Study of CAR-T Therapy in Older Patients

Multiple Myeloma Clinical Trial

Official title:

Observational Study of Commercial Chimeric Antigen Receptor T-cell (CAR T) Therapy in Older Patients With Hematologic Malignancies and With an Embedded Pilot Study of Longitudinal Geriatric and Neurocognitive Evaluation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04300998
• Other study ID #: 19-452
• Status: Recruiting
• Start date: March 4, 2020
• Est. completion date: March 4, 2025

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Richard Lin, MD, PhD
• Phone: 646-608-2646
• Email: ABMTTrials[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is being done to find out how older patients respond to CAR-T cell therapy and how the treatment affects their quality of life. This is a quality of life study and participating in the study does not involve receiving any treatment, other than the standard treatment for participants' disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: March 4, 2025
• Est. primary completion date: March 4, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• are =60 years old (all cohorts)
• have pathologically confirmed, relapsed refractory lymphoid malignancy or plasma cell disorder receiving a commercial CAR T-cell product (all cohorts)
• able to speak and understand English (cohort 1 only)

Exclusion Criteria:

• Any prior commercial or investigational CAR T therapy (all cohorts)
• Current diagnosis of major Axis I psychiatric disorder (DSM-IV), major depression, bipolar disorder, or schizophrenia, as per medical records or patient report (cohort 1 only)
• History of a neurological disorder, neurodegenerative disease, or traumatic brain injury with loss of consciousness (>60 minutes), as per medical records or patient report (cohort 1 only)
• Current ongoing substance abuse and/or history of substance abuse, as per medical records or patient report (cohort 1 only)

Related Conditions & MeSH terms

• DLBCL NOS
• High-grade B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Multiple Myeloma
• Refractory B-Cell Lymphoma

Intervention

Behavioral:
• Activities of Daily Living/ADLs
7 activities: bathing, dressing, grooming, feeding, walking inside the home, walking outside the home, and bladder and bowel control. Participants get 2 points for each activity that is not limited at all, 1 point for limited a little, and 0 points for limited a lot. Total ADL score ranges from 0 to 14
• Instrumental Activity of Daily Living
8 activities: telephone use, doing laundry, shopping, preparing meals, doing housework, handling own medications, handling money and finances, and transportation to visit one's doctor. Participants get 2 points for each activity that can be done without help, 1 point for needing some help, and 0 point for being unable to do. Total iADL score ranges from 0 to16.
• Timed Up and Go
Participants are asked to get up from the chair, walk 10 feet, turn, and walk back to the char (<10 seconds, 10-20 seconds, >20 seconds)
• Cognition
Mini-Cognition test: CDT and 3-word recall
• Geriatric Depression Scale
Four yes/no questions regarding patient's psychological status. Score ranges from 0 to 4, and a score of >/=1 is usually indicative of depression.
• Social Support
Four 5-point Likert scale questions addressing 4 domains of social support: emotional/ informational, tangible, affectionate, and positive social interaction. Score for each item ranges from 1 to 5, and total score ranges from 4 to 20. A higher score means better social support.
• Brief Test of Attention
assess selective auditory attention.
• Trail Making Test
Assesses visual scanning, graphomotor speed, and set shifting.
• Controlled Oral Word Association Test
A timed test of verbal fluency
• Hopkins Verbal Learning Test-Revised
The HVLT-R is a test of verbal learning and recall. Scores obtained are the total number of words: 1) recalled over three trials; 2)recalled after a delay; 3) correctly recognized.

Other:
• Blood draw
collection of blood tests

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who complete all required assessment visits prior to disease progression or death	Participants who complete all assessment visits prior to disease progression or death will be considered as a success for a feasibility endpoint.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center