A Study of Voice as a Way to Monitor for Side Effects in People Receiving CAR T-Cell Therapy

Purpose

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.

Conditions

  • Non-hodgkin Lymphoma
  • Multiple Myeloma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Participants diagnosed with non-Hodgkin lymphoma or multiple myeloma Participants must have pathologically confirmed Diagnosed with non-Hodgkin lymphoma or multiple myeloma.
  • 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

Recruiting Locations

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey 07920
Contact:
Roni Shoulval, MD, PhD
646-888-3483

Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey 07748
Contact:
Roni Shouval, MD, PhD
646-888-3483

Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey 07645
Contact:
Roni Shouval, MD, PhD
646-888-3483

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York 11725
Contact:
Roni Shouval, MD, PhD
646-888-3483

Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York 10604
Contact:
Roni Shouval, MD, PhD
646-888-3483

Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York 10065
Contact:
Roni Shouval, MD, PhD
646-888-3483

Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Rockville Centre, New York 11553
Contact:
Roni Shouval, MD, PhD
646-888-3483

More Details

Status
Recruiting
Sponsor
Memorial Sloan Kettering Cancer Center

Study Contact

Roni Shouval, MD, PhD
646-888-3483
shouvalr@mskcc.org