Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-Cel) Out-of-Specification (OOS) in Participants With Multiple Myeloma

Janssen (J&J Innovative Medicine)

Status

Conditions: Multiple Myeloma

Treatments: Drug: Cilta-cel OOS Therapy

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT05346835

68284528MMY4006 (Other Identifier)

CR108968

Details and patient eligibility

About

The purpose of this expanded access program (EAP) is to provide ciltacabtagene autoleucel (cilta-cel) that does not meet the commercial release specifications of CARVYKTI and is not available via the local health care system in the country where the treatment is requested.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Eligible for treatment with cilta-cel per United States Prescribing Information (USPI)
• Has serious or life-threatening multiple myeloma per USPI, and where re-apheresis, re-manufacturing, or other anti-myeloma directed therapy is not considered feasible or adequate per treating physician discretion
• Favorable participant benefit/risk assessment determined by Janssen medical review
• Treating physician confirms the favorable risk benefit profile, and that proceeding with this treatment is in the best interest of the participant
• Able to provide informed consent indicating they understand the purpose of this expanded access program (EAP)
• 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