A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy
This research study is about finding better ways to treat multiple myeloma, a cancer affecting certain white blood cells. It's for people newly diagnosed with multiple myeloma who are not planned to have a stem cell transplant as their first treatment. The study has two main groups. One group will receive a combination of standard treatments (Bortezomib, Lenalidomide, and Dexamethasone), followed by a single dose of a new cell therapy called cilta-cel. The other group will receive the same standard treatments but will then continue with two of those medicines (Lenalidomide and Dexamethasone) for ongoing care. The main goal is to see if the group receiving the new cilta-cel treatment stays cancer-free for longer.
At a glance
What is this study about?
Multiple myeloma is a type of cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. These cells normally help fight infections. When you have multiple myeloma, these cells become abnormal and can cause problems in the body. This study is designed to explore whether a new treatment approach can help people with newly diagnosed multiple myeloma live longer without their cancer getting worse.
The new treatment involves a type of therapy called CAR-T cell therapy, specifically one called cilta-cel. This therapy uses your own immune cells, called T-cells, which are specially modified in a lab to recognise and attack the cancer cells. The study is comparing this innovative approach against a more standard way of treating multiple myeloma. By doing this comparison, researchers hope to understand if the new treatment offers a significant improvement for patients.
It's important to note that this study is for individuals who are not planning to have a stem cell transplant as their very first treatment for multiple myeloma. This could be due to various reasons, such as their age or other health conditions. The study will carefully monitor participants over several years to track how effective each treatment is and to ensure patient safety.
Key takeaways
- Compares a new cell therapy (cilta-cel) with standard care for multiple myeloma.
- For adults newly diagnosed with multiple myeloma who aren't having a stem cell transplant.
- Aims to see if the new treatment helps people stay cancer-free longer.
- Involves regular health checks and assessments over a long period.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is looking for adults aged 18 and over who have recently been diagnosed with multiple myeloma. To be considered, your diagnosis must meet specific medical standards, and your cancer must be measurable, meaning doctors can track it through tests. You also need to be generally well enough to take part, as assessed by a doctor.
A key requirement is that you are not planning to have a stem cell transplant as your initial treatment for multiple myeloma. This might be because of your age, or if you have other health conditions that would make a transplant too risky. It could also be that a transplant isn't being considered as your first step.
There are also specific blood test results and other health checks you'd need to pass to make sure it's safe for you to participate in the study. For women who could become pregnant, special precautions and pregnancy tests will be required throughout 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 recently been diagnosed with multiple myeloma?
- Am I 18 years old or older?
- Am I not planning to have a stem cell transplant as my very first treatment?
- Am I generally well enough to take part in a study, as my doctor would confirm?
- Do I understand and agree to the need for regular checks and tests?
What does participation involve?
If you decide to take part in this study, it will involve several stages over a long period, approximately 12 years and 5 months in total. Initially, there will be a screening period lasting up to 28 days to confirm you're eligible. Following this, you'll enter the treatment phase, where you'll receive specific medications for multiple myeloma. Depending on which group you're in, this could include a new cell therapy called cilta-cel.
Throughout the study, you'll have regular appointments for various assessments. These will include check-ups like measuring your heart activity (ECG), vital signs (like blood pressure and pulse), and blood tests to monitor your health and how the treatment is working. Some assessments will involve asking you about your well-being. It's a long-term commitment designed to carefully track your health and the treatment's effects.
Potential risks and benefits
Locations (136)
- UCSFVerified postcodeSan Francisco, United States
- Yale Cancer CenterVerified postcodeNew Haven, United States
- University of Miami Health SystemVerified postcodeMiami, United States
- AdventHealth Cancer InstituteVerified postcodeOrlando, United States
- University of Iowa Hospitals and ClinicsVerified postcodeIowa City, United States
- University of KentuckyVerified postcodeLexington, United States
- Norton Cancer InstituteVerified postcodeLouisville, United States
- University Of Maryland Medical CenterVerified postcodeBaltimore, United States
- Beth Israel Deaconess Medical CenterVerified postcodeBoston, United States
- Barbara Ann Karmanos Cancer InstituteVerified postcodeDetroit, United States
- Henry Ford Cancer InstituteVerified postcodeDetroit, United States
- Columbia University Medical CenterVerified postcodeNew York, United States
Common questions
What is multiple myeloma?
Multiple myeloma is a cancer of bone marrow cells called plasma cells, which are important for your immune system.
What is cilta-cel therapy?
Cilta-cel is a new type of therapy that uses your own specially modified immune cells to find and destroy cancer cells.
Who is this study for?
This study is for adults newly diagnosed with multiple myeloma who are not planning to receive a stem cell transplant as their first treatment.
How long will the study last?
The study is expected to last for a long time, about 12 years and 5 months, including follow-up.
Will I receive the new treatment?
Participants will be assigned to one of two groups; one receives the new treatment (cilta-cel) with standard therapy, and the other receives standard therapy only.
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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