A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma (r/r MM)
This study is investigating a new medication called cemsidomide, given together with dexamethasone, for patients who have multiple myeloma that has either returned after treatment or hasn't responded to previous therapies. This type of study, called a Phase 2 trial, aims to find out how effective this new drug combination is in shrinking the cancer or stopping it from growing. We are also looking at how safe it is and what side effects people might experience. The main goal is to see how many patients respond positively to the treatment, and we will also be monitoring how long the treatment works, how long people live, and the levels of the drug in their body.
At a glance
What is this study about?
This research study is about a type of cancer called multiple myeloma. This disease affects certain white blood cells in your bone marrow. Sometimes, treatments don't work as well as hoped, or the cancer comes back after getting better. This is called 'relapsed' or 'refractory' multiple myeloma.
The study is testing a new drug called cemsidomide when it's given along with another common medicine for multiple myeloma called dexamethasone. The main aim is to see how well this new combination works in real patients. They want to find out if it can help stop the cancer from growing or even shrink it.
This is a 'Phase 2' study, which means it's an important step in understanding new treatments. Researchers are not only looking at how effective the treatment is, but also carefully checking for any side effects and how safe it is for people to take. This information helps doctors understand if this new treatment could be a good option for future patients.
Key takeaways
- This study is testing a new drug for multiple myeloma.
- It's for people whose cancer has returned or didn't respond to previous treatments.
- The new drug, cemsidomide, is given with another medicine, dexamethasone.
- The main goal is to see if the treatment works and how safe it is.
- Participants will be closely monitored by doctors.
Who may be eligible?
To join this study, people must be at least 18 years old. There's no upper age limit, so older adults can also take part. Both men and women are welcome to participate.
Because this study is specifically for relapsed or refractory multiple myeloma, it means participants must have been diagnosed with multiple myeloma that has either returned after previous treatment or hasn't improved as expected with other therapies. You will have had prior treatments for your multiple myeloma.
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?
- Do you have multiple myeloma?
- Has your multiple myeloma come back after treatment?
- Or, has your multiple myeloma not responded well to past treatments?
- Have you had previous treatments for multiple myeloma?
What does participation involve?
If you decide to take part in this study, you will receive the study drug, cemsidomide, in combination with dexamethasone. You will have regular visits to the clinic for medical check-ups, blood tests, and other assessments to see how you are responding to the treatment and to monitor for any side effects. These visits will likely include physical examinations and discussions about how you are feeling. Throughout the study, doctors will be closely tracking your health.
The total length of time you participate will depend on how well the treatment works for you and if you experience any side effects. You will continue treatment for as long as it is helping and is safe for you. After stopping treatment, there will be follow-up appointments to check on your long-term health and the lasting effects of the treatment.
Potential risks and benefits
Locations (4)
- —UnverifiedItaly
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedPoland
Common questions
What is relapsed/refractory multiple myeloma?
This means your multiple myeloma has either come back after past treatments or hasn't responded well to the treatments you've already had.
What is cemsidomide?
Cemsidomide is a new drug being tested for people with multiple myeloma. It's not yet widely available.
What is dexamethasone?
Dexamethasone is a steroid medicine often used with other treatments for multiple myeloma.
What does 'Phase 2' mean?
A Phase 2 study is an early stage of research to see if a new treatment works and is safe. It often involves a smaller group of people.
Will I definitely get better on this treatment?
No, there's no guarantee the treatment will work for everyone, but the study aims to see how many people might benefit.
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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