An Open-label, Randomized Phase Ib/II Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants with Relapsed or Refractory Multiple Myeloma
This is a UK-based study for individuals living with multiple myeloma, a type of blood cancer, especially if their condition has returned or didn't get better with other treatments. It's looking at different combinations of medicines, with a special focus on a new drug called Forimtamig. The main goals are to check how safe these new treatment combinations are, how well people tolerate them, and to see if they help improve the patient's condition. Researchers will be monitoring for any side effects and how many patients show signs of improvement. This study aims to find better 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, a type of cancer that affects plasma cells in the bone marrow. This study is specifically for those whose multiple myeloma has either come back after treatment or hasn't responded to previous treatments. The trial is being conducted in two stages, known as Phase I and Phase II, which means it's testing both brand-new medications and how well they work. The main goal is to find out if new combinations of existing and new drugs, including one called Forimtamig, are safe and effective.
The researchers will be giving participants different combinations of medicines. Some of these medicines you might recognise, like Dexamethasone or Darzalex, while others, like Forimtamig and RO7425781, are newer or being tested in new ways. By combining these treatments, the hope is to find a more powerful way to fight multiple myeloma. The study will carefully watch for any side effects and see how different people react to the medicines.
The study will measure several key things. Firstly, it will closely track any side effects to make sure the treatments are safe. Secondly, it will look at how many patients show an improvement in their cancer, from small changes to a complete disappearance of the cancer cells. Researchers also want to see how long these improvements last and overall how long people live. They will also check how the new drug, Forimtamig, travels through the body and if the body develops any resistance to it. All this information will help doctors understand if these new combinations could become standard treatments in the future.
Key takeaways
- This study is for adults with multiple myeloma that has returned or not responded to treatment.
- It's testing new combinations of drugs, including a new one called Forimtamig.
- The main goals are to check for safety, side effects, and how well the treatment works.
- You'll have regular hospital visits for treatment and check-ups.
- All treatment and study-related care will be provided by the research team.
Who may be eligible?
To be considered for this study, you must be 18 years of age or older. There is no upper age limit, meaning older adults are also welcome to participate if they meet other criteria.
This study is open to both men and women. The most important thing is that you have been diagnosed with multiple myeloma and that your cancer has either returned after previous treatments or hasn't responded to the standard care you've received so far. Your doctors will review your medical history carefully to make sure this particular study would be suitable and safe for you.
It's important to have a chat with your doctor or the study team to go through all the specific requirements. They will be able to tell you if the study is a good fit for your individual health situation.
- Are you 18 years old or older?
- Have you been diagnosed with multiple myeloma?
- Has your multiple myeloma come back after treatment or not responded to previous treatments?
- Are you able to attend regular hospital appointments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will receive combinations of different medications, including Forimtamig, Dexamethasone, Darzalex, Kyprolis, Diphenhydramine, Actemra, and RO7425781. These will be given as injections or infusions. You will have regular visits to the clinic so the study team can monitor your health, check for any side effects, and see how well the treatment is working. This will involve physical exams, blood tests, and potentially other scans or assessments. The exact number of visits and tests will depend on which treatment group you are in and how you respond to the medication. The study will also involve follow-up appointments after your main treatment period to continue monitoring your long-term health. The total duration of your participation could vary, from several months for the active treatment phase to longer for follow-up, but the study team will explain this in detail.
Potential risks and benefits
Locations (5)
- —Spain
- —Denmark
- —France
- —Germany
- —Italy
Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that develops from plasma cells. These are a type of white blood cell made in the bone marrow.
What does 'relapsed or refractory' mean?
It means your cancer has either come back after treatment (relapsed) or hasn't responded to previous treatments (refractory).
What is Forimtamig?
Forimtamig is a new medication being tested, specifically designed to target cancer cells in a particular way.
Will I get to choose which medications I receive?
Because this is a randomised study, you will be assigned to a treatment group, meaning you won't choose your specific combination of medicines.
How long will I be in the study?
The duration of your participation will depend on how you respond to the treatment and the study plan, but the team will give you more details.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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