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

Janssen Scientific Affairs, LLC (Industry)
Overall Status
CT.gov ID

Study Details

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 (cilta-cel out-of-specifications [OOS]) to appropriate adult participants (greater than or equal to 18 years) with relapsed/refractory multiple myeloma (MM).

Condition or Disease Intervention/Treatment Phase
  • Drug: Cilta-cel OOS Therapy

Study Design

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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)

    Contacts and Locations


    No locations specified.

    Sponsors and Collaborators

    • Janssen Scientific Affairs, LLC


    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Janssen Scientific Affairs, LLC
    ClinicalTrials.gov Identifier:
    Other Study ID Numbers:
    • CR108968
    • 68284528MMY4006
    First Posted:
    Apr 26, 2022
    Last Update Posted:
    Aug 16, 2022
    Last Verified:
    Aug 1, 2022
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 16, 2022