ClinicalTrials.gg
RecruitingNCT07740317CAR-T CogUpdated Oct 23, 2026

Neurocognitive Trajectories After BCMA CAR-T

An observational study in Multiple Myeloma (MM), CART Therapy and Refractory Multiple Myeloma (RRMM), sponsored by Wake Forest University Health Sciences. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Wake Forest University Health Sciences · Observational

Updated Oct 23, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 24 studies in Multiple Myeloma by Wake Forest University Health Sciences — 5 open to participants now, 7 under way, none of them phase 3. Multiple Myeloma · Wake Forest University Health Sciences.

Started
2026
with 1 other
Observational
7 of 24
4 open now
Registered
24th of 24
by date

Among the 24 studies in Multiple Myeloma by Wake Forest University Health Sciences, this one is one of 2 that started in 2026, is one of 7 observational ones, and was the 24th registered.

Multiple Myeloma

3,763 studies on the registry are indexed under Multiple Myeloma; 770 are open to participants now.

Browse Multiple Myeloma studies →

Open to participants now

5 of the 24 studies in Multiple Myeloma by Wake Forest University Health Sciences are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

Where they have run

Who these studies take

Of the 585 Multiple Myeloma studies recruiting now, 430 (74%) set no upper age limit and 106 (18%) stop at 75 or younger; 36 take children under 18; 24 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 24 studies in Multiple Myeloma by Wake Forest University Health Sciences, or all of them as a file.
02

Study 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).

Read the detailed 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.

03

Conditions studied

  • Multiple Myeloma (MM)
  • CART Therapy
  • Refractory Multiple Myeloma (RRMM)

Keywords

  • cancer
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Ability to understand and willingness to sign an IRB-approved
  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. 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

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 neuroactive drugs
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with RRMM

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

    Other: Standardized neurocognitive testing

Interventions

  • OtherStandardized neurocognitive testing

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

06

What researchers measure

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.

    Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T

Secondary outcomes

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

    HVLT-R recall score will be captured at baseline, 1-, 6-, and 12-months post-CAR-T. The total recall score is the sum of the raw scores from the three learning trials. Raw and standardized T-scores will be captured

    Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T

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

    HVLT-R retention score % will be captured at baseline, 1-, 6-, and 12-months post-CAR-T. The retention score % is the delayed recall score divided by the highest raw score from learning trial #2 or learning trial #3.

    Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T

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

    The HVLT-R RDI will be captured at baseline, 1-, 6-, and 12-months post-CAR-T. The RDI is the difference between total number of true positives and total number of false positives from the delayed recognition trial. Raw and standardized T-scores will be captured.

    Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T

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

    The OTMT-A results will be captured at baseline, 1-, 6-, and 12-months post-CAR-T. The OTMT-A is a count variable indicating number of seconds to complete OTMT Part A. Raw and standardized scores will be captured.

    Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T

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

    The OTMT-B results will be captured at baseline, 1-, 6-, and 12-months post-CAR-T. The OTMT-B is a count variable indicating number of seconds to complete OTMT Part B. Raw and standardized scores will be captured.

    Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T

  6. Controlled Oral Word Association Test (COWAT) results

    The COWAT results will be captured at baseline, 1-, 6-, and 12-months post-CAR-T. The COWAT is a count variable indicating number of words named during the test. Raw and standardized scores will be captured.

    Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T

  7. Wechsler Adult Intelligence Scale (WAIS)-III Digit Span subtest results

    The WAIS-III Digit Span subtest will be capture at baseline, 1-, 6-, and 12-months post-CAR-T. The WAIS-III Digit Span results are a count variable indicating number of trials completed on Digit Span Forward and Backward combined. Raw and standardized scores will be captured.

    Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T

  8. Number of participants who completed the study

    A binary variable indicating if the participant successfully completed the study, where study completion is defined as completing baseline and at least one post-treatment Cognitive Assessment Battery

    Time frame: 12 months post-CAR-T

  9. Patient Health Questionnaire-9 (PHQ-9) results

    The PHQ-9 includes 9 items that are used to screen for and monitor the severity of depression. The total score ranges from 0 - 27 with higher scores indicating higher depression severity. The PHQ-9 outcome will be evaluated at baseline, 1-, 6-, and 12-months post-CAR-T as a score and as a categorical variable, with categories defined according to standard documentation. None/minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19), Severe (20-27).

    Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T

  10. Generalized Anxiety Disorder 7-Item (GAD-7) results

    The GAD-7 includes 7 items that are used to screen for and monitor generalized anxiety disorder. The total score ranges from 0 - 21 with higher scores indicating higher anxiety. The GAD-7 outcome will be evaluated at baseline, 1-, 6-, and 12-months post-CAR-T as a score and also as a categorical variable, with categories defined according to standard documentation. Minimal anxiety (0-4), Mild anxiety (5-9), Moderate anxiety (10-14), Severe anxiety (15-19).

    Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T

  11. Functional Assessment of Cancer Therapy/Cognition (FACT-Cog) V3 Subscale Scores

    The FACT-Cog V3 includes 37 total items that are used to derive 4 subscales (CogPCI, CogPCA, CogQOL, CogOth). For each of the subscales, higher scores indicate better quality of life. Scoring for each subscale is according to standard documentation (FACT-Cog V3 scoring template 05 July 2023). Subscales will not be summed to derive a total score. The following subscales will be evaluated at baseline, 1-, 6-, and 12-months post-CAR-T. Perceived cognitive impairments score (CogPCI) - includes 18 items, with score ranging from 0-72. Perceived cognitive abilities score (CogPCA) - includes 7 items with score ranging from 0-28. Impact of perceived cognitive impairments on quality-of-life score (CogQOL) - includes 4 items, with score ranging from 0-16. Comments from others on cognition score (CogOth) - includes 4 items, with score ranging from 0-16.

    Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T

  12. Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a Scores

    The PROMIS Fatigue 7a includes 7 items with 5-level Likert scales (Never, Rarely, Sometimes, Often, Always). The total score ranges from 7 - 35 with higher scores indicating more fatigue is being measured. These raw scores will be converted to T-score metrics (and SE) using the scoring manual. PROMIS Fatigue 7a will be assessed at baseline, 1, 6, and 12 months after CAR T.

    Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T

  13. Hopkins Verbal Learning Test - Revised (HVLT-R) delayed recall score

    HVLT-R delayed recall score will be captured at baseline, 1-, 6-, and 12-months post-CAR-T. The delayed recall score is the number of recalled words during the delayed recall portion of the test. Raw and standardized T-scores will be captured.

    Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Nov 2029, 36 months later.

Of 173 non-industry observational studies under Multiple Myeloma, half reached primary completion within 70 months of starting (the median), counting those still running; a quarter within 33. This study's planned 36 months is below that.

Counting every sponsor, half of 239 studies reached it within 61 months; a quarter within 30 and three quarters within 126.

Start moved twice since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, last on Oct 23, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jul 28, 2026
First posted
Jul 31, 2026
StartEst.
Nov 2026was Sep 2026
Primary completionEst.
Nov 2029
CompletionEst.
Nov 2029
Last update
Oct 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 23, 2026
Sites
Atrium Health Levine Cancer is now Recruiting
Oct 23, 2026
Start date
Sep 2026→Nov 2026
moved 2 times, Sep 28, 2026 – Oct 23, 2026
Show all 2 updates
  1. Oct 23, 2026
    Not yet recruiting→Recruiting
    Atrium Health Levine Cancer is now Recruiting
    Start date Oct 2026→Nov 2026
    + 1 other change: verification date
  2. Sep 28, 2026
    Start date Sep 2026→Oct 2026
    + 2 other changes: identifiers and verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07740317
Collaborators
Atrium Health Wake Forest Baptist
Responsible party
Sponsor
First posted
Jul 31, 2026
Start date
Nov 2026 (estimated)
Primary completion
Nov 2029 (estimated)
Completion
Nov 2029 (estimated)
Last update
Oct 23, 2026

Study contacts

Courtney Schepel
Contact
courtney.schepel@advocatehealth.org
980-292-0817
Cindy Varga, MD
principal investigator · Atrium Health Levine Cancer

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion