Actively Recruiting
A Phase II Safety and Efficacy Study of Selinexor with Commercial Bispecific Antibody Therapy for Patients with Relapsed or Refractory Multiple Myeloma
Led by Duke University · Updated on 2026-06-04
27
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the drug Selinexor combined with commercial bispecific antibody therapy in patients with relapsed or refractory multiple myeloma. This Phase II study aims to determine the safety profile of Selinexor given with bispecific antibody therapy and to assess the rate of minimal residual disease (MRD) negativity at a sensitivity of 10-5 twelve months after bispecific antibody treatment. The study is sponsored by Duke University and plans to enroll 27 participants. Participants will receive 40 mg of oral Selinexor weekly, starting about 5 days after the first full dose of bispecific antibody therapy. Treatment will continue for up to 12 months or until the disease progresses. During this period, patients will be monitored closely through safety check calls and required to keep a drug diary. The study focuses on patients who have already received multiple prior therapies including proteasome inhibitors, immunomodulatory agents, and CD38 monoclonal antibodies, and who are planned to receive teclistamab, elranatamab, or talquetamab as the bispecific antibody therapy. Participants will undergo regular clinical assessments, history reviews, and laboratory tests during the treatment and follow-up periods. The study will track safety by measuring the severity of adverse events up to 13 months, and evaluate the MRD negativity rate at 12 months after treatment. Additional outcomes include response rates, progression-free survival, and monitoring for immune-related side effects such as cytokine release syndrome and neurotoxicity. Follow-up will continue for 24 months to observe long-term outcomes and safety.
CONDITIONS
Brief 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
- Able and willing to provide written informed consent
- ECOG performance status of 2 or less
- Diagnosis of symptomatic relapsed or refractory multiple myeloma
- Have received at least 4 prior lines of therapy including a proteasome inhibitor, immunomodulatory agent, and CD38 monoclonal antibody
- Planned to receive teclistamab, elranatamab, or talquetamab as bispecific antibody therapy
- Complete resolution of cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) if previously experienced from bispecific antibody
- Measurable disease by specified laboratory or clinical criteria
- Adequate liver function within 28 days before starting treatment
- Adequate kidney function with creatinine clearance of 15 mL/min or higher
- Adequate blood counts within 7 days before starting treatment
- Negative pregnancy test if able to become pregnant
- Use highly effective contraception during the study and for 5 months after last dose
- Agreement not to donate eggs or sperm during the study and for 90 days after last dose
You will not qualify if you...
- Previous refractory response to selinexor or similar SINE compounds
- Concurrent medical conditions likely to interfere with study procedures
- Uncontrolled active infections requiring treatment within 1 week before treatment start
- Pregnant or breastfeeding females
- Unstable cardiovascular conditions including recent heart attack or severe heart failure
- Active gastrointestinal problems affecting swallowing or absorption of study drugs
- Inability or unwillingness to take recommended supportive medications
- Psychiatric, medical, or other conditions interfering with treatment or consent
- Contraindications to required supportive drugs
- Inability or unwillingness to comply with study protocol
- Patients with ongoing cytokine release syndrome or neurotoxicity symptoms 5 days after bispecific antibody treatment
- Patients with well-controlled chronic viral infections may be eligible under specific conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months or until disease progression
Participants receive weekly oral doses of selinexor starting after step-up dosing and administration of the first full dose of bispecific antibody therapy, continuing for up to 12 months or until disease progression.
Weekly visits for treatment and monitoring
Trial Site Locations
Total: 1 location
1
Duke University Health System
Durham, North Carolina, United States, 27705
Actively Recruiting
Research Team
L
Lauren Hill
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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