Study Comparing CAR-T Therapy JNJ-68284528 with Standard Treatments for Relapsed Multiple Myeloma

Inclusion Criteria

• Have measurable multiple myeloma at the start of the study, which means certain protein levels in the blood or urine are above specific thresholds.
• Have received 1 to 3 previous treatments, including a proteasome inhibitor and an immunomodulatory drug.
• Show evidence of disease progression based on specific criteria within 6 months of the last treatment.
• Be resistant to lenalidomide, meaning the disease did not respond or got worse during or shortly after treatment with lenalidomide.
• Meet specific blood and organ function criteria, such as:
  • Hemoglobin level of at least 8 g/dL without recent blood transfusions.
  • Neutrophil count of at least 1,000 per microliter without recent growth factor support.
  • Platelet count of at least 75,000 per microliter without recent transfusions.
  • Lymphocyte count of at least 300 per microliter.
  • Liver enzymes and bilirubin levels within specified limits.
  • Kidney function with an estimated filtration rate of at least 40 mL/min.

Exclusion Criteria

• Have had previous CAR-T cell therapy targeting any antigen.
• Have had any previous treatment targeting B-cell maturation antigen (BCMA).
• Have ongoing side effects from previous cancer treatments that have not returned to normal or mild levels, except for hair loss.
• Have certain levels of nerve damage, which may affect eligibility for specific standard treatments.
• Have taken a high dose of corticosteroids within 7 days before starting the study.
• Have received monoclonal antibody treatment within 21 days.
• Have received cytotoxic therapy within 14 days.
• Have received proteasome inhibitor therapy within 14 days.
• Have received immunomodulatory drug therapy within 7 days.