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

R
Rafat Abonour, MD

Primary Investigator

Enrolling By Invitation
18 years and older
All
Phase N/A
1 participants needed
1 Location

Brief description of study

What is the purpose of this 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 notvailable via the local health care system in the country where the treatment is requested.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.

Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

What is the purpose of this study?
Cilta-cel (CARVYKTI) is a an autologous BCMA-targeted CAR-T cell therapy for multiple myeloma. Patients undergo a procedure to harvest their t-cells (white blood cells) which are genetically modified to better fight the patient's cancer. The FDA approval for Cilta-cel requires for the cells to meet a range of specific standards. When those cells fail to meet those requirements they are considered to be "Out of specification;" these cells, however, could still be of benefit to the patient's treatment but can only be administered in an EAP. This EAP is to provide patients access to their Cilta-cel OOS as part of their treatment plan for their cancer care.

Eligibility of study

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

  • Conditions: Multiple Myeloma
  • Age: 18 Years
  • 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,ufacturing, or other anti-myeloma directed therapy is not considered feasible ordequate per treating physician discretion
  • Favorable participant benefit/risk assessment determined by Janssen medical review
  • Treating physician confirms the favorable risk benefit profile, and that proceedingwith this treatment is in the best interest of the participant
  • Able to provide informed consent indicating they understand the purpose of thisded 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 andhe first dose of cyclophosphamide and fludarabine

Updated on 01 Aug 2024. Study ID: CR108968, ECRO-JANSSEN-EAP-MMY4006, 15362
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