LCI-HEM-MYE-PurD-001: Phase II Study of Daratumumab Pre-Mobilization and Post-Autologous Stem Cell Transplant in Patients With Multiple Myeloma and Sub-Optimal Response to Induction
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Complete Response (CR) Rate Post-ASCT
研究概览
简要总结
This study will use the drug daratumumab in patients who did not achieve at least a very good partial response (VGPR) and are already planned to have an Autologous Stem Cell Transplant (ASCT). Daratumumab will be given before the stem cell collection to attempt to get rid of any multiple myeloma cells that may be present in the stem cell collection and after the ASCT to get rid of any multiple myeloma cells that may be remaining.
详细描述
This is a single arm, two-stage, phase II study to evaluate the rate of ≥ Complete Response (CR) post-Autologous Stem Cell Transplant (ASCT) in Multiple Myeloma (MM) subjects who failed to achieve at least a Very Good Partial Response (VGPR) post initial induction therapy for newly diagnosed disease, and for whom an ASCT is planned. Subjects will be treated with four weekly doses of daratumumab before mobilization for Hematopoietic Progenitor Cells (HPC) collection, followed by high dose chemotherapy and ASCT and four weekly doses of daratumumab after ASCT. A two-stage design will be implemented. Twenty three (23) subjects will be enrolled in the first stage, and if at least 12 of the 23 subjects have at least a CR after ASCT, an additional 16 subjects will be enrolled in the second stage (a total of 39 subjects).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1: Daratumumab
Pre-ASCT and Post-ASCT: Daratumumab
干预措施: Daratumumab (Drug)
结局指标
主要结局
Complete Response (CR) Rate Post-ASCT
时间窗: up to 100 days post-ASCT
CR or better will be determined for each subject as binary variables indicating whether or not best overall response post-ASCT is a CR or better as determined by the IMWG 2016 response criteria.
次要结局
- Progression-Free Survival (PFS)(up to 7 years)
- Time to Progression (TTP)(up to 7 years)
- VGPR+ Rate(up to 100 days post-ASCT)
- Time to First Response (TTFR)(up to 100 days post-ASCT)
- Time to Best Response (TTBR)(up to 100 days post-ASCT)
- Duration of Response (DOR)(up to 7 years)
- Time to Next Treatment (TTNT)(up to 7 years)
- Overall Survival (OS)(up to 7 years)