Clinical Trial

Selinexor for the Treatment of Intermediate and High-Risk Smoldering Multiple Myeloma

Recruiting Phase 2
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Summary
Selinexor is a drug that has been approved in the treatment of patients with symptomatic multiple myeloma. The standard of care for patients with Smoldering Multiple Myeloma remains observation, but there are numerous clinical trials investigating interventions to delay progression to multiple myeloma and prevent or delay disease related outcomes. A subset of patients with intermediate or high risk smoldering multiple myeloma have a much higher risk of progressive to multiple myeloma, while the low risk smoldering myeloma patient population has a much lower risk. This is a clinical trial investigating the use of low-dose selinexor in patients with intermediate to high-risk smoldering multiple myeloma. The investigators hypothesize that the use of selinexor in intermediate to high risk smoldering myeloma patients will help to delay progression of disease to symptomatic multiple myeloma.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2022-10-24; most recent amendment 2026-01-08.
Status change: Recruiting → Active, Not Recruiting 2025-12-16
Status change: Not Yet Recruiting → Recruiting 2023-09-01
Trial Details
NCT Number NCT05597345
Lead Sponsor University of Rochester
Collaborators: Karyopharm Therapeutics Inc
Conditions Smoldering Multiple Myeloma
Enrollment 15 participants
Start Date 2023-08-21
Primary Completion 2024-10-29 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-02-10