Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-Cel) Out-of-Specification (OOS) in Participants With Multiple Myeloma
Study Details
Study Description
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 (cilta-cel out-of-specifications [OOS]) to appropriate adult participants (greater than or equal to 18 years) with relapsed/refractory multiple myeloma (MM).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Inclusion Criteria:
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Eligible for treatment with cilta-cel per United States Prescribing Information (USPI)
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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
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Favorable participant benefit/risk assessment determined by Janssen medical review
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Treating physician confirms the favorable risk benefit profile, and that proceeding with this treatment is in the best interest of the participant
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Able to provide informed consent indicating they understand the purpose of this expanded access program (EAP)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Janssen Scientific Affairs, LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR108968
- 68284528MMY4006