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

Conditions
Multiple Myeloma
Registration Number
NCT05346835
Lead Sponsor
Janssen Scientific Affairs, LLC
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
AVAILABLE
Sex
All
Target Recruitment
Not specified
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
Exclusion Criteria

Not provided

Study & Design

Study Type
EXPANDED_ACCESS
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (116)

University of Alabama at Birmingham

🇺🇸

Birmingham, Alabama, United States

Banner MD Anderson Cancer Center

🇺🇸

Gilbert, Arizona, United States

Cancer Treatment Center of America Phoenix

🇺🇸

Goodyear, Arizona, United States

HonorHealth Cancer Transplant Institute

🇺🇸

Scottsdale, Arizona, United States

Mayo Clinic

🇺🇸

Jacksonville, Florida, United States

University of Arizona Cancer Center

🇺🇸

Tucson, Arizona, United States

The University of Arkansas for Medical Sciences Myeloma Institute for Research and Therapy

🇺🇸

Little Rock, Arkansas, United States

City of Hope

🇺🇸

Duarte, California, United States

University of California at San Diego

🇺🇸

La Jolla, California, United States

USC Norris Comprehensive Cancer Center

🇺🇸

Los Angeles, California, United States

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University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States

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