Neurocognitive Trajectories After BCMA CAR-T
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients who have been scheduled to receive BCMA CAR-T therapy as their next line of therapy will be identified and approached for consent.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Standardized neurocognitive testing
Other interventionPerform standardized neurocognitive testing at baseline and serially at 1-, 6-, and 12-months post-infusion.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Patients with RRMM1 intervention
Trial outcomes
Primary outcomes
1
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-TSecondary outcomes
1
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-T2
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-T3
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-T4
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-TSponsors and contacts
Click on the lead sponsor to view all of their trials.
Wake Forest University Health Sciences
Lead sponsor
Atrium Health Wake Forest Baptist
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: