This study is not accepting new patients

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

a study on Multiple Myeloma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco 5391959, California 5332921 and other locations
Dates
study started

Description

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.

Official Title

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

Keywords

Multiple Myeloma, Cilta-cel OOS Therapy

Eligibility

For people ages 18 years and up

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

Locations

  • UCSF not accepting new patients
    San Francisco 5391959 California 5332921 94143 United States
  • Stanford University Medical Center not accepting new patients
    Stanford 5398563 California 5332921 94305 United States

Details

Status
not accepting new patients
Start Date
Sponsor
Janssen Scientific Affairs, LLC
ID
NCT05346835
Study Type
Expanded Access
Last Updated
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