Cognitive changes after BCMA CAR-T in multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, consent-based observational study that follows adults with RRMM receiving standard BCMA CAR-T therapy to see how their thinking and memory may change from baseline to 1, 6, and 12 months after treatment. Participants will complete standardized neurocognitive tests at defined time points, starting before CAR-T therapy and continuing after. The study will evaluate feasibility of longitudinal cognitive assessments in real-world clinical settings. Data will be collected at baseline (-30 days) and at 1, 6, and 12 months post-treatment to characterize trajectories over time.

Why it matters

Who can join: the full rules

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

Where it's running

• Atrium Health Levine Cancer
  Charlotte, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Cindy Varga, MD — Atrium Health Levine Cancer
• Study coordinator: Courtney Schepel
• Email: courtney.schepel@advocatehealth.org
• Phone: 980-292-0817

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.