NCT05346835Available不适用
Intermediate-Size Population Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) in Patients With Multiple Myeloma
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Available
- 试验地点
- 254
研究概览
简要总结
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.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究者
研究点 (254)
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