An Investigator-Initiated, Phase II, Multicenter, Open-Label, Single-Arm, Prospective Clinical Trial to Evaluate the Efficacy and Safety of Alternating Bortezomib-Based Regimens in Combination With DaratUMumab Followed by Maintenance With Daratumumab in the Frontline Setting of Primary Plasma CEll LEukemIA: A Trial of the Greek Myeloma Study Group The " EUMELEIA " Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 43
- 试验地点
- 7
- 主要终点
- Εfficacy of the alternating D-PAD/D-CVD induction regimen followed by D-CVD consolidation regimen and maintenance with daratumumab monotherapy, in terms of PFS, in the first-line setting of pPCL.
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of the alternating D-PAD/D-CVD induction regimen followed by D-CVD consolidation regimen and maintenance with daratumumab monotherapy, in terms of PFS, in the first-line setting of pPCL.
详细描述
This is an investigator-initiated, prospective, multicenter, phase II, open-label, single-arm, non-randomized, single-stage clinical trial.
The study comprises the following phases:
A 28-day screening phase An induction phase which includes six 21-day induction treatment cycles of alternating D-PAD and D-CVD (starting with D-PAD) Note: Based on the post-induction treatment disease evaluation, transplant-eligible subjects who have achieved ≥SD and PBPC ≤2% will undergo ASCT whereas those with SD or PBPC 2% will discontinue study treatment. Accordingly, transplant-eligible subjects who have achieved ≥PR will receive 2 additional D-CVD cycles whereas those with <PR will discontinue study treatment.
ASCT (single or tandem) (applicable for transplant-eligible patients) A consolidation phase which includes two 21-day consolidation cycles of D-CVD A maintenance phase which includes twenty-four 28-day cycles of daratumumab monotherapy (applicable for subjects who have achieved ≥PR at the end of consolidation phase [Cycle 8]) An End of Treatment (EOT) visit: 30 days (±7 days) after the last dose of all components of the study treatment have been discontinued
A Post-Treatment Follow-Up (PTFU) phase which will begin once a subject permanently discontinues study treatment. In particular:
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 80 Years（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
Single-arm
- A consolidation phase which includes two 21-day consolidation cycles of D-CVD
- A maintenance phase which includes twenty-four 28-day cycles of daratumumab monotherapy (applicable for subjects who have achieved ≥PR at the end of consolidation phase [Cycle 8])
干预措施: Daratumumab (Subcutaneously) (Drug)
结局指标
主要结局
Εfficacy of the alternating D-PAD/D-CVD induction regimen followed by D-CVD consolidation regimen and maintenance with daratumumab monotherapy, in terms of PFS, in the first-line setting of pPCL.
时间窗: Approximately 28 months (including induction/consolidation/maintenance phase and excluding transplantation) [168 days induction/consolidation plus 672 days maintenance].
Duration from the date of induction treatment initiation to the date of first documented evidence of progressive disease (PD) (assessed by the IMWG criteria) or death, whichever occurs earlier.
次要结局
未报告次要终点