Voice as a Digital Biomarker of Neurotoxicity in CAR T-Cell Therapy
Memorial Sloan Kettering Cancer Center
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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.,…
Interventions
- Diagnostic TestAudio 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
Locations (8)
- Memorial Sloan Kettering at Basking Ridge (Consent Only)Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Consent only)Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Consent Only)Montvale, New Jersey
- Memorial Sloan Kettering Suffolk-Commack (Consent Only)Commack, New York
- Memorial Sloan Kettering Westchester (Consent only)Harrison, New York
- Weill Cornell Medical Center (Data Analysis Only)New York, New York