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NCT05346835 Clinical Trial

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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT05346835
Other study ID # CR108968
Secondary ID 68284528MMY4006
Status Available
Phase
First received
Last updated

Study information
Verified date December 2023
Source Janssen Scientific Affairs, LLC
Contact Study Contact
Phone 1-800-526-7736
Email Janssenmedinfo@its.jnj.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Janssen Scientific Affairs, LLC
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