Prospective Evaluation of the Prognostic Impact of Measurable Residual Disease (MRD) Within a Phase III Study Comparing a Fixed Duration Therapy Versus Continuous Therapy With Daratumumab, Lenalidomide, and Dexamethasone for Relapsed Multiple Myeloma Requiring a First Salvage Treatment.
This research is focused on people with multiple myeloma, a type of blood cancer, who are already part of another large study called CONFIRM. The main goal is to understand what happens when patients who have responded very well to a specific treatment, called Dara-Len-Dex, either stop or continue their medication after two years. Specifically, it's looking at patients who, after two years, have no detectable cancer cells (this is called 'measurable residual disease negativity'). The scientists want to see if stopping the treatment, compared to continuing it, affects how long they remain free of these detectable cancer cells. This could help doctors decide the best treatment length for future patients.
At a glance
What is this study about?
This study is about a type of cancer called Multiple Myeloma, which affects plasma cells in your bone marrow. When this cancer returns and needs treatment again, doctors often use a combination of medicines called Dara-Len-Dex. This particular research is interested in what happens after two years of this treatment.
Imagine you've been on this treatment for two years and tests show that there are no detectable cancer cells left in your body – this is a great result! The big question then is: should you keep taking the medicine, or can you safely stop? This study aims to answer that. It will look closely at patients who already have no detectable cancer cells after two years of Dara-Len-Dex treatment.
By comparing what happens to those who stop treatment versus those who continue, researchers hope to learn whether stopping the medicine after two years makes it more likely for these undetectable cancer cells to return, or if it's safe to stop. The information gathered from this study could help doctors make better decisions about how long patients need to stay on their medication in the future, potentially reducing side effects and improving quality of life for many.
Key takeaways
- This study helps understand the best length of myeloma treatment.
- It focuses on patients who have no detectable cancer cells after two years.
- It compares stopping treatment versus continuing it at the two-year mark.
- No new medications or extra hospital visits are required for this study.
- Results could help doctors worldwide improve future patient care.
Who may be eligible?
To be part of this specific study, you first need to be an adult, aged 18 or over. You must already be taking part in another large study called the CONFIRM Phase III trial.
Additionally, you need to have been on your treatment for about two years within the CONFIRM study. At this two-year mark, your doctors need to have found that your multiple myeloma is in 'complete response,' which means tests show no signs of the cancer. Finally, you'll need to agree to take part by signing a consent form and be part of a social security system or similar.
There are no specific reasons listed that would prevent you from joining this part of the study, as long as you meet all the requirements mentioned above.
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?
- Are you currently in the CONFIRM Phase III trial?
- Have you been on your treatment in CONFIRM for about two years?
- Have your doctors confirmed you are in 'complete response' (no detectable cancer) at the two-year mark?
- Are you part of a social security system or similar?
What does participation involve?
If you are eligible and choose to take part, your participation will mainly involve allowing researchers to look at specific health information and test results you're already providing as part of the main CONFIRM study. This study specifically focuses on whether very small amounts of cancer cells (called measurable residual disease, or MRD) can be found in your body. They will be checking if these cells remain undetectable after two years, especially if you stop or continue your Dara-Len-Dex treatment.
You won't need to take any new medications for this specific study, nor will you have extra appointments or tests beyond what you're already doing for the CONFIRM trial. The researchers will be following your health progress, which means using the information they already collect from your regular check-ups and medical tests over time, to see how your condition changes based on whether you stopped or continued treatment.
Potential risks and benefits
Locations (1)
- Department of Hematology, Hospital Saint AntoineVerified postcodeParis, France· Recruiting
Common questions
What is 'Multiple Myeloma'?
It's a type of cancer that affects plasma cells, a kind of white blood cell found in your bone marrow.
What does 'measurable residual disease (MRD) negativity' mean?
It means advanced tests can't find any remaining cancer cells in your body, even very tiny amounts.
Will I have to take new medicine for this study?
No, this study uses information from the treatment you're already receiving in the main CONFIRM trial.
What is the 'CONFIRM Phase III trial'?
It's a large, ongoing clinical study comparing two different ways of giving treatment (fixed duration vs. continuous) for multiple myeloma.
Will I need extra hospital visits?
No, this study will use information collected during your existing appointments for the CONFIRM trial.
How to find out more
Mohamad MOHTY, PUPH
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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