Longitudinal Neurocognitive Trajectories After BCMA CAR-T in Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Clinically significant cognitive impairment
研究概览
简要总结
The purpose of this research study is to evaluate cognitive changes over time in participants with relapsed or refractory multiple myeloma who have received chimeric antigen receptor T-cell therapy (CAR-T).
详细描述
This is a prospective, consent-based study that will evaluate the changes in neurocognitive impairment over time in relapsed or refractory multiple myeloma (RRMM) patients receiving standard of care (SOC) commercial B-cell maturation antigen (BCMA) CAR-T therapy. This study will evaluate the feasibility of conducting longitudinal cognitive assessments at baseline (-30 days), 1-, 6-, and 12-months post BCMA CAR-T treatment. Baseline assessments will occur prior to SOC BCMA CAR-T therapy.
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
- •Ability to understand and willingness to sign an IRB-approved informed consent
- •Ability to retain independent decision-making capacity as per the enrolling investigator
- •Age ≥ 18 years of age at the time of consent
- •Scheduled to receive BCMA CAR-T therapy for RRMM as confirmed by the treating clinician
- •Ability to read and understand the English language
- •If actively taking benzodiazepine, must be able to hold for 3 hours prior to study assessments as per treating clinician
- •Reliable access to internet access; a tablet, laptop and/or desktop computer with a camera; or willingness to come into the clinic to conduct study procedures as outlined in the Study Calendar- as per participant self-report
- •Ability to complete required assessments, as determined by the treating clinician
排除标准
- •Active central nervous system (CNS) disease
- •Known neurodegenerative disease or major neurocognitive disorder
- •Stroke and/or traumatic brain injury (TBI) within 12 months
- •Concurrent investigational neuroactive drugs
结局指标
主要结局
Clinically significant cognitive impairment
时间窗: Baseline, 1-, 6-, and 12-months post-CAR-T
For each timepoint in which the Cognitive Assessment Battery is assessed (baseline, 1-, 6-, and 12 months post-CAR-T), the overall clinically significant impairment will be determined as a binary variable. Clinically significant impairment will be determined if 2 individual cognitive tests (from ICCTF or Digit Span subtest) have a standardized score at least 1.5 standard deviations below the mean or if 1 individual cognitive test has a standardized score at least 2 standard deviations below the mean.
次要结局
- Hopkins Verbal Learning Test - Revised (HVLT-R) total recall score(Baseline, 1-, 6-, and 12-months post-CAR-T)
- Hopkins Verbal Learning Test - Revised (HVLT-R) retention score %(Baseline, 1-, 6-, and 12-months post-CAR-T)
- Hopkins Verbal Learning Test - Revised (HVLT-R) Recognition Discrimination Index (RDI)(Baseline, 1-, 6-, and 12-months post-CAR-T)
- Oral Trail-Making Test Part A (OTMT-A) results, seconds(Baseline, 1-, 6-, and 12-months post-CAR-T)
- Oral Trail-Making Test Part B (OTMT-B) results, seconds(Baseline, 1-, 6-, and 12-months post-CAR-T)
- Controlled Oral Word Association Test (COWAT) results(Baseline, 1-, 6-, and 12-months post-CAR-T)
- Wechsler Adult Intelligence Scale (WAIS)-III Digit Span subtest results(Baseline, 1-, 6-, and 12-months post-CAR-T)
- Number of participants who completed the study(12 months post-CAR-T)
- Patient Health Questionnaire-9 (PHQ-9) results(Baseline, 1-, 6-, and 12-months post-CAR-T)
- Generalized Anxiety Disorder 7-Item (GAD-7) results(Baseline, 1-, 6-, and 12-months post-CAR-T)
- Functional Assessment of Cancer Therapy/Cognition (FACT-Cog) V3 Subscale Scores(Baseline, 1-, 6-, and 12-months post-CAR-T)
- Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a Scores(Baseline, 1-, 6-, and 12-months post-CAR-T)
- Hopkins Verbal Learning Test - Revised (HVLT-R) delayed recall score(Baseline, 1-, 6-, and 12-months post-CAR-T)