A Phase III Open-label, Randomised, Multicentre Study Comparing AZD0120, a Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA and CD19, versus Standard Regimens in Participants with Relapsed Refractory Multiple Myeloma (DURGA-4)
This research study, called DURGA-4, is looking into a new treatment for a type of blood cancer called multiple myeloma. This is for people whose myeloma has returned after treatment or isn't responding to their current medicines. The new treatment, AZD0120, is a special type of cell therapy that uses your own immune cells to fight the cancer. We want to see how well AZD0120 works compared to routine treatments already available. Researchers will check if AZD0120 can slow down the cancer's growth or make it disappear, and if it helps people live longer and feel better. This is a Phase III study, meaning it's one of the final steps before a new treatment might be approved for wider use.
At a glance
What is this study about?
This study is investigating a new treatment called AZD0120 for multiple myeloma. Multiple myeloma is a cancer of plasma cells, which are a type of white blood cell found in the bone marrow. When the myeloma comes back after treatment or isn't responding to current medicines, it's called 'relapsed' or 'refractory' multiple myeloma. This can be a challenging situation, and doctors are always looking for better ways to help patients.
AZD0120 is a cutting-edge type of treatment known as CAR-T cell therapy. It involves taking some of your own immune cells (T-cells), modifying them in a lab to better recognise and fight the cancer cells, and then giving them back to you. The special thing about AZD0120 is that it targets two different markers on the myeloma cells (BCMA and CD19) at the same time, which might make it more effective. The aim is to see if this new approach can control the myeloma for longer than existing standard treatments.
To find out if AZD0120 is an improvement, this study will compare it directly with standard treatments. Participants will be randomly assigned to receive either the new CAR-T cell therapy or one of the common medications currently used for multiple myeloma. Researchers will carefully track how well these treatments work, looking at things like how long it takes for the cancer to return, how many people go into remission (where the cancer isn't detectable), and how people's overall health and survival compare between the groups. This type of study, a 'Phase III', is crucial for proving if a new treatment is safe and effective enough to become a standard option.
Key takeaways
- Tests a new cell therapy (AZD0120) for multiple myeloma.
- For myeloma that has come back or isn't responding to current treatments.
- Compares AZD0120 to existing standard treatments.
- Uses your own immune cells to fight the cancer after they've been specially modified.
- Participation involves regular hospital visits, tests, and follow-ups over several years.
- You won't get to choose which treatment you receive.
Who may be eligible?
This study is looking for adults aged 18 and over, of any gender, who have multiple myeloma. To join, your multiple myeloma must have either returned after previous treatments or stopped responding to the treatments you've already had. This means your doctors have tried various ways to control your myeloma, but it's still active or has come back.
There will be specific health checks and tests to make sure that taking part in the study is the right and safest option for you. These checks are important because some treatments can have strong effects, and it's essential that participants are generally well enough to manage them.
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 returned after previous treatments?
- Or has your multiple myeloma not responded to past treatments?
- Are you willing to be assigned randomly to a treatment group?
What does participation involve?
If you decide to take part in this study, you would be randomly assigned to receive either the new AZD0120 cell therapy or one of several standard multiple myeloma treatments. This means you wouldn't get to choose which treatment you receive.
For the AZD0120 treatment, some of your blood would be collected to gather your immune cells. These cells would then be sent to a special lab to be modified and grown, which takes some time. After receiving the treatment, you would have regular hospital visits for blood tests, scans, and check-ups to monitor your health and how the treatment is working.
If you're in the standard treatment group, you'd receive regular doses of medication, which might involve injections, tablets, or infusions, depending on the specific drug. You would also have frequent doctor's appointments, blood tests, and scans to track your condition. The total length of your participation would depend on how your treatment progresses and could continue for several years as researchers follow up on your health.
Potential risks and benefits
Locations (6)
- —UnverifiedNorway
- —UnverifiedPoland
- —UnverifiedSpain
- —UnverifiedGermany
- —UnverifiedFrance
- —UnverifiedItaly
Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that affects the plasma cells in your bone marrow, which are part of your immune system.
What does 'relapsed or refractory' mean?
It means your multiple myeloma has come back after treatment, or it's not responding well to the treatments you've had so far.
What is CAR-T cell therapy?
It's a treatment that uses your own immune cells, specially trained in a lab, to find and destroy cancer cells.
Will I get to choose my treatment?
No, participants are randomly assigned to either the new therapy or a standard treatment, like flipping a coin, to ensure a fair comparison.
How long will I be in the study?
Participation can last for several years with regular check-ups to monitor your health and the treatment's effects.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.