A Phase III, Open-label, Multicentre, Randomised Study Comparing Consolidation Treatment with AZD0120, an Autologous Dual Targeting Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA and CD19, versus Autologous Stem Cell Transplant (ASCT) in Participants with Newly Diagnosed Multiple Myeloma who are Transplant Eligible (TE NDMM) (DURGA-6)
This clinical trial is looking at a new way to treat adults who have recently been diagnosed with multiple myeloma and are fit enough for intensive treatment. The usual standard care involves having a stem cell transplant using your own cells, followed by maintenance tablets. This study is testing an advanced treatment called CAR-T cell therapy (AZD0120). CAR-T therapy takes your own immune cells, trains them in a laboratory to spot two targets on myeloma cells, and puts them back into your body to fight the cancer. Researchers are comparing this new CAR-T therapy directly against the standard stem cell transplant. They want to find out which approach is better at keeping the cancer under control for longer, clearing all measurable signs of myeloma, and helping people live longer, healthier lives.
At a glance
What is this study about?
Multiple myeloma is a type of blood cancer that develops from plasma cells inside your bone marrow. When someone is first diagnosed and is well enough, standard NHS treatment often includes chemotherapy followed by an autologous stem cell transplant. This transplant uses your own healthy blood-forming cells to help your bone marrow recover after high-dose chemotherapy. While this works well for many people, doctors are constantly searching for treatments that keep the cancer away for even longer.
This trial tests an innovative treatment called CAR-T therapy, using a medicine named AZD0120. T-cells are vital parts of your immune system that fight off illness. In CAR-T therapy, your T-cells are collected and genetically updated in a special laboratory so they can recognize and attack myeloma cells. AZD0120 is designed to spot two separate targets on the cancer cells, called BCMA and CD19, giving it a double chance of finding and destroying them.
The main goal of this study is to see if CAR-T therapy works better than a traditional stem cell transplant. Researchers want to measure how long patients stay free from cancer progression and how many achieve a 'deep response', meaning no tiny traces of cancer can be found in the bone marrow with sensitive tests. Finding out whether CAR-T therapy is more effective could change the future standard of care for people newly diagnosed with myeloma.
Key takeaways
- Phase III study comparing new CAR-T cell therapy directly to standard stem cell transplantation.
- Aimed at adults newly diagnosed with multiple myeloma who are fit enough for intensive treatment.
- The CAR-T treatment uses your own immune cells, genetically trained to find and attack cancer cells.
- Participation involves hospital admissions, close medical monitoring, and long-term follow-up checks.
- Joining is completely voluntary and you can withdraw at any point without losing standard NHS care.
Who may be eligible?
This study is open to men and women aged 18 and older who have been recently diagnosed with multiple myeloma. Participants must be considered 'transplant eligible', which means their overall health, heart, kidneys, and lungs are strong enough to safely undergo intensive hospital treatments like high-dose chemotherapy.
People taking part will need to have had their initial initial myeloma treatment (called induction therapy) and be at the stage where a stem cell transplant would normally be planned. Your medical team will also check blood and bone marrow tests to make sure it is safe for you to take part.
You may not be able to join if your general health is poor, if you have severe heart or organ problems, or if you have an active serious infection. Your doctor can look at your specific test results and medical history to see if this study is an option 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 am aged 18 or older.
- I have been newly diagnosed with multiple myeloma.
- My doctor has told me that I am eligible for a stem cell transplant.
- I am well enough to undergo intensive medical treatments and stay in hospital.
- I am willing to attend regular hospital check-ups and follow-up visits.
What does participation involve?
If you take part, you will be randomly placed by a computer into one of two groups. One group receives the standard treatment, which involves high-dose chemotherapy (melphalan) and a stem cell transplant, followed by maintenance tablets (lenalidomide). The other group receives the new CAR-T cell therapy (AZD0120), which involves collecting your T-cells, conditioning chemotherapy, and an infusion of your modified cells.
Both treatments require time in hospital, frequent clinic visits, blood tests, bone marrow biopsies, and scans to monitor your health. You will be monitored closely for side effects and followed up over several years to check your response and long-term well-being.
Potential risks and benefits
Locations (7)
- —UnverifiedGermany
- —UnverifiedSpain
- —UnverifiedNorway
- —UnverifiedItaly
- —UnverifiedDenmark
- —UnverifiedFrance
- —UnverifiedPoland
Common questions
What is CAR-T therapy?
It is a type of immunotherapy where your own immune cells are collected, modified in a lab to hunt down cancer cells, and returned to your bloodstream to fight the disease.
Can I choose which treatment I receive?
No. A computer allocates participants randomly to either CAR-T therapy or the standard stem cell transplant to ensure the study results are fair and unbiased.
Will I have to stay in hospital?
Yes. Both stem cell transplants and CAR-T therapy require hospital stays so doctors can safely give the treatments and watch for any immediate side effects.
What does 'minimal residual disease negative' mean?
It means highly sensitive tests cannot find even one myeloma cell out of 100,000 bone marrow cells, showing an exceptionally deep response to treatment.
What happens if my cancer gets worse during the trial?
Your doctors will stop the trial treatment and immediately offer other available, approved therapies to best care for your health.
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.