NCT07740317

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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
39mo left

Started Sep 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2029

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

3.2 years

First QC Date

July 28, 2026

Last Update Submit

July 28, 2026

Conditions

Multiple Myeloma (MM)CART TherapyRefractory Multiple Myeloma (RRMM)

Keywords

cancer

Outcome Measures

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.

    Baseline, 1-, 6-, and 12-months post-CAR-T

Secondary Outcomes (13)

  • Hopkins Verbal Learning Test - Revised (HVLT-R) total recall score

    Baseline, 1-, 6-, and 12-months post-CAR-T

  • Hopkins Verbal Learning Test - Revised (HVLT-R) retention score %

    Baseline, 1-, 6-, and 12-months post-CAR-T

  • Hopkins Verbal Learning Test - Revised (HVLT-R) Recognition Discrimination Index (RDI)

    Baseline, 1-, 6-, and 12-months post-CAR-T

  • Oral Trail-Making Test Part A (OTMT-A) results, seconds

    Baseline, 1-, 6-, and 12-months post-CAR-T

  • Oral Trail-Making Test Part B (OTMT-B) results, seconds

    Baseline, 1-, 6-, and 12-months post-CAR-T

  • +8 more secondary outcomes

Study Arms (1)

Patients with RRMM

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

Other: Standardized neurocognitive testing

Interventions

Standardized neurocognitive testingOTHER

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

Patients with RRMM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • 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
  • Ability to read and understand the English language
  • ECOG 0-2
  • If actively taking benzodiazepine, must be able to hold for 3 hours prior to study assessments as per treating clinician
  • 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
  • Ability to complete required assessments, as determined by the treating clinician

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atrium Health Levine Cancer

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Multiple MyelomaNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Cindy Varga, MD

    Atrium Health Levine Cancer

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Courtney Schepel

CONTACT

980-292-0817courtney.schepel@advocatehealth.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2026

First Posted

July 31, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

November 1, 2029

Study Completion (Estimated)

November 1, 2029

Last Updated

July 31, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)