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

ID#: NCT05347485

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: May 09, 2022

End Date: May 08, 2026

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

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 during screening 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