Study on Different Doses and Schedules of Belantamab Mafodotin for Treating Resistant Multiple Myeloma

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05847569

Provider View

This clinical trial is exploring different doses and schedules of the drug belantamab mafodotin to treat multiple myeloma that has returned or is not responding to treatment. The study aims to find out if these changes can reduce side effects, like eye problems, and improve treatment outcomes.

Patient Parameters

Program Overview

This phase II study is testing different doses and schedules of belantamab mafodotin in patients with multiple myeloma that has come back or is not responding to treatment. Belantamab mafodotin is a targeted therapy that attaches to specific molecules on cancer cells and delivers a chemotherapy drug to kill them. The trial aims to see if these new dosing methods can help prevent side effects, such as eye toxicity, and improve treatment for patients with recurrent or refractory multiple myeloma.

Description

The main goal of this study is to see if different doses and schedules of belantamab mafodotin can prevent severe eye problems by the fourth dose in patients with relapsed or refractory multiple myeloma (RRMM).

Other goals include:

  • Checking how well the cancer responds to the new dosing schedule.
  • Evaluating the safety of the new dosing schedule.
  • Measuring how long it takes for the cancer to progress.
  • Assessing how long patients live without the cancer getting worse.
  • Determining the overall survival rate.
  • Checking for minimal residual disease in patients who achieve a complete response.

The study also looks at how pre-treatment levels of a specific molecule (BCMA) in the blood relate to treatment outcomes and how the drug is processed in the body.

Participants are divided into two groups:

  • Group I: Receives a low dose of belantamab mafodotin through an IV every 6 weeks, as long as the disease does not progress or cause unacceptable side effects. Patients will have various scans and tests, including bone marrow biopsies and blood samples.
  • Group II: Receives belantamab mafodotin through an IV every 3 weeks for the first cycle, then every 6 weeks, as long as the disease does not progress or cause unacceptable side effects. Similar tests and scans as Group I will be conducted.

After completing the trial treatment, patients will have follow-up visits every 12 weeks for up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a performance status score of 0, 1, or 2, indicating full activity or some restriction in strenuous activities.
  • Have a confirmed diagnosis of multiple myeloma.
  • If previously had a stem cell transplant, it must have been over 100 days ago.
  • Have had at least three prior treatments for multiple myeloma, including specific types of drugs.
  • Have measurable disease based on specific lab tests.
  • Have adequate blood cell counts and organ function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Agree to provide blood samples for research and return for follow-up visits.

Exclusion Criteria

  • Have active plasma cell leukemia or certain other blood disorders.
  • Have had prior treatment with belantamab mafodotin.
  • Have an active infection requiring treatment.
  • Have unresolved side effects from previous treatments, except for hair loss or mild nerve damage.
  • Have had major surgery within the last 4 weeks.
  • Have serious medical or psychiatric conditions that could interfere with the study.
  • Have active bleeding or unstable liver disease.
  • Have other cancers unless stable for over 2 years.
  • Have significant heart problems or uncontrolled high blood pressure.
  • Have known allergies to the study drug or its components.
  • Have HIV unless well-controlled.
  • Have hepatitis B or C unless well-controlled.
  • Have current eye disease except for mild conditions.
  • Have had a live vaccine within 30 days before the study.
  • Are pregnant or breastfeeding.
  • Plan to wear contact lenses during treatment.

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