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

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT05597345
Phase
PHASE2
Status
Recruiting
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Conditions

  • Smoldering Multiple Myeloma

Eligibility Criteria

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

Interventions

  • Selinexor — DRUG
    Low-dose Selinexor for the Treatment of Intermediate to High-Risk Smoldering Multiple Myeloma

Study Details

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.

Key Dates

Start date
Aug 21, 2023
Status verified
Feb 2025
Primary completion
Oct 29, 2024
Completion
Dec 31, 2025

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Treatment
    Selinexor 40mg weekly for up to 12 cycles. Each cycle will be 28 days in length.

Primary Outcome Measure

Rate of progression to Multiple Myeloma [ Time Frame: 2 years after end of treament ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of RochesterRochesterNew York14642

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By research site
University of Rochester· Rochester, NY

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