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

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What is this study about?

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.

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

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

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

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

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Fakultni Nemocnice Plzen Plzen Czechia
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Hospital Olomouc Olomouc Czechia
University Hospital Ostrava Ostrava Czechia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
17.04.2023

Trial locations

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.

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.

Trial ID:
2024-516250-22-00
Protocol code:
CMG012022
Trial Phase:
Therapeutic exploratory (Phase II)

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