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

Phase 2

• Conditions: Multiple Myeloma

• Registration Number: JPRN-jRCT2053220159
• Lead Sponsor: Fujikawa Ei

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 330

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified