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

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion date changed from estimate of Dec 31, 2024 to Oct 29, 2024
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    v7
  2. Re-verified, no change to tracked fieldsv6
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 1, 2023 to Aug 21, 2023
    v5
  4. Start date: May 1, 2023 to Aug 1, 2023v4
  5. Start date: Mar 31, 2023 to May 1, 2023v3
  6. Study description expanded, about 7 wordsv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05597345
Lead Sponsor University of Rochester
Collaborators: Karyopharm Therapeutics Inc
Conditions
(from sponsor)		 Smoldering Multiple Myeloma
Related terms Multiple Myeloma, Neoplasms, Plasma Cell, Smoldering Multiple Myeloma
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov