Recruiting

CAR-T

Sponsor:

Wake Forest University Health Sciences

Code:

NCT07740317

Conditions

Multiple Myeloma (MM)

CART Therapy

Refractory Multiple Myeloma (RRMM)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standardized neurocognitive testing

Study Details

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).

Conditions

Multiple Myeloma (MM)

CART Therapy

Refractory Multiple Myeloma (RRMM)

Study ID

NCT07740317

Start date

Nov, 2026

Status verified date

Oct, 2026

Completion date

Nov, 2029

Anticipated

Primary completion date

Nov, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with RRMM

RRMM patients being treated with SOC commercial BCMA CAR-T therapy

Interventions

Standardized neurocognitive testing

Perform standardized neurocognitive testing at baseline and serially at 1-, 6-, and 12-months post-infusion.

Primary outcome measure

  • Clinically significant cognitive impairment [ Time Frame: Baseline, 1-, 6-, and 12-months post-CAR-T ]

Central Contacts and Locations

Central contacts

Locations

Atrium Health Levine Cancer

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Principal Investigator:

Cindy Varga, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Oct 23, 2026

Last verified

Oct, 2026

Keywords

  • cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-10-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.