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

Sponsor: Janssen Scientific Affairs, LLC

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05346835

Patient View

This EAP provides ciltacabtagene autoleucel (cilta-cel) OOS for multiple myeloma patients who meet USPI criteria and lack feasible alternatives. Eligibility requires a favorable benefit/risk assessment and informed consent. The intervention involves a one-time intravenous infusion of cilta-cel OOS. Women of childbearing potential must test negative for pregnancy before treatment.

Patient Parameters

Program Overview

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.

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

Get This Program In Your Inbox

You can sign up and apply your patients for this program.