Not recruitingRare disease

Study of belantamab mafodotin, bortezomib and dexamethasone combination in adults with relapsed or refractory multiple myeloma who received at least one prior therapy

Fast replyRegistered drugNo placebo

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What is this trial about?

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

This study focuses on patients with relapsed/refractory multiple myeloma, a type of blood cancer that returns or stops responding to previous treatments. The study tests a combination of three medications: belantamab mafodotin, bortezomib, and dexamethasone. Belantamab mafodotin is given through an intravenous infusion, while bortezomib is administered as an injection under the skin, and dexamethasone is taken as an oral tablet.

The purpose of this research is to find the best dose and schedule for using belantamab mafodotin together with bortezomib and dexamethasone to achieve good treatment results while reducing side effects. The treatment period may last up to 60 months, with regular monitoring of participants' response to the medication combination.

During the study, participants will receive all three medications according to a specific schedule. The study team will monitor the effectiveness of the treatment and any potential side effects, particularly paying attention to effects on eye health. Regular check-ups and various tests will be performed throughout the study period to evaluate how well the treatment is working and ensure participant safety.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment and eligibility confirmation
Your medical history and current condition will be evaluated to confirm diagnosis of multiple myeloma
Laboratory tests will be performed to check blood counts, liver and kidney function
Your current disease measurements will be documented through blood and urine tests
Step 2
Treatment initiation
You will receive a combination of three medications:
Belantamab mafodotin - given through an intravenous (IV) infusion
Bortezomib - given as an injection under the skin
Dexamethasone - taken as oral tablets
Step 3
Regular monitoring
Your response to treatment will be regularly assessed through blood and urine tests
Eye examinations will be performed to monitor for any vision-related side effects
Regular checks of blood counts, liver and kidney function will continue throughout the study
Step 4
Treatment continuation
Treatment will continue as long as it is providing benefit
The study is planned to run until April 30, 2025
Your doctor will monitor your condition and adjust treatment if needed
Step 5
Safety monitoring
Any side effects will be monitored and recorded
Special attention will be paid to eye-related changes
Regular assessment of your overall health status will be performed

Who can join the trial?

16 criteria

Age 18 years or older
Confirmed diagnosis of multiple myeloma (a type of blood cancer)
Must have received at least 1 prior treatment for multiple myeloma and show disease progression during or after most recent therapy
ECOG performance status of 0 to 2 (a scale measuring ability to perform daily activities)
No active infections present
If previously had stem cell transplant, it must have been completed more than 100 days before starting study treatment
Must have at least one of these measurable disease indicators:
- Urine M-protein level of 200 mg or more in 24 hours
- Serum M-protein level of 0.5 g/dL or higher
- Abnormal free light chain levels in blood
- All side effects from previous treatments must be mild (Grade 1) or less, except for hair loss
- Must have adequate organ function, including:
  - Sufficient white blood cell count
  - Hemoglobin level of 8.0 g/dL or higher
  - Adequate platelet count
  - Acceptable liver function
  - Kidney function of 30 mL/min/1.73 m² or higher
  - Both men and women must use appropriate contraception methods according to local regulations

Who cannot join the trial?

14 criteria

Prior history of corneal disease (problems affecting the clear front part of the eye)
Active or symptomatic viral hepatitis (liver inflammation caused by viruses)
Known active HIV infection
Previous treatment with belantamab mafodotin
Plasma cell leukemia (an aggressive type of blood cancer)
History of other cancer within 2 years before screening (except for successfully treated skin cancer or early-stage cancer)
Major surgery within 4 weeks before starting the study treatment
Cardiovascular conditions including:
- Heart attack within last 6 months
- Unstable heart rhythm problems
- Uncontrolled high blood pressure
- Pregnant or breastfeeding women
- Known allergies to study medications
- Participation in other clinical trials within 30 days before this study
- Any condition that could interfere with study participation according to the doctor's assessment

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Verified sites

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

Verified
Fakultni Nemocnice Brno
Brno, Czechia
Verified
Fakultni Nemocnice Hradec Kralove
Novy Hradec Kralove, Czechia
Responsive
Fakultni Nemocnice Kralovske Vinohrady
Prague, Czechia

Trial locations

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Investigated drugs

Belantamab mafodotin
is a medication designed to treat multiple myeloma, a type of blood cancer. It works by targeting specific proteins on cancer cells to help destroy them while limiting damage to healthy cells.
Bortezomib
is an anticancer medication that belongs to a class of drugs called proteasome inhibitors. It works by blocking certain proteins in cancer cells, which helps to slow or stop cancer cell growth. It's commonly used in treating multiple myeloma.
Dexamethasone
is a corticosteroid medication that helps reduce inflammation and suppress the immune system. In cancer treatment, it's often used alongside other medications to help make them more effective and to help manage certain side effects of cancer therapy.

What is already known about the treatment

Belantamab mafodotin
An antibody-drug conjugate administered through intravenous infusion, specifically designed for treating relapsed/refractory multiple myeloma. This medication targets B-cell maturation antigen (BCMA) on myeloma cells and delivers a potent anti-cancer compound directly to tumor cells, while minimizing damage to healthy tissue. Currently being investigated in clinical trials in combination with bortezomib and dexamethasone for patients who have received at least one prior line of therapy.
Bortezomib
A proteasome inhibitor administered either intravenously or subcutaneously, used in the treatment of multiple myeloma. It works by blocking protein breakdown in cancer cells, leading to their death, and has been a standard treatment option for multiple myeloma for many years. The medication is often used in combination therapy and has shown significant effectiveness in both newly diagnosed and relapsed/refractory multiple myeloma patients.
Dexamethasone
A synthetic corticosteroid medication that can be taken orally or administered intravenously, commonly used in combination with other drugs to treat multiple myeloma. It works by reducing inflammation and suppressing the immune system, which helps to control myeloma cell growth and manage disease symptoms. This medication is a standard component of many multiple myeloma treatment regimens and helps enhance the effectiveness of other anti-myeloma drugs.

Investigated diseases

Multiple Myeloma – A type of blood cancer that develops in plasma cells, which are white blood cells that help fight infections. In this condition, cancerous plasma cells accumulate in the bone marrow, crowding out healthy blood cells and producing abnormal proteins. The disease often affects multiple areas of the body, particularly the bones, leading to bone weakening. Multiple myeloma typically progresses through cycles of active disease and remission, with the relapsed/refractory form (RRMM) occurring when the disease returns or becomes resistant to previous treatments. The disease can affect various body systems, including the bones, kidneys, and blood cell production.