Actively Recruiting
A Trial of Selinexor, Ruxolitinib and Methylprednisolone
Led by Oncotherapeutics · Updated on 2025-01-16
30
Participants Needed
1
Research Sites
142 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Selinexor, a first-in-class, oral selective exportin 1 (XPO1) inhibitor, has shown promise in pre-clinical and clinical studies. It functions by inhibiting the nuclear export protein XPO1, resulting in the accumulation of tumor suppressor proteins and inhibition of oncoprotein mRNAs, which is selectively lethal to myeloma cells. Selinexor has demonstrated activity in combination with various drugs, including glucocorticoids and proteasome inhibitors, leading to its FDA approval for the treatment of relapsed or refractory multiple myeloma.
CONDITIONS
Official Title
A Trial of Selinexor, Ruxolitinib and Methylprednisolone
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with multiple myeloma by standard criteria including clonal bone marrow plasma cells >10% or biopsy-proven plasmacytoma
- Evidence of active myeloma with at least one of the following: end organ damage, 60% or more bone marrow plasma cells, serum free light chain ratio ≥100, or more than one focal lesion on MRI ≥5mm
- Relapsed or refractory multiple myeloma with at least three prior lines of therapy including anti-CD38 antibody, immunomodulatory agent, and proteasome inhibitor
- Measurable disease with specified levels of monoclonal protein or free light chains
- Progressive multiple myeloma either relapsed (>60 days from last treatment) or refractory (progression during or within 8 weeks of last treatment)
- Adequate liver, kidney, and blood cell function within 14 days prior to treatment
- Interval requirements between growth factor support or blood transfusions and study start met
- Negative pregnancy test for females of childbearing potential and use of effective contraception for sexually active participants
- Able to take antiplatelet therapy if platelet count is above 30 x 10^9/L
- HIV patients eligible if controlled with CD4+ counts ≥350 cells/µL and negative viral load
- Untreated hepatitis C patients eligible if viral load is negative
- Age 18 years or older
- Able and willing to provide informed consent and follow study schedule
You will not qualify if you...
- Prior treatment with ruxolitinib or selinexor
- Previous cancer requiring treatment or recurrence within 3 years, except certain treated cancers
- Diagnosis of light chain amyloidosis or plasma cell leukemia
- History of active tuberculosis
- Medical conditions interfering with study procedures, including uncontrolled hypertension or diabetes, active infections, POEMS syndrome, primary amyloidosis
- Active infection requiring intravenous antibiotics, antivirals, or antifungals within 1 week prior to treatment
- Recent chemotherapy, immunotherapy, radiation, or experimental drug use within specified washout periods
- Use of strong CYP3A4 inhibitors or inducers or high-dose fluconazole before treatment
- Known intolerance or hypersensitivity to glucocorticoids, ruxolitinib, or similar compounds
- Concurrent use of other anti-cancer treatments
- Severe hypercalcemia (serum calcium ≥12 mg/dL)
- Any condition or lab abnormalities posing unacceptable risk or interfering with data interpretation
- Pregnant or breastfeeding females
- Body surface area less than 1.4 m2
- Life expectancy less than 3 months
- Major surgery within 4 weeks prior to treatment
- Active unstable heart conditions including recent myocardial infarction, stroke, or severe heart failure
- Active gastrointestinal problems interfering with swallowing or absorption
- Unwillingness or inability to take recommended supportive medications
- Serious psychiatric or medical conditions interfering with treatment or consent
- Contraindications to required supportive treatments
- Inability or unwillingness to comply with study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Berenson Cancer Center
West Hollywood, California, United States, 90069
Actively Recruiting
Research Team
R
Richard Bailey
CONTACT
Y
Yohana Sebhat
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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