Not recruiting

Study of belantamab mafodotin combined with pomalidomide, dexamethasone, and daratumumab in patients with relapsed/refractory multiple myeloma who previously had 1-3 treatments and are lenalidomide resistant

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 relapsed/refractory multiple myeloma, a type of blood cancer that returns after previous treatment. The study evaluates a combination of several medications: belantamab mafodotin, pomalidomide, dexamethasone, and in some cases daratumumab. These medications work together to target and fight cancer cells in different ways.

The main purpose of this research is to determine if this combination of medications is safe and effective for patients whose disease has returned after receiving one to three previous treatments, particularly in cases where a medication called lenalidomide is no longer working. The study is divided into two parts, with the first part focusing on finding the right dose and checking safety, while the second part looks at how well the treatment works.

During the study, participants will receive the medications through different methods - some are given as capsules by mouth, while others are administered through injections into the veins or under the skin. The doctors will monitor patients' responses to the treatment and check for any side effects, with particular attention to effects on vision. The study will continue to follow patients to measure how long the treatment remains effective and how it affects survival.

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 evaluation
The study is for patients with multiple myeloma who have received 1-3 previous treatments
A medical assessment will confirm eligibility, including blood tests, kidney and liver function tests
An eye examination will be performed before starting treatment
Step 2
Treatment combination
You will receive a combination of medications:
Belantamab mafodotin - given through an intravenous (IV) line
Pomalidomide - taken by mouth
Dexamethasone - taken by mouth
Some patients may also receive Daratumumab - given as an injection under the skin
Step 3
Regular monitoring
Regular blood tests to monitor your health
Eye examinations to check for any vision-related changes
Assessment of your response to treatment
Bone marrow tests may be performed if your response is very good
Step 4
Safety measures
Female patients must use two reliable birth control methods during treatment and for 4 weeks after stopping pomalidomide
Male patients must use specific contraception methods during treatment and for up to 6 months after the last dose
Regular pregnancy tests will be performed for women who can become pregnant
Step 5
Follow-up period
Your health will be monitored throughout the study until 2028
The medical team will track how long the treatment works
Long-term survival information will be collected

Who can join the trial?

17 criteria

Must be at least 18 years old
Must have a confirmed diagnosis of Multiple Myeloma according to established medical criteria
Must have at least one measurable disease indicator, such as:
- Specific protein levels in urine (at least 200 mg/24 hours)
- Specific protein levels in blood (at least 0.5 g/dL)
- Abnormal light chain protein levels in blood
- Must have a performance status of 0-2 (meaning able to perform most daily activities)
- Must have adequate organ function, including:
  - Acceptable blood cell counts
  - Normal liver function
  - Adequate kidney function
  - Must have received 1 to 3 previous treatments for Multiple Myeloma
  - Must be resistant to previous treatment with lenalidomide (a cancer medication)
  - For women who can become pregnant:
    
    Must not be pregnant or breastfeeding
    Must use two reliable birth control methods
    Must have negative pregnancy tests before starting treatment
    For men:
    
    Must use appropriate contraception methods
    Must agree not to donate sperm during treatment and for several months after
    Must be able to understand and sign an informed consent form

Who cannot join the trial?

15 criteria

Prior treatment with belantamab mafodotin (an antibody-drug used to treat multiple myeloma)
Active plasma cell leukemia (an aggressive type of blood cancer)
Known active central nervous system myeloma (cancer spread to brain or spinal cord)
Previous or concurrent malignancy (other types of cancer)
Major surgery within 4 weeks before starting the study
Active or uncontrolled infections
Current corneal epithelial disease (problems with the surface of the eye), unless successfully treated
History of Stevens Johnson syndrome (severe skin reaction)
Active hepatitis B or C infection (liver infections)
Known HIV infection
Pregnant or breastfeeding women
Unwillingness to use effective contraception during the study
Serious heart conditions or uncontrolled high blood pressure
Severe kidney or liver problems
History of severe allergic reactions to study medications

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Verified sites

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

Alexandra Hospital
Verified
Athens, Greece
Theageneio Cancer Hospital
Verified
Thessaloniki, Greece

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 specific proteins on cancer cells to help destroy them.
Pomalidomide
is an oral medication that helps strengthen the immune system's ability to fight cancer cells. It belongs to a class of drugs called immunomodulators and is used in treating multiple myeloma.
Dexamethasone
is a corticosteroid medication that helps reduce inflammation and suppress the immune system. In multiple myeloma treatment, it is often used in combination with other medications to enhance their effectiveness.
Daratumumab
is an antibody therapy that targets a specific protein found on myeloma cells. It works by helping the immune system identify and destroy cancer cells. This medication is given through an intravenous infusion.
Lenalidomide
is mentioned in the trial as a reference point for patient eligibility, as the study focuses on patients whose disease no longer responds to this medication (lenalidomide refractory).

What is already known about the treatment

Belantamab mafodotin
An antibody-drug conjugate administered intravenously for the treatment of relapsed/refractory multiple myeloma. This medication targets B-cell maturation antigen (BCMA) on myeloma cells and delivers a potent anti-cancer compound, leading to cancer cell death. Currently being studied in clinical trials in combination with pomalidomide and dexamethasone, with or without daratumumab, for patients who have received one to three prior therapies and are lenalidomide-refractory.
Pomalidomide
An oral immunomodulatory drug used in treating multiple myeloma. It works by enhancing the immune system's ability to destroy cancer cells while also preventing the growth of new blood vessels that feed tumors. This medication belongs to a class of drugs known as immunomodulators and is typically used in combination with other anti-myeloma treatments.
Dexamethasone
An oral or injectable corticosteroid medication that helps reduce inflammation and suppress immune system activity in multiple myeloma treatment. It works by decreasing the body's immune response and reducing inflammation, while also having direct anti-myeloma effects. This medication is commonly used in combination with other cancer treatments to enhance their effectiveness.
Daratumumab
A monoclonal antibody administered intravenously for treating multiple myeloma. It works by targeting the CD38 protein found on myeloma cells, helping the immune system identify and destroy these cancer cells. This targeted therapy is often used in combination with other medications and has shown significant effectiveness in treating relapsed or refractory multiple myeloma.

Investigated diseases

Multiple Myeloma - A type of blood cancer that develops in plasma cells, which are white blood cells that normally produce antibodies to help fight infections. In this disease, abnormal plasma cells multiply uncontrollably in the bone marrow, forming tumors in multiple bones throughout the body. These cancerous cells produce large amounts of abnormal proteins while crowding out healthy blood cells. The condition often affects multiple bones simultaneously, which can lead to bone pain, weakness, and easy fractures. Over time, the disease can cause anemia, frequent infections, and kidney problems due to the buildup of abnormal proteins.