Study on the Safety and Effects of Belantamab Mafodotin with Lenalidomide and Dexamethasone for Patients with Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

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What is this study about?

This clinical trial is focused on studying a condition called multiple myeloma, which is a type of cancer that affects the blood. The study is specifically for patients who have been newly diagnosed with multiple myeloma and are not eligible for a transplant. The trial will test the safety and effectiveness of a combination of three treatments: Belantamab Mafodotin, Lenalidomide, and Dexamethasone. Belantamab Mafodotin is a medication that targets cancer cells, Lenalidomide is a drug that helps the immune system fight cancer, and Dexamethasone is a steroid that reduces inflammation and helps with cancer treatment.

The purpose of the study is to find the best dose and schedule for these medications when used together. Participants will receive these treatments over a period of time, and researchers will monitor their health to see how well the treatment works and to check for any side effects. The study will be conducted in two parts: the first part will focus on finding the right dose, and the second part will further evaluate the treatment’s safety and effectiveness.

Throughout the study, participants will be closely observed by healthcare professionals. They will receive the medications either by mouth or through an injection into a vein, depending on the specific drug. The trial aims to provide valuable information that could lead to better treatment options for people with multiple myeloma in the future.

1 initial assessment

Upon joining the clinical trial, an initial assessment is conducted to confirm eligibility. This involves reviewing medical history and conducting necessary tests to ensure the patient meets the criteria for participation.

2 treatment phase 1

The first phase of treatment involves determining the appropriate dose of belantamab mafodotin in combination with lenalidomide and dexamethasone. This phase focuses on evaluating the safety and tolerability of the medication combination.

During this phase, lenalidomide is administered orally, while belantamab mafodotin and dexamethasone are given intravenously. The specific dosage and frequency are adjusted based on individual response and tolerance.

3 treatment phase 2

In the second phase, the focus shifts to further evaluating the safety and preliminary effectiveness of the established dose of belantamab mafodotin in combination with lenalidomide and dexamethasone.

The medications continue to be administered in the same manner as in phase 1, with adjustments made as necessary based on ongoing assessments.

4 regular monitoring

Throughout the trial, regular monitoring is conducted to assess the patient’s response to treatment and to identify any side effects. This includes routine blood tests, imaging studies, and other necessary evaluations.

Patients are required to attend scheduled appointments for these assessments, which are crucial for ensuring safety and effectiveness of the treatment.

5 completion and follow-up

Upon completion of the treatment phases, a final assessment is conducted to evaluate the overall response to the treatment.

Follow-up appointments may be scheduled to monitor long-term effects and to gather additional data on the treatment’s impact.

Who Can Join the Study?

Participant must be 18 years or older.
Must have newly diagnosed multiple myeloma, which is a type of blood cancer.
Must have monoclonal plasma cells in the bone marrow that are 10% or more, or have a biopsy-proven plasmacytoma. Must also meet at least one of the following criteria:
- Hypercalcemia: High levels of calcium in the blood.
- Renal insufficiency: Poor kidney function.
- Anemia: Low levels of red blood cells.
- Bone lesions: Damage to the bones seen on imaging tests.
Must have at least one measurable sign of the disease, such as:
- High levels of a protein called M-protein in urine or blood.
- Abnormal levels of free light chains in the blood.
Not suitable for high-dose chemotherapy with a stem cell transplant due to other health conditions affecting major organs like the heart or lungs.
Must have an ECOG status of 0-2, which means the participant is fully active or has some symptoms but is still able to care for themselves.
Must have adequate function of major organs, as shown by specific blood and urine tests.
Female participants must not be pregnant or breastfeeding and must use effective birth control methods if they are of childbearing potential.
Male participants must agree to use contraception and not donate sperm during the study and for a period after the study ends.
Must be able to understand the study procedures and agree to participate by providing written consent.

Who Cannot Join the Study?

Patients who have not been newly diagnosed with multiple myeloma cannot participate. Multiple myeloma is a type of cancer that affects plasma cells in the bone marrow.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not able to safely take the study medications, which include Belantamab mafodotin, lenalidomide, and dexamethasone, cannot participate. These are medications used to treat multiple myeloma.
Patients who are part of a vulnerable population, which may include those who cannot give informed consent, cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Alexandra Hospital	Athens	Greece

Trial status

Country	Status	Recruitment Start
Greece	Not recruiting	02.02.2021

Trial locations

Investigated drugs:

Belantamab Mafodotin is a type of medication used in this clinical trial to treat multiple myeloma, a kind of blood cancer. It works by targeting and attaching to specific cancer cells, helping to destroy them. This medication is being tested to see how safe it is and how well it works when used with other treatments.

Lenalidomide is another medication used in this trial. It helps the immune system fight cancer by affecting the way the immune cells work. It can also stop cancer cells from growing and spreading. This medication is often used to treat multiple myeloma and is being combined with other treatments in this study to see if it improves patient outcomes.

Dexamethasone is a steroid medication included in the trial. It helps reduce inflammation and can also help kill cancer cells. In this study, it is used alongside other medications to see if it can enhance their effectiveness in treating multiple myeloma.

Investigated diseases:

Plasma cell myeloma

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. The disease begins when abnormal plasma cells multiply uncontrollably, leading to the production of a large amount of abnormal proteins. As the disease progresses, it can cause damage to bones, kidneys, and the immune system. Patients may experience symptoms such as bone pain, fatigue, and frequent infections. Over time, the accumulation of abnormal cells can lead to anemia and other blood-related issues. The progression of multiple myeloma can vary, with periods of stability and periods of active disease.

Trial ID:

2024-515988-55-00

Protocol code:

EAE-2020/MM0107

NCT ID:

NCT05280275

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effects of Belantamab Mafodotin with Lenalidomide and Dexamethasone for Patients with Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?