Official Title
Intermediate-Size Population Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) in Patients With Multiple Myeloma
Brief Summary

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.

Intermediate-size Population
Multiple Myeloma

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

Eligibility 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

Eligibility Gender
Eligibility Age
Minimum: 18 Years

Study Contact
1-800-JANSSEN (1-800-526-7736)

Janssen Scientific Affairs, LLC
NCT Number
MeSH Terms
Multiple Myeloma
Neoplasms, Plasma Cell