Actively Recruiting
Maintenance Therapy With Belantamab, Pomalidomide and Dexamethasone (BPd) in High-Risk Myeloma Patients: A Phase 2 Study With a Safety Run-In
Led by Emory University · Updated on 2025-09-02
34
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of a combination therapy using belantamab mafodotin, pomalidomide, and dexamethasone in patients with high-risk myeloma. The trial focuses on patients who have undergone autologous stem cell transplant and achieved at least a partial response. This phase II study intends to assess the complete response rates and safety of this combined treatment approach for high-risk myeloma patients. Participants receive belantamab mafodotin intravenously over 30 minutes on day 1 of every other 28-day cycle, pomalidomide orally once daily on days 1 through 21, and dexamethasone orally once daily on days 1, 8, 15, and 22. Treatment cycles repeat every 28 days unless disease progression or unacceptable side effects occur. After completing treatment, patients are followed up every three months. During the study, participants will undergo regular assessments to monitor response to treatment, including complete response rates and other measures of tumor activity. Safety and tolerability will be closely evaluated through adverse event monitoring. Follow-up visits every three months after treatment completion will continue to track progression-free survival, overall survival, duration of response, and other outcomes for up to three years.
CONDITIONS
Brief 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 has achieved at least partial response
- High-risk disease defined by specific genetic changes or plasma cell leukemia at diagnosis with at least 20% circulating plasma cells
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Age 18 years or older
- Absolute neutrophil count of 1.5 x 10^9/L or higher
- Hemoglobin of 8.0 g/dL or higher
- Platelets of 75 x 10^9/L or higher
- Total bilirubin less than or equal to 1.5 times the upper limit of normal (ULN), with specific exceptions
- Alanine aminotransferase (ALT) less than or equal to 2.5 times ULN
- Estimated glomerular filtration rate (eGFR) of 30 mL/min/1.73 m^2 or higher
- Spot urine albumin/creatinine ratio less than 500 mg/g
- Women must not be pregnant or breastfeeding and follow specific contraceptive guidelines
- Men must agree to use contraception or abstinence during and after treatment
- All prior treatment-related toxicities must be grade 1 or less except for hair loss
- Ability to understand and provide written informed consent
You will not qualify if you...
- Current corneal epithelial disease except mild changes
- Unstable liver or biliary disease with severe symptoms
- Active renal conditions affecting safety, except isolated proteinuria from myeloma
- Use of contact lenses during study
- Participation in another interventional clinical trial
- Use of investigational drugs or systemic anti-myeloma therapy within 14 days before study drug
- Plasmapheresis within 7 days before study drug
- Prior monoclonal antibody treatment within 30 days before study drug
- Major surgery within 4 weeks before study treatment
- Active mucosal or internal bleeding
- Significant cardiovascular risks or uncontrolled heart conditions
- Known hypersensitivity to study drugs or components
- Active infections requiring treatment
- Untreated or uncontrolled HIV, hepatitis B or C infections
- Other invasive malignancies within 5 years, except specific treated skin or cervical cancers
- Serious or unstable medical or psychiatric conditions
- Diagnosed with smoldering myeloma, Waldenstrom's macroglobulinemia, POEMS syndrome, amyloidosis, or standard risk myeloma
- High-risk patients without at least partial response after stem cell transplant
- Peripheral neuropathy grade 2 or higher
- Pregnancy or lactation
- Known intolerance to steroids or contraindications to thromboembolic prophylaxis
- Central nervous system disease
- Known allergies to study drugs or related compounds
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 - Repeated 28-day cycles until disease progression or discontinuation
Participants receive belantamab mafodotin intravenously on day 1 of every other 28-day cycle, pomalidomide orally once daily on days 1 through 21, and dexamethasone orally once daily on days 1, 8, 15, and 22. Treatment continues in cycles every 28 days until disease progression or unacceptable toxicity.
Visits every 14 days for belantamab mafodotin infusion and additional visits for oral medication monitoring each cycle
Duration - Up to 3 years
After completion of study treatment, participants are followed up every 3 months to monitor health and disease status.
Quarterly visits every 3 months
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
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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