Phase 1/2 trial evaluating isatuximab in combination with pegenzileukin in relapsed or refractory multiple myeloma (RRMM) previously exposed to anti-CD38 and anti-BCMA
This study is exploring a new treatment combination for a type of blood cancer called multiple myeloma, specifically for patients whose cancer has returned or hasn't responded to previous treatments. Researchers are looking at two medicines: isatuximab and pegenzileukin. If you’ve already been treated with similar drugs (anti-CD38 and anti-BCMA), this study might be relevant. The first part of the study is about finding the right, safest dose of these medicines when they are given together. The second part will then check how many patients respond to this new combination. This means they will look to see if the cancer shrinks or stops growing. The ultimate goal is to find better ways to treat this serious illness.
At a glance
What is this study about?
This research study is focused on a type of blood cancer called multiple myeloma. If you have multiple myeloma that has come back after treatment, or if your current treatments are no longer working, this study might be looking into options for you. The study is particularly for patients who have already received specific kinds of treatments in the past, known as anti-CD38 and anti-BCMA therapies.
The main goal of this study is to test a new combination of two drugs, isatuximab and pegenzileukin. Researchers want to understand if these drugs work better when given together than when given separately or when other treatments have stopped working. They will carefully check for several things: first, what is the best and safest amount (or 'dose') of these drugs to give? Second, once they find that dose, how many people see their cancer respond to this new combination? This could mean the cancer shrinks, stops growing, or even disappears.
This study is divided into two main parts. In the first part, a small group of patients will help doctors figure out the safest dose of the new drug combination. They will carefully monitor how people react to different amounts of the medicines. Once the best dose is found, the second part of the study will involve more people. This larger group will help researchers see how many people respond to the treatment and how long those responses last. They'll also be looking at how the treatment affects your daily life and overall well-being, using questionnaires to understand your quality of life.
Key takeaways
- New combination treatment for multiple myeloma.
- For patients whose cancer has returned or didn't respond to previous treatments.
- Includes two drugs, isatuximab and pegenzileukin.
- Aims to find the safest dose and how well the treatment works.
- Also studies how the treatment affects your quality of life.
- Participation is voluntary and closely monitored.
Who may be eligible?
To be considered for this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
Critically, your multiple myeloma must either have returned after previous treatments, or it must not be responding to the treatments you're currently receiving. You also need to have tried specific types of previous treatments, called anti-CD38 and anti-BCMA therapies.
There will be other detailed health checks to make sure this study is safe and appropriate for you. Your doctor will be able to discuss these with you and see if you meet all the necessary requirements.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Has your multiple myeloma come back or stopped responding to treatment?
- Have you previously received anti-CD38 and anti-BCMA treatments?
- Are you able to attend regular hospital appointments for check-ups and treatment?
What does participation involve?
If you join this study, you will receive the experimental treatment combination of isatuximab and pegenzileukin. The study is split into two phases. In the first phase, different doses of the new drugs will be tested to find the safest and most effective amount. If you are in this phase, your doctors will closely monitor your response and any side effects.
In the second phase, once the best dose is found, you will receive that specific dose. Throughout the study, you'll have regular hospital visits for blood tests, scans, and other medical check-ups to track your progress and assess the treatment's effects. You will also be asked to fill out questionnaires about how you are feeling and how the treatment affects your daily life. The total time you would be in the study will depend on your individual response to the treatment, and how long the researchers need to follow your progress.
Potential risks and benefits
Locations (6)
- —UnverifiedGreece
- —UnverifiedGermany
- —UnverifiedItaly
- —UnverifiedFrance
- —UnverifiedPortugal
- —UnverifiedNorway
Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that affects plasma cells, which are a kind of white blood cell found in your bone marrow.
What does 'relapsed or refractory' mean?
'Relapsed' means your cancer has come back after treatment, and 'refractory' means your cancer hasn't responded to treatment or has stopped responding.
What are pegenzileukin and isatuximab?
These are investigational drugs being tested in this study. They work in different ways to help fight the cancer.
Will I know if I'm getting the active treatment?
This study does not involve a placebo; all participants will receive the experimental drug combination.
Why is 'quality of life' being measured?
Researchers want to understand not only if the treatment works, but also how it affects your daily life and overall well-being.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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