS before initiation of SEL
•7. Measurable disease as defined by at least one of the following:
•* Serum monoclonal (M) protein ≥1.0 g/dl by protein electrophoresis
•* \>200 mg of M protein in the urine on 24 hour electrophoresis
•* Serum immunoglobulin free light chain ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
+13 more criteria

Exclusion Criteria

•1. Patients who have received and were refractory to selinexor or another specific inhibitor of nuclear exporter (SINE) compound previously. Note: Patients who were exposed to selinexor or another SINE compound but were not refractory are eligible.
•2. Patients with any concurrent medical condition or disease (e.g., uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection) that is likely to interfere with study procedures.
•3. Patients with any uncontrolled active infection requiring medical or surgical management within 1 week prior to Cycle 1 Day 1 (C1D1). Note: Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are eligible.
•4. Females who are pregnant or breastfeeding females.
•5. Patients with active, unstable cardiovascular function, as indicated by the presence of any of the following:
•* Symptomatic ischemia
•* Uncontrolled clinically significant conduction abnormalities (e.g., ventricular tachycardia on anti-arrhythmics); note: patients with first degree atrioventricular block or asymptomatic left anterior fascicular block/right bundle branch block are eligible
•* Congestive heart failure of New York Heart Association Class ≥3
•* Known left ventricular ejection fraction \<40%
•* Myocardial infarction within 3 months prior to C1D1.
+10 more criteria

Locations (1)

Duke University Health System

Durham, North Carolina, United States

Key Dates

Start Date

August 22, 2025

Primary Completion Date

April 30, 2026

Completion Date

December 31, 2027

Last Updated

September 2, 2025

Enrollment

ESTIMATED participants

Conditions

Multiple Myeloma in RelapseMultiple Myeloma, Refractory

Interventions

Selinexor 40 mg

DRUG

Contacts

Lauren Hill

CONTACT

9196682369 lauren.hill@duke.edu

Subcutaneous Talquetamab in Elderly Patients With Multiple Myeloma in Early Relapse

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Subcutaneous Talquetamab in Elderly Patients With Multiple Myeloma in Early Relapse

Combination Treatment of Belantamab Mafodotin and Venetoclax in Treatment of Relapsed and Refractory T(11;14) Multiple Myeloma

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