Predicting Response to Selinexor-Based Therapy in Relapsed/Refractory Multiple Myeloma: A Multicenter Prospective Study

Sponsor
Shanxi Bethune Hospital
Study ID
NCT07514052
Status
Recruiting
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Conditions

  • Multiple Myeloma of Bone

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Selinexor-Based Regimen — DRUG
    Patients received a selinexor-based combination regimen consisting of selinexor 60 mg administered orally once weekly (QW, on Day 1 of each week) in combination with standard agents. Each treatment cycle lasted 28 days. Treatment response was assessed every two cycles using bone marrow examination, M-protein quantification, and imaging studies. After completion of treatment, patients were followed up every 3 months for 2 years.

Study Details

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 endpoints include progression-free survival (PFS), overall survival (OS), and safety. Exploratory endpoints focus on the association between the expression levels of candidate genes (hnRNPU, IRF3, ALB2RP, ZBTB17, ATRX, ABCC4, ASB8, and E2F1) and ORR following two cycles of selinexor-based therapy. Statistical Analysis: Statistical analyses are performed using Excel 2019 and SPSS 26.0. Continuous variables are tested for normality using the Shapiro-Wilk test and Q-Q plots. Normally distributed data are presented as mean ± standard deviation, while non-normally distributed data are described using median and interquartile range (IQR). Categorical variables are expressed as counts and percentages. Logistic regression analysis is used to evaluate factors associated with ORR. Survival outcomes (PFS and OS) are estimated using the Kaplan-Meier method. All statistical tests are two-sided, and a P-value \<0.05 is considered statistically significant. Ethics and Timeline: The study is conducted in accordance with ethical principles, and all patients provide written informed consent. Patient enrollment is planned from January 2026 to January 2027, with final data analysis expected in 2027. The total study duration is 2 years. Conclusion: This study aims to identify potential gene expression biomarkers predictive of response to selinexor-based therapy in RRMM, which may contribute to individualized treatment strategies and improved clinical outcomes.

Key Dates

Start date
Jan 1, 2026
Status verified
Mar 2026
Primary completion
Jan 31, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
127 participants (estimated)

Arms

  • Arm: RRMM Patients Receiving Selinexor-Based Therapy
    Patients with multiple myeloma (MM) were enrolled if they had a confirmed diagnosis by bone marrow examination, relapsed/refractory disease after 2-4 prior lines of therapy, were aged ≥18 years, and provided written informed consent. Patients were excluded if they had unresolved toxicities from prior chemotherapy, severe comorbidities, or hypersensitivity to study drugs. All patients received a selinexor-based regimen consisting of selinexor 60 mg administered orally once weekly (QW, on Day 1 of each week) in combination with standard agents. Each treatment cycle lasted 28 days.reatment response was evaluated every two cycles, including bone marrow assessment, M-protein quantification, and imaging studies.

Primary Outcome Measure

To evaluate the overall response rate (ORR) after two cycles of selinexor-based therapy. [ Time Frame: After 2 treatment cycles (approximately 8 weeks) ]

Central Contacts