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

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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