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Study of belantamab mafodotin with drug combination in adults aged 18 years and older with relapsed or 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

The study focuses on adults with Multiple Myeloma that has returned after previous treatment (relapsed) or that no longer responds to treatment (refractory). The investigational medicine is belantamab mafodotin, which will be given together with one of three commonly used treatment combinations: pomalidomide plus dexamethasone, bortezomib plus dexamethasone, or carfilzomib plus dexamethasone. All medicines are administered by mouth or by injection according to a schedule that extends the usual timing between doses.

The purpose of the study is to evaluate how many participants experience a measurable reduction in their cancer using these combination therapies. Participants will receive the assigned medicines in cycles, attend regular clinic visits for blood checks, and undergo eye examinations because the investigational drug can affect the cornea, the clear front part of the eye. Terms such as “response rate” refer to the percentage of patients whose disease shrinks or disappears, while “adverse event” means any side effect that may occur, and “dose modification” means adjusting the amount of medicine if needed. The study will continue for several months, during which safety and effectiveness are closely monitored.

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

    Baseline assessments

    After enrollment, you will attend a baseline visit where health status is evaluated. this includes physical examinations, laboratory tests, and eye examinations required before any study medication is given.

  2. Step 2

    First treatment administration

    On the first day of treatment you will receive an intravenous infusion of belantamab mafodotin at the dose specified in the study protocol (mg/kg).

    Depending on the assigned combination, additional therapy will be given:

    - if assigned to the BPd regimen, you will take pomalidomide 4 mg by mouth each day and dexamethasone 40 mg by mouth as directed.

    - if assigned to the BVd regimen, you will receive bortezomib 1.3 mg/m² by subcutaneous injection and take dexamethasone 40 mg by mouth as directed.

    - if assigned to the BKd regimen, you will receive carfilzomib 70 mg/m² by intravenous infusion and take dexamethasone 40 mg by mouth as directed.

  3. Step 3

    Subsequent treatment cycles

    Treatment continues in repeated cycles according to the study schedule.

    Each cycle includes another infusion of belantamab mafodotin at the same dose as the first infusion.

    The oral or injectable components of the assigned combination (pomalidomide, bortezomib, carfilzomib, and dexamethasone) are administered on the days specified in the protocol, using the same doses as at the start of treatment.

  4. Step 4

    Regular monitoring visits

    Before each treatment cycle you will have a visit for safety assessments, which includes blood tests, assessment of any side effects, and an eye examination to detect ocular changes.

    Additional visits may be scheduled if side effects occur or if dose adjustments are needed.

  5. Step 5

    Completion of treatment

    Treatment ends after the planned number of cycles are completed or earlier if the study protocol requires discontinuation because of disease progression or unacceptable toxicity.

    A final assessment is performed to evaluate response to therapy and overall safety.

Who can join the trial?

14 criteria

  • You must be able to sign a form called informed consent, showing that you understand the study and agree to take part.
  • You must be at least 18 years old when you give consent.
  • You must have a confirmed diagnosis of multiple myeloma (a type of blood cancer) as defined by specialist guidelines.
  • If you are a woman, you must use birth control methods that follow the rules in your country for clinical studies.
  • If you are a man, you must also use birth control methods that follow the rules in your country for clinical studies.
  • You must have a performance score called ECOG between 0 and 2, which means you are able to carry out daily activities with at most a moderate limitation.
  • You must have had one or two prior treatment plans for multiple myeloma, and your disease must have gotten worse after the most recent treatment.
  • If you are assigned to the BPd regimen, you must have previously received a drug called lenalidomide for at least two treatment cycles as part of those prior therapies.
  • You must have at least one sign of measurable disease, such as:
    • Urine protein (M‑protein) level of 200 mg or more in a 24‑hour collection, or
    • Blood (serum) M‑protein level of 0.5 g/dL (5 g/L) or higher, or
    • Blood free light chain level of 10 mg/dL (100 mg/L) with an abnormal ratio, if the other tests are negative.
    • If you have had an autologous stem cell transplant (ASCT), the transplant must have been performed more than 100 days before starting the study medication, and you must not have any active bacterial, viral, or fungal infection.
    • Any side effects from previous cancer treatments must be mild (grade 1 or less) according to a standard toxicity scale, except for hair loss, which is allowed.
    • Your laboratory tests must show that your major organ systems (like kidneys, liver, and blood‑forming organs) are working well enough to safely receive the study treatment.

Who cannot join the trial?

34 criteria

  • Having active plasma cell leukemia (a rare, aggressive blood cancer) at the time of screening.
  • Having symptomatic amyloidosis (a condition where abnormal protein builds up in organs) or active POEMS syndrome (a disorder causing nerve, organ, and skin problems).
  • Being intolerant to or not responding to the drug bortezomib (a chemotherapy medicine) for the BVd arm.
  • Being intolerant to or not responding to the drug carfilzomib (another chemotherapy medicine) for the BKd arm.
  • Having received any prior therapy that targets BCMA (a protein on myeloma cells) for the BPd or BKd arms.
  • Participating in, or having taken part in, another clinical study with an experimental drug within the last 30 days or within five times the drug’s half‑life (the time it takes for half of the drug to leave the body) before the first dose.
  • Being known to have HIV infection unless all special protocol requirements for HIV are met (for BPd and BKd arms).
  • Being pregnant or nursing (for the BVd arm and also for BPd and BKd arms).
  • Having a liver enzyme level called ALT that is more than 2.5 times the normal upper limit (for BVd arm) or having a total bilirubin level more than 1.5 times normal (for BPd and BKd arms).
  • Having liver disease called cirrhosis or unstable liver or bile‑duct disease, shown by fluid buildup in the abdomen (ascites), confusion (encephalopathy), problems with blood clotting (coagulopathy), low blood protein (hypoalbuminemia), swollen veins in the esophagus or stomach (varices), or ongoing yellowing of the skin (jaundice) (for BVd, BPd, and BKd arms).
  • Testing positive for hepatitis C antibodies within three months unless a follow‑up test shows no active virus (for the BVd arm).
  • Testing positive for hepatitis C antibodies and having detectable hepatitis C virus RNA (active infection) (for BPd and BKd arms).
  • Testing positive for hepatitis B surface antigen (HBsAg) or core antibody (HBcAb) or having active hepatitis B virus RNA, unless specific protocol conditions are met (for BPd, BKd, and Bvd arms).
  • Having a known immediate or delayed allergic (hypersensitivity) reaction to belantamab mafodotin (a study drug) or any related substances (for the BPd arm).
  • Having any other invasive cancer besides multiple myeloma (for the BVd and BKd arms).
  • Having evidence of cardiovascular risk, such as heart disease or high blood pressure (for the Bvd and BPd arms).
  • Having a prolonged heart rhythm interval called QTc greater than 450 ms (or 480 ms if you have a bundle branch block, a type of heart conduction problem) (for the BVd, BPd, and BKd arms).
  • Having pericardial disease (issues with the heart’s outer lining) such as pericarditis, fluid around the heart, cardiac tamponade, or constrictive pericarditis (for the BKd arm).
  • Having current or past significant lung disease called interstitial lung disease (ILD) or a past diagnosis of progressive multifocal leukoencephalopathy (PML, a serious brain infection) (for the BPd arm).
  • Having active corneal (eye surface) disease, except for very mild changes called punctate keratopathy (for the BVd and BKd arms).
  • Having ongoing peripheral neuropathy (nerve damage) of grade 2 or higher or pain from nerve damage (for the BVd arm).
  • Having recent pleural effusion (fluid around the lungs) that needed drainage, recent ascites (fluid in the abdomen) that needed drainage, inability to tolerate fluids because of lung or heart problems, or known high blood pressure in the lungs (pulmonary hypertension) (for the BKd arm).
  • Having any serious or unstable medical or psychiatric condition, or lab abnormality, that could affect safety, consent, or study participation (for all arms).
  • Having had a previous allogeneic stem cell transplant (a transplant using donor cells) (for BPd, BVd, and BKd arms).
  • Receiving any systemic anti‑myeloma therapy (such as chemotherapy or steroids) or a monoclonal antibody drug for myeloma within 30 days before the first study dose (for BPd, BVd, and BKd arms).
  • Having had plasmapheresis (a procedure that filters blood) within 7 days before the first dose (for BPd and BKd arms).
  • Having an active infection that required antibiotics, antiviral (except hepatitis B treatment), or antifungal medication within 14 days before enrollment, unless the infection is fully resolved (for BPd arm).
  • Having any major surgery within 4 weeks before the first study drug dose, except certain bone‑stabilizing procedures after review (for BPd, BVd, and BKd arms).
  • Being unable to take or having a contraindication to antiviral prophylaxis medication (used to prevent viral infections) (for BPd, BVd, and BKd arms).
  • Having active kidney problems, except isolated protein in the urine caused by myeloma, if other criteria are met (for BPd arm); or having active kidney disease that needs dialysis or could affect safety (for BVd and BKd arms).
  • Having a history of blood clots in veins or arteries within the past 3 months (for BPd arm).
  • Having received prior treatment with or being intolerant to pomalidomide (a myeloma drug) (for BPd arm).
  • Having received prior BCMA‑targeted therapy (for the BVd arm).
  • Having documented presence of hepatitis B surface antigen or core antibody (HBsAg/HBcAb) or hepatitis B virus RNA at screening, unless protocol criteria are met (for BPd, BKd, and Bvd arms).
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Investigated drugs

  • Belantamab mafodotin

    is a specially designed antibody that finds a protein on multiple myeloma cells and delivers a cell‑killing drug directly to them. In this study it is given by IV infusion using an extended dosing schedule and is tested together with other standard medicines to see if it improves the treatment response.

  • Pomalidomide

    is a pill that works by changing the immune system and directly attacking myeloma cells. It is part of the usual care for relapsed or refractory multiple myeloma and is combined with belantamab mafodotin and dexamethasone in one of the study arms.

  • Dexamethasone

    is a steroid taken orally that reduces inflammation and helps cancer‑killing drugs work better. In the trial it is used together with belantamab mafodotin and each of the standard agents (pomalidomide, bortezomib, or carfilzomib).

  • Carfilzomib

    is an intravenous drug that blocks a protein‑degrading system inside myeloma cells, causing them to die. It is paired with belantamab mafodotin and dexamethasone to test whether this combination is safe and effective.

  • Bortezomib

    is an injection given under the skin that also blocks the same protein‑degrading system, helping to stop myeloma cells from growing. It is used together with belantamab mafodotin and dexamethasone as another combination tested in the study.

What is already known about the treatment

  • Pomalidomide

    This medicine is taken by mouth as a tablet. It is an approved drug that is widely used and studied for treating relapsed or refractory multiple myeloma. Pomalidomide works by binding to a protein called cereblon, which changes how immune cells and cancer cells behave, helping to slow tumor growth. It belongs to the class of immunomodulatory imide drugs (IMiDs).

  • Dexamethasone

    Dexamethasone is taken orally in tablet form. It is a well‑known and approved corticosteroid that is often added to multiple myeloma treatment regimens. The drug binds to glucocorticoid receptors, lowering inflammation and suppressing immune activity that can support cancer cells. It is classified as a glucocorticoid steroid.

  • Carfilzomib

    Carfilzomib is given by intravenous infusion. It is an approved proteasome inhibitor used for relapsed or refractory multiple myeloma and has been studied in many clinical trials. The drug blocks the proteasome, a cell structure that breaks down proteins, causing cancer cells to accumulate damaged proteins and die. It belongs to the proteasome‑inhibitor drug class.

  • Bortezomib

    Bortezomib is administered by subcutaneous injection. It is an approved proteasome inhibitor for multiple myeloma and has a long record in medical literature. It works by stopping the proteasome’s ability to dispose of proteins, leading to a buildup of toxic proteins inside myeloma cells and resulting in cell death. It is classified as a proteasome inhibitor.

  • Belantamab mafodotin

    Belantamab mafodotin is given intravenously as a powder that is mixed for injection. It is a newly approved antibody‑drug conjugate for relapsed or refractory multiple myeloma and is the focus of current research. The antibody part of the drug finds a protein called BCMA on myeloma cells, and the attached toxic payload kills those cells once attached. It is classified as an antibody‑drug conjugate (targeted therapy).

Investigated diseases

Relapsed or Refractory Multiple Myeloma - A type of blood cancer that originates in plasma cells, which are responsible for making antibodies. In this condition the disease has either returned after a period of improvement (relapsed) or does not respond to standard treatments (refractory). The cancer cells can build up in the bone marrow, causing bone pain, weakened bones, and lower blood counts. Over time, the abnormal cells may affect kidney function and increase fatigue as they continue to multiply. The disease typically progresses slowly but can become more widespread if not controlled.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523117-28-00Protocol code224317Estimated enrolment200 patientsSponsorGlaxosmithkline Research & Development Limited

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