An observational study in Multiple Myeloma (MM), CART Therapy and Refractory Multiple Myeloma (RRMM), sponsored by Wake Forest University Health Sciences. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Wake Forest University Health Sciences · Observational
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).
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.
Patients who have been scheduled to receive BCMA CAR-T therapy as their next line of therapy will be identified and approached for consent.
Exclusion Criteria:
RRMM patients being treated with SOC commercial BCMA CAR-T therapy
Other: Standardized neurocognitive testing
Perform standardized neurocognitive testing at baseline and serially at 1-, 6-, and 12-months post-infusion.
Clinically significant cognitive impairment
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.
Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T
Hopkins Verbal Learning Test - Revised (HVLT-R) total recall score
HVLT-R recall score will be captured at baseline, 1-, 6-, and 12-months post-CAR-T. The total recall score is the sum of the raw scores from the three learning trials. Raw and standardized T-scores will be captured
Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T
Hopkins Verbal Learning Test - Revised (HVLT-R) retention score %
HVLT-R retention score % will be captured at baseline, 1-, 6-, and 12-months post-CAR-T. The retention score % is the delayed recall score divided by the highest raw score from learning trial #2 or learning trial #3.
Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T
Hopkins Verbal Learning Test - Revised (HVLT-R) Recognition Discrimination Index (RDI)
The HVLT-R RDI will be captured at baseline, 1-, 6-, and 12-months post-CAR-T. The RDI is the difference between total number of true positives and total number of false positives from the delayed recognition trial. Raw and standardized T-scores will be captured.
Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T
Oral Trail-Making Test Part A (OTMT-A) results, seconds
The OTMT-A results will be captured at baseline, 1-, 6-, and 12-months post-CAR-T. The OTMT-A is a count variable indicating number of seconds to complete OTMT Part A. Raw and standardized scores will be captured.
Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T
Oral Trail-Making Test Part B (OTMT-B) results, seconds
The OTMT-B results will be captured at baseline, 1-, 6-, and 12-months post-CAR-T. The OTMT-B is a count variable indicating number of seconds to complete OTMT Part B. Raw and standardized scores will be captured.
Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T
Controlled Oral Word Association Test (COWAT) results
The COWAT results will be captured at baseline, 1-, 6-, and 12-months post-CAR-T. The COWAT is a count variable indicating number of words named during the test. Raw and standardized scores will be captured.
Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T
Wechsler Adult Intelligence Scale (WAIS)-III Digit Span subtest results
The WAIS-III Digit Span subtest will be capture at baseline, 1-, 6-, and 12-months post-CAR-T. The WAIS-III Digit Span results are a count variable indicating number of trials completed on Digit Span Forward and Backward combined. Raw and standardized scores will be captured.
Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T
Number of participants who completed the study
A binary variable indicating if the participant successfully completed the study, where study completion is defined as completing baseline and at least one post-treatment Cognitive Assessment Battery
Time frame: 12 months post-CAR-T
Patient Health Questionnaire-9 (PHQ-9) results
The PHQ-9 includes 9 items that are used to screen for and monitor the severity of depression. The total score ranges from 0 - 27 with higher scores indicating higher depression severity. The PHQ-9 outcome will be evaluated at baseline, 1-, 6-, and 12-months post-CAR-T as a score and as a categorical variable, with categories defined according to standard documentation. None/minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19), Severe (20-27).
Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T
Generalized Anxiety Disorder 7-Item (GAD-7) results
The GAD-7 includes 7 items that are used to screen for and monitor generalized anxiety disorder. The total score ranges from 0 - 21 with higher scores indicating higher anxiety. The GAD-7 outcome will be evaluated at baseline, 1-, 6-, and 12-months post-CAR-T as a score and also as a categorical variable, with categories defined according to standard documentation. Minimal anxiety (0-4), Mild anxiety (5-9), Moderate anxiety (10-14), Severe anxiety (15-19).
Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T
Functional Assessment of Cancer Therapy/Cognition (FACT-Cog) V3 Subscale Scores
The FACT-Cog V3 includes 37 total items that are used to derive 4 subscales (CogPCI, CogPCA, CogQOL, CogOth). For each of the subscales, higher scores indicate better quality of life. Scoring for each subscale is according to standard documentation (FACT-Cog V3 scoring template 05 July 2023). Subscales will not be summed to derive a total score. The following subscales will be evaluated at baseline, 1-, 6-, and 12-months post-CAR-T. Perceived cognitive impairments score (CogPCI) - includes 18 items, with score ranging from 0-72. Perceived cognitive abilities score (CogPCA) - includes 7 items with score ranging from 0-28. Impact of perceived cognitive impairments on quality-of-life score (CogQOL) - includes 4 items, with score ranging from 0-16. Comments from others on cognition score (CogOth) - includes 4 items, with score ranging from 0-16.
Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T
Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a Scores
The PROMIS Fatigue 7a includes 7 items with 5-level Likert scales (Never, Rarely, Sometimes, Often, Always). The total score ranges from 7 - 35 with higher scores indicating more fatigue is being measured. These raw scores will be converted to T-score metrics (and SE) using the scoring manual. PROMIS Fatigue 7a will be assessed at baseline, 1, 6, and 12 months after CAR T.
Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T
Hopkins Verbal Learning Test - Revised (HVLT-R) delayed recall score
HVLT-R delayed recall score will be captured at baseline, 1-, 6-, and 12-months post-CAR-T. The delayed recall score is the number of recalled words during the delayed recall portion of the test. Raw and standardized T-scores will be captured.
Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T
Plan to share: No
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Wake Forest University Health Sciences