Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis

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

Belantamab mafodotin 1.0 mg/kg (12 weeks)

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

Safety/Tolerability as measured by number of subjects with dose limiting toxicity (Part 1)

Time frame: Up to 24 weeks from Cycle 1 Day 1

Safety/Tolerability is measured by the number of participants treated with different dose level of belantamab mafodotin who experience dose limiting toxicity adverse events (AE) \>= Grade 3, as defined by Common Terminology Criteria for Adverse Events by CTCAE v5.0 for Part 1.

Safety/Tolerability at the recommended Phase II dose of Belantamab Mafodotin, as measured by number of subjects with dose limiting toxicity (Part 2)

Time frame: Up to 90 days after completing therapy

Safety/Tolerability at the recommended Phase II dose of Belantamab Mafodotin is measured by the number of subjects who experience dose limiting toxicities (\>= Grade 3, as defined by Common Terminology Criteria for Adverse Events by CTCAE v5.0) and cardiac and ocular AEs.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.