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Active not recruitingPHASE2INTERVENTIONAL

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

Status
Active not recruiting
Phase
PHASE2
Sponsor
Janssen Research & Development, LLC
Enrolment target
208
Start
07 Nov 2019
Estimated completion
03 Sep 2029

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.

  1. Are you 18 years old or older?
  2. Do you have multiple myeloma?
  3. Have you been told your cancer hasn't responded well to certain past treatments?
  4. Did your cancer return within 12 months of previous treatments or a stem cell transplant?
  5. Could you be newly diagnosed with myeloma and fall into a 'high-risk' category?
  6. Are you able to commit to regular hospital visits and follow-ups?
Answer every question to see your result.

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

Taking part in any clinical trial has potential benefits and risks. You might benefit from receiving a new treatment that isn't yet widely available, and it could be very effective for your condition. However, new treatments can also have side effects, and it's possible that this therapy might not work for everyone. Some of the medications used in the study are already known, but JNJ-68284528 is new, and its full range of effects is still being understood. The study team will explain all the known risks and potential side effects in detail. Remember, choosing to join a study is always your decision, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (47)

  • University Of California San Diego
    Verified postcode
    San Diego, United States
  • University of California San Francisco
    Verified postcode
    San Francisco, United States
  • Yale University School Of Medicine
    Verified postcode
    New Haven, United States
  • Moffitt Cancer Center
    Verified postcode
    Tampa, United States
  • Emory University
    Verified postcode
    Atlanta, United States
  • Northwestern University
    Verified postcode
    Chicago, United States
  • University of Chicago
    Verified postcode
    Chicago, United States
  • Indiana University
    Verified postcode
    Indianapolis, United States
  • University of Iowa Hospitals and Clinics
    Verified postcode
    Iowa City, United States
  • University of Kansas Cancer Center
    Verified postcode
    Westwood, United States
  • Norton Cancer Institute
    Verified postcode
    Louisville, United States
  • Dana Farber Cancer Institute
    Verified postcode
    Boston, 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.

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