The Role of the Comprehensive Geriatric Assessment in Elderly Patients With Multiple Myeloma: A Single Center Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Incidence of treatment-related adverse events
研究概览
简要总结
This study evaluates the association between a comprehensive geriatric assessment and laboratory biomarkers with the side effects of chemotherapy in older patients with multiple myeloma (MM). The comprehensive geriatric assessment is a tool that can help to determine how fit a patient is. It is composed of a series of questions and tests designed for older people to evaluate their physical function, mental status, mental health, nutritional status, social support, level of social activity, and the presence of other medical problems. In addition to geriatric assessment domains, laboratory biomarkers may provide information on physiologic dysfunction as a measure for evaluation of frailty in the cancer setting. This study will help researchers in the future by predicting which patients will have more side effects with chemotherapy based on their comprehensive geriatric assessment and laboratory biomarkers, which will allow adjustments to treatment in older adult patients with MM.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the association between a baseline comprehensive geriatric assessment (cGA) and chemotherapy toxicity in the first 4 months of treatment measured by treatment-related adverse events, patient-reported outcomes (PROs), and treatment discontinuation in older patients (>= 65 years) with multiple myeloma (MM).
SECONDARY OBJECTIVES:
I. To evaluate the association between a baseline cGA and baseline disease- and host- related laboratory characteristics and cytogenetic risk profile by fluorescence in situ hybridization among newly diagnosed older (>= 65 years) patients with MM.
II. To evaluate how the cGA changes over 4 months from the start of treatment and the association between those changes and treatment response in older patients (>= 65 years) with MM.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 65 years
- •Diagnosis of MM based on International Myeloma Working Group (IMWG) diagnostic criteria
- •Newly diagnosed or have received 1 prior line of treatment
- •Planned to start a new treatment for MM within 30 days
- •Transplant eligible or ineligible
- •Fluent in English (all assessment tools are in English)
- •Able to provide written informed consent
排除标准
- •Received > 1 prior line of treatment
- •Patients included in an interventional therapeutic trial
- •Not able to give informed consent
- •Severe mental or cognitive disorder precluding geriatric assessment
研究组 & 干预措施
Observational (Surveys, cGA, blood sample, EHR review)
Patients complete surveys and undergo cGA, blood sample collection, and EHR review on study.
干预措施: Biospecimen Collection (Procedure)
Observational (Surveys, cGA, blood sample, EHR review)
Patients complete surveys and undergo cGA, blood sample collection, and EHR review on study.
干预措施: Comprehensive Geriatric Assessment (Other)
Observational (Surveys, cGA, blood sample, EHR review)
Patients complete surveys and undergo cGA, blood sample collection, and EHR review on study.
干预措施: Electronic Health Record Review (Other)
Observational (Surveys, cGA, blood sample, EHR review)
Patients complete surveys and undergo cGA, blood sample collection, and EHR review on study.
干预措施: Survey Administration (Other)
结局指标
主要结局
Incidence of treatment-related adverse events
时间窗: Up to 4 months
Will graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The maximum observed grade per adverse event and capture grade \>= 3 toxicities.
次要结局
- Chemotherapy toxicity(Up to 4 months)
- Patient reported outcome (PRO) questionnaire(Up to 4 months)
- Patient reported outcome (PRO-CTCAE) questionnaire(Up to 4 months)