A Phase 1b, Open-Label Study of Eftozanermin Alfa (ABBV-621) in Combination with Bortezomib and Dexamethasone in Subjects with Relapsed or Refractory Multiple Myeloma
This research study is looking at a new medicine called Eftozanermin Alfa (ABBV-621), used together with two standard treatments, Bortezomib and Dexamethasone. It's for adults in the UK who have multiple myeloma, a type of blood cancer, which has either returned (relapsed) or isn't getting better with current treatments (refractory). This is an early phase (Phase 1b) study, meaning doctors are carefully checking the new combination's safety and how well people tolerate it, as well as if it shows signs of helping. The aim is to find effective new ways to treat multiple myeloma.
At a glance
What is this study about?
This clinical trial is designed for people in the UK who have multiple myeloma. Multiple myeloma is a cancer that affects certain cells in your bone marrow. Sometimes, after initial treatment, the cancer can return (this is called 'relapsed') or it might not respond to the treatments you've already had (this is called 'refractory'). When this happens, doctors are always looking for new and more effective ways to help.
This study is testing a new medicine called Eftozanermin Alfa, which is also known as ABBV-621. This new medicine will be given alongside two treatments that are already commonly used for multiple myeloma: Bortezomib and Dexamethasone. The main goal of this early-stage study (called a Phase 1b study) is to carefully check if this new combination of medicines is safe for patients and how well people can tolerate it. They also want to see if there are any early signs that it might be an effective treatment for multiple myeloma.
The information gathered from studies like this one is very important. It helps doctors understand if a new treatment has the potential to become a standard option for patients in the future. By joining, you'd be helping scientists learn more about new ways to fight multiple myeloma.
Key takeaways
- This study is testing a new drug for multiple myeloma that has come back or isn't responding to current treatments.
- The new drug, Eftozanermin Alfa, will be combined with two existing treatments.
- It's an early-stage study focusing on safety and how well patients tolerate the new combination.
- Participants will receive close medical care and frequent check-ups.
- Joining could offer access to a new treatment and help advance understanding of multiple myeloma.
- You can stop participating at any time.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women can take part. The study is specifically for people who have been diagnosed with multiple myeloma.
Crucially, your multiple myeloma must be in a specific situation: it needs to have either come back after previous treatment, or it must not be responding to the treatments you've tried so far. This means the study is for people who need new treatment approaches because their current options haven't worked or are no longer working.
There will also be other specific medical requirements that your study doctor will discuss with you. These usually involve checking your overall health, how well your organs are working, and the types of previous treatments you've had. These checks are to make sure that taking part in the study is as safe as possible 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.
- Are you 18 years old or older?
- Do you have a diagnosis of multiple myeloma?
- Has your multiple myeloma come back after treatment, or is it not responding to your current treatments?
- Are you able and willing to attend regular hospital or clinic visits for treatment and monitoring?
- Are you looking for new treatment possibilities for your multiple myeloma?
What does participation involve?
If you decide to join this study, you will receive the study medication (Eftozanermin Alfa, Bortezomib, and Dexamethasone) according to a specific schedule. This will involve regular visits to the hospital or clinic for your treatments and check-ups. During these visits, the study team will carry out various assessments, which may include blood tests, physical examinations, and other tests to see how you are responding to the treatment and to monitor for any side effects.
The study will involve several cycles of treatment, and the duration of each cycle and the total length of your participation will be explained in detail by the study team. After your main treatment period, there will also be follow-up visits or calls to continue monitoring your health and any long-term effects of the treatment. The total time you'd be involved in the study, from beginning to end, will vary depending on your individual response and the study's design, but the full plan will be clearly outlined for you.
Potential risks and benefits
Locations (1)
- —UnverifiedItaly
Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that develops in plasma cells, which are a type of white blood cell found in your bone marrow.
What does 'relapsed or refractory' mean?
It means the cancer has either returned after treatment (relapsed) or hasn't responded to previous treatments (refractory).
What is Eftozanermin Alfa (ABBV-621)?
It's a new medicine being tested in this study to see if it can help treat multiple myeloma when combined with other medicines.
What is a Phase 1b study?
It's an early-stage study that mainly checks the safety of a new treatment and how well people tolerate it, while also looking for signs it might be effective.
Can I take part if I'm under 18?
No, this study is only for adults aged 18 years or older.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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