A Study to Investigate the Clinical Benefit of Isatuximab in Combination With Bortezomib, Lenalidomide and Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant
This research study is investigating a new combination treatment for adults who have recently been diagnosed with multiple myeloma, a cancer affecting plasma cells in the blood. The study particularly focuses on individuals who, due to their age (65 or older) or other health problems, are not suitable for a stem cell transplant. The main goal is to see if adding a new drug called isatuximab to an existing treatment (which includes bortezomib, lenalidomide, and dexamethasone) can help people live longer without their cancer progressing. Researchers will also look at how well the treatment shrinks the cancer, how long the effects last, and the overall quality of life for participants, while also checking for any side effects.
At a glance
What is this study about?
This study is for adults recently diagnosed with multiple myeloma, a type of cancer that affects certain white blood cells in your body. It's specifically for people who, because of their age (65 or older) or other health conditions, are not able to have a stem cell transplant, which is a common treatment for this type of cancer. The study wants to find out if adding a new medicine called isatuximab to a standard combination of drugs (bortezomib, lenalidomide, and dexamethasone) can make the treatment more effective.
The main thing the researchers want to learn is if this new combination helps people live longer without their cancer getting worse. They will also be looking at other important things, like how many people have their cancer shrink, how long the treatment keeps the cancer under control, and how people feel in terms of their quality of life. Understanding these points helps doctors decide the best way to treat multiple myeloma.
By taking part, you would be helping doctors learn more about multiple myeloma and potentially find better ways to treat it for future patients. This kind of research is really important for improving care and outcomes for people living with this condition.
Key takeaways
- This study is for adults with newly diagnosed multiple myeloma who cannot have a stem cell transplant.
- It tests a new drug, isatuximab, combined with standard treatments.
- The main goal is to see if the new combination helps people live longer without their cancer progressing.
- Participation involves regular hospital visits, tests, and taking study medications.
- You can withdraw from the study at any time.
- It's important to discuss all aspects with your doctor before deciding to join.
Who may be eligible?
To join this study, you must be an adult aged 18 to 80 years old who has recently been diagnosed with multiple myeloma. Crucially, you should also be unsuitable for a stem cell transplant, either because you are 65 years old or older, or because you are under 65 but have other health issues that make a transplant too risky. You also need to have clear signs that your multiple myeloma can be measured by doctors.
There are also some reasons why you wouldn't be able to join. For example, if you are under 18 or have already received treatment for multiple myeloma. People with other serious illnesses that might interfere with the study, or those with very specific organ problems, cannot take part. Your general health also needs to be at a certain level, as assessed by a doctor.
Also, to ensure safety, pregnant or breastfeeding women cannot participate. Women who could become pregnant and men must agree to use effective birth control methods while in 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 you recently been diagnosed with multiple myeloma?
- Are you 18 to 80 years old?
- Have doctors told you that you cannot have a stem cell transplant for your myeloma?
- Do you have measurable signs of your multiple myeloma?
- Have you not received any prior treatment for multiple myeloma?
- If you are a woman who could become pregnant, are you willing to use effective contraception?
What does participation involve?
If you decide to take part in this study, your journey will involve a few stages. First, there's a screening period of up to four weeks when doctors will do tests to make sure you're a good fit for the study. After that, you'll enter the 'induction' period, which lasts 24 weeks (this involves four treatment cycles, each about six weeks long).
Following the induction, you'll move into a continuous treatment period, where each treatment cycle will be about four weeks long. Some people might also enter a 'crossover' period, which means they might switch treatment groups at some point. During all these periods, you'll receive the study medications (isatuximab, bortezomib, lenalidomide, and dexamethasone, or just bortezomib, lenalidomide, and dexamethasone, depending on your group). You'll have regular visits for check-ups, blood tests, and to assess how you're feeling and how the treatment is working. The total time you'll be involved in the study can vary and your study team will explain this in more detail.
Potential risks and benefits
Locations (104)
- Investigational Site Number: 8400006Verified postcodeFort Myers, United States
- Investigational Site Number: 8400004Verified postcodeSt. Petersburg, United States
- Investigational Site Number: 8400007Verified postcodeKansas City, United States
- Investigational Site Number: 8400005Verified postcodeNashville, United States
- Investigational Site Number: 8400001Verified postcodeHouston, United States
- Investigational Site Number : 0360003Verified postcodeLiverpool, Australia
- Investigational Site Number : 0360001Verified postcodeWaratah, Australia
- Investigational Site Number : 0360002Verified postcodeWollongong, Australia
- Investigational Site Number : 0360007Verified postcodeSouth Brisbane, Australia
- Investigational Site Number : 0360005Verified postcodeClayton, Australia
- Investigational Site Number : 0360004Verified postcodeHeidelberg West, Australia
- Investigational Site Number : 0360006Verified postcodeNedlands, Australia
Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that develops from plasma cells. These are white blood cells that help your body fight infections. In multiple myeloma, cancerous plasma cells build up in the bone marrow and can cause problems.
What does 'not eligible for transplant' mean?
This means that for various reasons, such as your age (65 or older) or other existing health conditions, a stem cell transplant (a common intensive treatment) isn't considered the safest or most suitable option for you.
What are 'isatuximab,' 'bortezomib,' 'lenalidomide,' and 'dexamethasone'?
These are all medicines used to treat multiple myeloma. Isatuximab is the drug being tested in combination with the other three, which are already established treatments.
Will I know if I'm getting the new drug combination or the standard one?
In this type of study, participants are usually split into groups by chance (like flipping a coin) to compare treatments fairly. Often, neither you nor your doctor will know which specific treatment you are receiving until the study is over, though there are safeguards in place.
How long will I have to be in the study?
The study involves a screening period of up to 4 weeks, an initial treatment period of 24 weeks, followed by a continuous treatment phase. The full duration will be discussed with you, but it's important to understand it's a long-term commitment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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