Longitudinal Neurocognitive Trajectories After BCMA CAR-T in Multiple Myeloma
Wake Forest University Health Sciences
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).
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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 comp…
Interventions
- OtherStandardized neurocognitive testing
Perform standardized neurocognitive testing at baseline and serially at 1-, 6-, and 12-months post-infusion.
Location
- Atrium Health Levine CancerCharlotte, North Carolina