An Open-label, Randomized Phase 3 Study of Linvoseltamab Monotherapy and Linvoseltamab plus Carfilzomib versus Standard of Care Combination Regimens in Patients with Relapsed/Refractory Multiple Myeloma
This study is looking into new ways to treat multiple myeloma, a blood cancer, especially when it has returned or hasn't responded to earlier treatments. Researchers are comparing two new approaches: one uses a drug called Linvoseltamab by itself, and the other combines Linvoseltamab with another drug called Carfilzomib. These new treatments will be measured against the standard treatments currently used for this type of cancer. The main goal is to understand how safe these new treatments are and how well they help patients. They will be looking at side effects and how many patients respond positively to the treatment, comparing all the different treatment groups to find the most effective and safe options.
At a glance
What is this study about?
This study is for people who have multiple myeloma, a type of blood cancer where abnormal plasma cells build up in the bone marrow and form tumours. This particular study focuses on multiple myeloma that has either returned after previous treatment (we call this 'relapsed') or hasn't responded to other treatments (we call this 'refractory'). It's a really important area of research because finding new and better ways to control the cancer is key for patients.
The study is testing two new treatment options against the usual ways doctors treat this condition. One new option uses a drug called Linvoseltamab on its own. The other option combines Linvoseltamab with another drug called Carfilzomib. These will be compared to standard treatments that are already available. By doing this, the researchers want to see if the new treatments are more effective at shrinking the cancer or stopping it from growing, and if they have fewer or different side effects than the current standard of care.
This is a 'Phase 3' study, which means it's one of the final steps before a new treatment might become widely available. The study will look closely at a few key things: how often patients have side effects and how serious those side effects are, how many people respond to the treatment (meaning their cancer shrinks or stops growing), and how long people live without their cancer getting worse. They also want to see if the treatments can get rid of all signs of the cancer, even tiny amounts (this is called 'minimal residual disease negative complete response'). Overall, the goal is to find out if these new drugs offer a better treatment choice for people with relapsed or refractory multiple myeloma.
Key takeaways
- This study evaluates new treatments for multiple myeloma that has returned or is resistant to prior therapies.
- It compares Linvoseltamab (alone or with Carfilzomib) against standard care.
- The main goals are to check treatment safety and how well they work.
- Participants will receive regular medical check-ups and monitoring.
- Being part of a trial means access to potentially new treatments but also unknown risks.
- You can stop participating at any time without affecting your normal care.
Who may be eligible?
To join this study, people generally need to be 18 years old or older. The good news is that both men and women can take part. The study is specifically looking for people who have been diagnosed with multiple myeloma and whose cancer has either come back after past treatments or is no longer responding to the treatments they've tried before.
There might be specific health requirements that your doctor will need to check, such as your general health, how well your organs are working, and what other medical conditions you might have. These checks are important to make sure the study treatments are as safe as possible for you and that you can fully take part.
It's important to talk to your doctor about your complete medical history, including any other medications you are taking or any past health problems. They will be able to tell you if you meet all the specific criteria for this study and discuss whether it's a suitable option 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 after previous treatment or stopped responding to it?
- Are you generally well enough to undergo cancer treatment?
- Are you able to attend regular hospital visits for treatment and check-ups?
What does participation involve?
If you decide to join this study, you will be assigned to one of several treatment groups, which will be decided randomly, like drawing a name out of a hat. This means you could receive Linvoseltamab alone, Linvoseltamab with Carfilzomib, or one of the standard treatments for multiple myeloma. You won't get to choose which group you are in.
Throughout the study, you will have regular visits to the hospital or clinic. These visits will involve various tests, such as blood tests, physical examinations, and scans, to check how you are responding to the treatment and to monitor for any side effects. You will receive your assigned medication as prescribed by the study doctors.
Some of the specific medications that might be involved include Dexamethasone, Carfilzomib (Kyprolis), Pomalidomide (Imnovid), Daratumumab (DARZALEX), and Bortezomib (VELCADE), along with other supportive medications like Paracetamol or antiviral tablets. The frequency and duration of these visits and treatments will depend on the specific treatment plan for your group and how you respond. The study will also involve regular follow-up appointments even after active treatment, to continue monitoring your health and the long-term effects of the treatment. The total duration of your involvement in the study will be discussed by your study team.
Potential risks and benefits
Locations (10)
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- —UnverifiedGermany
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- —UnverifiedFrance
Common questions
What is multiple myeloma?
Multiple myeloma is a type of blood cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow.
What does 'relapsed/refractory' mean?
Relapsed means the cancer has come back after treatment, and refractory means the cancer didn't respond or stopped responding to previous treatments.
What are Linvoseltamab and Carfilzomib?
These are drugs being tested in the study, either alone or in combination, to see if they can effectively treat multiple myeloma.
Will I know which treatment I'm receiving?
In this type of study, participants are usually assigned to a treatment group randomly, and often you won't know which specific treatment you are getting until after the study is over, or if medically necessary.
How long will I be in the study?
The total length of time you're involved in the study will depend on your treatment plan and how you respond, but it will involve regular follow-up even after active treatment ends. Your study team will give you more specific 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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