S0120, A Prospective Observational Biologic Study of Asymptomatic Patients With Monoclonal Gammopathy and Plasmaproliferative Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 69
- 主要终点
- Disease progression
研究概览
简要总结
RATIONALE: Studying samples of blood and bone marrow in the laboratory from patients with monoclonal gammopathy of undetermined significance, multiple myeloma, or plasmacytoma may help doctors learn more about changes that occur in DNA and identify biomarkers related to these diseases. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This research study is looking at blood and bone marrow samples from patients with monoclonal gammopathy of undetermined significance, multiple myeloma, or plasmacytoma.
详细描述
OBJECTIVES:
- Establish a serum, cell, and bone marrow tissue bank of prospectively collected samples from patients with monoclonal gammopathy of undetermined significance (MGUS), asymptomatic multiple myeloma, solitary plasmacytoma, or other plasma cell dyscrasias.
- Evaluate the feasibility of accruing patients with these diseases.
- Determine whether patterns of gene expression or cytogenetics exist that allow molecular delineation of MGUS subtypes.
- Characterize cellular and humoral immune response to known tumor antigens in these patients.
- Cryopreserve serum/T cells for future evaluation.
- Preliminarily identify biological correlates that may relate to progression to symptomatic disease.
OUTLINE: Patients are stratified according to diagnosis (monoclonal gammopathy of undetermined significance [MGUS] or other plasma cell dyscrasias vs asymptomatic multiple myeloma vs solitary plasmacytoma).
Blood and bone marrow samples are collected and analyzed for microarray analysis, cytogenetic analysis, and immunobiology studies.
Unused samples may be stored for future research studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 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
结局指标
主要结局
Disease progression
时间窗: 5 years
次要结局
未报告次要终点