Multiple Myeloma (MM)CAR-T CogNCT07740317
Neurocognitive Trajectories After BCMA CAR-T
An observational study of Multiple Myeloma (MM) and CART Therapy, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma (MM), CART Therapy, Refractory Multiple Myeloma (RRMM)
- What is being tested?
- Standardized neurocognitive testing
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Nov 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Atrium Health Levine Cancer
Charlotte, North Carolina, 28204
Courtney Schepel, 980-292-0817, courtney.schepel@advocatehealth.org
Cindy Varga, MD
About this study
Official title: Longitudinal Neurocognitive Trajectories After BCMA CAR-T in Multiple Myeloma
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.
- Being tested
- Standardized neurocognitive testing
- Keywords
- cancer
- Medical subject headings
- Multiple Myeloma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized neurocognitive testingOther
Perform standardized neurocognitive testing at baseline and serially at 1-, 6-, and 12-months post-infusion.
| Study group | Role | What they receive |
|---|---|---|
| Patients with RRMM | RRMM patients being treated with SOC commercial BCMA CAR-T therapy Receives: Other: Standardized neurocognitive testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1-, 6-, and 12-months post-CAR-T
Secondary outcomes (13)
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
Measured: Baseline, 1-, 6-, and 12-months post-CAR-T
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.
Measured: Baseline, 1-, 6-, and 12-months post-CAR-T
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.
Measured: Baseline, 1-, 6-, and 12-months post-CAR-T
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.
Measured: Baseline, 1-, 6-, and 12-months post-CAR-T
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.
Measured: Baseline, 1-, 6-, and 12-months post-CAR-T
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.
Measured: Baseline, 1-, 6-, and 12-months post-CAR-T
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.
Measured: Baseline, 1-, 6-, and 12-months post-CAR-T
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
Measured: 12 months post-CAR-T
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).
Measured: Baseline, 1-, 6-, and 12-months post-CAR-T
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).
Measured: Baseline, 1-, 6-, and 12-months post-CAR-T
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.
Measured: Baseline, 1-, 6-, and 12-months post-CAR-T
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.
Measured: Baseline, 1-, 6-, and 12-months post-CAR-T
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.
Measured: Baseline, 1-, 6-, and 12-months post-CAR-T
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma (MM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Atrium Health Wake Forest Baptist
- Responsible party
- Sponsor
- Investigators
- Cindy Varga, MD, Principal investigator, Atrium Health Levine Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740317
- Sponsor's protocol ID
- IRB00154580
- Other IDs
- ONC-MM-2506
- Acronym
- CAR-T Cog
- Status last verified
- Oct 2026
- First submitted
- 28 Jul 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Neurocognitive Trajectories After BCMA CAR-T in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07740317
- Acronym / sponsor ID
- CAR-T Cog / IRB00154580
- Keywords
- cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Atrium Health Wake Forest Baptist
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with RRMM | – | Other: Standardized neurocognitive testingRRMM patients being treated with SOC commercial BCMA CAR-T therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized neurocognitive testingPerform standardized neurocognitive testing at baseline and serially at 1-, 6-, and 12-months post-infusion. | Other | Patients with RRMM |
Primary outcome
Clinically significant cognitive impairment
Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T
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.
13 secondary outcomes
Hopkins Verbal Learning Test - Revised (HVLT-R) total recall score
Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T
Hopkins Verbal Learning Test - Revised (HVLT-R) retention score %
Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T
Hopkins Verbal Learning Test - Revised (HVLT-R) Recognition Discrimination Index (RDI)
Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T
Oral Trail-Making Test Part A (OTMT-A) results, seconds
Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T
Oral Trail-Making Test Part B (OTMT-B) results, seconds
Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T
Controlled Oral Word Association Test (COWAT) results
Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T
Wechsler Adult Intelligence Scale (WAIS)-III Digit Span subtest results
Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T
Number of participants who completed the study
Time frame: 12 months post-CAR-T
Patient Health Questionnaire-9 (PHQ-9) results
Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T
Generalized Anxiety Disorder 7-Item (GAD-7) results
Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T
Functional Assessment of Cancer Therapy/Cognition (FACT-Cog) V3 Subscale Scores
Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T
Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a Scores
Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T
Hopkins Verbal Learning Test - Revised (HVLT-R) delayed recall score
Time frame: Baseline, 1-, 6-, and 12-months post-CAR-T
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cindy Varga, MD principal investigator
Atrium Health Levine Cancer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma (MM) and CART Therapy, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Courtney Schepel (980-292-0817, courtney.schepel@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically significant cognitive impairment (time frame: Baseline, 1-, 6-, and 12-months post-CAR-T). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.