Title
Intermediate-Size Population Expanded Access Program (EAP) for Ciltacabtagene autoleucel (cilta-cel) Out-of-Specification (OOS) in patients with Multiple Myeloma

Description
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.

Objective
This is an Expanded Access Protocol and does not have any investigational objectives. Other than providing the study drug, only safety information will be collected.

This Expanded Access (EAP) Protocol pertains to the provision of treatment by use of an investigational product. Such access may be considered for patients with serious/life-threatening diseases or conditions, where there are no alternative treatments or where alternative treatments have been exhausted. Cilta-cel OOS 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.

Treatment Drug: Cilta-cel OOS Therapy
Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) will be provided as a one-time administration as an intravenous infusion.
Other Name: JNJ-68284528

Key Eligibility 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

Applicable Disease Sites
Multiple Myeloma

Participating Institutions
UW Health University Hospital