A study to investigate safety and efficacy with SAR445514 in participants with relapsed/refractory multiple myeloma (RRMM) and relapsed/refractory light-chain amyloidosis (RRLCA)
This research study is investigating a new medication, SAR445514, for people living with specific blood conditions: multiple myeloma and light-chain amyloidosis. These are conditions where the body makes abnormal proteins. The study is for patients whose conditions have either returned after treatment (relapsed) or haven't responded well to previous treatments (refractory). This is an early-stage trial, called Phase I and Phase II, which means it's one of the first times this medicine is being given to people. Researchers want to find out if SAR445514 is safe to use and if it can help improve the condition. The results from this study will help us understand more about this new treatment.
At a glance
What is this study about?
This study is exploring a new medicine named SAR445514. It's designed for adults who have specific types of blood conditions: multiple myeloma or light-chain amyloidosis. These conditions can be serious and involve the body making unusual proteins. For example, multiple myeloma is a type of cancer that affects plasma cells in the bone marrow, while light-chain amyloidosis is a condition where abnormal protein pieces can build up in organs and cause damage. The patients taking part in this study have found that their condition has either come back after previous treatments failed, or it didn't get better with their past treatments.
Because this is an early study (a 'Phase I and II' trial), it's one of the first times this particular medicine, SAR445514, is being used in people. The main goals are to carefully check if the medicine is safe and if it has any helpful effects. Researchers will be looking closely at how the body reacts to the medicine, what doses are best, and if it helps to control the condition in patients.
Understanding how new medicines work and if they are safe is a very important part of finding better treatments for serious illnesses. This study aims to gather crucial information that could, in the future, lead to new options for those living with these challenging conditions. It helps us learn more about potential new ways to fight the disease.
Key takeaways
- This study is testing a new medicine (SAR445514) for specific blood conditions.
- It's for people whose multiple myeloma or light-chain amyloidosis has returned or not responded to treatment.
- This is an early-stage trial (Phase I/II) to check safety and if the medicine works.
- Participants must be 18 or older; both men and women can join.
- Regular clinic visits and health checks will be required.
Who may be eligible?
To join this study, participants must be at least 18 years old. There's no upper age limit, meaning older adults can also take part. The study is open to both men and women.
Specifically, you would need to have been diagnosed with either multiple myeloma or light-chain amyloidosis. It's important that your condition has either come back after you've had treatment for it, or it hasn't responded well to the treatments you've received in the past. This is what 'relapsed/refractory' means.
The research team will have other specific health requirements and medical tests to make sure that taking part is safe for you and that the study results are clear. They will carefully review your medical history to see if you fit all the necessary criteria.
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 or light-chain amyloidosis?
- Has your condition come back after treatment (relapsed)?
- Did your condition not respond well to previous treatments (refractory)?
- Are you able to attend regular clinic appointments?
What does participation involve?
If you decide to take part in this study, you would first have a number of tests and checks to see if you are suitable. Once enrolled, you would receive the study medicine, SAR445514, which will likely be given over a period of time. You would need to come to the clinic for regular visits. During these visits, the research team would monitor your health very closely. They would conduct physical exams, take blood samples, and perform other tests relevant to your condition, such as scans.
The number of visits and the types of tests will change over the course of the study, and these will be clearly explained before you agree to participate. You might need to take some medicines at home, or come back to the clinic for infusions. After you stop taking the study medicine, there will be follow-up visits or phone calls to continue monitoring your health for a certain amount of time. The total length of your participation, including the treatment and follow-up, will be explained in detail.
Potential risks and benefits
Locations (6)
- —UnverifiedHungary
- —UnverifiedBelgium
- —UnverifiedSpain
- —UnverifiedCzechia
- —UnverifiedItaly
- —UnverifiedGreece
Common questions
What does 'relapsed/refractory' mean?
This means your multiple myeloma or light-chain amyloidosis has either come back after treatment, or it didn't get better with previous treatments.
What is SAR445514?
It's a new, experimental medicine being tested for the first time in people to see if it's safe and effective for these conditions.
What are Phase I and Phase II studies?
These are early stages of research. Phase I checks safety and dose, and Phase II starts to look at how well the medicine works, often combined in one study like this one.
Will I definitely get better if I join?
There's no guarantee the medicine will help your condition. The main purpose of this early study is to find out if it's safe and if it shows any signs of working.
How long will the study last?
The team will tell you the expected total duration of your involvement, including treatment and follow-up, during the consent process.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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