Multiple Myeloma Outcomes Based on Maintenance Therapy Post Autologous Stem Cell Transplant
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- MRD conversion rate
研究概览
简要总结
The purpose of the study is to determine outcomes for Multiple Myeloma patients on maintenance single agent vs. doublet (IMiD + PI) combination chemotherapy post Autologous Stem Cell Transplant (ASCT).
详细描述
This non-interventional, cohort prospective research study will assess outcomes for Multiple Myeloma patients on maintenance single agent vs. doublet (IMiD + PI) combination chemotherapy post ASCT.
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
- •All MM patients (18 years or greater) receiving autologous transplantation given as first line therapy (Melphalan at least 140 mg/m2) will be screened and enrolled in the study if they qualify and willing to participate.
- •Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed.
- •Histologically confirmed diagnosis of multiple myeloma.
- •Received high dose melphalan (≥ 140 mg/m2) followed by ASCT based on the institutional guidelines and within +60 and +180 after ASCT at the time of maintenance initiation.
- •Disease status must be very good partial response (VGPR), complete remission (CR), or stringent complete remission (sCR) per IMWG response criteria at time of study entry.
- •Measurable disease at diagnosis per IMWG criteria serum M spike ≥ 1g/dL, or Urine M protein ≥ 200 mg/24h or involved free light chain ≥ 100 mg/L with an abnormal ratio.
- •Patients must have the Clonoseq ID sample showing a trackable clone in bone marrow.
排除标准
- •Patients who have purely non-secretory multiple myeloma (i.e., the absence of a measurable protein in serum by electrophoresis and immunofixation and the absence of Bence-Jones protein in the urine defined by use of electrophoresis and immunofixation)
- •Prior evidence of disease progression
- •Patients who have other malignancy associated with a high risk of progression in the next 2 years.
研究组 & 干预措施
Single Maintenance After Autologous Stem Cell Transplant
Prospectively enrolled cohort of patients receiving single maintenance therapy with an immunomodulatory drug after Autologous Stem Cell Transplant for Multiple Myeloma
干预措施: Autologous Stem Cell Transplant (Other)
Single Maintenance After Autologous Stem Cell Transplant
Prospectively enrolled cohort of patients receiving single maintenance therapy with an immunomodulatory drug after Autologous Stem Cell Transplant for Multiple Myeloma
干预措施: Immunomodulatory Agent (Drug)
Double Maintenance After Autologous Stem Cell Transplant
Prospectively enrolled cohort of patients receiving double maintenance therapy with the combination of an immunomodulatory drug and a proteasome inhibitor after Autologous Stem Cell Transplant for Multiple Myeloma.
干预措施: Autologous Stem Cell Transplant (Other)
Double Maintenance After Autologous Stem Cell Transplant
Prospectively enrolled cohort of patients receiving double maintenance therapy with the combination of an immunomodulatory drug and a proteasome inhibitor after Autologous Stem Cell Transplant for Multiple Myeloma.
干预措施: Immunomodulatory Agent (Drug)
Double Maintenance After Autologous Stem Cell Transplant
Prospectively enrolled cohort of patients receiving double maintenance therapy with the combination of an immunomodulatory drug and a proteasome inhibitor after Autologous Stem Cell Transplant for Multiple Myeloma.
干预措施: Proteasome Inhibitor (Drug)
结局指标
主要结局
MRD conversion rate
时间窗: At 1 year after transplant
To determine rate of MRD conversion (positive to negative) in MM patients receiving an immunomodulatory drug in combination with a proteasome inhibitor as maintenance therapy 1-year post transplant.
次要结局
- Progression Free Survival (PFS) at 2 Years(At 2 years)
- MRD by NGS Clonoseq testing(At 2 years)
- Progression Free Survival (PFS) at 1 Year(At 1 Years)