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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants diagnosed with non-Hodgkin lymphoma or multiple myeloma | Participants must have pathologically confirmed Diagnosed with non-Hodgkin lymphoma or multiple myeloma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Audio Tasks | Diagnostic Test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of daily voice recordings collected | To prospectively collect and curate a dataset of twice daily smartphone-based voice recordings and daily neurocognitive assessments from patients undergoing CAR T-cell therapy. | 30 days after baseline |
| Number of neurocognitive assessments collected | To prospectively collect and curate a dataset of twice daily smartphone-based voice recordings and daily neurocognitive assessments from patients undergoing CAR T-cell therapy. | 30 days after baseline |
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Inclusion Criteria:
Documentation of Disease
o Patients must have pathologically confirmed Diagnosed with non-Hodgkin lymphoma or multiple myeloma.
Definition of treatment and ability
Age ≥ 18
ECOG Performance Status of ≤ 2
Required
Comorbid Conditions
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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Participants will be identified from the population of patients scheduled to receive CAR T-cell therapy at Memorial Sloan Kettering Cancer Center. The primary treating team or designated research staff will approach eligible patients for participation in this non-therapeutic study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roni Shouval, MD, PhD | Contact | 646-888-3483 | shouvalr@mskcc.org | |
| Mohammad Alhomoud, MD | Contact | 646-608-4375 | alhomom@mskcc.org |
| Name | Affiliation | Role |
|---|---|---|
| Roni Shouval, MD, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge (Consent Only) | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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• Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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| Memorial Sloan Kettering Monmouth (Consent only) | Recruiting | Middletown | New Jersey | 07748 | United States |
|
| Memorial Sloan Kettering Bergen (Consent Only) | Recruiting | Montvale | New Jersey | 07645 | United States |
|
| Memorial Sloan Kettering Suffolk-Commack (Consent Only) | Recruiting | Commack | New York | 11725 | United States |
|
| Memorial Sloan Kettering Westchester (Consent only) | Recruiting | Harrison | New York | 10604 | United States |
|
| Weill Cornell Medical Center (Data Analysis Only) | Not yet recruiting | New York | New York | 10021 | United States |
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| Memorial Sloan Kettering Cancer Center (All Protocol Activites) | Recruiting | New York | New York | 10065 | United States |
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| Memorial Sloan Kettering Nassau (Consent Only) | Recruiting | Rockville Centre | New York | 11553 | United States |
|
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
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