NCT01109407终止不适用
Natural History Study of Monoclonal Gammopathy of Undetermined Significance (MGUS) and Smoldering Myeloma (SMM)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Characterize the natural history and prognosis of MGUS and SMM
研究概览
简要总结
Background:
- Multiple myeloma is a type of cancer that affects white blood cells and has a poor long-term survival rate. Two other types of cancer, monoclonal gammopathy of undetermined significance (MGUS) and smoldering myeloma (SMM), may eventually progress and develop into multiple myeloma. Researchers are interested in collecting samples from individuals who have been diagnosed with MGUS and SMM to study possible risk factors for developing multiple myeloma.
Objectives:
- To study risk factors that may cause MGUS and SMM to progress to multiple myeloma.
Eligibility:
- Individuals at least 18 years of age who have been diagnosed with either MGUS or SMM but do not have multiple myeloma.
Design:
- Participants will be examined by study researchers at the initial visit, at 6 months following enrollment, and every 12 months for a maximum of 5 years.
- The following tests may be performed: (1) blood and urine tests, (2) bone marrow aspiration and biopsy, (3) imaging studies, and (4) a skeletal survey (a series of skeletal X-rays of the skull, spine, pelvis, ribs, shoulders, upper arm, and thigh bones).
- Treatment will not be provided as part of this protocol. - Participants will remain on the study for 5 years, or until their MGUS or SMM progresses to multiple myeloma requiring treatment.
详细描述
Background:
- Multiple Myeloma (MM) is an incurable plasma cell neoplasm with a median survival of 3-4 years.
- Monoclonal gammopathy of undetermined significance (MGUS) and smoldering myeloma (SMM) are premalignant plasma cell proliferative disorders characterized by elevated monoclonal protein and bone marrow plasma cells. MGUS affects 3.2% of Caucasians over the age of 50 and has a 1% annual risk of progression to MM. approximately 3000 cases of SMM are diagnosed annually with a 10% annual risk of progression to MM.
- Current risk stratification schemes rely on serum protein markers and phenotyping by flow cytometry. While they can differentiate high and low risk patients, they cannot predict outcome for individual patients, are not integrated with one another, and have limited direct correlation to biology.
- Paired samples linked to clinical information can advance research into improved risk stratification, the pathogenesis of MGUS, SMM, and MM, and the potential for an early treatment window for these incurable diseases.
Objectives:
- To characterize the natural history and prognosis of MGUS and SMM
- To integrate protein markers (including immunoglobulin free light-chains) and immunophenotyping by flow cytometry with molecular profiles (including gene expression profiles) and clinical outcomes
- To apply expertise and diagnostic technology to provide improved evaluation, monitoring, and risk-stratification for patients on this protocol
- To provide paired samples of blood and tissue linked to clinical and molecular information for pilot translational studies
Eligibility:
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Characterize the natural history and prognosis of MGUS and SMM
时间窗: 6 months
determination of subtypes of MM based on GEP, and determination of prognostic indicators
Integrate protein markers with molecular profiles and clinical outcomes.
时间窗: 6 months
comparison of molecular profiles and rate of disease progression per MM subtype
次要结局
未报告次要终点
研究者
研究点 (1)
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