Actively Recruiting
Selinexor for the Treatment of Intermediate and High-Risk Smoldering Multiple Myeloma
Led by University of Rochester · Updated on 2025-02-10
15
Participants Needed
1
Research Sites
123 weeks
Total Duration
On this page
Sponsors
U
University of Rochester
Lead Sponsor
K
Karyopharm Therapeutics Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Selinexor for the Treatment of Intermediate and High-Risk Smoldering Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed diagnosis of smoldering multiple myeloma with serum M-protein 3 g/dL or higher or bone marrow plasma cells between 10% and less than 60%, or both
- No symptoms like hypercalcemia, anemia, bone lesions, or kidney problems caused by the plasma cell disorder
- Intermediate risk defined by at least one of the following: bone marrow plasma cells 20% or higher, M-spike 2 g/dL or higher, or involved to uninvolved serum free light chain ratio 20 or higher; high risk defined by two or more of these factors
- Normal liver function within 28 days before treatment start
- Adequate kidney function with creatinine clearance 15 mL/min or higher within 28 days before treatment start
- Adequate blood counts: neutrophils 1.5 x10^9/L or higher, hemoglobin 10 g/dL or higher, platelets 150 x10^9/L or higher within 28 days before treatment start
- Life expectancy more than 12 months
- ECOG performance status 0 or 1
- Willingness and ability to understand and comply with the study requirements
- If of reproductive potential, willing to use two effective contraception methods or abstain from sexual activity during and 6 months after the study
You will not qualify if you...
- Meeting criteria for symptomatic multiple myeloma including hypercalcemia (calcium >11.0 mg/dL), anemia (hemoglobin <10 g/dL), renal insufficiency (creatinine >2.0 mg/dL), or bone lesions
- Bone marrow plasma cells 60% or higher
- Serum free light chain involved level 100 mg/L or higher with ratio 10 or higher
- Known systemic light chain amyloidosis
- Use of systemic corticosteroids above 10 mg prednisone or equivalent daily for other conditions
- Active invasive cancer within the past 3 years that could affect study results
- Non-invasive cancer not cured within the past 3 years that could affect study results
- Active infection requiring intravenous antibiotics, antivirals, or antifungals within 14 days before treatment
- Known active HIV infection without adequate treatment
- Active gastrointestinal problems preventing swallowing or absorption of pills
- Pregnant, breastfeeding, or planning pregnancy within 6 months after treatment
- Not willing to use two effective contraception methods during and 6 months after treatment if of reproductive potential
- Major medical or psychiatric conditions preventing study completion or interfering with results
- Prior treatment with selinexor or similar nuclear export inhibitors
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
Research Team
J
Jodi Lipof
CONTACT
B
Brea Lipe
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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