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Recruiting Phase 2 NCT05847569

Alternate Doses and Dosing Schedules of Belantamab Mafodotin for Treatment of Triple-Class Refractory Multiple Myeloma

Trial Parameters

Condition Recurrent Multiple Myeloma
Sponsor Mayo Clinic
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 62
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-01-04
Completion 2029-06-29
Interventions
Belantamab MafodotinBiospecimen CollectionBone Marrow Aspirate

Brief 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.

Eligibility Criteria

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 (eg.thalidomide, lenalidomide or pomalidomide) and one anti-CD38 monoclonal antibody (eg.daratumumab or isatuximab) * Prior non-belantamab mafodotin anti-BCMA agent exposure is allowed; patients with prior treatment with an anti-BCMA chimeric antigen receptor (CAR)-T or bispecific antibody will be allowed to participate in the study * Has measurable disease with at least one of the following: * Serum M-

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