Actively Recruiting
Alternate Doses and Dosing Schedules of Belantamab Mafodotin for Treatment of Triple-Class Refractory Multiple Myeloma
Led by Mayo Clinic · Updated on 2026-02-03
62
Participants Needed
1
Research Sites
547 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial tests alternate doses and dosing schedules of belantamab mafodotin in treating patients with triple-class multiple myeloma that has come back (after a period of improvement) (recurrent) and/or does not respond to treatment (or that has not responded to previous treatment) (refractory). Belantamab mafodotin is a monoclonal antibody, belantamab, linked to a chemotherapy drug, mafodotin. Belantamab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as BCMA receptors, and delivers mafodotin to kill them. This trial may help researchers determine if alternate doses and dosing schedules work better in preventing certain side effects, such as eye toxicity, and treating patients with recurrent or refractory multiple myeloma.
CONDITIONS
Official 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 0, 1, or 2
- Confirmed diagnosis of multiple myeloma per International Myeloma Working Group criteria
- If stem cell transplant was done, it must have been more than 100 days before registration
- Disease progression after three or more prior treatments including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody
- Prior treatment with non-belantamab mafodotin anti-BCMA agents allowed including CAR-T or bispecific antibodies
- Measurable disease defined by specified levels of serum or urine M-protein or serum free light chain
- Absolute neutrophil count ≥ 0.75 x 10^9/L without recent growth factor support or transfusion
- Hemoglobin ≥ 7.0 g/dL without recent growth factor support or transfusion
- Platelets ≥ 50 x 10^9/L without recent growth factor support or transfusion
- Total bilirubin ≤ 2.0 x upper limit normal (with conditions for higher levels)
- Alanine aminotransferase ≤ 2.5 x upper limit normal
- Aspartate transaminase ≤ 2.5 x upper limit normal
- Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m^2
- Urine albumin/creatinine ratio ≤ 500 mg/g with confirmation if needed
- Negative pregnancy test within 7 days for persons of childbearing potential
- Written informed consent and agreement to blood specimen collection
- 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, or Waldenstrom Macroglobulinemia
- Prior belantamab mafodotin therapy
- Active infection requiring treatment
- Unresolved toxicity grade 2 or higher from previous treatment except alopecia or mild neuropathy
- Major surgery within 4 weeks prior to registration
- Serious or unstable medical or psychiatric conditions interfering with safety or compliance
- Active mucosal or internal bleeding
- Unstable liver or biliary disease with specific signs; stable chronic liver disease allowed
- Previous or concurrent malignancies other than multiple myeloma unless stable for over 2 years
- Cardiovascular risks including significant untreated arrhythmias, recent heart attack or interventions, severe heart failure, or uncontrolled hypertension
- Known hypersensitivity to belantamab mafodotin or related drugs
- HIV infection without controlled viral load and adequate immune status
- Hepatitis B or C not meeting specific control 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
- Pregnancy or lactation
- 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
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here