Study of Belantamab Mafodotin Alone and with Drug Combination for Patients with Relapsed/Refractory Multiple Myeloma

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What is this study about?

This clinical trial is focused on studying a disease called Multiple Myeloma, which is a type of cancer that affects plasma cells in the bone marrow. The study is exploring the use of a treatment called Belantamab Mafodotin, both on its own and in combination with other anti-cancer treatments. The purpose of the study is to determine the safety and tolerability of these treatments and to find the best dose to use in future studies.

Participants in the study will receive Belantamab Mafodotin and may also receive other medications such as Dexamethasone, Lenalidomide, Pomalidomide, Nirogacestat, Isatuximab, and Feladilimab. Some participants may receive a placebo. The study will involve regular check-ups and monitoring to assess how the treatments are working and to identify any side effects.

The study is designed to help researchers understand how effective Belantamab Mafodotin is when used alone or with other treatments in people with relapsed or refractory Multiple Myeloma. This information will be used to improve treatment options for patients with this condition in the future.

1 joining the study

Upon joining the study, the participant will be informed about the trial’s objectives and procedures. The participant will sign a consent form to confirm understanding and agreement to participate.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes a review of medical history, a physical examination, and laboratory tests to ensure the participant meets the study criteria.

3 treatment phase

The participant will receive belantamab mafodotin as a monotherapy or in combination with other treatments. The specific combination and dosage will depend on the sub-study the participant is enrolled in.

Medications may include dexamethasone, pomalidomide, lenalidomide, isatuximab, and nirogacestat. These are administered either orally or intravenously, depending on the specific drug and protocol.

4 monitoring and follow-up

Regular monitoring will occur throughout the treatment phase. This includes clinical assessments, laboratory tests, and imaging studies to evaluate the participant’s response to treatment and monitor for any side effects.

The frequency of these assessments will be determined by the study protocol and may vary depending on the treatment regimen.

5 end of treatment

Upon completion of the treatment phase, a final assessment will be conducted. This includes a comprehensive evaluation of the participant’s health status and response to the treatment.

The participant will be informed about the next steps, which may include additional follow-up visits or transitioning to standard care.

Who Can Join the Study?

Must be 18 years or older at the time of signing the consent form.
Can take small doses of oral steroids (less than 10 mg per day), inhaled steroids, or eye-related steroids during the study.
Can be male or female. Must follow local rules for using birth control methods.
Must sign a written consent form, agreeing to follow the study’s rules and requirements.
Must have a confirmed diagnosis of Multiple Myeloma (MM), a type of blood cancer, as defined by experts.
Must have been treated with at least three different types of anti-myeloma treatments, including an immunomodulating agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
If you have had a stem cell transplant, you can join if it was more than 100 days ago and you have no active infections.
Must have an ECOG performance status of 0-1, which means you are fully active or have some symptoms but can still do light work. If your status is 2, it should only be due to bone issues or pain from MM.
Must have a measurable disease, meaning the disease can be measured or tracked by doctors.
Must have organ functions that meet specific laboratory test requirements.
If positive for HBcAb, a marker related to hepatitis B, you can join if certain conditions are met.
Any side effects from previous treatments must be mild (Grade 1 or less) at the time of screening, except for hair loss, mild nerve issues, or hormone problems managed with treatment.

Who Cannot Join the Study?

Patients who have a different type of cancer other than Multiple Myeloma cannot participate. Multiple Myeloma is a type of cancer that affects certain cells in the bone marrow.
Patients who are not within the specified age range for the study cannot participate. The study is open to adults.
Patients who are part of a vulnerable population, such as those who cannot give consent or are unable to understand the study, cannot participate.
Patients who have not been diagnosed with Relapsed or Refractory Multiple Myeloma (RRMM) cannot participate. Relapsed means the cancer has returned after treatment, and Refractory means the cancer does not respond to treatment.
Patients who are not able to follow the study procedures or take the study medication as required cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oslo Universitetssykehus HF	Oslo	Norway
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Region Dalarna	Falun	Sweden
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie	Lublin	Poland
Cosnwi Lrgw Birqbe	Lyon	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	14.11.2019
Norway	Not recruiting	14.11.2019
Poland	Not recruiting	14.11.2019
Sweden	Not recruiting	14.11.2019

Trial locations

Investigated drugs:

Belantamab Mafodotin is a medication being studied for its effects on multiple myeloma, a type of blood cancer. It is used alone or in combination with other cancer treatments to see how well it works in patients whose cancer has returned or is not responding to other treatments. The study aims to find the best dose that is both safe and effective for patients.

Multiple Myeloma – Multiple Myeloma is a type of blood cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In this disease, cancerous plasma cells multiply rapidly, leading to an overproduction of abnormal proteins that can cause damage to bones, kidneys, and the immune system. As the disease progresses, it can lead to bone pain, fractures, anemia, and increased susceptibility to infections. The accumulation of these abnormal cells can also result in high levels of calcium in the blood, which can cause further complications. Over time, the disease can lead to significant organ damage and affect the body’s ability to produce healthy blood cells.

Trial ID:

2023-509550-55-00

Protocol code:

208887

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study of Belantamab Mafodotin Alone and with Drug Combination for Patients with Relapsed/Refractory Multiple Myeloma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?