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Recruiting
NCT07740317
Neurocognitive Trajectories After BCMA CAR-T
Conditions: Multiple Myeloma (MM), CART Therapy, Refractory Multiple Myeloma (RRMM)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 50
Sponsor: Wake Forest University Health Sciences
Location: Atrium Health Levine Cancer Charlotte North Carolina
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).
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07740317). StuddyBuddy aggregates publicly available trial information.