Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Janssen Scientific Affairs, LLC
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
