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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
Janssen Scientific Affairs, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

    First Posted
    March 21, 2022
    Last Updated
    October 4, 2022
    Sponsor
    Janssen Scientific Affairs, LLC
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    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
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    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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