CART Therapy, Multiple Myeloma (MM), Refractory Multiple Myeloma (RRMM)
Conditions
Keywords
cancer
Brief summary
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
OTHERStandardized neurocognitive testing
Perform standardized neurocognitive testing at baseline and serially at 1-, 6-, and 12-months post-infusion.
Sponsors
Wake Forest University Health Sciences
Atrium Health Wake Forest Baptist
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Ability to understand and willingness to sign an IRB-approved informed consent 2. Ability to retain independent decision-making capacity as per the enrolling investigator 3. Age ≥ 18 years of age at the time of consent 4. Scheduled to receive BCMA CAR-T therapy for RRMM as confirmed by the treating clinician 5. Ability to read and understand the English language 6. ECOG 0-2 7. If actively taking benzodiazepine, must be able to hold for 3 hours prior to study assessments as per treating clinician 8. 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 9. Ability to complete required assessments, as determined by the treating clinician
Exclusion criteria
1. Active central nervous system (CNS) disease 2. Known neurodegenerative disease or major neurocognitive disorder 3. Stroke and/or traumatic brain injury (TBI) within 12 months 4. Concurrent investigational neuroactive drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically significant cognitive impairment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hopkins Verbal Learning Test - Revised (HVLT-R) total recall score | Baseline, 1-, 6-, and 12-months post-CAR-T | 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 |
| Hopkins Verbal Learning Test - Revised (HVLT-R) retention score % | Baseline, 1-, 6-, and 12-months post-CAR-T | 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. |
| Hopkins Verbal Learning Test - Revised (HVLT-R) Recognition Discrimination Index (RDI) | Baseline, 1-, 6-, and 12-months post-CAR-T | 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. |
| Oral Trail-Making Test Part A (OTMT-A) results, seconds | Baseline, 1-, 6-, and 12-months post-CAR-T | 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. |
| Oral Trail-Making Test Part B (OTMT-B) results, seconds | Baseline, 1-, 6-, and 12-months post-CAR-T | 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. |
| Controlled Oral Word Association Test (COWAT) results | Baseline, 1-, 6-, and 12-months post-CAR-T | 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. |
| Wechsler Adult Intelligence Scale (WAIS)-III Digit Span subtest results | Baseline, 1-, 6-, and 12-months post-CAR-T | 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. |
| Number of participants who completed the study | 12 months post-CAR-T | 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 |
| Patient Health Questionnaire-9 (PHQ-9) results | Baseline, 1-, 6-, and 12-months post-CAR-T | 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). |
| Generalized Anxiety Disorder 7-Item (GAD-7) results | Baseline, 1-, 6-, and 12-months post-CAR-T | 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). |
| Functional Assessment of Cancer Therapy/Cognition (FACT-Cog) V3 Subscale Scores | Baseline, 1-, 6-, and 12-months post-CAR-T | 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. |
| Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a Scores | Baseline, 1-, 6-, and 12-months post-CAR-T | 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. |
| Hopkins Verbal Learning Test - Revised (HVLT-R) delayed recall score | Baseline, 1-, 6-, and 12-months post-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. |
Countries
United States
Contacts
CONTACTCourtney Schepel
PRINCIPAL_INVESTIGATORCindy Varga, MD
Atrium Health Levine Cancer
Outcome results
None listed