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Comparison of belantamab mafodotin, bortezomib and dexamethasone versus daratumumab, bortezomib and dexamethasone in 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 study focuses on treating patients with Multiple Myeloma that has returned or not responded to previous treatment. The research compares two different treatment combinations. The first combination includes belantamab mafodotin, bortezomib, and dexamethasone. The second combination uses daratumumab instead of belantamab mafodotin, along with bortezomib and dexamethasone.

The medications will be given in different ways - some as tablets taken by mouth, while others will be given through an intravenous line (directly into a vein). Dexamethasone comes as tablets and can also be given through an intravenous line. Bortezomib and daratumumab are given through an intravenous line, while belantamab mafodotin is given as a powder that is mixed into a solution for intravenous use.

The main purpose of this study is to determine if the treatment combination with belantamab mafodotin works better than the combination with daratumumab in preventing the cancer from getting worse. The study will measure how long participants live without their disease getting worse, along with tracking side effects and other health outcomes.

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 treatment assignment

    You will be randomly assigned to one of two treatment groups:

    Group 1: Belantamab mafodotin with bortezomib and dexamethasone

    Group 2: Daratumumab with bortezomib and dexamethasone

  2. Step 2

    Treatment administration

    Medications will be given in the following ways:

    Belantamab mafodotin and daratumumab: through an intravenous (IV) infusion into your vein

    Bortezomib: through an IV injection

    Dexamethasone: as tablets taken by mouth or through IV injection

  3. Step 3

    Health monitoring

    Regular check-ups will monitor your health status

    Blood tests will be performed to check your body's response to treatment

    Eye examinations will be conducted regularly

    Your doctor will assess if your disease is stable, improving, or progressing

  4. Step 4

    Response evaluation

    Your response to treatment will be measured through:

    Regular blood and urine tests to check protein levels

    Assessment of any changes in your symptoms

    Evaluation of your overall health and quality of life

  5. Step 5

    Follow-up period

    After completing treatment, you will continue to be monitored

    Regular check-ups will track your long-term health status

    The study will continue until June 2026

Who can join the trial?

15 criteria

  • Must be at least 18 years old at the time of giving consent
  • Must have a confirmed diagnosis of multiple myeloma and have received at least one previous treatment that was not successful
  • Must be able to understand and sign an informed consent form
  • Must have an ECOG performance status of 0 to 2 (a measure of daily living abilities, where 0 means fully active and 2 means able to do light activities)
  • For female participants:
    • Must not be pregnant or breastfeeding
    • Must use highly effective contraception during treatment and for 4 months after
    • Must have a negative pregnancy test before starting treatment
    • For male participants:
      • Must use contraception during treatment and for 6 months after
      • Must agree not to donate sperm during this period
      • If previously had stem cell transplant, it must have been completed more than 100 days before starting the study and have no current infections
      • Must have measurable disease through at least one of these tests:
        • Protein levels in urine of 200 mg or more in 24 hours
        • Protein levels in blood of 0.5 g/dL or more
        • Abnormal light chain protein levels in blood
        • Must have adequate organ function as shown by blood tests
        • Any side effects from previous treatments must be resolved or mild before starting the study

Who cannot join the trial?

15 criteria

  • Active plasma cell leukemia (a type of blood cancer where abnormal plasma cells are found in the blood)
  • Known active central nervous system myeloma (cancer spread to brain or spinal cord)
  • Stem cell transplant within 12 weeks before starting the study treatment
  • Prior treatment with belantamab mafodotin (study medication)
  • Severe corneal conditions (eye surface problems) that could affect vision
  • Major surgery within 4 weeks before starting study treatment
  • Active hepatitis B or C infection (liver infections)
  • HIV infection or AIDS
  • Any other type of active cancer requiring treatment
  • Severe heart conditions including heart failure or unstable heart disease
  • Severe kidney problems requiring dialysis
  • History of serious allergic reactions to similar treatments
  • Pregnancy or breastfeeding
  • Unable to swallow oral medications
  • Any condition that could interfere with study participation according to the doctor's assessment
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Investigated drugs

  • Belantamab mafodotin

    is a targeted antibody therapy used to treat multiple myeloma, a type of blood cancer. It works by attaching to a specific protein on cancer cells and delivering a medication that helps destroy them.

  • Bortezomib

    is a cancer medication that belongs to a class of drugs called proteasome inhibitors. It works by blocking certain proteins that cancer cells need to grow and survive, helping to slow or stop the spread of cancer cells.

  • Dexamethasone

    is a corticosteroid medication that helps reduce inflammation and suppress the immune system. In cancer treatment, it's often used alongside other medications to help make them more effective and manage certain side effects.

  • Daratumumab

    is a monoclonal antibody therapy that targets a specific protein found on multiple myeloma cells. It works by helping the immune system recognize and destroy cancer cells.

What is already known about the treatment

  • Belantamab Mafodotin

    An antibody-drug conjugate administered through intravenous infusion, specifically developed for treating relapsed/refractory multiple myeloma. This medication targets B-cell maturation antigen (BCMA) on myeloma cells, delivering a potent anti-cancer compound directly to tumor cells while minimizing damage to healthy tissue. It belongs to the class of targeted immunotherapy drugs and is currently being evaluated in clinical trials for its effectiveness when combined with other multiple myeloma treatments.

  • Bortezomib

    A proteasome inhibitor administered either intravenously or subcutaneously, used in the treatment of multiple myeloma. It works by blocking protein breakdown in cancer cells, leading to their death, and has been a standard treatment option for multiple myeloma for many years. This medication belongs to the class of targeted cancer therapies and is often used in combination with other anti-myeloma drugs to enhance treatment effectiveness.

  • Dexamethasone

    An oral or injectable corticosteroid medication that helps reduce inflammation and suppress immune system activity in multiple myeloma treatment. It is commonly used in combination with other cancer medications to enhance their effectiveness and manage treatment-related symptoms. This medication belongs to the glucocorticoid class and has been a cornerstone in multiple myeloma therapy protocols.

  • Daratumumab

    A monoclonal antibody administered through intravenous infusion, designed to target the CD38 protein found on multiple myeloma cells. It works by helping the immune system identify and destroy cancer cells, and has shown significant effectiveness in treating relapsed or refractory multiple myeloma. This medication belongs to the targeted immunotherapy class and is frequently used in combination with other anti-myeloma treatments.

Investigated diseases

Multiple Myeloma - A type of blood cancer that develops in plasma cells, which are white blood cells that normally produce antibodies to help fight infections. In this condition, abnormal plasma cells multiply uncontrollably in the bone marrow, forming tumors in multiple bones throughout the body. These cancerous cells produce large amounts of abnormal proteins while preventing the production of normal, healthy blood cells. The disease can weaken bones, decrease normal blood cell production, and cause problems with kidney function. Multiple myeloma often develops slowly and may not cause symptoms in its early stages.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510537-28-00Protocol code207503Estimated enrolment541 patientsSponsorGlaxosmithkline Research & Development Limited

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