Not recruiting

Study of belantamab mafodotin with bortezomib, lenalidomide, and dexamethasone in newly diagnosed multiple myeloma patients eligible for transplant

Verified siteRegistered 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 Multiple Myeloma, a type of blood cancer that affects plasma cells in the bone marrow. The research examines a combination treatment using several medications: belantamab mafodotin (given through intravenous injection), lenalidomide (taken as oral capsules), bortezomib (given as an injection under the skin), and dexamethasone (taken as oral tablets). This treatment combination is being tested in patients who have been newly diagnosed with multiple myeloma and are eligible for stem cell transplantation.

The main purpose of this research is to evaluate whether the combination of these medications is safe and well-tolerated by patients during their initial treatment. The study will monitor how patients respond to the treatment and track any side effects that may occur. The treatment period consists of six cycles of therapy, during which patients will receive different combinations of the study medications.

Throughout the study, patients will undergo regular medical examinations and tests to monitor their health status. These include blood tests to check blood cell counts, tests to evaluate liver and kidney function, and eye examinations. The researchers will also track how well the cancer responds to the treatment and how long these responses last. Patients will be monitored for potential side effects for several months after completing the treatment.

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 treatment phase
You will receive treatment in 6 cycles combining several medications:
- Belantamab mafodotin through intravenous infusion
- Lenalidomide capsules taken by mouth
- Bortezomib given as injection under the skin
- Dexamethasone tablets taken by mouth
Regular blood tests will monitor your health during treatment
Step 2
Eye examinations
Regular eye examinations will be performed to check for any changes in your vision
Your eye health will be monitored throughout the treatment period
Step 3
Disease monitoring
Your response to treatment will be regularly assessed through blood and urine tests
Tests will check for signs of multiple myeloma (bone marrow cancer) activity
Step 4
Safety monitoring
Regular checks of your:
- Blood cell counts
- Liver function
- Kidney function
- General health status
Step 5
Long-term follow-up
Your health status will be monitored after completing the initial treatment
Follow-up will continue until May 2025

Who can join the trial?

10 criteria

Must be newly diagnosed with multiple myeloma with symptoms according to current medical criteria
Must have measurable disease levels shown by either: - Blood protein level ≥0.5 g/dl, or - Urine protein level ≥200 mg in 24 hours
Must be eligible for stem cell transplant (a procedure where damaged bone marrow is replaced with healthy cells)
Must have good enough physical function to perform daily activities (ECOG score of 2 or less)
Must be at least 18 years old
Must have adequate organ function, including: - Sufficient blood cell counts - Normal liver function - Kidney function of at least 30 mL/min - Normal calcium levels
For women who can become pregnant: - Must not be pregnant or breastfeeding - Must use effective birth control during treatment and for 4 months after - Must have negative pregnancy tests before starting treatment
For men: - Must use contraception during treatment and for 6 months after - Must agree not to donate sperm during this period
Must have any side effects from previous treatments resolved to mild level or less
Must be able to understand and agree to study procedures by providing written consent

Who cannot join the trial?

15 criteria

Age below 18 years or above 75 years
Previous treatment for multiple myeloma
Known hypersensitivity (severe allergic reaction) to study medications
Active or chronic infections, including hepatitis B, hepatitis C, or HIV
Significant heart conditions, including heart failure or recent heart attack (within 6 months)
Severe kidney dysfunction
Severe liver problems
Active other cancer within the last 3 years
Pregnancy or breastfeeding
Unable to follow study procedures
History of severe eye problems or current eye conditions
Uncontrolled high blood pressure
Major surgery within 4 weeks before starting the study
Mental conditions that could interfere with study participation
Current participation in other clinical trials

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Verified sites

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

El Hospital Universitario De Gran Canaria Dr. Negrin
Verified
Las Palmas De Gran Canaria, Spain
Hospital Clinic De Barcelona
Verified
Barcelona, Spain
Hospital General Universitario Gregorio Maranon
Verified
Madrid, Spain

Trial locations

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Investigated drugs

Belantamab mafodotin is a medication used to treat multiple myeloma, a type of blood cancer. It works by targeting a specific protein on cancer cells to help destroy them while limiting damage to healthy cells. VRd is a combination therapy that consists of three medications: - Velcade (bortezomib): A medication that blocks certain proteins to slow or stop cancer cell growth - Revlimid (lenalidomide): A medication that helps strengthen the immune system's ability to fight cancer cells - dexamethasone: A steroid medication that reduces inflammation and suppresses the immune system to help fight cancer These medications are being studied together as a treatment for people who have been newly diagnosed with multiple myeloma and are eligible for transplant.

What is already known about the treatment

Belantamab mafodotin
An innovative antibody-drug conjugate administered through intravenous infusion, specifically developed for treating multiple myeloma. This medication works by targeting B-cell maturation antigen (BCMA) on myeloma cells, delivering a toxic payload that causes cancer cell death. It belongs to the class of targeted immunotherapy drugs and represents a new approach in multiple myeloma treatment, particularly being studied in combination with standard therapies for newly diagnosed patients who are eligible for transplantation.
VRd (Velcade, Revlimid, and dexamethasone)
A combination therapy administered through various routes (subcutaneous injection for Velcade, oral tablets for Revlimid, and oral or intravenous for dexamethasone) that serves as a standard treatment regimen for multiple myeloma. This three-drug combination works through multiple mechanisms, including proteasome inhibition, immunomodulation, and anti-inflammatory effects, making it a powerful treatment option for newly diagnosed multiple myeloma patients. It belongs to the category of combination chemotherapy regimens and has shown significant efficacy in clinical practice.

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, pushing out healthy blood cells and creating abnormal proteins. The disease usually develops gradually and affects multiple bones in the body. As it progresses, it can cause bone pain, weakness, frequent infections, and changes in kidney function. Multiple myeloma typically affects several different parts of the body, particularly where there is active bone marrow.