A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4)
This study, called DURGA-4, is looking into a new treatment named AZD0120 for people with multiple myeloma that has returned or stopped responding to previous treatments. Multiple myeloma is a type of cancer that affects plasma cells in the bone marrow. The study will compare AZD0120 with existing standard treatments to see which is more effective and safer. Patients will be randomly assigned to receive either the new treatment or one of the standard therapies. The main goal is to find out if AZD0120 offers a better way to manage this challenging condition. This is a large, worldwide study, and it's in its final stages of testing before a new medicine can be considered for wider use.
At a glance
What is this study about?
This clinical trial is designed for people who have multiple myeloma, a type of a cancer that affects specific white blood cells called plasma cells, and where their current treatments are no longer working or the cancer has come back. This is often called 'relapsed refractory multiple myeloma'. The study wants to find out if a new medicine, AZD0120, is a better and safer option compared to the treatments currently available.
AZD0120 is a new type of treatment that targets two specific markers on cancer cells. Researchers believe that by targeting these markers, AZD0120 might be more effective at fighting the myeloma cells. The study is comparing AZD0120 against several standard treatment combinations that doctors already use for multiple myeloma. These include medicines like Daratumumab, Carfilzomib, Dexamethasone, Bortezomib, and Pomalidomide, used in different combinations.
This is a 'Phase 3' study, which means it will involve a larger group of patients and is the final step before the new treatment could potentially be approved for general use. The study is 'randomised', meaning that participants will be assigned to either the new treatment or a standard treatment by chance, like flipping a coin. It's also 'open-label', which means both you and your doctor will know which treatment you are receiving. The aim is to gather strong evidence to see if AZD0120 offers a valuable new option for patients facing this challenging form of myeloma.
Key takeaways
- This study is for multiple myeloma that has come back or isn't responding to treatment.
- It compares a new medicine (AZD0120) against standard treatments.
- It's a Phase 3 study, the final step before potential approval.
- You will be randomly assigned to either the new or a standard treatment.
- You'll receive close medical care and monitoring throughout the study.
Who may be eligible?
To be considered for this study, you need to be at least 18 years old and have a confirmed diagnosis of multiple myeloma that has either returned or isn't responding to your current treatment. Doctors will need to see clear signs that the myeloma is still active, which they'll check through specific blood or urine tests. You must also have received between one and three previous treatments for your multiple myeloma, including certain types of medicines called IMiDs and either PIs or CD38 antibodies.
It's important that your general health is stable enough to take part. This means your blood counts and kidney function need to be within certain ranges, and your overall physical fitness, as assessed by a doctor, should be good. Your doctor must also confirm that one of the standard treatments used in this study would be suitable for you. If your myeloma has spread to your brain or spinal cord, or if you have specific other conditions like active plasma cell leukaemia, you unfortunately wouldn't be able to join this particular study.
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?
- Has your multiple myeloma come back or stopped responding to previous treatment?
- Have you had between 1 and 3 prior treatments for your myeloma, including specific types of drugs?
- Are your blood tests and kidney function generally stable?
- Is your overall health good enough for clinic visits and treatment?
What does participation involve?
If you decide to participate, you will be randomly assigned to receive either the new treatment, AZD0120, or one of the standard treatment combinations. This decision is made by chance, like drawing straws. You will have regular visits to the clinic where you will receive your medication, have blood tests, and undergo physical examinations to monitor your health and how the treatment is working. Doctors will also check for any side effects. The exact schedule of visits and the duration of treatment will vary depending on which treatment you receive and how you respond. The study will also involve follow-up appointments after your treatment period to continue monitoring your health over time. The total duration of your involvement could range from several months to a few years, depending on your individual response and the study's requirements.
Potential risks and benefits
Locations (111)
- Research SiteVerified postcodeGilbert, United States· Not yet recruiting
- Research SiteVerified postcodePhoenix, United States· Not yet recruiting
- Research SiteVerified postcodeTucson, United States· Not yet recruiting
- Research SiteVerified postcodeLa Jolla, United States· Withdrawn
- Research SiteVerified postcodeSacramento, United States· Not yet recruiting
- Research SiteVerified postcodeSanta Monica, United States· Not yet recruiting
- Research SiteVerified postcodeDenver, United States· Not yet recruiting
- Research SiteVerified postcodeNew Haven, United States· Not yet recruiting
- Research SiteVerified postcodeWashington D.C., United States· Not yet recruiting
- Research SiteVerified postcodeCoral Gables, United States· Not yet recruiting
- Research SiteVerified postcodeAtlanta, United States· Not yet recruiting
- Research SiteVerified postcodeChicago, United States· Not yet recruiting
Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that starts in the plasma cells, which are a kind of white blood cell found in your bone marrow. These cells are important for your immune system, but in multiple myeloma, they grow out of control.
What does 'relapsed refractory' mean?
It means the myeloma has returned after previous treatments (relapsed) or it's no longer responding to the treatments you've been given (refractory).
What is a 'Phase 3' study?
A Phase 3 study is the final step in testing a new medicine before it can be considered for widespread use. It compares the new treatment against existing ones in a larger group of patients to confirm its effectiveness and safety.
Will I know which treatment I'm getting?
Yes, in this study, both you and your doctor will know whether you are receiving the new treatment (AZD0120) or one of the standard treatments. This is called an 'open-label' study.
Can I leave the study at any time?
Yes, you have the right to leave the study at any point, for any reason, without it affecting your future medical care.
How to find out more
AstraZeneca Clinical Study Information Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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