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

Trial ID or NCT#

NCT05347485

Status

not recruiting iconNOT RECRUITING

Purpose

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

Official Title

A Safety and Efficacy Study of JNJ-68284528 (Ciltacabtagene Autoleucel) Out-of-Specification (OOS) for Commercial Release in Patients With Multiple Myeloma

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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
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Investigator(s)

Surbhi Sidana, MD
Surbhi Sidana, MD
Blood and marrow transplant specialist, Hematologist-Oncologist
Assistant Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Contact us to find out if this trial is right for you.

Contact

Kristin Ana-Marie Muller
+1 650-725-1647

View on ClinicalTrials.gov