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

Recruitingn/aAges 18 Years - anyAllMemorial Sloan Kettering Cancer Center
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 18 * ECOG Performance Status of โ‰ค 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.
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What it tests

  • Audio Tasks
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Where

8 sites
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, United States
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, United States
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, United States
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, United States
Memorial Sloan Kettering Westchester (Consent only)
Harrison, United States
Weill Cornell Medical Center (Data Analysis Only)
New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Rockville Centre, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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