Phase II Trial for Evaluation of Alternate Doses and Dosing Schedules of Belantamab Mafodotin in Triple-Class Refractory Multiple Myeloma
Mayo Clinic
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.
Description
PRIMARY OBJECTIVE: I. To assess the grade 3/4 keratopathy-free rate at the time of dose #4 of an alternative dose/dosing schedule of belantamab mafodotin in patients with relapsed or refractory multiple myeloma (RRMM). SECONDARY OBJECTIVES: I. To assess the overall response rate (ORR; partial response or better) of an alternative dose/dosing schedule of belantamab mafodotin in patients with RRMM. II. To assess the safety of an alternative dose/dosing schedule of belantamab mafodotin in patients with RRMM. III. To assess the time to progression (TTP) of an alternative dose/dosing schedule…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2 * Histologically or cytologically confirmed diagnosis of multiple myeloma (MM), as defined in International Myeloma Working Group (IMWG) criteria, and: * If patients have undergone stem cell transplantation (SCT), day 0 of SCT must be \> 100 days prior to registration to be eligible for the study * Has had disease progression after \>= 3 prior lines of anti-myeloma treatments including one proteasome inhibitor (eg. bortezomib, carfilzomib or ixazomib), one immunomodulatory agent…
Interventions
- BiologicalBelantamab Mafodotin
Given IV
- ProcedureBiospecimen Collection
Undergo collection of blood samples
- ProcedureBone Marrow Aspirate
Undergo bone marrow aspirate
- ProcedureBone Marrow Biopsy
Undergo biopsy
- ProcedureComputed Tomography
Undergo CT scan
- ProcedureMagnetic Resonance Imaging
Undergo MRI scan
- ProcedurePositron Emission Tomography
Location
- Mayo Clinic in FloridaJacksonville, Florida