Neurocognitive and Neuroimaging Outcomes in Older Patients With Multiple Myeloma Treated With Autologous Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Changes in regional brain volume and functional connectivity when baseline and follow-up MRIs are compared.
研究概览
简要总结
The purpose of this study is to learn about possible changes in thinking (cognitive) abilities, such as memory skills, and in brain anatomy and function, in adults with multiple myeloma who are treated with high-dose chemotherapy followed by ASCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with multiple myeloma and in complete, partial or very good partial remission at enrollment as per standard International Myeloma Working Group Criteria
- •Scheduled to have high-dose chemotherapy and ASCT
- •Age 60 - 75 years at study entry
- •In the judgment of the consenting professional, fluent and able to communicate well enough in English to complete the study assessments and provide informed consent.
- •Patients who report that English is not their primary language will be asked the US Census English proficiency question "How well do you speak English" and the answer "very well" will be required
排除标准
- •With signs and/or symptoms of central nervous system cancers (e.g., tumors, metastases, leptomeningial disease) as determined by their physician, medical records, or by a brain MRI, either at the time of enrollment or during the study period
- •With current diagnosis of major Axis I psychiatric disorder (DSM-IV), major depression, bipolar disorder, or schizophrenia, as per medical records or patient report
- •As per patient report or as confirmed by the medical record, if the patient is taking anti-depression or anti-anxiety medication, < 2 months on these medications or a change in the prescribed dose in the past 2 months
- •With history of a neurological disorder, neurodegenerative disease, or traumatic brain injury with loss of consciousness (>60 minutes), as per medical records or patient report
- •With a history of another cancer, except for non-melanoma skin cancer, as per medical records or patient report
- •With current substance abuse and/or history of substance abuse, as per medical records or patient report
- •With evidence of visual or auditory impairment that would preclude completion of the assessments, as per medical records or patient report
- •With contraindications to MRI examinations as per standard screening guidelines used in the Department of Radiology (i.e., ferromagnetic material or implants, pacemakers or defibrillators, stents, claustrophobia)
研究组 & 干预措施
rsfMRI + Neurocognitive Tests
Participants diagnosed with multiple myeloma in complete, partial or very good partial remission per standard International Myeloma Working Group Criteria will complete neurocognitive tests and structural and functional rsfMRI (brain MRIs).
干预措施: Brief Test of Attention (Behavioral)
rsfMRI + Neurocognitive Tests
Participants diagnosed with multiple myeloma in complete, partial or very good partial remission per standard International Myeloma Working Group Criteria will complete neurocognitive tests and structural and functional rsfMRI (brain MRIs).
干预措施: Structural Image (Diagnostic Test)
rsfMRI + Neurocognitive Tests
Participants diagnosed with multiple myeloma in complete, partial or very good partial remission per standard International Myeloma Working Group Criteria will complete neurocognitive tests and structural and functional rsfMRI (brain MRIs).
干预措施: Functional Image (Diagnostic Test)
rsfMRI + Neurocognitive Tests
Participants diagnosed with multiple myeloma in complete, partial or very good partial remission per standard International Myeloma Working Group Criteria will complete neurocognitive tests and structural and functional rsfMRI (brain MRIs).
干预措施: Digit Span subtest (Behavioral)
rsfMRI + Neurocognitive Tests
Participants diagnosed with multiple myeloma in complete, partial or very good partial remission per standard International Myeloma Working Group Criteria will complete neurocognitive tests and structural and functional rsfMRI (brain MRIs).
干预措施: Trail Making Test (Parts A & B) (Behavioral)
rsfMRI + Neurocognitive Tests
Participants diagnosed with multiple myeloma in complete, partial or very good partial remission per standard International Myeloma Working Group Criteria will complete neurocognitive tests and structural and functional rsfMRI (brain MRIs).
干预措施: Auditory Consonant Trigrams Test (Behavioral)
rsfMRI + Neurocognitive Tests
Participants diagnosed with multiple myeloma in complete, partial or very good partial remission per standard International Myeloma Working Group Criteria will complete neurocognitive tests and structural and functional rsfMRI (brain MRIs).
干预措施: Controlled Oral Word Association Test (Behavioral)
rsfMRI + Neurocognitive Tests
Participants diagnosed with multiple myeloma in complete, partial or very good partial remission per standard International Myeloma Working Group Criteria will complete neurocognitive tests and structural and functional rsfMRI (brain MRIs).
干预措施: Hopkins Verbal Learning Test-Revised (Behavioral)
rsfMRI + Neurocognitive Tests
Participants diagnosed with multiple myeloma in complete, partial or very good partial remission per standard International Myeloma Working Group Criteria will complete neurocognitive tests and structural and functional rsfMRI (brain MRIs).
干预措施: The Center for Epidemiological Study-Depression (Behavioral)
rsfMRI + Neurocognitive Tests
Participants diagnosed with multiple myeloma in complete, partial or very good partial remission per standard International Myeloma Working Group Criteria will complete neurocognitive tests and structural and functional rsfMRI (brain MRIs).
干预措施: The Functional Assessment of Chronic Illness Therapy-Fatigue Subscale, Version 4 (Behavioral)
rsfMRI + Neurocognitive Tests
Participants diagnosed with multiple myeloma in complete, partial or very good partial remission per standard International Myeloma Working Group Criteria will complete neurocognitive tests and structural and functional rsfMRI (brain MRIs).
干预措施: Blood draw (Other)
结局指标
主要结局
Changes in regional brain volume and functional connectivity when baseline and follow-up MRIs are compared.
时间窗: up to 4 months following chemotherapy and ASCT
Changes in neurocognitive functions in older participants with Multiple Myeloma following high-dose (HD) chemotherapy and autologous stem cell transplantation (ASCT) assessed by initial and follow-up neurocognitive evaluation
时间窗: up to 4 months following chemotherapy and ASCT
次要结局
未报告次要终点