Not recruitingRare disease

Study on Belantamab Mafodotin with Daratumumab, Lenalidomide, and Dexamethasone for Patients with Newly Diagnosed Multiple Myeloma Not 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 clinical trial is focused on studying a blood cancer called Multiple Myeloma, which affects certain cells in the bone marrow. The study is specifically for patients who have been newly diagnosed with this condition and are not eligible for a stem cell transplant. The trial will explore the safety and effects of a combination of medications, including Belantamab Mafodotin (also known by the code name GSK2857916), Daratumumab, Lenalidomide, and Dexamethasone. These medications are used to target and treat the cancer cells in different ways.

The purpose of the study is to find a safe and effective dose of Belantamab Mafodotin when used with the other medications. The study will be conducted in two parts. The first part will focus on determining the best dose of Belantamab Mafodotin, while the second part will further evaluate its safety and initial effectiveness. Participants will receive these medications in different forms, such as oral solutions, capsules, or injections, depending on the specific drug. The study will monitor how patients respond to the treatment and any side effects they may experience.

Throughout the study, participants will be closely observed to ensure their safety and to gather information on how well the treatment works. The trial aims to provide valuable insights into the potential benefits of this combination therapy for patients with Multiple Myeloma who cannot undergo a transplant. The study is expected to continue until 2027, allowing researchers to collect comprehensive data on the treatment's impact over time.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant will be informed about the trial's objectives and procedures. The participant will provide informed consent to participate in the study.
Step 2
Initial assessment
An initial assessment will be conducted to confirm eligibility. This includes evaluating the participant's health status and ensuring they meet the criteria for the study.
Step 3
Treatment phase 1: dose finding
The participant will receive a combination of medications to determine the safe and effective dose. The medications include belantamab mafodotin (administered intravenously), daratumumab (administered subcutaneously), lenalidomide (administered orally), and dexamethasone (administered orally).
The frequency and dosage will be adjusted based on the participant's response and tolerance.
Step 4
Treatment phase 2: dose expansion
In this phase, the participant will continue to receive the established dose of the medication combination. The focus will be on further evaluating the safety and effectiveness of the treatment.
The participant's health and response to the treatment will be closely monitored.
Step 5
Monitoring and follow-up
Throughout the trial, regular monitoring will be conducted to assess the participant's health and any side effects. This includes routine check-ups and laboratory tests.
The participant will be required to attend scheduled visits for ongoing evaluation.
Step 6
End of trial
Upon completion of the trial, a final assessment will be conducted to evaluate the overall health and treatment outcomes for the participant.
The participant will receive information about the results and any necessary follow-up care.

Who can join the trial?

14 criteria

Must be at least 18 years old.
Have a certain type of abnormal cells in the bone marrow or a specific tumor, and meet at least one of the following conditions:
- High calcium levels in the blood.
- Kidney problems with low filtration rate or high creatinine levels.
- Anemia, which means low red blood cell count.
- Bone damage seen on scans.
- Other specific markers of cancer activity.
- Have at least one measurable sign of the disease, such as:
  - High levels of a specific protein in urine or blood.
  - Abnormal levels of certain light chains in the blood.
  - Not suitable for high-dose chemotherapy with stem cell transplant due to other health issues. This will be assessed using a specific frailty index.
  - Have an ECOG performance status of 0 to 2, which measures daily living abilities.
  - Have adequate function of major organs, as shown by specific blood and urine tests.
  - Female participants must not be pregnant or breastfeeding and must meet certain conditions regarding menopause or use reliable birth control methods.
  - Male participants must agree to not donate sperm and use contraception during the study and for a period after the study ends.
  - Must be able to understand the study procedures and agree to participate by signing a consent form.

Who cannot join the trial?

4 criteria

Patients who have not been newly diagnosed with 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 cannot participate. The age range includes adults and older adults.
Patients who are not able to safely take the combination of medications being tested cannot participate. These medications include belantamab mafodotin, daratumumab, lenalidomide, and dexamethasone.
Patients who are part of a vulnerable population, meaning they might have additional health or social challenges, cannot participate.

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Verified sites

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Verified
Alexandra Hospital
Athens, Greece

Trial locations

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Investigated drugs

Belantamab Mafodotin
is a medication being studied for its safety and effectiveness in treating patients with newly diagnosed multiple myeloma who are not eligible for a transplant. It is used in combination with other medications to help control the disease.
Daratumumab
is a medication that helps the immune system to find and destroy cancer cells. It is used in this study to see how well it works with other treatments for multiple myeloma.
Lenalidomide
is a medication that affects the immune system and helps slow the growth of cancer cells. It is being tested in combination with other drugs to treat multiple myeloma.
Dexamethasone
is a type of steroid that helps reduce inflammation and can also help kill cancer cells. It is used in this study to see how it works with other medications in treating multiple myeloma.

What is already known about the treatment

Belantamab Mafodotin – This medication is administered intravenously and is currently being studied in clinical trials for its safety and effectiveness in treating newly diagnosed multiple myeloma, particularly in patients who are not eligible for transplant. It is used in combination with other medications like daratumumab, lenalidomide, and dexamethasone. Belantamab mafodotin works by targeting and binding to a specific protein on the surface of cancer cells, delivering a toxic agent that helps to kill these cells. It is classified as an antibody-drug conjugate, which combines the targeting ability of an antibody with the cancer-killing power of a drug.

Investigated diseases

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 and crowd out healthy blood cells, leading to symptoms such as bone pain, fatigue, and frequent infections. As the disease progresses, it can cause damage to bones, kidneys, and the immune system. The abnormal plasma cells produce a protein that can lead to kidney problems and other complications. Over time, the disease can result in anemia, increased risk of fractures, and other health issues. It is considered a chronic condition that requires ongoing management.