Condition: Multiple Myeloma of Bone · Sponsor: Shanxi Bethune Hospital
Background: Relapsed/refractory multiple myeloma (RRMM) remains a major clinical challenge due to treatment resistance and disease heterogeneity. Selinexor-based regimens have demonstrated promising efficacy; however, predictive biomarkers for treatment response are still lacking. This study aims to evaluate the predictive value of differential multigene expression in RRMM patients treated with selinexor-based therapy. Methods: This is a multicenter, prospective clinical study enrolling 127 patients with RRMM. Eligible patients are aged ≥18 years, have a confirmed diagnosis of multiple myeloma based on International Myeloma Working Group (IMWG) criteria, and have received 2-4 prior lines of therapy. Key exclusion criteria include unresolved toxicities from prior treatments, severe comorbidities, prior bone marrow transplantation within 6 months, hypersensitivity to study drugs, HIV infection, pregnancy or lactation, and participation in other clinical trials within 30 days. All patients receive a selinexor-based regimen consisting of selinexor 60 mg orally once weekly (Day 1 of each week) in combination with standard agents. Each treatment cycle lasts 28 days. Treatment response is assessed every two cycles using bone marrow examination, M-protein quantification, and imaging studies. After treatment completion, patients are followed every 3 months for up to 2 years. Endpoints: The primary endpoint is overall response rate (ORR) after two treatment cycles. Secondary endp…
This description comes directly from the study's public registry record.
Tian Weiwei Tian Weiwei, PhD · 156-13485304136 · tianweiwei@yesh.net
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| ShanxiBethuneH | Taiyuan, Shanxi, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07514052