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

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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 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.

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

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

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

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

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 Study?

  • 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 Study?

  • 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

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
Alexandra Hospital Athens Greece
General University Hospital Of Patras Patras Greece
Tibgydvkjf Crcrqk Hjshtgte Thessaloniki Greece

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

Trial status

Country Status Recruitment Start
Greece Greece
Not recruiting
01.09.2022

Trial locations

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).

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.

Trial ID:
2024-516147-32-00
Protocol code:
EAE127
NCT ID:
NCT05581875
Trial Phase:
Human Pharmacology (Phase I) – Other

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