A Study Evaluating the Efficacy and Safety of Cevostamab in Prior B Cell Maturation Antigen (BCMA)-Exposed Participants With Relapsed/Refractory Multiple Myeloma
This research study is testing a new drug named cevostamab for individuals in the UK diagnosed with multiple myeloma. This is a type of blood cancer that affects plasma cells. The study is specifically for those whose myeloma has either returned after previous treatments or isn't responding to their current therapies. Cevostamab will be given through a drip (intravenous infusion). Researchers want to find out how effective cevostamab is at treating the myeloma, how safe it is, and how the body handles the medicine. The study will also look at a second medicine called tocilizumab in some cases. This is an early-stage study, meaning it's one of the first times this drug is being thoroughly tested in people.
At a glance
What is this study about?
This study is about a new treatment called cevostamab for a type of blood cancer called multiple myeloma. Multiple myeloma affects important cells in your bone marrow. Sometimes, after initial treatments, the cancer can return (relapse) or simply stop responding to the medicines (refractory). When this happens, doctors need new options.
Cevostamab is a special type of drug designed to target certain features of the myeloma cells. Researchers want to understand if this new medicine can help slow down or stop the growth of myeloma cells, and crucially, how safe it is for patients. The study involves giving cevostamab through a drip into your vein. In some situations, another medicine called tocilizumab may also be used alongside it.
The main goals of this study are to see how well cevostamab works in treating your myeloma, to check for any side effects, and to learn how your body processes the medicine. This information is vital for doctors to decide if cevostamab could become a standard treatment in the future for people living with multiple myeloma.
Key takeaways
- Tests a new medicine, cevostamab, for multiple myeloma.
- For myeloma that has returned or stopped responding to treatment.
- Compares how well cevostamab works and its safety.
- Involves regular hospital visits and health checks.
- You have the right to withdraw from the study at any time.
Who may be eligible?
To join this study, people need to have been diagnosed with multiple myeloma using standard tests. Your doctor must also confirm that your myeloma has either worsened or not responded to your most recent treatments. This includes people who have previously received specific BCMA-targeting treatments like CAR-T cell therapy or certain antibody drugs, and whose myeloma is still not responding to at least three different types of standard treatments.
You also need to be generally in good health, able to look after yourself, and not have any health problems that would make taking part unsafe. For instance, your daily activities shouldn't be significantly limited by your illness, and you should be expected to live for at least 12 more weeks. Any side effects from your previous cancer treatments should have mostly cleared up and be mild.
It's important that you haven't been pregnant or breast-feeding before or during the study, as the medication could affect an unborn baby or breastfed infant. Men and women capable of having children will need to use effective contraception during and for some time after the study. You also can't have been treated with cevostamab or a very similar medicine before, or be unable to attend hospital visits as required by the study.
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.
- Have I been diagnosed with multiple myeloma?
- Has my myeloma worsened or not responded to my last treatment(s)?
- Am I generally well enough to manage my daily activities without much trouble?
- Have I used effective contraception if I could become pregnant or make someone pregnant?
- Have any side effects from my previous treatments mostly cleared up and are mild?
What does participation involve?
If you decide to take part in this study, you will receive the study medication, cevostamab, through a drip into your vein. In some cases, a second medicine called tocilizumab might also be given. You will need to attend regular hospital visits so the medical team can monitor your health, check how you are responding to the treatment, and manage any side effects. This will involve various assessments, including blood tests. You will also need to provide bone marrow samples (a biopsy and aspirate) at specific times during the study, as outlined by the research team. The study involves regular follow-up to ensure your safety and track your progress. The total length of your participation will depend on how you respond to the treatment and the study's specific plan, but it will involve ongoing assessments as long as you are receiving the study drug and for a period afterwards.
Potential risks and benefits
Locations (27)
- University of ColoradoVerified postcodeAurora, United States
- Mayo Clinic-JacksonvilleVerified postcodeJacksonville, United States
- University of Maryland Greenebaum Cancer CenterVerified postcodeBaltimore, United States
- Dana Farber Cancer InstituteVerified postcodeBoston, United States
- Mayo Clinic - RochesterVerified postcodeRochester, United States
- Icahn School of Medicine at Mount Sinai (ISMMS)Verified postcodeNew York, United States
- Memorial Sloan Kettering Cancer CenterVerified postcodeNew York, United States
- Tennessee Oncology - NashvilleVerified postcodeNashville, United States
- Hunstman Cancer InstituteVerified postcodeSalt Lake City, United States
- Calvary Mater NewcastleVerified postcodeWaratah, Australia
- St Vincent's Hospital MelbourneVerified postcodeFitzroy, Australia
- UZ Leuven GasthuisbergVerified postcodeLeuven, Belgium
Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that affects plasma cells, which are a kind of white blood cell found in your bone marrow.
What is cevostamab?
Cevostamab is a new investigational drug being tested to treat multiple myeloma. It is given through a drip.
Why is this study important?
This study aims to find out if cevostamab is an effective and safe new treatment option for people with multiple myeloma that has come back or is no longer responding to other therapies.
Will I have to stay in the hospital?
The study mentions you must be able to comply with required hospital stays, so it's likely there will be some hospitalisation, particularly at the start of treatment.
What happens if I want to stop taking part?
You are free to leave the study at any time, for any reason, and this will not affect your standard medical care.
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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