Not yet recruitingRare disease

Reduced vs Standard Dose Belantamab Mafodotin with Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma: A Phase II MRD‑Guided Study

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What is this trial about?

A plain-language summary of the goals, design and what participants do

Patients with relapsed/refractory Multiple Myeloma have a type of blood cancer that has returned after previous treatment or does not respond to standard therapy. The study investigates a combination of three medicines: an injection called belantamab mafodotin, an oral capsule containing pomalidomide, and a steroid called dexamethasone. The goal is to see whether a lower dose of the injection can work as well as the standard dose while causing fewer eye‑related side effects.

The purpose of the trial is to compare the effectiveness and safety of the reduced‑dose regimen with the standard regimen. Participants will be randomly placed into one of the two dosing groups and will receive treatment cycles that include the three medicines given on a regular schedule, with visits for blood work, bone‑marrow testing, and eye examinations to monitor for problems such as blurry vision or damage to the surface of the eye. Throughout the study, doctors will also check for MRD, which stands for minimal residual disease and means looking for very small numbers of cancer cells that may remain after treatment. The study continues for several months, with regular check‑ups to assess how well the cancer is responding and to record any side effects.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and randomization
After signing the consent form, you become a participant in the study and are assigned to one of two treatment groups: a standard dose group or a reduced dose group for the study drug.
The assignment is done by a computer system and you will not know which dose you receive.
Step 2
Baseline assessments
A series of initial tests are performed to record your health status before treatment begins.
These include a review of your medical history, blood tests, a bone‑marrow sample to measure mr d (minimal residual disease), and an eye examination to check for any existing ocular issues.
Step 3
Start of medication regimen
You will begin taking pomalidomide oral capsules at a dose of 4 mg each day as directed by the study team.
You will also take dexamethasone, a steroid medication, according to the schedule provided by the study team.
On the same day, you will receive an intravenous infusion of belantamab mafodotin at a dose of 2.5 mg per kilogram of body weight, or a lower dose if you are in the reduced‑dose group.
Step 4
Treatment cycles and monitoring
The medication schedule is repeated in cycles; each cycle includes daily oral pomalidomide, prescribed dexamethasone, and an intravenous infusion of belantamab mafodotin.
Before each infusion you will have an eye examination to detect any signs of ocular toxicity, which is a known side effect of the study drug.
Regular blood tests are performed to monitor your blood counts and overall health during each cycle.
Step 5
Mr d‑guided assessments
If you achieve a complete response, bone‑marrow samples will be taken at 6, 12, 18, 24, 30, 36, and 42 months after randomization to evaluate mr d status.
Mr d (minimal residual disease) testing looks for very small amounts of cancer cells that may remain after treatment.
Step 6
Continuation until progression or toxicity
Treatment cycles continue until the disease shows signs of progression or until side effects become unacceptable.
The study doctor will decide when to stop treatment based on these factors.
Step 7
Post‑treatment follow‑up
After stopping the study medication, you will attend periodic follow‑up visits to monitor your health, survival, and quality of life.
These visits may include blood tests, physical examinations, and questionnaires about your well‑being.

Who can join the trial?

8 criteria

Must be 18 years or older and have a confirmed diagnosis of multiple myeloma (a type of blood cancer) according to international guidelines (IMWG criteria).
Must have relapsed or refractory disease, meaning the cancer has returned or did not respond to treatment, and must have received at least one previous therapy that included the drug lenalidomide, with the cancer getting worse during or after the most recent treatment.
Must have disease that can be measured with tests, as defined by the IMWG criteria (measurable disease).
Must have an ECOG performance status score of 0–2, a scale that rates how well a person can carry out daily activities (0 = fully active, 2 = able to care for self but unable to work).
Either must have had a prior autologous stem cell transplant (using the patient’s own cells) performed more than 100 days before the first dose, or be ineligible for such a transplant.
Must have adequate organ function, meaning sufficient blood (hematologic), liver (hepatic), and kidney (renal) health as required by the study.
Any side effects from previous treatments must have improved to mild (Grade ≤ 1) severity, except for hair loss (alopecia) which can be any level, and nerve problems (peripheral neuropathy) which can be up to moderate (Grade ≤ 2).
Must be able to sign a written informed consent form and follow the study’s procedures.

Who cannot join the trial?

21 criteria

Having active plasma cell leukemia (a rare blood cancer), AL amyloidosis (a condition where abnormal proteins build up in organs), POEMS syndrome (a disorder affecting nerves, skin, and other parts), a previous allogeneic stem cell transplant (receiving stem cells from another person), or ongoing graft‑versus‑host disease (a reaction where donor cells attack the body) excludes participation.
Having serious liver problems such as cirrhosis (severe scarring of the liver) or unstable liver or bile‑duct disease makes you ineligible.
If you cannot safely take the required antiviral medicines (drugs that prevent viral infections), you cannot join.
Having an active, uncontrolled infection caused by bacteria, viruses, or fungi prevents enrollment.
Being diagnosed with HIV (the virus that causes AIDS) unless it is well‑controlled according to the study’s rules excludes you.
Having active hepatitis B or hepatitis C (viral infections of the liver) unless they are well‑controlled as defined by the study also excludes you.
Severe or unstable kidney disease that could affect your safety makes you ineligible.
Having ongoing nerve problems or nerve pain that are rated Grade 3 or higher (meaning severe) prevents participation.
If you had a blood clot in a vein (known as a venous thromboembolism) within the past three months, you cannot join.
If you cannot take the required antithrombotic medicines (drugs that prevent blood clots), you are excluded.
Having an active eye disease of the cornea (the clear front part of the eye) except for very mild spots called punctate keratopathy excludes you.
Receiving recent multiple myeloma treatment or an experimental therapy right before the first dose of the study drug, as defined by the study, makes you ineligible.
Any serious or unstable medical or mental health condition that could affect your safety, ability to give consent, or follow study procedures excludes you.
Being pregnant or breastfeeding prevents participation.
Having had plasmapheresis (a procedure that filters blood) within seven days before the first study dose excludes you.
If you have previously been treated with the drugs belantamab mafodotin or pomalidomide at any point, you cannot join.
Having significant heart problems such as uncontrolled irregular heartbeats, a recent heart attack, severe heart failure (NYHA class III‑IV), or uncontrolled high blood pressure excludes you.
Having major surgery within four weeks before enrollment makes you ineligible.
Having another active cancer, unless it is stable and does not need ongoing systemic treatment, excludes you.
Being known to be allergic to belantamab mafodotin or any ingredient of the study medication prevents participation.
Having active bleeding inside the mouth, nose, gastrointestinal tract, or other internal areas excludes you.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Verified
Wroclaw, Poland
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Verified
Cracow, Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Responsive
Warsaw, Poland

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Investigated drugs

Pomalidomide
is an oral medication that helps the immune system fight multiple myeloma. It belongs to a class of drugs that can slow the growth of cancer cells and make them more vulnerable to other treatments. In this study, it is given together with other medicines as part of the standard treatment plan.
Belantamab mafodotin
is a specially designed drug that combines an antibody with a chemotherapy agent. It is given through an IV infusion and works by attaching to a protein on the surface of myeloma cells, delivering the chemotherapy directly to the cancer while sparing many healthy cells. The trial is testing a reduced‑intensity dosing schedule to see if it works as well as the standard schedule but with fewer eye‑related side effects.
Dexamethasone
is a steroid that is often used in cancer therapy to reduce inflammation and help other drugs work better. In this trial, it is taken alongside pomalidomide and belantamab mafodotin to enhance the overall anti‑myeloma effect and manage symptoms.

What is already known about the treatment

Pomalidomide
Pomalidomide is taken as a 4 mg hard capsule by mouth. It is an approved drug that is widely studied and used for patients with relapsed or refractory multiple myeloma. It works by changing the activity of immune cells and blocking signals that help myeloma cells grow. It belongs to the class of immunomodulatory imide drugs (IMiDs).
Belantamab mafodotin
Belantamab mafodotin is given as a powder that is mixed and injected into a vein. It is an approved antibody‑drug conjugate that is being investigated in this trial for relapsed or refractory multiple myeloma. The medicine attaches to a protein on myeloma cells and then releases a toxin that kills the cell. It is classified as a monoclonal antibody linked to a cytotoxic agent.

Investigated diseases

Relapsed/refractory multiple myeloma - Relapsed/refractory multiple myeloma is a type of blood cancer where malignant plasma cells accumulate in the bone marrow. In the relapsed phase, the disease returns after a period of improvement, while refractory indicates that it no longer responds to standard treatments. The cancer cells continue to produce abnormal proteins that can build up in the blood and affect organ function. Over time, the disease can cause increasing bone damage, anemia, and kidney problems as the abnormal cells multiply.