Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2025-12-24 @ 10:12 PM
NCT ID:
NCT05346835
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
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05346835
Study Brief:
Protocol Section:
NCT05346835