A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis
This research study is for people who have recently been diagnosed with AL amyloidosis. This is a rare condition where abnormal proteins collect in organs, which can stop them from working properly. The study wants to find out if adding a newer medicine, daratumumab, to a standard treatment called CyBorD (which includes cyclophosphamide, bortezomib, and dexamethasone) is more effective and safe. They will compare patients who get the new combination with those who only receive the standard CyBorD treatment. The main goal is to see if more people have a complete stop in the production of the unhealthy protein with the new combination. This is a Phase 3 study, meaning it's a large trial to confirm if the new treatment is better than what's currently available.
At a glance
What is this study about?
This study explores a new treatment approach for AL amyloidosis, a serious condition where your body produces unusual proteins that can gather in various organs, like your heart, kidneys, or liver. When these proteins build up, they can stop these organs from working correctly. This particular study is for people who have just been diagnosed with this type of amyloidosis.
Currently, a common treatment for AL amyloidosis is a combination of medicines called CyBorD. This includes drugs like cyclophosphamide, bortezomib (which you might know as VELCADE), and dexamethasone. Researchers are now investigating whether adding another drug, called daratumumab, to this standard CyBorD treatment can make it even more effective.
The main aim of this study is to see if the new combination treatment (daratumumab plus CyBorD) is better at stopping the production of the unhealthy proteins compared to just having the CyBorD treatment alone. They are particularly interested in whether more people achieve a 'complete hematologic response' – which basically means the tests for the unhealthy protein return to normal. Finding better treatments is really important for people living with AL amyloidosis, as it could improve their health and quality of life.
Key takeaways
- This study is for newly diagnosed AL amyloidosis.
- It tests adding daratumumab to a common treatment (CyBorD).
- The main goal is to see if more people stop producing unhealthy proteins.
- It's a Phase 3 study, meaning it's a large-scale comparison.
- Participation involves regular visits and careful monitoring.
- You can stop participating at any time.
Who may be eligible?
To join this study, you must be an adult aged 18 or older. The study is looking for both men and women.
The most important requirement is that you have been newly diagnosed with systemic AL amyloidosis. 'Systemic' means the condition affects more than one part of your body. The doctors in the study will confirm your diagnosis using specific tests.
There will be other detailed health checks to make sure your overall health is suitable for the study and that the treatments would be safe for you. This helps protect your well-being.
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?
- Have you recently been diagnosed with AL amyloidosis?
- Does your diagnosis affect more than one part of your body (systemic)?
- Are you otherwise in good enough health to potentially receive study treatments?
What does participation involve?
If you decide to take part, you'll be randomly assigned to one of two groups: one group will receive daratumumab along with the standard CyBorD treatment, and the other group will receive CyBorD alone. You won't get to choose which group you are in, and neither will your doctor. Both treatments involve injections and tablets.
You'll have regular hospital visits for check-ups, blood tests, and to receive your medication. These visits will help the doctors monitor your health, how you're responding to the treatment, and any effects you might feel. The total length of your participation, including follow-up, will be determined by the study design, but generally, these types of studies involve treatment cycles followed by a period where doctors continue to monitor your health.
Potential risks and benefits
Locations (11)
- —UnverifiedDenmark
- —UnverifiedItaly
- —UnverifiedNetherlands
- —UnverifiedBelgium
- —UnverifiedHungary
- —UnverifiedGermany
- —UnverifiedGreece
- —UnverifiedSweden
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedPoland
Common questions
What is AL amyloidosis?
It's a rare and serious condition where abnormal proteins build up in your body's organs, stopping them from working properly.
What is the new drug being tested?
The new drug is called daratumumab. It's being added to a standard treatment to see if it helps more.
What does 'Phase 3 study' mean?
It means this is a large study comparing the new treatment to the current best treatment to see if it's better and safe.
Will I know which treatment I'm getting?
You will be randomly assigned to one of two groups, and initially, neither you nor your doctor will get to choose which treatment you receive.
Can I leave the study if I change my mind?
Yes, you can withdraw from the study at any time, for any reason, without affecting your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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