Alternate Doses and Dosing Schedules of Belantamab Mafodotin for Treatment of Triple-Class Refractory Multiple Myeloma
NCT05847569 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62
Last updated 2026-02-03
Summary
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
- Recurrent Multiple Myeloma
- Refractory Multiple Myeloma
Interventions
- BIOLOGICAL
-
Given IV
- PROCEDURE
-
Biospecimen Collection
Undergo collection of blood samples
- PROCEDURE
-
Bone Marrow Aspirate
Undergo bone marrow aspirate
- PROCEDURE
-
Bone Marrow Biopsy
Undergo biopsy
- PROCEDURE
-
Computed Tomography
Undergo CT scan
- PROCEDURE
-
Magnetic Resonance Imaging
Undergo MRI scan
- PROCEDURE
-
Positron Emission Tomography
Undergo PET/CT scan
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Ricardo D. Parrondo, M.D. · Mayo Clinic
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-04
- Primary Completion
- 2029-06-29
- Completion
- 2034-06-29
- FDA Drug
- Yes
Countries
- United States
Study Locations
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