Actively Recruiting
Pilot Study Using Changes in Serum BCMA to Determine Disease Progression in Multiple Myeloma
Led by Oncotherapeutics · Updated on 2024-12-17
30
Participants Needed
1
Research Sites
321 weeks
Total Duration
On this page
Sponsors
O
Oncotherapeutics
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase 1, multicenter, open-label study evaluating the safety and efficacy of ruxolitinib, steroids and lenalidomide among MM patients who currently show progressive disease using BCMA to test progression.
CONDITIONS
Official Title
Pilot Study Using Changes in Serum BCMA to Determine Disease Progression in Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of multiple myeloma based on standard criteria including specific major and minor markers
- Measurable disease with defined levels of monoclonal immunoglobulin or serum free light chain
- Progressive multiple myeloma with at least 2 prior treatments including lenalidomide, proteasome inhibitor, and anti-CD38 antibody
- Have not previously received ruxolitinib
- Able and willing to sign informed consent
- Able to follow study visit schedule and protocol requirements
- ECOG performance status of 2 or less
- Life expectancy greater than 3 months
- Laboratory results within specified ranges for neutrophil count, platelet count, hemoglobin, creatinine clearance, bilirubin, liver enzymes, and potassium
- Females of childbearing potential must have negative pregnancy tests and agree to birth control and testing requirements
- Able to take antiplatelet therapy if platelet count is above 30 x 10^9/L
- Patients receiving lenalidomide must be registered in the REVLIMID REMS program and comply with its requirements
You will not qualify if you...
- Diagnosis of POEMS syndrome
- Plasma cell leukemia with high circulating plasma cells
- Primary amyloidosis
- Non-hematologic cancer within the past 5 years except certain treated or low-risk cancers
- Uncontrolled infections
- Significant heart conditions including recent myocardial infarction, heart failure, angina, pericardial disease, severe arrhythmias, low heart function, or ischemia
- Serious medical, psychiatric, or laboratory conditions preventing consent or safe participation
- Major surgery within 28 days prior to enrollment or not recovered from surgery side effects
- Pregnant or breastfeeding females
- Recent chemotherapy, corticosteroids, immunotherapy, radiation, experimental drugs, or JAK inhibitors within specified timeframes
- Use of strong CYP3A4 inhibitors, inducers, or high-dose fluconazole shortly before study
- Known allergy to thalidomide, lenalidomide, or steroids
- Using other anti-cancer treatments concurrently
- History of erythema nodosum with desquamating rash on thalidomide or similar drugs
- Known HIV, hepatitis B or C, or active or latent tuberculosis infection
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, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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