A Phase 1 With Extension Cohort, Single Arm, Single Center, Open Label Trial of Belantamab Mafodotin for the Treatment of High-Risk Smoldering Multiple Myeloma

This is a single-center, single arm, phase I study designed to determine the safety and find the recommended Phase 2 dose (RP2D) or maximum dose level (MTD) of Belantamab Mafodotin in patients with high-risk smoldering multiple myeloma. The study will have a dose-finding part and a dose-expansion part. The maximum number of enrolled patients will be 30 with 18 patients for the dose-finding part and 12 patients for the dose-expansion part. Once we determine the MTD or RP2D in the dose-finding part, we will enroll and treat 12 additional patients at the MTD or RP2D in the expansion part. Efficac

Trial Details

NCT ID
NCT05055063
Phase
PHASE1
Sponsor
M.D. Anderson Cancer Center
Status
RECRUITING
Cancer Type
Multiple Myeloma
Interventions
  • Belantamab mafodotin
Locations (sample)
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • Patients must be diagnosed with high-risk smoldering multiple myeloma (SMM) as confirmed by the following (all three must be present):
  • Bone marrow plasmacytosis with ≥ 10% plasma cells in bone marrow biopsy
  • Immunoparesis (reduction in at least one uninvolved immunoglobulin in blood)
  • ≥ 95% aberrant plasma cells of all plasma cells by flow cytometry of the bone marrow aspirate

For full eligibility, visit ClinicalTrials.gov.

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