Mass General - Division of Clinical Research

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

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

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

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

Arm	Description	Assigned Intervention
Experimental Ciltacabtagene Autoleucel (Cilta-cel)	Eligible participants will receive bridging therapy (that is, anti-plasma cell directed treatment) based on participant's clinical status and timing of availability of cilta-cel (JNJ-68284528) along with lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square [mg/m^2] intravenous [IV] and fludarabine 30 mg/m^2 IV daily, for 3 days). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants will receive a single IV infusion of cilta-cel (JNJ-68284528) at a total targeted dose of 0.75*10^6 chimeric antigen receptor (CAR)-positive viable T cells per kilogram (cells/kg).	Drug: Cilta-cel Cilta-cel will be administered as an IV infusion. Other names: JNJ-68284528 Drug: Lymphodepleting Therapy (Cyclophosphamide and Fludarabine) Lymphodepleting therapy (cyclophosphamide and fludarabine) will be administered intravenously.