A Dose-Finding and Proof-of-Concept Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis

Summary

The goal of this study is to test the safety of drug, Belantamab Mafodotin, and see what effects (good and bad) it has on people who take it and have amyloidosis, and to determine the most effective dose of the drug. The study will have 2 phases (parts). The first phase of the study will test different doses of Belantamab Mafodotin. The second phase will test Belantamab Mafodotin at the dose level found to be safe and effective in phase 1

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Belantamab mafodotin 2.5 mg/kg (8 weeks)

  2.5 mg/kg IV Belantamab mafodotin IV every 8 weeks for Part 1

• Drug
  Belantamab mafodotin 1.9 mg/kg (8 weeks)

  1.9 mg/kg IV Belantamab mafodotin IV every 8weeks for Part 1

• Drug
  Belantamab mafodotin 1.4 mg/kg (12 weeks)

  1.4 mg/kg Belantamab mafodotin IV every 12 weeks for Part 1

• Drug
  Belantamab mafodotin 1.9 mg/kg (12 weeks)

  1.9 mg/kg Belantamab mafodotin IV every 12 weeks for Part 1

• Drug
  Belantamab mafodotin every 8 weeks or 12 weeks as determined by Part 1 recommended dosages

  Belantamab mafodotin Dose 1.0 mg/kg, 1.4 mg/kg, 1.9mg/kg or 2.5mg/kg every 8 weeks or 12 weeks as determined by Part 1 recommended dosages.

• Drug

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