A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple Myeloma

Overview

The purpose of this study is to evaluate the efficacy and safety of cilta-cel out-of-specification (OOS).

SparkCures ID 1286
Trial Phase Phase 2
Enrollment 86 Patients
Treatments
Trial Sponsors
  • Janssen Research & Development
NCT Identifier

NCT05347485

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Eligible for treatment with cilta-cel per United States prescribing information (USPI) or locally approved label
  • Participant is suffering from serious or life threatening multiple myeloma per USPI (or locally approved label, respectively), and re-apheresis, re-manufacturing, or other anti-myeloma directed therapies is not considered feasible or adequate per investigator
  • Has adequate general health status and organ function per investigator assessment and meets the criteria to receive cilta-cel out-of-specifications (OOS)
  • Meets the criteria to receive lymphodepleting chemotherapy
  • A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) pregnancy test at consenting and prior to the first dose of cyclophosphamide and fludarabine

Exclusion Criteria:

  • History of active uncontrolled infection or condition where an administration of cilta-cel OOS constitutes serious health risk to the participant
  • Known allergies, hypersensitivity, or intolerance to the excipients of cilta-cel OOS including dimethyl sulfoxide (DMSO), dextran 40, or residual kanamycin per USPI
  • Hepatitis B infection
  • Hepatitis C infection defined as (anti hepatitis C virus [HCV] antibody positive or detectable HCV ribonucleic acid [RNA]) or known to have a history of hepatitis C
  • Seropositive for human immunodeficiency virus (HIV)
  • Uncontrolled autoimmune disease

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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