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Evaluation of belantamab mafodotin plus drug combination in adult patients with newly diagnosed light chain amyloidosis

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 who have been newly diagnosed with amyloid light chain amyloidosis, a rare condition in which abnormal protein fragments build up in organs such as the heart, kidneys, or liver, leading to organ problems. The treatment being tested combines an antibody drug called belantamab mafodotin with three chemotherapy agents: cyclophosphamide, bortezomib, and dexamethasone. All four medicines are given by mouth, injection under the skin, or infusion into a vein according to a set schedule.

The purpose of the study is to see whether this combination can more effectively control the disease while remaining safe. Participants will receive the medication cycles over several months, with regular clinic visits for drug administration, blood tests, and eye examinations to watch for any side effects. The study follows each person from the start of treatment through a follow‑up period to observe how the disease responds.

Effectiveness will be judged mainly by the proportion of people who achieve a Complete Hematologic Response, meaning blood tests show no detectable disease activity. Additional assessments include improvement in the function of affected organs (heart, kidney, liver) and monitoring of eye health because the antibody can cause changes on the surface of the eye. Safety will be tracked by recording any unwanted events, changes in laboratory results, and any signs of the body forming antibodies against the new drug.

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

    Enrollment and baseline assessments

    After signing the consent form, you will be assigned to the study group and undergo initial assessments. these include a medical history review, blood tests, and an eye examination to record baseline vision.

    The eye examination checks the cornea and visual acuity to detect any pre‑existing problems before treatment starts.

  2. Step 2

    First treatment cycle

    You will receive belantamab mafodotin as an intravenous infusion. the dose is 1.9 mg per kilogram of body weight, given in a solution that is infused through a vein.

    On the same day you will take cyclophosphamide tablets by mouth. each tablet contains 500 mg of the active substance.

    You will receive an injection of bortezomib under the skin (subcutaneous use). the dose is 1.3 mg per square meter of body surface area.

    You will also take dexamethasone tablets by mouth. each tablet provides a total of 40 mg of the medication.

  3. Step 3

    Repeated treatment cycles

    The combination of belantamab mafodotin, cyclophosphamide, bortezomib, and dexamethasone will be given again in subsequent cycles according to the study schedule. each cycle follows the same pattern of oral tablets, subcutaneous injection, and intravenous infusion.

    The exact interval between cycles is defined by the study protocol and will be explained by the study team.

  4. Step 4

    Safety monitoring and examinations

    Regular blood tests will be performed to monitor how your body is responding to the medications and to detect any side effects.

    Periodic eye examinations will be scheduled to assess corneal health and visual acuity, because the study tracks ocular findings as a safety measure.

    Any adverse events, such as symptoms or changes in laboratory results, will be recorded and evaluated throughout the trial.

  5. Step 5

    Completion of treatment and follow‑up

    After the planned number of treatment cycles is completed, you will enter a follow‑up period. during this time, additional visits will be made to assess the durability of the treatment response and to continue monitoring safety.

    Follow‑up visits may include blood tests, eye examinations, and assessments of organ function, as defined by the study.

Who can join the trial?

8 criteria

  • You must be at least 18 years old (or the legal age to give consent in your country) when you sign the study consent form.
  • You must have a new diagnosis of AL amyloidosis that is confirmed by a tissue test showing amyloid deposits, a special stain called Congo red that appears green under polarized light, and lab evidence of an abnormal plasma cell (a type of blood cell) producing a single kind of protein.
  • Your blood tests must show a measurable amount of the abnormal protein, such as a serum protein level of 0.5 g/dL or higher, or a free light chain level of 5 mg/dL or higher with an abnormal kappa : lambda ratio, or a difference between involved and uninvolved light chains (dFLC) of at least 5 mg/dL.
  • You must not be planned to receive high‑dose chemotherapy with an autologous stem cell transplant (a procedure that uses your own stem cells) as the first line of treatment.
  • You must agree to use effective birth control during the study and for a period after treatment. This includes men agreeing not to donate sperm and women agreeing not to donate eggs, and following the specific timing for contraception described in the study protocol.
  • You must be able to understand the study information and sign the informed consent form.
  • Your overall health must allow an ECOG performance status of 0, 1, or 2 (a scale that measures how well you can carry out daily activities) with no recent worsening in the past two weeks.
  • Your recent lab results must show adequate organ function, including a white blood cell count (ANC) of at least 1.0 × 10⁹/L, a platelet count of at least 75 × 10⁹/L, liver tests within allowed limits (total bilirubin ≤1.5 times the normal upper limit and ALT ≤2.5 or ≤3 times normal depending on liver involvement), and kidney function (eGFR) of 30 mL/min/1.73 m² or higher.

Who cannot join the trial?

26 criteria

  • Having a diagnosis of POEMS syndrome (a condition with nerve problems, enlarged organs, hormone issues, abnormal protein, and skin changes) or having active multiple myeloma (a cancer of plasma cells) that includes bone damage, bone tumors, or a high level of abnormal plasma cells in the bone marrow.
  • Having IgM-related AL amyloidosis, a specific type of amyloidosis linked to the IgM protein.
  • Having any other type of amyloidosis that is not AL amyloidosis, such as ATTR amyloidosis (amyloidosis caused by a different protein).
  • Having serious heart or blood vessel problems as defined in the study protocol.
  • Having Mayo stage 3B disease, which indicates very advanced amyloidosis.
  • Having an active eye surface disease (corneal epithelial disease) that is more than mild, small spots on the eye.
  • Having other cancers besides AL amyloidosis, unless the other cancer has been stable without treatment for at least two years and you are not receiving active therapy (except hormone therapy for that cancer).
  • Having had major surgery within two weeks before the first study drug dose or not having fully recovered from surgery.
  • Having had a previous bone‑marrow transplant (allogenic or autologous) or any solid‑organ transplant.
  • Having a known immediate or delayed allergic reaction (hypersensitivity) or unusual reaction (idiosyncratic) to any of the study drugs (belantamab mafodotin, cyclophosphamide, bortezomib, dexamethasone) or related substances such as boron or mannitol.
  • Having a serious or unstable medical or mental health condition, or abnormal lab results, that could affect safety, the ability to give consent, or follow study procedures.
  • Having an active infection or active bleeding.
  • Being unable to tolerate or having a contraindication to antiviral preventive medication.
  • Having known HIV infection, unless you have been on antiretroviral therapy for at least four weeks, have a low viral load (<400 copies/mL), a CD4+ cell count of 350 or higher, and no serious AIDS‑related infections in the past year.
  • Having received any prior treatment for AL amyloidosis or multiple myeloma, except for a limited amount of dexamethasone (up to 160 mg) before entering the study.
  • Having received any live or weakened (live‑attenuated) vaccine within 30 days before the first dose of belantamab mafodotin.
  • Being enrolled in, or having participated in, another clinical trial with an investigational drug within 28 days before enrollment.
  • Having a liver enzyme level (ALT) more than 2.5 times the normal upper limit, or more than 3 times if the liver is affected by AL amyloidosis.
  • Having a total bilirubin level (a measure of liver function) more than 1.5 times the normal upper limit.
  • Having liver cirrhosis or unstable liver or bile‑duct disease, such as fluid buildup in the abdomen (ascites), brain changes from liver disease (encephalopathy), clotting problems (coagulopathy), low blood protein (hypoalbuminemia), enlarged veins in the esophagus or stomach (varices), or persistent yellowing of the skin (jaundice).
  • Having a positive test for hepatitis B surface antigen (HBsAg) or core antibody (HBcAb) at screening or within three months before the first dose, unless special exceptions apply.
  • Having a positive hepatitis C antibody or RNA test at screening or within three months before the first dose, unless you have a negative RNA test after successful antiviral treatment and a wash‑out period of at least four weeks.
  • Having chronic hepatitis B infection (positive HBsAg or detectable HBV DNA) or hepatitis D co‑infection (positive hepatitis D antibody or RNA) within three months.
  • Having a known blockage that prevents urine from flowing normally.
  • Having an acute, widespread lung disease that also involves the lining around the heart (pericardial disease).
  • Having any form of urinary outflow obstruction.
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Investigated drugs

  • Belantamab mafodotin

    is an antibody‑drug conjugate designed to find and attach to a protein on the abnormal plasma cells that cause AL amyloidosis. By binding to these cells, it helps the body’s immune system recognize and destroy them, aiming to reduce the disease‑causing proteins.

  • Dexamethasone

    is a steroid medication that reduces inflammation and weakens the immune response. In this study it is given to help control symptoms of amyloidosis and to support the activity of the other cancer‑fighting drugs.

  • Cyclophosphamide

    is a chemotherapy agent that interferes with the DNA of fast‑growing cells. It helps to kill the abnormal plasma cells that produce harmful light chains, working together with the other drugs to improve overall treatment effect.

  • Bortezomib

    works by blocking a cellular “recycling” system called the proteasome. This causes a buildup of proteins inside the abnormal plasma cells, leading them to die. It is a key part of the standard combination used for AL amyloidosis.

  • GSK5764227

    is an experimental drug given by IV infusion. Its role in the trial is to test whether adding this new agent can provide extra benefit when combined with the standard regimen, although its exact mechanism is still being studied.

What is already known about the treatment

  • Dexamethasone

    This medication is taken as an oral tablet that is swallowed whole. It is an approved corticosteroid that has been used for many years to treat inflammation and immune‑related conditions. It works by binding to glucocorticoid receptors inside cells, which then reduces the production of inflammatory chemicals. It is classified as a glucocorticoid anti‑inflammatory drug.

  • Bortezomib

    Bortezomib is supplied as a powder that is mixed with liquid and given by subcutaneous injection. It is an approved proteasome‑inhibitor used mainly for certain blood cancers such as multiple myeloma and for amyloid light‑chain amyloidosis. The drug blocks the proteasome, a cellular “recycling” complex, causing cancer cells to accumulate damaged proteins and die. It belongs to the class of proteasome‑inhibiting anticancer agents.

  • Cyclophosphamide

    Cyclophosphamide comes as a film‑coated tablet that is taken by mouth. It is a well‑known chemotherapy drug that is approved for many cancers and for use in combination regimens for amyloidosis. It is an alkylating agent that attaches to DNA and prevents the cells from dividing properly, leading to cell death. It is classified as an alkylating chemotherapy agent.

  • GSK5764227

    GSK5764227 is provided as a powder for solution that is administered by intravenous infusion. It is an investigational compound that is currently being studied in clinical trials and is not yet approved for routine medical use. Early research suggests it may act on specific molecular pathways involved in disease, but its exact mechanism is still under investigation. It is considered an experimental therapeutic agent.

Investigated diseases

Light chain amyloidosis - Light chain amyloidosis is a condition where abnormal proteins called light chains build up as sticky deposits in various organs. These deposits can cause the affected organ to become stiff and function less efficiently. Over time, the amount of protein buildup may increase, leading to gradual worsening of organ performance. Commonly involved organs include the heart, kidneys, and liver, and the disease may spread to additional sites as it advances. Symptoms often develop slowly, reflecting the progressive nature of the protein accumulation. The disease course is marked by a steady increase in tissue involvement unless the underlying process is halted.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522803-60-00Protocol code223963Estimated enrolment60 patientsSponsorGlaxosmithkline Research & Development Limited

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