Daratumumab-containing Induction Effects on Stem Cells Mobilization, colLection and Engraftment in Newly Diagnosed Multiple MyelomA Patients (DILEMMA).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- To assess the difference in the mean number of collected CD34+ cells/kg during total harvest between Daratumumab and control group.
研究概览
简要总结
Daratumumab is a human first-in-class monoclonal antibody that targets a cluster of differentiation (CD) 38, a cell surface protein that is overexpressed on multiple myeloma (MM) cells, showing significant activity in relapsed/refractory disease. More recently, it was demonstrated that the addition of daratumumab to pre-autologous hematopoietic stem cell transplant (ASCT) induction regimens in newly diagnosed multiple myeloma increased the rate of complete responses and disease-free survival. However, in consideration of the expression of CD38 antigen also by stem cells, daratumumab could exert effects on their mobilization, collection, and engraftment. The primary objective of this retrospective/prospective observational study is to investigate the impact of adding daratumumab to standard induction regimens (VTD:bortezomib-thalidomide and dexamethasone, VD: bortezomib and dexamethasone) on stem cell mobilization in patients with newly diagnosed multiple myeloma (NDMM) who are candidates for ASCT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Age ≥ 18 years.
- •NDMM candidate to stem cell mobilization, collection, and ASCT who received a Daratumumab-containing induction regimen.
- •Signed written informed consent to study participation.
排除标准
- •Age <18 y.o.
- •Inability to obtain written informed consent.
- •Patients not proceeding to stem cell mobilization because of disease progression.
- •Patients not eligible for high-dose cyclophosphamide according to baseline cardiologic evaluation.
研究组 & 干预措施
Cases (prospective cohort)
Patients who fulfill the inclusion criteria (newly diagnosed multiple myeloma patients undergoing daratumumab-containing induction regimens).
干预措施: Daratumumab (Drug)
结局指标
主要结局
To assess the difference in the mean number of collected CD34+ cells/kg during total harvest between Daratumumab and control group.
时间窗: 12 months
To assess the difference in the mean number of collected CD34+ cells/kg during total harvest between Daratumumab and control group.
次要结局
- Graft composition in Daratumumab group in term of concentration of CD34+ cells x10^6/kg, TNC (total nucleated cells) x 10^8/kg, and MNC (mononuclear cells) x 10^8/kg.(12 months)
- Proportion (%) of patients who received plerixafor rescue for poor mobilization in Daratumumab versus control group.(12 months)
- Proportion (%) of patients achieving at least two minimum transplant doses (4x10^6 CD34+ cells/kg) at first day of apheresis in Daratumumab versus control group.(12 months)
- Rate (%) of CD38 expression and clonogenic potential of collected CD34+ cells in both groups.(12 months)
- To compare transplant outcome in term of time (days) to platelets and neutrophils engraftment in Daratumumab versus control group.(12 months)