A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma
This study is investigating a new type of treatment called JNJ-68284528 for multiple myeloma, a cancer affecting a type of white blood cell. This therapy is a special kind of cell treatment designed to find and fight cancer cells. Researchers want to understand how often this new treatment can completely clear all signs of the cancer, even tiny amounts that are hard to detect, in different groups of patients with multiple myeloma. The study is in Phase 2, meaning it's still in the earlier stages of testing, after initial safety checks have been done, to see how effective the treatment is.
At a glance
What is this study about?
This research study is about a new way to treat multiple myeloma, a type of cancer that starts in your bone marrow. The treatment being looked at is called JNJ-68284528. It's a special kind of 'cell therapy'. This means doctors take some of your own immune cells, called T-cells, from your blood. They then cleverly change these cells in a lab so they become very good at finding and killing the myeloma cancer cells inside your body. Once they've been changed, these powerful cells are given back to you.
The main goal of this study is to see how well JNJ-68284528 works. Specifically, the researchers want to find out how many people who receive this treatment have no signs of their cancer left at all, even at a very tiny level that normal tests might miss. This is called achieving a 'minimal residual disease (MRD) negative rate'. Having an MRD negative result suggests the treatment has been very effective in getting rid of the cancer.
This study is important because multiple myeloma can be a challenging cancer to treat. Researchers are always looking for new and more effective treatments, especially for people whose cancer has come back or hasn't responded well to other therapies. By testing JNJ-68284528, they hope to get a better understanding of its potential benefits and how it might help patients in the future.
Key takeaways
- This study is testing a new cell therapy for multiple myeloma.
- The treatment uses your own immune cells to fight cancer.
- Researchers want to see if the treatment can clear all signs of cancer.
- It's for adults with multiple myeloma, including those who've had previous treatments or are newly diagnosed.
- You might receive other standard myeloma medications as part of the study.
- Taking part means regular check-ups and monitoring by the study team.
Who may be eligible?
This study is particularly looking for adults aged 18 or over who have been diagnosed with multiple myeloma. The study is divided into several groups, each with different requirements based on your past treatments and how your condition has progressed.
For example, some groups are for people who have already had certain treatments, like a proteasome inhibitor (PI) and an IMiD (immunomodulatory therapy), and whose cancer hasn't responded well to lenalidomide. Other groups are for those whose cancer returned within a year after a stem cell transplant or a year after starting their first anti-myeloma treatment. There are also specific groups for people who have received a particular set of treatments including an anti-CD38 antibody and another type of therapy that targets BCMA.
Some parts of this study are even looking at people who are newly diagnosed with multiple myeloma, either after they've had some initial intensive treatment, or if they have certain features that classify their cancer as 'high risk'. The doctors running the study will carefully check all your medical history to see if you meet the specific criteria for any of the study groups.
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?
- Have you been told your cancer hasn't responded well to certain past treatments?
- Did your cancer return within 12 months of previous treatments or a stem cell transplant?
- Could you be newly diagnosed with myeloma and fall into a 'high-risk' category?
- Are you able to commit to regular hospital visits and follow-ups?
What does participation involve?
If you join this study, you would receive the investigational cell therapy called JNJ-68284528. Depending on which group you're in, you might also receive other standard treatments for multiple myeloma, such as lenalidomide, daratumumab, bortezomib, or dexamethasone, either before or after the main study treatment. Taking part will involve regular visits to the hospital or clinic for check-ups, blood tests, and scans to monitor your health and how you're responding to the treatment. This is to make sure the treatment is safe and working as expected. They will also be looking closely for any remaining cancer cells. The total duration of your involvement could vary depending on the study group and your response, but these types of studies often involve an initial treatment period followed by a longer period of follow-up visits to track your progress.
Potential risks and benefits
Locations (47)
- University Of California San DiegoVerified postcodeSan Diego, United States
- University of California San FranciscoVerified postcodeSan Francisco, United States
- Yale University School Of MedicineVerified postcodeNew Haven, United States
- Moffitt Cancer CenterVerified postcodeTampa, United States
- Emory UniversityVerified postcodeAtlanta, United States
- Northwestern UniversityVerified postcodeChicago, United States
- University of ChicagoVerified postcodeChicago, United States
- Indiana UniversityVerified postcodeIndianapolis, United States
- University of Iowa Hospitals and ClinicsVerified postcodeIowa City, United States
- University of Kansas Cancer CenterVerified postcodeWestwood, United States
- Norton Cancer InstituteVerified postcodeLouisville, United States
- Dana Farber Cancer InstituteVerified 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 in your bone marrow.
What is JNJ-68284528?
It's a new type of cell therapy, where your own immune cells are specially trained to fight your cancer.
What does 'minimal residual disease (MRD)' mean?
MRD means that after treatment, there are no detectable cancer cells left, even with very sensitive tests.
Will I have to stop my current treatment to join?
This depends on the specific group you might fit into. The study rules are different for different situations, so speak to your doctor.
Is this treatment available outside the study?
No, as an investigational therapy in a Phase 2 study, JNJ-68284528 is not yet widely available outside of specific clinical trials like this one.
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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