A phase I/II, single arm, open label study of dasatinib as toxicity prophylaxis in the context of therapy with idecabtagene vicleucel in relapsed/refractory multiple myeloma
This study is testing a medication called dasatinib (known as Sprycel) in people with multiple myeloma, a type of blood cancer. They are trying to find out if dasatinib can help prevent or lessen severe side effects like cytokine release syndrome (CRS) when patients receive another advanced treatment called ide-cel (known as Abecma). Ide-cel is a unique cell therapy that uses a patient's own modified immune cells to fight cancer. The study will carefully monitor patients for any side effects from the treatments and track how well the cancer responds. It's an important step in making these powerful new therapies safer and more effective for patients.
At a glance
What is this study about?
This research study is looking at a new way to make groundbreaking cancer treatments safer. It focuses on people in the UK who have multiple myeloma, a blood cancer that has come back or hasn't responded to previous treatments. These patients are receiving a cutting-edge therapy called ide-cel, also known as Abecma. Ide-cel works by taking a patient's own immune cells, known as T-cells, strengthening them in a lab, and then putting them back into the body to find and kill cancer cells. While very effective, this treatment can sometimes cause serious side effects, such as cytokine release syndrome (CRS), which is like a strong flu-like reaction.
The main goal of this study is to see if another drug, dasatinib (known as Sprycel), can help prevent or reduce the severity of these side effects, especially CRS. Researchers will give patients dasatinib alongside their ide-cel treatment and closely watch for any side effects that occur. They will also track how well patients feel and how their cancer responds to the treatment. By doing this, they hope to find better ways to manage the powerful effects of cell therapies, making them more tolerable for patients.
This is an early-stage study, combining what's called 'Phase I' and 'Phase II'. Phase I studies usually involve a small number of people and focus on finding a safe dose and understanding potential side effects. Phase II studies then look at whether the treatment works and continue to monitor for side effects in a larger group. The findings from this study will be crucial in improving cell therapies for multiple myeloma patients in the future.
Key takeaways
- This study explores a new way to reduce harsh side effects from a powerful cancer therapy.
- It combines two treatments: ide-cel (a cell therapy) and dasatinib (a tablet medication).
- The main focus is on preventing or lessening a side effect called cytokine release syndrome (CRS).
- You'll be closely watched for at least a year to check for side effects and how your cancer responds.
- This research hopes to make advanced treatments for multiple myeloma safer for patients.
Who may be eligible?
To be part of this study, you must be 18 years old or older. Both men and women are welcome to take part.
More detailed specific reasons for joining or not joining the study will be discussed with your doctor. These often include things like your overall health, other medical conditions you might have, and previous treatments you've received. It's really important that you talk through all these details with your specialist cancer doctor to find out if this study is right for you.
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?
- Do you have multiple myeloma that has come back or is not responding to current treatments?
- Are you able to take a cell therapy called ide-cel (Abecma)?
- Are you able to take the tablet medication dasatinib (Sprycel)?
What does participation involve?
If you decide to join this study, you will receive two main treatments. First, you'll get ide-cel (Abecma) as a liquid infusion, which is given into your vein. The amount you receive will be carefully chosen by the study doctors. In addition, you will take dasatinib (Sprycel) as daily tablets.
The study team will closely monitor you. Before your treatment, you'll have appointments to check your health. After receiving the treatments, you'll have regular checks and assessments for at least a year (360 days) to see how you're responding and to track any side effects. This includes monitoring for side effects like cytokine release syndrome (CRS) and other immune-related problems, as well as checking your blood counts and how long you might need to stay in hospital or intensive care, if necessary. You'll also have checks to see how well your cancer is responding to the treatment.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that affects plasma cells, a kind of white blood cell found in the bone marrow. These cells are part of your immune system.
What is ide-cel (Abecma)?
Ide-cel is a cell therapy where your own immune cells are specially trained in a lab to find and destroy cancer cells, then put back into your body.
What is dasatinib (Sprycel)?
Dasatinib is a tablet medicine that can block certain signals in cancer cells and may also help reduce unwanted immune reactions in the body.
What is cytokine release syndrome (CRS)?
CRS is an immune reaction that can happen with cell therapies, causing flu-like symptoms, fever, and sometimes more serious problems. The study hopes to reduce this.
How long will I be in the study?
You will be closely monitored for at least a year (360 days) after your treatment to track your progress and any effects.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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