A Phase III Open-Label, Randomised, Multicentre Study of Consolidation with a Single Administration of AZD0120, a Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR T) Therapy Directed Against BCMA and CD19, Compared with Continuous Standard Therapy in Participants with NDMM Who Are Ineligible to Receive ASCT as Initial Therapy (DURGA-5).
Multiple myeloma is a type of bone marrow cancer. Standard treatment often includes a stem cell transplant, but not everyone is well enough to have one. People who cannot have a transplant usually take long-term medication to keep the cancer under control. This trial compares standard continuous drug therapy with a newer approach called CAR T-cell therapy (AZD0120). CAR T-cell therapy uses a person's own immune cells, collects them from the blood, and trains them in a laboratory to hunt down and attack myeloma cells. Patients are given this back as a single drip. The main goal is to find out if this one-time cell treatment works better at clearing the cancer and preventing it from coming back than taking standard medicines over a long period. Taking part is voluntary, and participants are closely monitored by a specialist hospital team.
At a glance
What is this study about?
Multiple myeloma is a cancer that starts in plasma cells, which are white blood cells found inside the bone marrow. For many people, intensive chemotherapy followed by a stem cell transplant is the first choice of treatment. However, older adults or those with other health conditions often cannot safely have a transplant. Instead, they are usually offered ongoing combinations of targeted cancer drugs to keep the disease in check.
This study, called DURGA-5, is testing whether a new type of immunotherapy called AZD0120 can offer a better option. AZD0120 is an autologous CAR T-cell therapy. 'Autologous' means it is made from your own blood. Doctors collect your T-cells (the soldiers of your immune system) and genetically alter them in a laboratory so they can recognise two specific proteins found on myeloma cells (BCMA and CD19). Once reprogrammed, these cells are returned to your bloodstream in a single infusion to search for and destroy cancer cells.
Researchers want to see if having a single dose of AZD0120 helps people stay in remission for longer compared to having standard, continuous drug therapy. They also want to measure how deeply the treatment clears cancer cells from the body and check how it affects everyday quality of life.
Key takeaways
- DURGA-5 is a Phase III study testing a new CAR T-cell therapy for newly diagnosed multiple myeloma.
- It is designed for people who cannot have an intensive stem cell transplant.
- The trial compares a single infusion of AZD0120 against continuous standard drug combinations.
- The main aim is to see which treatment keeps the cancer in remission for longer.
- Taking part is completely voluntary and you can stop at any time.
Who may be eligible?
This trial is for adults aged 18 and over who have been newly diagnosed with multiple myeloma and have not yet had extensive treatment. It is specifically designed for people who are not able to have a stem cell transplant, often due to their age or other medical conditions.
To take part, you must be well enough to carry out daily activities and have adequate heart, liver, and kidney function so that you can safely receive treatment.
You might not be able to join if you have already had certain previous myeloma therapies, if you have active infections, or if you have other serious health problems that could make the treatment unsafe. The trial doctor will run tests to confirm whether the study is a safe fit for you.
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.
- I have been newly diagnosed with multiple myeloma.
- I am 18 years old or older.
- My medical team has decided that a stem cell transplant is not suitable for me.
- I have not yet started long-term treatment for my myeloma.
- I am well enough to attend regular hospital appointments.
What does participation involve?
If you decide to take part, you will first have screening tests, such as blood tests, scans, and a bone marrow sample, to make sure the trial is safe for you. Because this is a randomised study, a computer will assign you by chance to one of two groups. Neither you nor your doctor can choose which group you join. One group will receive standard continuous drug treatments (combinations such as daratumumab, bortezomib, lenalidomide, or dexamethasone). The other group will receive the new CAR T-cell therapy.
If you are in the CAR T-cell group, your T-cells will be collected through a vein in a process called apheresis. While your cells are being modified in a laboratory, you may receive temporary treatment to keep your myeloma stable. Before the modified cells are put back, you will receive a short course of mild chemotherapy to prepare your body. You will then receive the CAR T-cells through a single drip, followed by a short stay in hospital so doctors can monitor you closely.
All participants will have regular hospital visits for check-ups, blood tests, and scans. The study team will follow your progress over several years to monitor your health and see how well the treatment is working.
Potential risks and benefits
Locations (7)
- —UnverifiedPoland
- —UnverifiedItaly
- —UnverifiedDenmark
- —UnverifiedFrance
- —UnverifiedSweden
- —UnverifiedGermany
- —UnverifiedSpain
Common questions
What is CAR T-cell therapy?
It is a type of immunotherapy that takes your own immune cells, modifies them in a lab to target cancer cells, and gives them back to you through a drip.
Can I choose which treatment I get?
No. A computer randomly puts you into either the CAR T-cell therapy group or the standard medication group to ensure the test is fair and unbiased.
Will I have to stay in hospital?
If you receive the CAR T-cell therapy, you will need to stay in hospital for a short time after the infusion so the medical team can watch for any side effects.
Do I have to pay to take part?
No. Clinical trial treatments and all required study tests are provided free of charge.
What happens if I change my mind?
You are free to leave the trial at any point. Your doctors will continue to give you the best available standard treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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