Dose-Escalation Study of Cevostamab in Participants with Relapsed or Refractory Multiple Myeloma
This research study is looking at a new potential treatment called Cevostamab for adults who have multiple myeloma. This is a type of cancer that affects a specific kind of white blood cell. Participants in this study have multiple myeloma that has either returned after previous treatments or hasn't improved with other medicines. This is the very first time Cevostamab is being given to people, so it's an early-stage study. The main goals are to find a safe dose of the medicine and to understand any side effects it might have. Researchers will also start to see if Cevostamab can help treat multiple myeloma. All adults, male and female, aged 18 and older, can be considered for this study.
At a glance
What is this study about?
This study is about a new medicine called Cevostamab, which doctors hope could help people living with multiple myeloma. Multiple myeloma is a type of cancer that starts in certain cells in your bone marrow. When these cells become cancerous, they can cause problems throughout your body.
For some people with multiple myeloma, the disease might come back after they've had treatment, or it might not get better with the medicines they've tried. This study is for these individuals. It's a very early-stage study, meaning it's the first time this new medicine, Cevostamab, is being given to humans. Researchers need to carefully find the right amount (dose) of the medicine that is safe for people to take.
By taking part, you would be helping doctors learn more about Cevostamab. They will be watching very closely to see if it causes any unwanted effects and also if it shows any signs of helping to treat multiple myeloma. This kind of research is really important for developing new treatments in the future.
Key takeaways
- This is an early-stage study testing a new medicine, Cevostamab, for multiple myeloma.
- It's for adults whose multiple myeloma has returned or not responded to prior treatments.
- The main goals are to find a safe dose and look for any side effects.
- Participation involves receiving the new medicine and close monitoring by doctors.
- You can stop participating at any time.
- Your doctor can help you decide if this study might be right for you.
Who may be eligible?
To be considered for this study, you must be an adult, 18 years old or older. The study is open to both men and women.
Crucially, you would need to have a diagnosis of multiple myeloma, and your condition must have either returned after you've received other treatments, or it hasn't responded well to the treatments you've tried so far. This means that if your multiple myeloma is currently well-controlled or you haven't received treatment yet, this particular study might not be suitable for you.
There will be other detailed health checks and specific medical criteria that the study doctors will go through with you to make sure it's safe and appropriate for you to participate.
- I am 18 years old or older.
- I have been diagnosed with multiple myeloma.
- My multiple myeloma has either returned after treatment or didn't get better with other medicines.
- I am willing to attend regular appointments and follow study instructions.
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 would receive the new medicine, Cevostamab. Because this is the first time the medicine is being given to people, there would likely be frequent visits to the clinic, especially at the beginning, so that the study team can carefully monitor your health and how you respond to the treatment. These visits would involve various assessments, which might include blood tests, physical examinations, and other tests to check on your multiple myeloma and look for any side effects.
The medication would be given in a way determined by the study protocol, and the duration of your participation would depend on how your body responds to the treatment and the safety results. There would also be follow-up appointments after you stop receiving the medication to ensure your health is still being monitored. The study team will explain the full schedule of visits, tests, and medication administration in detail.
Potential risks and benefits
Locations (1)
- —Spain
Common questions
What is Cevostamab?
Cevostamab is a new investigational medicine being tested for multiple myeloma. It's not yet approved for general use. 'Investigational' means it's still in the research phase.
Why is this study called 'Phase I'?
Phase I means it's the very first time the medicine is being given to people. The main goals are to find a safe dose and see how the body reacts to it, rather than primarily testing how well it cures the disease.
What does 'relapsed or refractory' multiple myeloma mean?
This means your multiple myeloma has either come back after you've had treatment, or it hasn't responded to the treatments you've tried in the past.
Will I get the actual medicine or a dummy treatment (placebo)?
This study is different from some others; in a dose-escalation study like this, all participants usually receive the active study medicine, Cevostamab, but at different doses.
How long will I be in the study if I join?
The total length of time you'd be in the study would be discussed by the research team. It can vary depending on your individual response and how well you tolerate the medicine.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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