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Study on Belantamab Mafodotin for Patients with Relapsed or Refractory Multiple Myeloma

Verified siteInvestigationalNo 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 trial is testing a treatment known as Belantamab Mafodotin, also referred to by its code name GSK2857916. This treatment is given as a powder that is mixed into a solution and then injected into the bloodstream. The purpose of the study is to explore different ways of giving this treatment to see how safe and effective it is for people whose multiple myeloma has returned or has not responded to previous treatments.

Participants in the study will receive the treatment in one of several different dosing schedules. The study will monitor the effects of the treatment over time, particularly focusing on any changes in the eyes, as these are known to be a possible side effect. The study will also look at how the treatment moves through the body and how the body responds to it. Participants will be observed for any side effects and how well the treatment works in controlling the disease.

The trial will continue for a set period, during which participants will have regular check-ups and tests to track their health and the progress of their multiple myeloma. The study aims to gather information that could help improve treatment options for people with this condition in the future.

The research process

The trial runs in 6 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 purpose and procedures. The participant must provide signed informed consent, confirming understanding and agreement to comply with the study requirements.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes verifying the diagnosis of multiple myeloma and ensuring the participant meets specific health criteria, such as performance status and previous treatment history.

  3. Step 3

    Treatment administration

    The participant will receive belantamab mafodotin, a medication administered as a powder for solution for injection through intravenous use. The dosing regimen will vary depending on the study arm assigned to the participant.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring will occur to assess the participant's response to the treatment and to identify any side effects, particularly corneal events. The frequency and duration of these assessments will be determined by the study protocol.

  5. Step 5

    Completion of treatment

    Upon completion of the treatment phase, a final evaluation will be conducted to assess the overall impact of the medication on the participant's condition and to document any lasting effects.

  6. Step 6

    End of study participation

    The participant's involvement in the study will conclude after the final evaluation. The participant will be informed about the study's findings and any further steps, if applicable.

Who can join the trial?

10 criteria

  • Participant must be at least 18 years old at the time of signing the consent form.
  • Participant must meet any specific criteria required by their country, if applicable.
  • Participant must have an ECOG performance status of 0 to 2, which is a scale used to assess how a disease affects a patient's daily living abilities.
  • Participant must have a confirmed diagnosis of multiple myeloma, a type of blood cancer, and must have either undergone a stem cell transplant or be considered ineligible for one. They must have tried at least three previous treatments, including a specific type of antibody treatment, and not responded to certain other medications.
  • Participant must have measurable disease, which means the disease can be measured using specific tests like blood or urine tests.
  • Participants who have had a stem cell transplant are eligible if the transplant was done more than 100 days before joining the study, they have no active infections, and they meet all other criteria.
  • Any side effects from previous treatments must be mild (Grade 1 or less) at the time of joining the study, except for hair loss and moderate nerve damage.
  • Participant must have a life expectancy of at least 6 months, as judged by the study doctor.
  • Participants must follow local rules for contraception. Women must not be pregnant or breastfeeding and must use effective birth control if they can have children. Men must agree to use contraception and not donate sperm during the study and for a period after.
  • Participant must be able to give informed consent, meaning they understand the study and agree to follow its rules.

Who cannot join the trial?

5 criteria

  • Patients who have a different condition than Multiple Myeloma cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are not part of the specified clinical trial group cannot participate.
  • Both male and female patients are considered, but those who do not meet other criteria cannot participate.
  • Patients who are part of a vulnerable population may not be eligible.
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Investigated drugs

Belantamab Mafodotin (GSK2857916) is a medication being studied for its effects on patients with relapsed or refractory multiple myeloma, a type of blood cancer. This medication is designed to target and kill cancer cells. The study aims to understand how different dosing schedules of this medication affect the eyes, specifically looking at any corneal events, which are changes or issues that might occur in the cornea, the clear front part of the eye.

What is already known about the treatment

Belantamab Mafodotin – This medication is administered intravenously and is currently being studied in clinical trials for its safety and effectiveness in treating relapsed or refractory multiple myeloma. It is an antibody-drug conjugate that targets a specific protein on the surface of cancer cells, delivering a toxic agent directly to the cells to kill them. Belantamab Mafodotin is classified as an anti-cancer agent and is being investigated for its potential to improve outcomes in patients with multiple myeloma. The study aims to explore different dosing regimens to better understand its effects and manage any associated side effects, particularly those affecting the eyes.

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. These 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 result in bone pain, fractures, anemia, and increased susceptibility to infections. The accumulation of these abnormal cells can also lead to a decrease in the production of normal blood cells, causing fatigue and weakness. Over time, the disease can cause significant complications, including kidney dysfunction and bone lesions.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508213-16-00Protocol code209628Estimated enrolment180 patientsSponsorGlaxosmithkline Research & Development Limited

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