A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma
This research study is looking at the best way to treat multiple myeloma, a type of blood cancer, in people who have recently been diagnosed. It's comparing two different treatment approaches. Both start with a combination of medicines (Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone). After this initial treatment, one group of patients will receive a special cell therapy called Cilta-cel. The other group will have a stem cell transplant. Doctors want to find out if Cilta-cel or a stem cell transplant is more effective in keeping the cancer from coming back and how well patients respond to the treatment. About 750 people will take part, with half getting one treatment path and half getting the other.
At a glance
What is this study about?
You might be reading this because you, or someone you know, has recently been diagnosed with multiple myeloma. This is a cancer of certain white blood cells called plasma cells, which are found in your bone marrow. These cells normally help fight infections, but in multiple myeloma, they grow too much and can cause problems in your body.
Doctors are always looking for better ways to treat multiple myeloma, and this study aims to do just that. It's comparing two different treatment plans for people who are newly diagnosed. Both plans start with a four-drug combination. After these initial drugs, one group will receive a newer type of treatment called Cilta-cel, which is a 'CAR-T cell' therapy. This treatment uses your own specially modified immune cells to fight the cancer. The other group will receive what's currently considered a standard strong treatment for newly diagnosed patients – a stem cell transplant.
The main goal of this study is to see which of these paths is better at stopping the cancer from growing or coming back, and also to see if one treatment helps more patients achieve a very deep and lasting response where the cancer cells become undetectable. By comparing these two approaches, researchers hope to improve future treatments for multiple myeloma.
Key takeaways
- This study compares two different treatment plans for newly diagnosed multiple myeloma.
- One path involves a cell therapy called Cilta-cel; the other uses a stem cell transplant.
- Both treatment paths start with the same combination of four medicines.
- The main goal is to find out which treatment is better at controlling the cancer long-term.
- About 750 participants will be randomly assigned to one of the two groups.
- Long-term follow-up is involved to track how well the treatments work and if side effects occur.
Who may be eligible?
To be part of this study, you would need to have been recently diagnosed with multiple myeloma. Doctors should also have determined that a strong treatment, like a stem cell transplant, would normally be part of your initial treatment plan. We'll need to see that your cancer can be measured in your blood or urine. Also, you need to be generally well and able to carry out your daily activities without much trouble.
There are some reasons why you might not be able to join. For example, if you've already had certain types of cell therapy (like other CAR-T therapies), or if you've already received a treatment that targets a specific protein called BCMA. You also can't have had any other treatment for multiple myeloma before this study, apart from a short course of steroids.
Other reasons that might prevent you from joining include a history of your myeloma affecting your brain or spine, or if you've had a stroke or seizure recently. We also need to check that your blood test results are within a healthy range.
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 been recently diagnosed with multiple myeloma?
- Has my doctor said a stem cell transplant is usually part of my treatment plan?
- Am I generally well and able to go about my daily activities?
- Have I had any previous treatment for multiple myeloma (apart from a short course of steroids)? (If yes, you might not be eligible)
- Do I have any other serious health conditions like a recent stroke or seizures, or my myeloma affecting my brain/spine?
- Have I had previous CAR-T cell therapy or other specific immune treatments?
What does participation involve?
If you decide to take part in this study, you'll first undergo some checks to make sure the study is right for you. If you qualify, you'll be randomly assigned to one of two treatment groups, like flipping a coin, so it's fair. You will receive an initial course of four drugs. After this, depending on your group, you'll either have Cilta-cel cell therapy or an autologous stem cell transplant. Both of these are complex treatments that take place in a hospital.
Throughout the study, you'll have regular hospital visits, blood tests, and other examinations to check how you're responding to treatment and to monitor for any side effects. This will continue for a number of years, even after your main treatment is finished, to see how you're doing long-term. The total duration of your participation in the study will involve initial treatment, active follow-up, and then longer-term monitoring, which can span several years to assess the lasting effects of the treatment.
Potential risks and benefits
Locations (106)
- University of ArkansasVerified postcodeLittle Rock, United States
- City of HopeVerified postcodeDuarte, United States
- UC San Diego Health Moores Cancer CenterVerified postcodeSan Diego, United States
- University of California San Francisco (UCSF)Verified postcodeSan Francisco, United States
- Stanford UniversityVerified postcodeStanford, United States
- Moffit Cancer CenterVerified postcodeTampa, United States
- Emory University HospitalVerified postcodeAtlanta, United States
- University of ChicagoVerified postcodeChicago, United States
- University of IowaVerified postcodeIowa City, United States
- University Of Maryland Medical CenterVerified postcodeBaltimore, United States
- Massachusetts General HospitalVerified postcodeBoston, United States
- Boston Medical CenterVerified postcodeBoston, United States
Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that affects plasma cells, which are a kind of white blood cell found in your bone marrow. These cells normally help your body fight infection.
What is a 'stem cell transplant'?
A stem cell transplant involves giving you high-dose chemotherapy to kill cancer cells, followed by new, healthy blood-forming cells (stem cells) to help your body recover.
What is 'Cilta-cel'?
Cilta-cel is a special type of cell therapy that uses your own immune cells, called T-cells. These cells are taken from your blood, changed in a lab to better fight cancer, and then given back to you.
How will I know which treatment I get?
You will be randomly assigned to one of the two treatment groups, like drawing lots. Neither you nor your doctor will get to choose which group you are in, to make the comparison fair.
Can I stop being in the study at any time?
Yes, taking part is voluntary. You can decide to leave the study at any point, for any reason, and it won't affect your future medical care.
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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