Study on CAR-T Cell Therapy JNJ-68284528 for Treating Multiple Myeloma
Sponsor: Janssen Research & Development, LLC
Sponsor score: 60
Inactive
ClinicalTrials ID:NCT04133636
This clinical trial is testing a new CAR-T cell therapy, JNJ-68284528, to see if it can effectively treat multiple myeloma by reducing the amount of cancer cells left in the body after treatment.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate how well the new CAR-T cell therapy, JNJ-68284528, works in treating multiple myeloma by achieving a state where minimal cancer cells remain in the body.
Eligibility Criteria
Inclusion Criteria
- Participants in different groups based on their previous treatments and current condition:
- Group A: Had 1 to 3 previous treatments, including specific drugs, and the cancer did not respond to lenalidomide.
- Group B: Had one previous treatment and the cancer returned within 12 months after stem cell transplant or starting treatment.
- Group C: Previously treated with specific drugs and therapies targeting BCMA.
- Group D: Newly diagnosed with multiple myeloma and had 4 to 8 cycles of initial treatment, including stem cell transplant.
- Group E: Newly diagnosed, high-risk multiple myeloma with specific lab results or genetic features.
- Group F: Showed a good response to initial treatment with specific drug combinations.
- Group G: Not suitable for high-dose chemotherapy and stem cell transplant due to age, health conditions, or personal choice.
- Group H: Suitable for high-dose chemotherapy and stem cell transplant.
- Must have a certain level of cancer protein in blood or urine, or measurable disease by scans.
- Good overall health with a performance status score of 0 or 1.
Exclusion Criteria
- Cannot have had previous BCMA-targeted therapy or CAR-T therapy.
- Must not have unresolved side effects from previous cancer treatments, except for hair loss or mild nerve damage.
- Cannot have taken high doses of steroids recently.
- No serious medical conditions like active infections, autoimmune diseases, or mental health issues.
- No history of cancer affecting the brain or spinal cord.
- No other active cancers, except for certain types that are considered cured or very low risk.
- Must not be frail according to a specific assessment for certain groups.
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