Medical Questionnaire and Tissue Banking For Multiple Myeloma, Waldenstrom Macroglobulinemia and Related Disorders
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 656
- 试验地点
- 2
- 主要终点
- Databank
研究概览
简要总结
The purpose of this study is to obtain bone marrow and peripheral blood samples, along with clinical data from patients with Multiple Myeloma (MM), Waldenstrom's Macroglobulinemia (WM), Smoldering MM, and other lymphoplasmacytic lymphomas (LPL) including but not limited to MGUS and IgG or IgA LPL. These samples will become part of a tissue bank and will be used in ongoing studies to find out more about the causes and biology of MM, WM and LPL; to identify what factors result in normal cells becoming cancer; to determine how to improve treatment options; to study how the immune system identifies abnormal cells; and to evaluate the immune function in these diseases. The investigators will also study the tumor cells at the level of the participant's genes to develop treatment strategies as well as to better understand how biologic differences affect patient outcomes.
详细描述
- Participants will be asked to complete a medical survey which includes demographics, diagnosis, and treatment history, medical history, lab results and symptoms experienced.
- Participants will then receive instructions for the tissue banking procedure, which involves donating bone marrow and blood samples. These will be collected only at times when necessary clinical bone marrow samples are obtained and will not require an extra visit to the doctor.
- The investigators are also requesting permission to collect medical information from the participant's record and link this information to the specimens so that we may better understand the participant's response to treatment. For samples obtained prior to beginning therapy, this information might allow us to develop new ways of predicting response to therapy. The investigators are also requesting permission to store samples of blood and bone marrow to establish a tissue bank for future research to these diseases. These samples will be de-identified; any of the participant's personal health information identifiers will be removed.
- The tumor sample may be obtained at diagnosis, during treatment and/or as the time of relapse. The timing of sample collection will coincide with other bone marrow tests required to assess the response to therapy or any other clinical purpose.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Any individual diagnosed with Multiple Myeloma, Waldenstrom Macroglobulinemia, MGUS, smoldering MM or other lymphoplasmacytic lymphomas
- •Signed informed consent
- •18 years of age or older
排除标准
- 未提供
结局指标
主要结局
Databank
时间窗: 3 years
To establish a databank of patients with MM, WM, MGUS, sMM, or related disorders. This databank will include medical history data and bone marrow and peripheral blood samples.
Unique characteristics
时间窗: 3 years
To determine whether patients with MM, WM, MGUS, sMM, or related disorders have unique proteomic, genetic and epigenetic characteristics in the malignant clone or the microenvironment and linking information to the clinical characteristics of the patients through exploratory tests.
次要结局
未报告次要终点
研究者
Irene Ghobrial, MD
Principal Investigator
Dana-Farber Cancer Institute