Neurocognitive Trajectories After BCMA CAR-T
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standardized neurocognitive testing.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma (MM), CART Therapy, Refractory Multiple Myeloma (RRMM). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Longitudinal Neurocognitive Trajectories After BCMA CAR-T in Multiple Myeloma
Overview
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).
Detailed description
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.
Interventions
- Other Standardized neurocognitive testing
Perform standardized neurocognitive testing at baseline and serially at 1-, 6-, and 12-months post-infusion.
Primary outcome measures
- Clinically significant cognitive impairment [Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T]
Secondary outcome measures (12)
- Hopkins Verbal Learning Test - Revised (HVLT-R) total recall score [Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T]
- Hopkins Verbal Learning Test - Revised (HVLT-R) retention score % [Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T]
- Hopkins Verbal Learning Test - Revised (HVLT-R) Recognition Discrimination Index (RDI) [Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T]
- Oral Trail-Making Test Part A (OTMT-A) results, seconds [Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T]
- Oral Trail-Making Test Part B (OTMT-B) results, seconds [Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T]
- Controlled Oral Word Association Test (COWAT) results [Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T]
- Wechsler Adult Intelligence Scale (WAIS)-III Digit Span subtest results [Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T]
- Number of participants who completed the study [Time frame: 12 months post-CAR-T]
- Patient Health Questionnaire-9 (PHQ-9) results [Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T]
- Generalized Anxiety Disorder 7-Item (GAD-7) results [Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T]
- Functional Assessment of Cancer Therapy/Cognition (FACT-Cog) V3 Subscale Scores [Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T]
- Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a Scores [Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T]
Eligibility criteria
Inclusion criteria
- 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
- ECOG 0-2
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Atrium Health Levine Cancer — Charlotte
Identifiers
NCT: NCT07740317 · IRB00152390 · ONC-MM-2506