Multiple Myeloma Support + Trials

What's the purpose of this trial?

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

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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 at consenting 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