Predicting Progression of Developing Myeloma in a High-Risk Screened Population (PROMISE)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30,000
- 试验地点
- 1
- 主要终点
- Time to progression (TTP) from MGUS/SMM to overt multiple myeloma.
研究概览
简要总结
The PROMISE Study aims to establish a prospective cohort of individuals with precursor conditions to multiple myeloma, such as monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). We will study these patients as a means to identify risk factors for progression to symptomatic multiple myeloma.
详细描述
The goal of the PROMISE research study is to determine clinical/genomic alterations present in individuals with MGUS and SMM, who are diagnosed through screening of a high-risk population. We also seek to determine clinical/genomic/epigenetic and immune environmental predictors of progression to multiple myeloma in patients with MGUS and SMM.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for Cohort 1:
- •Age ≥ 30 years
- •AA race (self-identified) and/or first-degree relative of a patient with a plasma cell dyscrasia such as MGUS, SMM, MM, and Waldenström's Macroglobulinemia, or another blood cancer.
- •Those over 18 are also eligible if they have 2 or more family members with a blood cancer
- •Inclusion Criteria for Cohort 2A:
- •Screened positive by mass spectrometry in the Ghobrial Lab for SMM or MGUS as part of the Mass General Brigham Biobank arm AND fits one of the following two groups of criteria:
- •Age ≥ 30 years
- •AA race (self-identified) and/or first-degree relative of a patient with a plasma cell dyscrasia such as MGUS, SMM, MM, and Waldenström's Macroglobulinemia, or another blood cancer.
- •OR • Those over 18 are also eligible if they have 2 or more family members with a blood cancer
- •Inclusion Criteria for Cohort 2B:
- •Screened positive by mass spectrometry in the Ghobrial Lab for SMM or MGUS as part of the Mass General Brigham Biobank arm AND fits the criteria listed below:
- •Age ≥ 18 years
排除标准
- •for Cohort 1:
- •Persons diagnosed with cancer at any site (including hematologic cancers) with symptomatic disease requiring active therapy.
- •Persons with an already diagnosed plasma cell dyscrasia such as MGUS, SMM, MM, and Waldenström's Macroglobulinemia
- •Exclusion Criteria for Cohort 2A and 2B:
- •Persons under the age of 18 years old
- •First-degree relatives would not need to be identified by the participant.
- •This study includes all special populations who fall within the eligible high-risk age range, ≥ 30 years of age, including adults unable to consent, pregnant women, and prisoners. These populations will not be excluded as this is a non-therapeutic study.
研究组 & 干预措施
Cohort 1
Healthy individuals who meet this protocols high-risk criteria for developing MM in their lifetime.
- Samples of blood (2-4 tablespoons) from 4 tubes will be collected
- Analysis will be performed on the blood to test for multiple myeloma precursor conditions.
干预措施: Samples of blood (2-4 tablespoons) from 4 tubes will be collected -Analysis will be performed on the blood to test for multiple myeloma precursor conditions. (Other)
Cohort 2
People who have screened positive by mass spectrometry in the Ghobrial Lab for SMM or MGUS as part of the Mass General Brigham Biobank.
- Samples of blood (2-4 tablespoons) from 4 tubes will be collected
- Analysis will be performed on the blood to test for multiple myeloma precursor conditions.
干预措施: Samples of blood (2-4 tablespoons) from 4 tubes will be collected -Analysis will be performed on the blood to test for multiple myeloma precursor conditions. (Other)
结局指标
主要结局
Time to progression (TTP) from MGUS/SMM to overt multiple myeloma.
时间窗: 15 years
Progression to symptomatic multiple myeloma
次要结局
未报告次要终点
研究者
Irene Ghobrial, MD
Principal Investigator
Dana-Farber Cancer Institute