Isatuximab in Combination With Novel Agents in RRMM - Master Protocol
This research is investigating new ways to treat multiple myeloma, a type of blood cancer. Specifically, it's looking at a drug called isatuximab when combined with several other new medicines, sometimes with or without an additional steroid called dexamethasone. The study focuses on patients whose myeloma has returned after previous treatments or hasn't responded to them (this is called 'relapsed or refractory' myeloma). By testing different drug combinations, researchers hope to find more effective treatments to help these patients. The study is divided into several smaller studies, each looking at a different combination of drugs.
At a glance
What is this study about?
This study is focused on a type of blood cancer called multiple myeloma. In multiple myeloma, certain white blood cells in your bone marrow grow abnormally. When these cells multiply too much, they can cause problems throughout your body. For many patients, treatment can help, but sometimes the cancer comes back or doesn't respond well to standard treatments. This is often called 'relapsed or refractory' multiple myeloma.
Researchers are always looking for better and more effective treatments. In this particular study, they are investigating a drug called isatuximab alongside several other newer medicines. Isatuximab is a type of antibody therapy that targets specific cells. The study aims to see how well these new combinations work together, sometimes with or without an additional steroid medicine called dexamethasone, to control the cancer and improve patient outcomes.
The study is set up like an 'umbrella' with several smaller studies underneath it, each looking at different drug combinations. The goal is to carefully test these new approaches to find out which ones are most promising for patients who have limited treatment options left.
Key takeaways
- This study is testing new drug combinations for multiple myeloma.
- It focuses on patients whose cancer has returned or hasn't responded to previous treatments.
- The main drug being studied is isatuximab, often with other new medicines.
- Participation could last up to about 28 months, with regular medical check-ups.
- You might get access to new treatments, but there's no guarantee of benefit.
- You can withdraw from the study at any time without affecting your care.
Who may be eligible?
To join this study, people generally need to be 18 years or older. They should also be well enough to take part, meaning they can mostly do their usual activities without too much difficulty. Participants must have multiple myeloma that has either returned after previous treatments or hasn't responded to them, and they should have had at least two different types of myeloma treatments before.
The study also looks for specific signs of myeloma in blood or urine tests, like certain protein levels. Both men and women who could potentially have children must agree to use effective birth control during the study. Some parts of the study might have additional rules based on whether you've had specific types of anti-CD38 or anti-BCMA treatments in the past, and how recently.
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 that has come back or not responded to previous treatments?
- Have you already had at least two different treatments for your myeloma?
- Are you generally well enough to do your daily activities?
- Are you willing to use contraception if necessary during the study?
- Can your myeloma be measured by blood or urine tests?
What does participation involve?
If you join this study, you will receive treatment with the study drugs. You will continue with this treatment for as long as it is helping you and you are tolerating it well. This could be for up to about 28 months. Throughout the study, you will have regular visits to the clinic for medical check-ups, blood tests, and to see how the treatment is affecting you and your myeloma. You might also have imaging scans or other procedures to monitor your health and the cancer. The study is carefully monitored by doctors and other healthcare professionals.
Potential risks and benefits
Locations (28)
- Winship Cancer Institute of Emory University- Site Number : 8400010Verified postcodeAtlanta, United States· Recruiting
- University of Illinois-Chicago - College of Medicine- Site Number : 8400007Verified postcodeChicago, United States· Completed
- University of Michigan Health System - Ann Arbor- Site Number : 8400004Verified postcodeAnn Arbor, United States· Recruiting
- Roswell Park Cancer Institute- Site Number : 8400008Verified postcodeBuffalo, United States· Recruiting
- The Ohio State University- Site Number : 8400012Verified postcodeColumbus, United States· Recruiting
- Investigational Site Number : 0360006Verified postcodeWollongong, Australia· Recruiting
- Investigational Site Number : 0360002Verified postcodeMelbourne, Australia· Recruiting
- Investigational Site Number : 0360001Verified postcodeRichmond, Australia· Recruiting
- Investigational Site Number : 2500003Verified postcodeParis, France· Recruiting
- Investigational Site Number : 2500002Verified postcodeLille, France· Recruiting
- Investigational Site Number : 2500001Verified postcodeNantes, France· Recruiting
- Investigational Site Number : 2500004Verified postcodeParis, France· Recruiting
Common questions
What is multiple myeloma?
Multiple myeloma is a cancer of the plasma cells, which are a type of white blood cell found in the bone marrow.
What does 'relapsed or refractory' mean?
It means the cancer has come back after treatment (relapsed) or hasn't responded to previous treatments (refractory).
What is isatuximab?
Isatuximab is a targeted drug that works by helping your immune system find and kill myeloma cells.
How long will I take part in the study?
You could be on the study treatment for up to about 28 months, or for as long as it's helping you and you're feeling well.
Can I leave the study at any time?
Yes, you can choose to stop participating in the study at any point, and it won't affect your future medical care.
How to find out more
Trial Transparency email recommended (Toll free number for US & Canada)
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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