NCT06698887招募中不适用
Long-Term Safety Follow-Up Surveillance for Phase 3 Trial (KarMMA-9/CA089-1043) to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation
Bristol-Myers Squibb5 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年9月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 5
- 主要终点
- Participant adverse events
研究概览
简要总结
The purpose of this study is to monitor the long-term safety of participants who received idecabtagene vicleucel treatment as part of the KarMMa-9 (CA089-1043) Phase 3 clinical trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult participants ≥19 years of age
- •Korean participants with newly diagnosed multiple myeloma who had a suboptimal response after autologous stem cell transplantation (ASCT) and who were treated with idecabtagene vicleucel (assigned to Arm A) in the KarMMa-9 trial (CA089-1043)
- •Participants must understand and voluntarily sign and informed consent form (ICF) for the Korea long-term follow-up surveillance study prior to any surveillance-related procedures being conducted
排除标准
- •Participants who participate in KarMMa-9 trial (CA089-1043) but disagree with long-term follow-up surveillance in Korea
- •Participants who are not possible to treat with Ide-cel within 9 days post-completion of lymphodepleting chemotherapy (LDC), if delays occur. However, depending on the participants recovery status, whether idecabtagene vicleucel is administered or not, should be discussed with a medical monitor
研究组 & 干预措施
Participants receiving idecabtagene vicleucel
干预措施: Idecabtagene vicleucel (Drug)
结局指标
主要结局
Participant adverse events
时间窗: Monthly from months 4-18, every 2 months from months 19-59, and annually from month year 5 to 15
Number of participants with positive replication-competent lentivirus test results
时间窗: At 4, 7, 13, and 25 months, and annually up to 15 years
Persistent vector sequence monitoring
时间窗: Months 7-18 and annually from years 5-15
次要结局
- Progression-free survival (PFS)(Monthly up to 18 months and every two months after month 19 up to 15 years)
- Overall survival (OS)(Every 3 months up to month 60, annually thereafter up to 15 years)
- Number of participants that achieve complete response or stringent complete response(At months 4-18, every 2 months from months 19-59, and annually from years 5-15)
- Health-related quality of life (HRQoL) measured by the European Organization for Research and Treatment of Cancer core quality of life (EORTC QLQ-C30) questionnaire(At months 4-18, every 2 months from months 19-59, and annually from years 5-15)
- Health-related quality of life (HRQoL) measured by the European Organization for Research and Treatment of Cancer assessment of quality of life of myeloma patients (EORTC QLQ-MY20) questionnaire(At months 4-18, every 2 months from months 19-59, and annually from years 5-15)
- Health-related quality of life (HRQoL) measured by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire(At months 4-18, every 2 months from months 19-59, and annually from years 5-15)
研究者
研究点 (5)
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