Actively Recruiting
Belantamab Mafodotin, Pomalidomide and Dexamethasone for the Treatment of High-Risk Myeloma
Led by Emory University · Updated on 2025-09-02
34
Participants Needed
1
Research Sites
274 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial studies the effect of belantamab mafodotin, pomalidomide, and dexamethasone in treating patents with high-risk myeloma. Belantamab mafodotin is a monoclonal antibody, called belantamab, linked to a chemotherapy drug, called mafodotin. Belantamab is a form of targeted therapy because it attaches to specific molecules on the surface of cancer cells, known as BCMA receptors, and delivers mafodotin to kill them. Chemotherapy drugs, such as pomalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as dexamethasone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Giving belantamab mafodotin, pomalidomide, and dexamethasone may kill more cancer cells.
CONDITIONS
Official Title
Belantamab Mafodotin, Pomalidomide and Dexamethasone for the Treatment of High-Risk Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Transplant-eligible myeloma patient who had autologous stem cell transplant within one year of diagnosis and achieved partial response or better
- Diagnosed with high-risk disease defined by specific genetic markers or plasma cell leukemia with at least 20% circulating plasma cells
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- At least 18 years old
- Adequate blood counts: ANC ≥1.5 x 10^9/L, hemoglobin ≥8.0 g/dL, platelets ≥75 x 10^9/L
- Liver function within limits: total bilirubin ≤1.5 times normal, ALT ≤2.5 times normal
- Kidney function with estimated glomerular filtration rate ≥30 mL/min/1.73 m^2
- Urine albumin/creatinine ratio less than 500 mg/g
- Women must not be pregnant or breastfeeding and use effective contraception if of childbearing potential
- Men must agree to contraceptive measures during and after treatment
- All prior treatment-related toxicities must be grade 1 or lower except hair loss
- Ability to understand and agree to study procedures with informed consent
You will not qualify if you...
- Current corneal epithelial disease except mild changes
- Unstable liver or biliary disease such as ascites, encephalopathy, coagulopathy, or cirrhosis
- Active kidney conditions requiring dialysis or causing safety concerns
- Use of contact lenses during study participation
- Concurrent enrollment in another interventional clinical trial
- Use of investigational or systemic anti-myeloma drugs within 14 days before first dose
- Plasmapheresis within 7 days before first dose
- Prior monoclonal antibody treatment within 30 days before first dose
- Major surgery within 4 weeks before treatment
- Active bleeding or serious cardiovascular risks including uncontrolled arrhythmias or recent heart attack
- Known allergy or intolerance to study drugs
- Active infection requiring treatment
- HIV infection unless well controlled with therapy and stable counts
- Positive hepatitis C or B tests unless successfully treated and controlled
- Other invasive cancers within 5 years except certain skin or cervical cancers
- Serious unstable medical, psychiatric, or laboratory conditions
- Diagnosed with smoldering myeloma, certain other plasma cell disorders, or standard risk myeloma
- Peripheral neuropathy grade 2 or higher
- Pregnancy or lactation
- Any condition placing participant at unacceptable risk per investigator
- Known intolerance to steroids or anti-viral drugs
- Contraindications to blood clot prevention medications
- Known central nervous system disease
- Poor tolerance or allergy to study drugs or similar compounds
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
A
Ajay K. Nooka, MD,MPH,FACP
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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