Last updated on July 2020

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


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Multiple Myeloma | Lymphoproliferative disorders | Lymphoproliferative Disorder
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Cohort A: Received a minimum of 1 to a maximum of 3 prior lines of therapy including a proteasome inhibitor (PI) and immunomodulatory therapy (IMiD), and lenalidomide refractory per International Myeloma Working Group (IMWG) guidelines
  • Cohort B: Received one line of prior therapy including a PI and an IMiD, and disease progression per IMWG criteria less than (<) 12 months after treatment with autologous stem cell transplantation (ASCT) or <12 months from the start of anti-myeloma therapy for participants who have not had an ASCT
  • Cohort C: Previously treated with a PI, an IMiD, an anti-CD38 monoclonal antibody and B-cell maturation antigen (BCMA)-directed therapy
  • Cohort D: Newly diagnosed multiple myeloma per IMWG with a history of 4 to 8 total cycles of initial therapy, including induction, high-dose therapy, and ASCT with or without consolidation

Cohort A, B, C

  • Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL) or urine M-protein level >=200 milligram (mg)/24 hours
  • Light chain multiple myeloma in whom only measurable disease is by serum free light chain (FLC) levels in the serum: Serum immunoglobulin FLC >=10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio
  • Cohort A, B, C, D: Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1

Exclusion Criteria:

  • Cohort A, B, D: Any therapy that is targeted to BCMA

Cohort A, B, C, D

  • Prior treatment with chimeric antigen receptor T (CAR-T) therapy directed at any target
  • Ongoing toxicity from previous anticancer therapy must resolve to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
  • Received a cumulative dose of corticosteroids equivalent to >=70 mg of prednisone within the 7 days (Cohort A, B, C) or 14 days (Cohort D) prior to apheresis
  • Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma
  • Serious underlying medical condition, such as (a) evidence of active viral or bacterial infection requiring systemic antimicrobial therapy, or uncontrolled systemic fungal infection; (b) active autoimmune disease or a history of autoimmune disease within 3 years; (c) overt clinical evidence of dementia or altered mental status; (d) any history of Parkinson's disease or other neurodegenerative disorder

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.