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Study of Belantamab Mafodotin Alone and with Drug Combination for Patients with Relapsed/Refractory Multiple Myeloma

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a disease called Multiple Myeloma, which is a type of cancer that affects plasma cells in the bone marrow. The study is exploring the use of a treatment called Belantamab Mafodotin, both on its own and in combination with other anti-cancer treatments. The purpose of the study is to determine the safety and tolerability of these treatments and to find the best dose to use in future studies.

Participants in the study will receive Belantamab Mafodotin and may also receive other medications such as Dexamethasone, Lenalidomide, Pomalidomide, Nirogacestat, Isatuximab, and Feladilimab. Some participants may receive a placebo. The study will involve regular check-ups and monitoring to assess how the treatments are working and to identify any side effects.

The study is designed to help researchers understand how effective Belantamab Mafodotin is when used alone or with other treatments in people with relapsed or refractory Multiple Myeloma. This information will be used to improve treatment options for patients with this condition in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be informed about the trial's objectives and procedures. The participant will sign a consent form to confirm understanding and agreement to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes a review of medical history, a physical examination, and laboratory tests to ensure the participant meets the study criteria.

  3. Step 3

    Treatment phase

    The participant will receive belantamab mafodotin as a monotherapy or in combination with other treatments. The specific combination and dosage will depend on the sub-study the participant is enrolled in.

    Medications may include dexamethasone, pomalidomide, lenalidomide, isatuximab, and nirogacestat. These are administered either orally or intravenously, depending on the specific drug and protocol.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring will occur throughout the treatment phase. This includes clinical assessments, laboratory tests, and imaging studies to evaluate the participant's response to treatment and monitor for any side effects.

    The frequency of these assessments will be determined by the study protocol and may vary depending on the treatment regimen.

  5. Step 5

    End of treatment

    Upon completion of the treatment phase, a final assessment will be conducted. This includes a comprehensive evaluation of the participant's health status and response to the treatment.

    The participant will be informed about the next steps, which may include additional follow-up visits or transitioning to standard care.

Who can join the trial?

12 criteria

  • Must be **18 years or older** at the time of signing the consent form.
  • Can take small doses of oral steroids (less than 10 mg per day), inhaled steroids, or eye-related steroids during the study.
  • Can be **male or female**. Must follow local rules for using birth control methods.
  • Must sign a written consent form, agreeing to follow the study's rules and requirements.
  • Must have a confirmed diagnosis of **Multiple Myeloma (MM)**, a type of blood cancer, as defined by experts.
  • Must have been treated with at least three different types of anti-myeloma treatments, including an immunomodulating agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
  • If you have had a **stem cell transplant**, you can join if it was more than 100 days ago and you have no active infections.
  • Must have an **ECOG performance status** of 0-1, which means you are fully active or have some symptoms but can still do light work. If your status is 2, it should only be due to bone issues or pain from MM.
  • Must have a **measurable disease**, meaning the disease can be measured or tracked by doctors.
  • Must have organ functions that meet specific laboratory test requirements.
  • If positive for **HBcAb**, a marker related to hepatitis B, you can join if certain conditions are met.
  • Any side effects from previous treatments must be mild (Grade 1 or less) at the time of screening, except for hair loss, mild nerve issues, or hormone problems managed with treatment.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of cancer other than Multiple Myeloma cannot participate. Multiple Myeloma is a type of cancer that affects certain cells in the bone marrow.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to adults.
  • Patients who are part of a vulnerable population, such as those who cannot give consent or are unable to understand the study, cannot participate.
  • Patients who have not been diagnosed with Relapsed or Refractory Multiple Myeloma (RRMM) cannot participate. Relapsed means the cancer has returned after treatment, and Refractory means the cancer does not respond to treatment.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
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Investigated drugs

Belantamab Mafodotin is a medication being studied for its effects on multiple myeloma, a type of blood cancer. It is used alone or in combination with other cancer treatments to see how well it works in patients whose cancer has returned or is not responding to other treatments. The study aims to find the best dose that is both safe and effective for patients.

What is already known about the treatment

Belantamab Mafodotin – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory multiple myeloma. It is in the investigational stage, with ongoing research to determine its safety and optimal dosing when used alone or in combination with other cancer treatments. The main therapeutic indication is for multiple myeloma, a type of blood cancer. At the molecular level, belantamab mafodotin works by targeting and binding to a specific protein on the surface of cancer cells, delivering a toxic agent that helps to kill these cells. It is classified as an antibody-drug conjugate, combining an antibody with a chemotherapy drug to enhance its cancer-fighting capabilities.

Investigated diseases

Multiple Myeloma – Multiple Myeloma is a type of blood cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In this disease, cancerous plasma cells multiply rapidly, leading to an overproduction of abnormal proteins that can cause damage to bones, kidneys, and the immune system. As the disease progresses, it can lead to bone pain, fractures, anemia, and increased susceptibility to infections. The accumulation of these abnormal cells can also result in high levels of calcium in the blood, which can cause further complications. Over time, the disease can lead to significant organ damage and affect the body's ability to produce healthy blood cells.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-509550-55-00Protocol code208887Estimated enrolment167 patientsSponsorGlaxosmithkline Research & Development Limited

sourced from the EU Clinical Trials Register and site verification

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