Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-Cel) Out-of-Specification (OOS) in Participants With Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Cilta-cel OOS Therapy
Sponsored by
About this trial
This is an expanded access trial for Multiple Myeloma
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT05346835
First Posted
March 21, 2022
Last Updated
October 4, 2022
Sponsor
Janssen Scientific Affairs, LLC
1. Study Identification
Unique Protocol Identification Number
NCT05346835
Brief Title
Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-Cel) Out-of-Specification (OOS) in Participants With Multiple Myeloma
Official Title
Intermediate-Size Population Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) in Patients With Multiple Myeloma
Study Type
Expanded Access
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Scientific Affairs, LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Cilta-cel OOS Therapy
Other Intervention Name(s)
JNJ-68284528
Intervention Description
Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) will be provided as a one-time administration as an intravenous infusion.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
1-800-JANSSEN (1-800-526-7736)
Email
Janssenmedinfo@its.jnj.com
12. IPD Sharing Statement
Learn more about this trial
Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-Cel) Out-of-Specification (OOS) in Participants With Multiple Myeloma
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