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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

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Hopital Saint Antoine Paris France
Centre Hospitalier Victor Dupouy Argenteuil France
Hopitaux Universitaires Pitie Salpetriere Paris France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Centre Henri Becquerel Rouen France
Centre Hospitalier Universitaire d’Orléans Orléans France
Centre Hospitalier Le Mans Le Mans France
Centre Hospitalier De La Cote Basque Bayonne France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
L’Hopital Prive Du Confluent Nantes France
Iryzmowy Bkggdzta Bordeaux France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
02.01.2026

Trial locations

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.

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 ID:
2025-520976-25-00
Protocol code:
24CH294
Trial Phase:
Therapeutic exploratory (Phase II)

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