Gene patterns that predict response to selinexor for relapsed or refractory multiple myeloma

Efficacy Prediction of Selinexor-Based Regimens in Relapsed/Refractory Multiple Myeloma Based on Differential Multigene Expression: A Multicenter Prospective Clinical Study

We will test if multigene expression patterns can predict how adults with relapsed or refractory multiple myeloma respond to selinexor-based treatment.

Quick facts

• Study type: Observational
• Enrollment: 127 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanxi Bethune Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Taiyuan, Shanxi)
• Trial ID: NCT07514052 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter observational study enrolling 127 adults with relapsed or refractory multiple myeloma who have received 2–4 prior lines of therapy. Participants receive selinexor-based regimens while tumor or bone marrow samples are collected for multigene expression profiling. Investigators will track clinical responses and correlate them with gene expression signatures to identify predictors of sensitivity or resistance. Key exclusions include unresolved toxicities, recent bone marrow transplantation, active severe comorbidities, pregnancy, and uncontrolled infections.

Who should consider this trial

Good fit: Adults (≥18 years) with relapsed or refractory multiple myeloma who have had 2–4 prior lines of therapy and can provide informed consent and clinical/sample follow-up are ideal candidates.

Not a fit: Patients with newly diagnosed disease, fewer than two or more than four prior therapies, recent bone marrow transplant within 6 months, uncontrolled severe comorbidities, or who cannot provide required samples are unlikely to be eligible or benefit.

Why it matters

Potential benefit: If successful, the findings could help clinicians select patients most likely to benefit from selinexor-based therapy and spare others from ineffective treatment and side effects.

How similar studies have performed: Selinexor-based regimens have shown clinical activity in heavily pretreated myeloma, but using multigene expression signatures to predict response remains a novel approach with limited prior validation.

Eligibility criteria

Inclusion Criteria:

1. Patients with a confirmed diagnosis of multiple myeloma (MM) based on bone marrow aspiration or biopsy, in accordance with the International Myeloma Working Group (IMWG) criteria.
2. Patients with relapsed/refractory MM after 2-4 prior lines of therapy.
3. Age ≥18 years.
4. Provision of written informed consent, with willingness to participate in the study and to provide relevant clinical samples and follow-up information.

Exclusion Criteria:

1. Patients with relapsed MM whose toxicities from prior chemotherapy have not recovered to baseline or ≤ Grade 1.
2. Presence of other active malignancies or severe systemic diseases (e.g., significant cardiovascular or cerebrovascular disease, hepatic or renal insufficiency) that may affect study outcomes or limit tolerance to treatment or follow-up.
3. Prior history of bone marrow transplantation or other treatments that may affect the bone marrow microenvironment or immune function within 6 months before study initiation.
4. Known hypersensitivity to selinexor, ixazomib, or any components of the study drugs, or a history of severe allergic reactions.
5. Known human immunodeficiency virus (HIV) infection (HIV antibody positive).
6. Participation in another clinical trial within 30 days prior to study initiation or during the study period.
7. Pregnant or breastfeeding women.
8. Patients with psychiatric disorders or those unable to comply with study procedures.

Where this trial is running

Taiyuan, Shanxi

• ShanxiBethuneH — Taiyuan, Shanxi, China (RECRUITING)

Study contacts

• Study coordinator: Tian Weiwei Tian Weiwei, PhD

Conditions: Multiple Myeloma of Bone, Selinexor, Relapsed/Refractory Multiple Myeloma, Multigene Expression, Biomarkers