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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• ShanxiBethuneH
  Taiyuan, Shanxi, China Recruiting

Study contacts

• Study coordinator: Tian Weiwei Tian Weiwei, PhD
• Email: tianweiwei@yesh.net
• Phone: 156-13485304136

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.