A Phase III, Multicentre Study to Evaluate Consolidation Treatment With AZD0120 Compared With ASCT, in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible (DURGA-6).
This important study, called DURGA-6, is for people recently diagnosed with multiple myeloma who are fit enough for a stem cell transplant. We want to see if a new treatment, AZD0120, works better than the standard stem cell transplant to keep the cancer from coming back or getting worse. Both treatments will also include a common medicine called lenalidomide afterwards. Researchers will compare how well both treatments work to get rid of the cancer and stop it from progressing. The study aims to find the most effective way to help patients achieve a good, lasting response to treatment.
At a glance
What is this study about?
Imagine your body has special cells that fight off illness, but sometimes they can go wrong and grow too much, like in multiple myeloma. This study is for people who have just found out they have multiple myeloma and are strong enough to have a stem cell transplant, which is a common treatment.
Researchers want to see if a new medicine, AZD0120, is a better treatment option than the standard stem cell transplant. Both treatments are designed to help control the myeloma and stop it from coming back. This is called 'consolidation treatment' because it's given after initial treatment to make sure the cancer is really under control. The study will look closely at how well each treatment works to keep the cancer at bay.
Finding better ways to treat multiple myeloma is really important because it can help people live longer and have a better quality of life. By comparing a new medicine to a well-known treatment, doctors hope to discover which approach offers the best chance of a lasting positive outcome for patients.
Key takeaways
- Compares a new treatment (AZD0120) with standard stem cell transplant for newly diagnosed multiple myeloma.
- Aims to see which treatment is better at keeping the cancer under control.
- Involves a single infusion of AZD0120 or a stem cell transplant, followed by maintenance medicine.
- This is a long-term study, with follow-up for participants potentially lasting many years.
- For adults recently diagnosed with multiple myeloma who are fit for a transplant.
- Both treatment groups will receive lenalidomide maintenance therapy for up to 2 years.
Who may be eligible?
This study is for adults aged 18 and over who have recently been diagnosed with multiple myeloma. You would need to have already had some initial treatment for your myeloma (usually 4 to 6 cycles) and that treatment must have helped to stabilise or improve your condition. You also need to be generally well and fit enough to have a high-dose chemotherapy followed by a stem cell transplant.
There are certain health conditions that would mean you couldn't join the study. For example, if your myeloma has spread to your brain or spinal cord, or if you have certain other serious medical problems. Also, if you've had specific types of cell therapy or targeted treatments in the past, you might not be able to take part.
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 recently been diagnosed with multiple myeloma?
- Have you already had 4 to 6 cycles of initial treatment that helped your myeloma?
- Are you generally well enough to have a stem cell transplant?
- Does your medical history show no signs of myeloma in your brain or spinal cord?
What does participation involve?
If you join this study, it's a long-term commitment. The study itself could last up to 13 years for everyone involved. For you personally, if you receive the AZD0120 treatment, you'll be followed up for a total of 15 years after your treatment infusion.
Treatment involves different steps depending on which group you're in. If you receive AZD0120, you'll have 3 days of preparation, a single day for the AZD0120 infusion, and then you'll take a maintenance medicine called lenalidomide for up to 2 years. If you're in the stem cell transplant group, you'll have 1-2 days of preparation, the stem cell transplant, and then up to 2 years of lenalidomide maintenance medicine. This is an 'open-label' study, meaning both you and your doctors will know which treatment you are receiving, and you'll be randomly assigned to one of the two treatment groups.
Potential risks and benefits
Locations (65)
- Research SiteVerified postcodeTampa, United States
- Research SiteVerified postcodeAtlanta, United States
- Research SiteVerified postcodeAtlanta, United States
- Research SiteVerified postcodeChicago, United States
- Research SiteVerified postcodeDetroit, United States
- Research SiteVerified postcodeRochester, United States
- Research SiteVerified postcodeCleveland, United States
- Research SiteVerified postcodeSan Antonio, United States
- Research SiteVerified postcodeSeattle, United States
- Research SiteVerified postcodeMilwaukee, United States
- Research SiteVerified postcodeBrisbane, Australia
- Research SiteVerified postcodeCamperdown, Australia
Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that affects plasma cells, which are a type of white blood cell found in your bone marrow.
What does 'consolidation treatment' mean?
Consolidation treatment is given after initial therapy to strengthen the response and help prevent the cancer from returning or worsening.
What is a 'stem cell transplant' in this context?
Here, it refers to an 'autologous' stem cell transplant, where your own healthy blood-forming stem cells are collected and given back to you after high-dose chemotherapy.
Will I know which treatment I'm getting?
Yes, this is an 'open-label' study, which means both you and your doctors will know whether you are receiving AZD0120 or the standard stem cell transplant.
How long will I be involved in the study?
If you receive AZD0120, you'll be followed up for up to 15 years from your infusion date to track your long-term health.
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?
Discussion
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