UPCC 39422 Intermediate-Size Population Expanded Access Program (EAP) for Ciltacabtagene autoleucel (cilta-cel) Out-of-Specification (OOS) in patients with Multiple Myeloma

Investigation of an Investigational Treatment for Multiple Myeloma

Enrolling By Invitation
18 years or above
All
Phase N/A
1 Location

Brief description of study

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 of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Multiple Myeloma
  • Age: 18 years or above
  • Gender: All

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

This study investigates the use of an investigational treatment for patients with multiple myeloma. The purpose of this study is to provide access to ciltacabtagene autoleucel, a treatment that is not available through the local healthcare system, for patients whose condition is serious or life-threatening and who cannot use other therapies.

Participants in this study will receive ciltacabtagene autoleucel, which involves the use of genetically modified cells to target and destroy cancer cells. Before receiving the treatment, participants must undergo specific testing, including a pregnancy test for women of childbearing potential. This study does not involve any changes to the participant's usual treatment regimen outside of the investigational therapy.

  • Who can participate: Participants must have serious or life-threatening multiple myeloma and be eligible for treatment with ciltacabtagene autoleucel according to US guidelines. They must be able to provide informed consent and, if applicable, have a negative pregnancy test before treatment.
  • Study details: Participants will receive ciltacabtagene autoleucel, an investigational treatment, as part of this study. Before starting the treatment, women of childbearing potential must have a negative pregnancy test. The study focuses on providing access to this treatment for eligible patients.
Updated on 13 Feb 2026. Study ID: 22-1616
If you need assistance finding a non-cancer clinical research study or if you have any questions, please email psom-ocr@pobox.upenn.edu For Cancer trials contact Penn Medicine's Cancer Trial Navigator at: PMCancerResearch@pennmedicine.upenn.edu or 215-349-8245

Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

Contact Abramson Cancer Center Navigator