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Study Comparing Belantamab Mafodotin with Lenalidomide and Dexamethasone to Daratumumab with Lenalidomide and Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma

Fast replyRegistered 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 the blood. The study is comparing two different treatment combinations for people who have been newly diagnosed with this disease and are not eligible for a procedure called autologous stem cell transplantation. The first treatment combination includes a medication called belantamab mafodotin (also known by the code name GSK2857916), along with lenalidomide and dexamethasone. The second treatment combination includes daratumumab, lenalidomide, and dexamethasone.

The purpose of the study is to evaluate how effective and safe these two treatment combinations are for patients with newly diagnosed multiple myeloma. Participants in the study will be randomly assigned to receive one of the two treatment combinations. The study will monitor the participants over time to see how their disease responds to the treatment and to check for any side effects. The study will also look at how long the participants live without their disease getting worse and other health-related outcomes.

During the study, participants will receive their assigned treatment and will have regular check-ups to monitor their health and the progress of their disease. The study will continue for several years to gather enough information to determine which treatment combination is more effective and safer for patients with multiple myeloma. This research aims to improve treatment options for people with this type of cancer.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

    Blood tests and other diagnostic procedures may be performed to ensure all criteria are met for participation.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two treatment groups. This process ensures that each participant has an equal chance of receiving either treatment option.

  3. Step 3

    Treatment phase

    Participants in the first group receive a combination of belantamab mafodotin, lenalidomide, and dexamethasone. Belantamab mafodotin is administered intravenously, while lenalidomide and dexamethasone are taken orally.

    Participants in the second group receive a combination of daratumumab, lenalidomide, and dexamethasone. Daratumumab is given as a subcutaneous injection, and the other medications are taken orally.

    The dosage and frequency of each medication are determined by the study protocol and are monitored by the study team.

  4. Step 4

    Monitoring and follow-up

    Regular follow-up visits are scheduled to monitor health and response to treatment. These visits may include physical exams, blood tests, and other assessments.

    Participants are encouraged to report any side effects or changes in health to the study team immediately.

  5. Step 5

    End of treatment

    At the end of the treatment phase, a final assessment is conducted to evaluate the overall response to the treatment.

    Participants may be asked to continue follow-up visits to monitor long-term health outcomes.

Who can join the trial?

9 criteria

  • Must be at least 18 years old or the legal age of consent in the area where the study is conducted.
  • Must be able to give signed informed consent, which means you understand the study and agree to follow its rules.
  • Must have been newly diagnosed with multiple myeloma, a type of blood cancer, and need treatment according to specific medical criteria.
  • Must have at least one measurable sign of the disease, such as certain levels of proteins in the blood or urine.
  • Must not be a candidate for high-dose chemotherapy with ASCT (a type of stem cell transplant) due to age restrictions or other health conditions.
  • Must have an ECOG performance status of 0 to 2, which means you are fully active or have some symptoms but can take care of yourself.
  • Must have adequate organ function based on specific laboratory tests.
  • Male participants must agree to use contraception and avoid donating sperm during the study and for 6 months after the last dose of the study drug.
  • Female participants must not be pregnant or breastfeeding and must use effective contraception during the study and for 4 months after the last dose of the study drug. They must also have two negative pregnancy tests before starting the study.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer other than multiple myeloma cannot participate.
  • Patients who have had a heart attack or stroke in the past 6 months cannot participate.
  • Patients with severe heart disease, which means their heart is not working well, cannot participate.
  • Patients with severe lung disease, which means their lungs are not working well, cannot participate.
  • Patients with severe liver disease, which means their liver is not working well, cannot participate.
  • Patients with severe kidney disease, which means their kidneys are not working well, cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have an active infection that needs treatment cannot participate.
  • Patients who have had another experimental treatment in the last 4 weeks cannot participate.
  • Patients who are allergic to any of the study medications cannot participate.
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Investigated drugs

  • Belantamab mafodotin

    is a medication used in this clinical trial to treat multiple myeloma, a type of blood cancer. It works by targeting and attaching to a specific protein found on the surface of cancer cells. Once attached, it delivers a toxic substance directly into the cancer cells, helping to kill them and slow down the progression of the disease.

  • Lenalidomide

    is another medication used in the trial, which helps to treat multiple myeloma by affecting the immune system. It works by enhancing the body's immune response to fight cancer cells and also by directly attacking the cancer cells to prevent them from growing and spreading.

  • Dexamethasone

    is a type of steroid medication included in the trial. It helps reduce inflammation and suppresses the immune system, which can be beneficial in treating multiple myeloma. It is often used in combination with other cancer treatments to enhance their effectiveness.

  • Daratumumab

    is a medication used in the trial that targets a specific protein on the surface of multiple myeloma cells. By binding to this protein, it helps the immune system to identify and destroy the cancer cells. This medication is used to help control the disease and improve patient outcomes.

What is already known about the treatment

Belantamab mafodotin – This medication is administered through an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating multiple myeloma, a type of blood cancer. The main purpose of using belantamab mafodotin is to help control the growth of cancer cells. It works by targeting a specific protein on the surface of cancer cells, delivering a toxic substance that helps kill these cells. Belantamab mafodotin is classified as an antibody-drug conjugate, which is a type of targeted cancer therapy.

Investigated diseases

Multiple myeloma – Multiple myeloma is a type of blood cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. It begins when a single plasma cell becomes abnormal and starts to multiply uncontrollably, leading to an accumulation of abnormal cells in the bone marrow. These abnormal cells produce a large amount of a single type of antibody, which can cause damage to the bones and interfere with the production of normal blood cells. As the disease progresses, it can lead to bone pain, fractures, anemia, kidney dysfunction, and increased susceptibility to infections. The disease often progresses in a series of relapses and remissions, with periods of active disease followed by periods of stability. Over time, the disease can become more aggressive and resistant to treatment.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516030-35-00Protocol code214828Estimated enrolment556 patientsSponsorGlaxosmithkline Research & Development Limited

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