Actively Recruiting
A Phase I Trial of Selinexor, Ruxolitinib and Methylprednisolone for Patients With Relapsed or Refractory Multiple Myeloma
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
Researchers are evaluating a new treatment approach for patients with relapsed or refractory multiple myeloma, a type of blood cancer that affects plasma cells. This Phase 1 trial studies the combination of Selinexor, Ruxolitinib, and Methylprednisolone. Selinexor is an oral drug that blocks a protein called exportin 1, leading to the accumulation of tumor suppressor proteins and killing myeloma cells. Ruxolitinib is an oral inhibitor of JAK1/2 enzymes, previously approved for myelofibrosis, and has shown potential in combination with steroids to inhibit myeloma cell growth. The study aims to explore the safety and efficacy of using a lower dose of Selinexor combined with Ruxolitinib and Methylprednisolone for this patient group. Participants will receive the investigational drugs Selinexor, Ruxolitinib, and Methylprednisolone, all taken orally. The study focuses on determining the maximum tolerated dose and the recommended dose for future studies over a 30-month period. The trial builds on previous evidence showing individual and combined effects of these agents in myeloma treatment. This combination therapy is being assessed to provide a potential new option for patients who have already undergone multiple prior treatments. During the study, participants will undergo regular assessments including monitoring for side effects, laboratory tests, and evaluations of disease status to determine how well the treatment is working and its safety. Researchers will carefully track dose limits and adverse reactions to establish safe dosing guidelines. The study requires informed consent and adherence to scheduled visits and assessments throughout the participation period.
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
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Trial Site Locations
Total: 1 location
1
Berenson Cancer Center
West Hollywood, California, United States, 90069
Actively Recruiting
Research Team
R
Richard Bailey
Y
Yohana Sebhat
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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