Actively Recruiting
A Phase 1 Trial of Selinexor, Ruxolitinib and Methylprednisolone for Patients With Relapsed/Refractory Multiple Myeloma
Led by Oncotherapeutics · Updated on 2025-01-16
30
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of selinexor, ruxolitinib, and methylprednisolone for patients with relapsed or refractory multiple myeloma. Selinexor is an oral drug that inhibits the nuclear export protein XPO1, leading to the buildup of tumor suppressor proteins and targeting myeloma cells. Ruxolitinib is an oral JAK1/2 inhibitor approved for myelofibrosis and has shown potential in combination with steroids for multiple myeloma. This phase 1 study aims to investigate the effectiveness of a lower dose of selinexor combined with ruxolitinib and methylprednisolone. The treatment involves a 3+3 dose escalation schedule with three dose levels. At dose level 0, patients receive 40 mg selinexor once weekly, 10 mg ruxolitinib twice daily for 28 days, and 40 mg oral methylprednisolone every other day. Dose level 1 increases selinexor to 60 mg weekly while maintaining ruxolitinib at 10 mg BID and methylprednisolone at 40 mg QOD. Dose level 2 maintains selinexor at 60 mg weekly, increases ruxolitinib to 15 mg BID, and continues methylprednisolone at 40 mg QOD. Participants will undergo assessments to determine the maximum tolerated dose and recommended phase 2 dose over 30 months. Researchers will monitor overall response rates, clinical benefit rates, and disease parameters during treatment. Safety and side effects will be closely observed. The study requires participants to adhere to scheduled visits and protocol requirements, including laboratory tests and disease evaluations throughout the study period.
CONDITIONS
Brief Title
A Trial of Selinexor, Ruxolitinib and Methylprednisolone
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of multiple myeloma based on standard criteria including clonal bone marrow plasma cells >10% or biopsy-proven plasmacytoma
- Evidence of active myeloma with end organ damage or other specific markers such as bone marrow plasma cells ≥60%, serum free light chain ratio ≥100, or multiple focal lesions on MRI
- Relapsed or refractory multiple myeloma with at least three prior lines of therapy including anti-CD38 antibody, immunomodulatory agent, and proteasome inhibitor
- Measurable disease defined by specific monoclonal immunoglobulin or protein levels
- Adequate liver, kidney, and blood function within 14 days prior to treatment
- Ability to adhere to study schedule and provide informed consent
- Age 18 years or older
- Female patients of childbearing potential and fertile male patients must agree to contraception and pregnancy testing requirements
- Patients with controlled HIV or hepatitis C virus infection meeting specified criteria
You will not qualify if you...
- Prior treatment with selinexor or ruxolitinib
- Prior malignancy requiring treatment or recurrence within 3 years, except certain treated cancers
- Light chain amyloidosis or plasma cell leukemia
- History of active tuberculosis
- Concurrent medical conditions likely to interfere with the study
- Active infection requiring intravenous antimicrobial therapy within 1 week prior to treatment
- Recent chemotherapy, corticosteroids, immunotherapy, radiotherapy, or experimental drug within specified washout periods
- Use of strong CYP3A4 inhibitors or inducers prior to study drugs
- Known allergies or intolerance to study drugs or glucocorticoids
- Concurrent use of other anti-cancer treatments
- Severe hypercalcemia or unacceptable medical risk
- 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 cardiovascular conditions
- Gastrointestinal dysfunction affecting drug intake or absorption
- Inability or unwillingness to take supportive medications
- Serious psychiatric or medical conditions interfering with participation
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days per treatment cycle
Participants receive study drugs including selinexor once weekly, ruxolitinib twice daily for 28 days, and methylprednisolone every other day at specified doses in a dose escalation schedule.
Multiple visits during each 28-day treatment cycle
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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