Neurocognitive Trajectories After BCMA 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.

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

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.

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.

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.

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.

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.

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.

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

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).

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).

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.

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.

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.