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)
Dates
study started
Principal Investigator
by Thomas Martin
Headshot of Thomas Martin
Thomas Martin

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, Plasma Cell Neoplasms, 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

Lead Scientist at UCSF

  • Thomas Martin
    A leading expert in hematology-oncology, Dr. Thomas Martin is associate director of UCSF's myeloma program and director of the unrelated donor transplantation programs for adults at UCSF Medical Center. Martin is clinical research director of hematologic malignancies (blood cancers) at the UCSF Helen Diller Family Comprehensive Cancer Center.

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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