Clinical trial · Observational
Neurocognitive Trajectories After BCMA CAR-T
Longitudinal Neurocognitive Trajectories After BCMA CAR-T in Multiple Myeloma
NCT07740317CI-TRIAL-00120030CAR-T Cognot yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CART Therapy | — | UNRESOLVED | — |
| Multiple Myeloma (MM) | Multiple Myeloma | CURATED_EXACT | 0.85 |
| Refractory Multiple Myeloma (RRMM) | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standardized neurocognitive testing | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with RRMM
- description
- RRMM patients being treated with SOC commercial BCMA CAR-T therapy
- interventionNames
- Other: Standardized neurocognitive testing
Primary outcomes (1)
- measure
- Clinically significant cognitive impairment
- timeFrame
- Baseline, 1-, 6-, and 12-months post-CAR-T
- description
- 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.
Secondary outcomes (13)
- measure
- Hopkins Verbal Learning Test - Revised (HVLT-R) total recall score
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.