Actively Recruiting
Phase II Trial Evaluating Alternate Doses and Schedules of Belantamab Mafodotin for Triple-Class Refractory Multiple Myeloma
Led by Mayo Clinic · Updated on 2026-02-03
62
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating alternate doses and dosing schedules of belantamab mafodotin for patients with triple-class refractory or recurrent multiple myeloma. This phase II trial aims to determine if these alternate approaches can better prevent side effects like eye toxicity while treating this condition. The study also explores important outcomes such as overall response rate, safety, time to progression, progression-free survival, overall survival, and minimal residual disease negativity. Participants are randomly assigned to one of two groups. Group I will receive a low dose of belantamab mafodotin intravenously on day 1 of each 6-week cycle. Group II will receive belantamab mafodotin intravenously on day 1, with the second cycle given at 3 weeks and subsequent cycles every 6 weeks, provided there is no disease progression or unacceptable toxicity. Imaging scans such as CT, MRI, or PET/CT are done at screening, with additional scans for those with plasmacytoma. Bone marrow aspirate and biopsy, along with blood sample collections, occur during screening and throughout the study. After treatment ends, patients are followed every 12 weeks for up to 5 years. During the study, participants will undergo various assessments including imaging scans, bone marrow tests, and blood sample collections to monitor disease status and treatment effects. Researchers will measure outcomes like the rate of serious eye toxicity at dose 4, response rates, adverse events, and survival outcomes over up to 5 years. Safety is closely monitored, and participants must return for regular follow-ups during an active monitoring phase. The total study duration varies with individual treatment and follow-up schedules.
CONDITIONS
Brief Title
Alternate Doses and Dosing Schedules of Belantamab Mafodotin for Treatment of Triple-Class Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG performance status of 0, 1, or 2
- Confirmed diagnosis of multiple myeloma per International Myeloma Working Group criteria
- If stem cell transplant was done, at least 100 days have passed since day 0
- Disease progression after at least 3 prior lines of anti-myeloma treatments including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody
- Prior non-belantamab mafodotin anti-BCMA agent exposure allowed; prior anti-BCMA CAR-T or bispecific antibody treatment allowed
- Measurable disease by serum M-protein, urine M-protein, or serum free light chain assay; non-secretory disease allowed
- Absolute neutrophil count ≥ 0.75 x 10^9/L without growth factor support or transfusion within 14 days
- Hemoglobin ≥ 7.0 g/dL without growth factor support or transfusion within 14 days
- Platelets ≥ 50 x 10^9/L without growth factor support or transfusion within 14 days
- Total bilirubin ≤ 2.0 x upper limit of normal; fractionated bilirubin acceptable if direct bilirubin < 35%
- Alanine aminotransferase ≤ 2.5 x upper limit of normal
- Aspartate transaminase ≤ 2.5 x upper limit of normal
- Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m²
- Spot urine albumin/creatinine ratio ≤ 500 mg/g or negative/trace urine dipstick
- Negative pregnancy test within 7 days for persons of childbearing potential
- Written informed consent
- Willingness to provide blood specimens for research
- Willingness to return for follow-up visits during active monitoring phase
You will not qualify if you...
- Active plasma cell leukemia, symptomatic amyloidosis, active POEMS syndrome, Waldenstrom Macroglobulinemia
- Prior belantamab mafodotin therapy
- Systemic active infection requiring treatment
- Unresolved toxicity ≥ grade 2 from previous treatment except alopecia or peripheral neuropathy up to grade 2
- Major surgery within 4 weeks prior to registration
- Serious or unstable medical or psychiatric conditions that may interfere with safety or study compliance
- Active mucosal or internal bleeding
- Unstable liver or biliary disease with ascites, encephalopathy, coagulopathy, or cirrhosis
- Previous or concurrent malignancies other than multiple myeloma unless stable for > 2 years and not receiving active therapy
- Cardiovascular risk including untreated arrhythmias, recent myocardial infarction or acute coronary syndrome, class III or IV heart failure, or uncontrolled hypertension
- Known hypersensitivity to belantamab mafodotin or components
- HIV infection unless on stable antiretroviral therapy with controlled viral load and adequate CD4 count
- Hepatitis B or C infection not meeting specific controlled criteria
- Current corneal epithelial disease except mild punctate keratopathy
- Plasmapheresis within 7 days prior to registration
- Prior allogeneic stem cell transplant
- Live or live-attenuated vaccine within 30 days prior to registration
- Pregnant or lactating women
- Plans to wear contact lenses during treatment with belantamab mafodotin
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 cycles every 3 to 6 weeks until disease progression or unacceptable toxicity
Participants receive belantamab mafodotin intravenously on scheduled days depending on their assigned group. Group I receives low dose on day 1 of each 6-week cycle. Group II receives a dose on day 1, repeats the next cycle at 3 weeks, then every 6 weeks thereafter, unless disease progression or unacceptable toxicity occurs. Bone marrow aspirate and biopsy, blood sample collection, and imaging scans are performed during treatment as needed.
Visits on day 1 of each cycle; additional visits for imaging and bone marrow assessments as scheduled
Duration - Up to 5 years
After completing treatment, participants are followed up to monitor their health and disease status every 12 weeks for up to 5 years.
Visits every 12 weeks
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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