A multicenter phase 2 study of Belantamab mafodotin and Mezigdomide in combination with a phase Ib Safety run in patients with relapsed multiple myeloma following BCMA-targeting CAR-T cells or bispecific antibodies. The IFM 2024-01 clinical trial (BELAMI)
This research study, called BELAMI (IFM 2024-01), is investigating a new combination treatment for a type of blood cancer called multiple myeloma. It's specifically for adults whose cancer has come back or hasn't responded to earlier treatments, particularly those who have already had certain cell therapies (CAR-T) or specific antibody treatments. The study will look at how well the new treatment works to shrink or control the cancer, how long its effects last, and how it affects patients' overall health. Importantly, it will also carefully check for any side effects, especially those affecting the eyes. This is a Phase 2 study, meaning it builds on earlier research but still aims to gather more information about safety and effectiveness.
At a glance
What is this study about?
This study is called BELAMI, and it's looking into a new way to treat multiple myeloma. Multiple myeloma is a cancer that affects certain cells in your bone marrow. Sometimes, despite treatment, the cancer can come back (relapse) or not respond as well as doctors hoped (become refractory). This study is for people who are in this situation, especially if they've already had particular types of modern treatments like CAR-T cell therapy or specific antibody-based drugs.
The main goal of this study is to see how well a new combination of medicines works. The researchers want to know if these medicines can stop the cancer from growing, shrink it, or make it disappear. They will also be paying close attention to how long these effects last and if the treatment helps people feel better or live longer. During the study, a team of doctors and nurses will regularly check your health and your cancer status.
Another very important part of this study is to understand the safety of this new treatment. The study team will be carefully monitoring for any side effects, particularly those that might affect your eyes. By collecting this information, doctors hope to learn more about how to use this new combination treatment safely and effectively for people with multiple myeloma.
Key takeaways
- This study is for adults with multiple myeloma that has returned or hasn't responded to previous treatment.
- It tests a new combination treatment, including a drug called CC-92480.
- Researchers will monitor how well the treatment controls cancer and any side effects, especially eye-related ones.
- It's a Phase 2 study, meaning it's exploring safety and effectiveness in a larger group of patients.
- Participation involves regular hospital visits for treatment and check-ups.
Who may be eligible?
This study is for adults aged 18 or older who have multiple myeloma.
You might be able to join if your multiple myeloma has come back after previous treatments or if it didn't respond to those treatments. Specifically, this study is looking for people who have already had certain types of modern treatments, including 'BCMA-targeting CAR-T cells' or 'bispecific antibodies'.
There might be other health requirements that the study doctors will discuss with you to make sure the study is a good fit for your situation and safe 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?
- Have you been diagnosed with multiple myeloma?
- Has your multiple myeloma come back or not responded to previous treatments?
- Have you previously had CAR-T cell therapy or bispecific antibody treatment?
- Are you able to attend regular hospital visits for treatment and monitoring?
What does participation involve?
If you join this study, you will receive the new combination treatment. You'll have regular hospital visits for check-ups, blood tests, and to receive your medication. The doctors will closely monitor how your cancer responds to the treatment and keep a very close eye on any side effects, especially eye-related ones. You'll likely undergo various scans and tests at different points to track your progress. The total duration of your participation will depend on how you respond to the treatment and will involve regular follow-up for a period after treatment finishes.
Potential risks and benefits
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Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that starts in the bone marrow and affects plasma cells, a type of white blood cell.
What does 'relapsed/refractory' mean?
It means the cancer has returned after previous treatments, or it didn't respond well to those treatments.
What are CAR-T cells or bispecific antibodies?
These are newer, advanced treatments for cancer that help your immune system fight the cancer cells. This study is for people who have already tried these.
What is the new treatment being tested?
The study is testing a new combination of medicines, which includes a drug called CC-92480, to see how well it works and if it's safe.
Will I get a placebo (dummy treatment)?
No, this study is testing a specific new combination treatment, so everyone in the study will receive the active drugs.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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