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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT05847569
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Recurrent Multiple Myeloma
  • Refractory Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belantamab Mafodotin — BIOLOGICAL
    Given IV
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Bone Marrow Aspirate — PROCEDURE
    Undergo bone marrow aspirate
  • Bone Marrow Biopsy — PROCEDURE
    Undergo biopsy
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI scan
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT scan

Study Details

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.

Key Dates

Start date
Jan 4, 2024
Status verified
Jan 2026
Primary completion
Jun 29, 2029
Completion
Jun 29, 2034

Study Design

Enrollment
62 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group I (low dose belantamab mafodotin)
    Patients receive low dose belantamab mafodotin intravenously (IV) on day 1 of each cycle. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. All patients undergo a CT scan, a MRI scan, or a PET/CT scan during screening and patients with plasmacytoma (a MM tumor in bone or soft tissue) also undergo imaging scans on study. Patients undergo bone marrow aspirate and biopsy during screening and on study as well as collection of blood samples throughout the trial.
  • Experimental: Group II (low dose and high dose belantamab mafodotin)
    Patients receive belantamab mafodotin IV on day 1. Cycle repeats at 3 weeks for the next cycle and then every 6 weeks for subsequent cycles in the absence of disease progression or unacceptable toxicity. All patients undergo a CT scan, a MRI scan, or a PET/CT scan during screening and patients with plasmacytoma (a MM tumor in bone or soft tissue) also undergo imaging scans on study. Patients undergo bone marrow aspirate and biopsy during screening and on study as well as collection of blood samples throughout the trial.

Primary Outcome Measure

Grade 3/4 keratopathy-free rate [ Time Frame: At the time of dose 4 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
Clinical Trials Referral Office
[email protected]
855-776-0015
Ricardo D. Parrondo, M.D. (PRINCIPAL_INVESTIGATOR)

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Mayo Clinic in Florida· Jacksonville, FL

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