Alternate Doses and Dosing Schedules of Belantamab Mafodotin for Treatment of Triple-Class Refractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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
Qualifiers
Age >= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2
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)
Disqualifiers
Active plasma cell leukemia at the time of screening. Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasmaproliferative disorder, myeloma protein, and skin changes), Waldenstrom Macroglobulinemia
Prior belantamab mafodotin therapy. However, patients with prior exposure to another non-belantamab mafodotin anti-BCMA agent such as an anti-BCMA CAR-T or anti-BCMA bispecific antibody will be allowed to participate in the study
Systemic active infection requiring treatment
Any unresolved toxicity >= grade 2 from previous treatment except for alopecia, or peripheral neuropathy up to grade 2
Trial design
Treatments tested in this trial
- Belantamab Mafodotin
- Biospecimen Collection
- Bone Marrow Aspirate
- Bone Marrow Biopsy
- Computed Tomography
- Magnetic Resonance Imaging
- Positron Emission Tomography
Treatment groups
62 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov