Actively Recruiting
HCMT/MM2401: Ph2 Study of Selinexor + Bispecific Antibody for RRMM
Led by Duke University · Updated on 2025-09-02
27
Participants Needed
1
Research Sites
123 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
HCMT/MM2401: Ph2 Study of Selinexor + Bispecific Antibody for RRMM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of consent
- Ability and willingness to provide written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Diagnosis of symptomatic multiple myeloma with relapsed or refractory disease
- Received at least 4 prior lines of therapy including a proteasome inhibitor, immunomodulatory agent, and CD38 monoclonal antibody
- Planned treatment with teclistamab, elranatamab, or talquetamab per approved dosing
- Complete resolution of cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) from bispecific antibody therapy before starting Selinexor
- Measurable disease by serum or urine monoclonal protein, immunoglobulin free light chain levels, or plasmacytoma
- Adequate liver function with total bilirubin less than 1.5 times upper limit of normal (ULN) and AST/ALT less than 2.5 times ULN
- Adequate kidney function with creatinine clearance of 15 mL/min or higher
- Adequate blood counts with neutrophils ≥1500/mm3, hemoglobin ≥8.5 g/dL, and platelets ≥100,000/mm3 or ≥50,000/mm3 depending on bone marrow plasma cell percentage
- Negative pregnancy test for those able to become pregnant
- Use of highly effective contraception during the study and for 5 months after last treatment dose
- Agreement to not donate eggs or sperm during treatment and up to 90 days after last Selinexor dose
You will not qualify if you...
- Previous refractory response to Selinexor or other nuclear export inhibitors
- Concurrent medical conditions likely to interfere with study participation
- Active uncontrolled infections requiring treatment within one week before study start
- Pregnant or breastfeeding females
- Active or unstable heart conditions including symptomatic ischemia, significant conduction abnormalities, severe heart failure, low ejection fraction, or recent myocardial infarction
- Unresolved CRS/ICANS at 5 days after first full bispecific antibody dose
- Active gastrointestinal issues interfering with swallowing or absorption of study drugs
- Inability or unwillingness to take recommended supportive medications
- Psychiatric or other conditions interfering with compliance or consent
- Contraindications to required supportive treatments
- Inability or unwillingness to comply with study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Duke University Health System
Durham, North Carolina, United States, 27705
Actively Recruiting
Research Team
L
Lauren Hill
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here