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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Salamanca	Salamanca	Spain
Hospital Jerez de la Frontera	Jerez De La Frontera	Spain

Other Sites

Site Name	City	Country
Asklepios Kliniken Hamburg GmbH	Hamburg	Germany
Haga Hospital	Hague	The Netherlands
Staedtisches Klinikum Karlsruhe gGmbH	Karlsruhe	Germany
Hospital Universitario 12 De Octubre	Madrid	Spain
Geniko Nosokomeio Thessalonikis George Papanikolaou	Thessaloniki	Greece
Institut Fuer Versorgungsforschung In Der Onkologie GbR	Koblenz	Germany
Evangelismos S.A.	Athens	Greece
University General Hospital Of Ioannina	Ioannina	Greece
Alexandra Hospital	Athens	Greece
Meander Medical Center	Amersfoort	The Netherlands
Hospital Universitario Araba	Vitoria	Spain
Hospital Ruber Juan Bravo	Madrid	Spain
Centre Hospitalier Universitaire De Nantes	Nantes	France
University General Hospital Of Alexandroupoli	Alexandroupoli	Greece
Rotkreuzklinikum Muenchen gGmbH	Munich	Germany
Hopital Beaujon	Clichy	France
Sozialstiftung Bamberg Medizinisches Versorgungszentrum am Bruderwald gGmbH	Bamberg	Germany
Spaarne Gasthuis	Hoofddorp	The Netherlands
L’Hopital Alexandra Lepeve	Dunkirk	France
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Muo ad Kggyfdur Agmbrbkmfqzpb Gwak	Hösbach	Germany
Txfdgqaprh Czxpgf Hxculhtt	Thessaloniki	Greece
Cjpblzr ftt Huuahfxhoxj udc Opqljmvdg ad Bfpmehcfpvjzihcnsovtq	Frankfurt	Germany
Hffutbdr Umuowtidwnntg Hwgfyker Teyli y Pytdcb Ifzllkoq Cjlshr dowubscbwalhwotmq (utzp	Badalona	Spain
Ikuszqwj do Cuedbhbjgatt Hbbiofrwgdv Uhvdtfggddxap dy Steva Eyganpq (ipqlidx	Saint Priest En Jarez	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	22.04.2026
Germany	Not yet recruiting	22.04.2026
Greece	Not yet recruiting	22.04.2026
Spain	Not yet recruiting	22.04.2026
The Netherlands	Not yet recruiting	22.04.2026

Trial locations

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.

Investigated diseases:

Plasma cell myeloma refractory

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 ID:

2025-523117-28-00

Protocol code:

224317

NCT ID:

NCT07227311

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?