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

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ClinicalTrials.gov Identifier: NCT05346835
Expanded Access Status : Available
First Posted : April 26, 2022
Last Update Posted : October 5, 2022
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC

Tracking Information
First Submitted Date March 21, 2022
First Posted Date April 26, 2022
Last Update Posted Date October 5, 2022
 
Descriptive Information
Brief Title Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-Cel) Out-of-Specification (OOS) in Participants 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.
Detailed Description Not Provided
Study Type Expanded Access
Expanded Access Type Intermediate-size Population
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.
Other Name: JNJ-68284528
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Available
Contacts
Contact: Study Contact 1-800-JANSSEN (1-800-526-7736) Janssenmedinfo@its.jnj.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT05346835
Current Responsible Party Janssen Scientific Affairs, LLC
Original Responsible Party Same as current
Current Study Sponsor Janssen Scientific Affairs, LLC
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Janssen Scientific Affairs, LLC
Verification Date October 2022