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A study of belantamab mafodotin and mezigdomide in patients with relapsed multiple myeloma who have previously received CAR-T cell therapy or bispecific antibodies

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 study investigates a treatment approach for patients with Relapsed/refractory multiple myeloma. This is a type of blood cancer that has returned after previous treatments or has stopped responding to them, specifically in individuals who have already received BCMA-targeting CAR-T cells or bispecific antibodies. The purpose of the study is to evaluate how well a combination of medications works to stop the cancer from growing.

The treatment involves using belantamab mafodotin, which is given through an intravenous infusion, meaning it is delivered directly into a vein. This is used alongside mezigdomide, which is taken as an oral capsule. Additionally, dexamethasone, a type of steroid, is included in the combination therapy. During the study, participants will receive these medications according to a specific schedule to monitor how the cancer responds and to check for any side effects.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initiation of treatment

    The treatment involves the use of two main medications, belantamab mafodotin and mezigdomide, along with dexamethasone, which is a type of steroid used to reduce inflammation.

    belantamab mafodotin is administered through an intravenous infusion, which means it is delivered directly into a vein. the dose is 1.90 mg/kg, calculated based on body weight.

  2. Step 2

    Oral medication administration

    mezigdomide is taken as an oral capsule. the dosage for this medication is 1 mg.

  3. Step 3

    Monitoring and evaluation

    Regular evaluations are conducted to monitor how the multiple myeloma, a type of blood cancer, responds to the treatment. this includes checking for progressive disease, which is a sign that the cancer is growing or spreading.

    Specific attention is given to ocular events, which are side effects related to the eyes, to ensure the safety of the cornea, the clear front part of the eye.

    The duration of the treatment is monitored until the time of disease progression, death, or when the therapy is stopped due to toxicity, which refers to harmful side effects.

Who can join the trial?

15 criteria

  • You must be at least 18 years old at the time of signing the consent forms.
  • You must have adequate organ function, meaning your organs like the heart, liver, and kidneys are working well enough to participate safely.
  • The doctor must believe you have a life expectancy of at least 6 months.
  • You must agree to use contraception (methods to prevent pregnancy, such as birth control or condoms) to minimize the risk of pregnancy during and after the study.
  • Female participants who can become pregnant must have a negative pregnancy test and use highly effective birth control; they must also agree not to donate eggs during the study.
  • Male participants must agree to avoid donating sperm and must either practice abstinence or use a condom along with another highly effective birth control method used by their partner.
  • You must sign an informed consent form, which is a document where you agree to join the study after understanding all the details, risks, and rules.
  • You must have a confirmed diagnosis of multiple myeloma, which is a type of blood cancer that starts in the plasma cells.
  • You must have an ECOG performance status of 0, 1, or 2, which is a scale used by doctors to measure how well you can perform daily activities and your overall physical health.
  • You must be transplant ineligible (not a candidate for a stem cell transplant) or have had a previous autologous stem cell transplant (a procedure where your own stem cells are collected, stored, and given back to you) more than 100 days before starting this study.
  • You must have measurable disease, meaning the cancer can be clearly seen or measured through specific laboratory tests, such as checking levels of M protein (an abnormal protein found in the blood or urine of people with multiple myeloma) or free light chains (small proteins produced by plasma cells).
  • You must have used at least four different types of previous myeloma treatments, known as being quadruple-class exposed, and have failed at least 3 previous lines of therapy.
  • You must have a documented presence of BCMA, which is a specific protein found on the surface of certain cancer cells that the study treatment targets.
  • You must not have any active infections caused by bacteria, viruses, or fungi.
  • Any toxicities (side effects or harmful effects) from previous treatments must be low-grade, meaning they are mild, with the exception of alopecia (hair loss) and peripheral neuropathy (nerve damage that causes tingling or numbness in the hands or feet), which can be moderate.

Who cannot join the trial?

26 criteria

  • You cannot participate if you have received a treatment that targets BCMA (a specific protein on cancer cells) within the last 90 days.
  • You cannot participate if you have taken an experimental drug or approved anti-myeloma therapy (medicine used to treat multiple myeloma, which may include systemic steroids or strong anti-inflammatory drugs) within 14 days or within five half-lives (the time it takes for the amount of a drug in your body to reduce by half) of the study drugs.
  • You cannot participate if you have corneal epithelial disease (a condition affecting the surface layer of the eye), except for very mild cases.
  • You cannot participate if you wear contact lenses during belamaf treatment.
  • You cannot participate if you have a known hypersensitivity or idiosyncratic reaction (an unusual or unexpected allergic-like reaction) to belamaf, mezigdomide, or any other part of the study treatment.
  • You cannot participate if you are taking strong CYP3A4/5 modulators (medicines that change how your body processes certain drugs).
  • You cannot participate if you are pregnant or lactating (breastfeeding).
  • You cannot participate if you have an HIV infection, unless you have been on antiretroviral therapy (medicine to treat HIV) for at least 4 weeks, have a low viral load (the amount of virus in the blood), have a CD4+ T-cell count (a type of immune cell) of 350 or higher, and have had no opportunistic infections (infections that occur more easily in people with weakened immune systems) related to AIDS in the last 12 months.
  • You cannot participate if you have Hepatitis B, unless you meet specific medical requirements regarding your blood tests.
  • You cannot participate if you have Hepatitis C, unless you have completed successful antiviral treatment and have a negative RNA test (a test that detects the presence of the virus).
  • You cannot participate if you have previously received an antibody-drug conjugate (a type of medicine that uses an antibody to deliver a drug directly to cancer cells) or mezigdomide.
  • You cannot participate if you have any serious or unstable psychiatric disorder (mental health condition) or medical condition that could make the study unsafe or prevent you from following the rules.
  • You cannot participate if you have had an allogenic stem cell transplant (a procedure where healthy stem cells are given to a patient from a donor).
  • You cannot participate if you have had major surgery within the last 4 weeks (or 2 weeks if you are stable).
  • You cannot participate if you have received a live or attenuated vaccine (a vaccine that uses a weakened version of the virus) within the last 30 days.
  • You cannot participate if you have had plasmapheresis (a process that filters your blood to remove certain substances) within the last 7 days.
  • You cannot participate if you have an active renal condition (a problem with the kidneys), such as an infection or the need for dialysis (a machine that cleans your blood).
  • You cannot participate if you are under guardianship or conservatorship (legal arrangements where someone else makes decisions for you).
  • You cannot participate if you do not speak French well enough to understand the study.
  • You cannot participate if you have active mucosal or internal bleeding.
  • You cannot participate if you have cirrhosis (severe scarring of the liver) or unstable liver disease, including ascites (fluid buildup in the abdomen), encephalopathy (brain issues caused by liver problems), coagulopathy (blood clotting problems), hypoalbuminemia (low levels of protein in the blood), or jaundice (yellowing of the skin or eyes).
  • You cannot participate if you have certain cardiovascular risks (heart problems), such as arrhythmias (irregular heartbeats), a history of myocardial infarction (heart attack), coronary angioplasty (a procedure to open blocked heart arteries), or heart failure (when the heart cannot pump blood well enough).
  • You cannot participate if you have uncontrolled hypertension (high blood pressure).
  • You cannot participate if you have other malignancies (cancers) other than the one being studied, unless that cancer has been gone for more than 5 years and is a non-invasive type, such as certain skin cancers.
  • You cannot participate if you have an active infection that requires antibiotics, antivirals, or antifungals.
  • You cannot participate if you have amyloidosis (a disease where abnormal proteins build up in organs), POEMS syndrome (a rare disease involving nerves and organs), or plasma cell leukemia (a type of blood cancer).
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Investigated drugs

  • Belantamab mafodotin

    is a type of targeted therapy used to treat certain types of blood cancer. It works by attaching to a specific protein found on the surface of cancer cells, which helps the medication deliver a toxic substance directly to those cells to destroy them.

  • Mezigdomide

    is an oral medication used to help the body's immune system fight against cancer cells. It works by helping to increase the effectiveness of the immune system in recognizing and attacking the myeloma cells.

What is already known about the treatment

  • Belantamab mafodotin

    This medication is given as an intravenous infusion using a powder that is mixed into a liquid solution before being injected into a vein. It is currently being studied in clinical trials to treat patients with multiple myeloma whose cancer has returned or stopped responding to other treatments. It belongs to a group of drugs called antibody-drug conjugates, which work by attaching to a specific protein on the surface of cancer cells and then releasing a powerful medicine directly into those cells to destroy them.

  • Mezigdomide

    This medicine is taken orally in the form of a capsule. It is an experimental treatment used in research for people with relapsed or hard-to-treat multiple myeloma. As part of a class of drugs known as immunomodulators, it works by helping the body's own immune system recognize and attack cancer cells more effectively at a molecular level.

Investigated diseases

Relapsed/refractory multiple myeloma - This is a type of blood cancer that develops from plasma cells in the bone marrow. In its relapsed or refractory form, the disease has either returned after a period of improvement or has stopped responding to previous medical therapies. The condition progresses as abnormal plasma cells multiply uncontrollably within the bone marrow. These cells can interfere with the production of healthy blood cells and may affect bone strength. As the disease advances, the number of these cancerous cells typically increases over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-520976-25-00Protocol code24CH294Estimated enrolment44 patientsSponsorCentre Hospitalier Universitaire De Saint Etienne

sourced from the EU Clinical Trials Register and site verification

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