Phase Ib of Cyclophosphamide, Pomalidomide, Dexamethasone and Daratumumab (CPD-DARA) in patients with relapsed/refractory multiple myeloma. (The CPD-DARA Study).
This study is called The CPD-DARA Study and is testing a new combination of four medicines: Cyclophosphamide, Pomalidomide, Dexamethasone, and Daratumumab. These medicines are being investigated for people in the UK who have multiple myeloma that has either returned after previous treatment (relapsed) or isn't responding to current treatments (refractory). This is an early stage (Phase Ib) trial, meaning researchers are primarily focused on checking the safety of this new combination and understanding how the body reacts to it. It's not yet about proving if it's better than existing treatments, but rather gathering important initial information to see if it's safe enough to study further. Doctors are hoping to find a new way to help patients whose myeloma is difficult to treat.
At a glance
What is this study about?
Imagine your body like a construction site, and multiple myeloma is when some of your bone marrow cells — which are like special builders — start to grow out of control, causing problems. If these cells come back after being treated before, or if they don't respond to the treatments you've already had, it can be really tough. That's why doctors are always looking for new and better ways to help.
This study, called The CPD-DARA Study, is a very early step in testing a new treatment idea. It combines four existing medicines: Cyclophosphamide, Pomalidomide, Dexamethasone, and Daratumumab. Think of it like trying out a new team of specialists – each medicine works in a slightly different way to fight the myeloma cells. Researchers want to see if putting them together is safe and if the body handles this combination well.
Because this is an early stage trial (Phase Ib), the main goal isn't yet to prove that this new combination works better than other treatments. Instead, it's about making sure it's safe for people to take and finding the right amount of each medicine to use. This information is crucial for deciding if this treatment should move forward to larger studies, which would then measure how effective it is. It's an important step in developing potential new options for people living with multiple myeloma.
Key takeaways
- This study is for adults with multiple myeloma that has returned or isn't responding to treatment.
- It tests a new combination of four existing medicines.
- The main goal is to check the safety of this new combination.
- It's an early-stage study (Phase Ib).
- You would be closely monitored if you take part.
- You can stop participating at any time.
Who may be eligible?
To be considered for this study, you would need to be an adult, 18 years old or older. There is no upper age limit, meaning people of all adult ages could potentially join.
Both men and women are welcome to participate in this research. The study is specifically for individuals who have been diagnosed with multiple myeloma that has either come back after previous treatment, or is not responding well to the treatments they are currently receiving.
It's important to understand that there will be other specific health requirements and tests you need to meet to make sure the study is safe for you. Your doctor will carefully review all your medical information to see if this particular study is a good fit for your individual situation.
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 been diagnosed with multiple myeloma?
- Has your multiple myeloma come back after treatment or isn't responding to current treatment?
- Are you able to travel to study visits as required?
What does participation involve?
If you decide to take part in this study, you would receive the new combination of medicines (Cyclophosphamide, Pomalidomide, Dexamethasone, and Daratumumab) as part of a structured treatment plan. Your participation would involve regular visits to the hospital or clinic. During these visits, doctors and nurses would carefully monitor your health, take blood and urine samples, and perform physical examinations to check how you are responding to the treatment and to look for any side effects.
The specific number of visits, tests, and the total length of time you'd be involved might vary, and your study team will explain this in detail. There will also be a follow-up period after your main treatment to continue monitoring your health and any long-term effects. You would receive all the study medications as part of your participation.
Potential risks and benefits
Locations (1)
- —UnverifiedIreland
Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that affects the plasma cells in your bone marrow, which are important parts of your immune system.
What does 'relapsed/refractory' mean?
It means your multiple myeloma has either returned after getting better with previous treatment, or it's not responding to the treatments you're currently receiving.
What is a Phase Ib study?
This is an early stage study to primarily check the safety of a new treatment and how well the body can handle it, rather than proving how effective it is yet.
Will I get a placebo (dummy treatment)?
No, this study is not designed to use a placebo. All participants will receive the active study medications in the new combination.
Who is funding this study?
The information provided does not specify the funding source. This is a question you should ask the study team.
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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