A Study of Voice as a Way to Monitor for Side Effects in People Receiving CAR T-Cell Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Audio Tasks.
- Who it may be relevant to
- Registry conditions: Non-hodgkin Lymphoma, Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Voice as a Digital Biomarker of Neurotoxicity in CAR T-Cell Therapy
Overview
The purpose of this study is to collect voice recordings and nervous system (neurologic) assessments from people with non-Hodgkin lymphoma (NHL) or multiple myeloma (MM) who are receiving standard treatment with CAR T-cell therapy. Researchers will study whether these voice recordings and assessments are a practical (feasible) way to monitor for immune effector cell-associated neurotoxicity syndrome (ICANS). Feasibility will be measured by tracking how many participants join the study and complete the assessments.
Interventions
- Diagnostic test Audio Tasks
Voice recordings will be collected at baseline (pre-infusion), twice daily from Day 0 through Day +10, and, if ICANS develops, twice daily until three days after clinical resolution. A final voice recording will also be performed on Day +30
Primary outcome measures
- Number of daily voice recordings collected [Time frame: 30 days after baseline]
- Number of neurocognitive assessments collected [Time frame: 30 days after baseline]
Eligibility criteria
Inclusion criteria
- Documentation of Disease
o Patients must have pathologically confirmed Diagnosed with non-Hodgkin lymphoma or multiple myeloma.
- Definition of treatment and ability
- Scheduled to receive an FDA-approved CAR-T product: Axi-cel, Liso-cel, Tisa-cel, Ide-cel, Cilta-cel, or Brexu-cel.
- Ability to comply with twice daily voice recordings or daily neurologic assessments, as determined by the investigator.
- Age ≥ 18
- ECOG Performance Status of ≤ 2
- Required
- Perform twice daily voice recordings using a smartphone.
- Undergo daily neurologic assessments (e.g., ICE score, tremor evaluation).
- Smartphone ownership.
- Sufficient English proficiency to complete structured voice tasks in the study application.
- Comorbid Conditions
- No pre-existing neurological conditions that significantly impair speech, including but not limited to severe dysarthria, expressive aphasia, or neurodegenerative disorders.
- No history of significant speech or voice disorders, including laryngeal paralysis, severe dysphonia, or recent vocal cord surgery or radiation to the area.
- No pathology affecting the vocal cords that could interfere with voice analysis, such as vocal cord paralysis, chronic laryngitis, vocal cord nodules, polyps, granulomas, or malignancies.
- No severe hearing impairment that would interfere with voice assessments
- Language o Proficiency in spoken English is required, without the need for native-level fluency. This ensures participants can accurately perform structured voice tasks, as the application and underlying acoustic models are currently validated only in English, despite the limitation in generalizability. Participants with language barriers that prevent reliabletask completion or data interpretation will be excluded.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 8 centers
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge
- Memorial Sloan Kettering Monmouth (Consent only) — Middletown
- Memorial Sloan Kettering Bergen (Consent Only) — Montvale
- Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) — Commack
- Memorial Sloan Kettering Westchester (Consent only) — Harrison
- Weill Cornell Medical Center (Data Analysis Only) — New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activites) — New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Rockville Centre
Identifiers
NCT: NCT07249528 · 25-317