This clinical trial compares the effectiveness of geriatric assessment (GA) guided interventions to accelerate functional recovery after chimeric antigen receptor T-cell (CAR-T) therapy compared to standard of care (SOC) in patients 60 years and older with B-cell non-Hodgkin lymphoma (NHL) or multiple myeloma (MM). A large number of patients diagnosed with cancer are over the age of 60, yet most cancer treatments are developed for younger patients. Therefore, older patients may be less likely to be offered stronger treatments, such as CAR-T therapy, due to possible side effects. Geriatric assessment is a multi-dimensional health assessment tool combining patient reported and objective measures covering physical function, mental processes (cognitive), and nutrition. Pre-treatment assessments may identify weaknesses in older adults and may guide interventions for physical therapy, cognitive changes and nutrition to decrease CAR-T therapy side effects and improve care in older adults with NHL or MM.
Ability to provide informed consent
Patient's physician must agree for patient participation. A physician may elect to provide blanket agreement for participation of any eligible CAR-T patient under their care
Ability to read English, or Spanish. Other languages will be acceptable with site principal investigator (PI) agreement if surveys are available and language does not preclude completing study procedures
Age: >= 60 years at the time of enrollment
Prior CAR-T therapy
Any condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Parallel
Best Practice
Other interventionUndergo standard of care
Cognitive Intervention
Other interventionReceive delirium prevention education
Comprehensive Geriatric Assessment
Other interventionUndergo geriatric assessment
Nutritional Intervention
Other interventionUndergo nutritional optimization
Physical Therapy
Procedure/SurgeryUndergo physical function optimization
Questionnaire Administration
Other interventionAncillary studies
Changes in Short Physical Performance Battery (SPPB)
T-test will be used to compare SPPB changes score between two arms at 30 days after CAR-T infusion.
Successful in coordinating initial optimization
A physical or virtual visit will be tabulated separately for functional optimization, delirium prevention and nutrition. Adherence will be deemed to have been met if \>=70% or more comlete tri-modality optimization before lymphodepletion in the modified intent to treat population.
Frailty progression
Frailty progression will be defined as a score of 3 or more at T2 if T1 not frail (\<3); if frail at T1 (score 3-5), any worsening of the score; a score of 5 at day 30 if baseline score already at the maximum frailty of 5.
Cognitive impairment
Assessed using the Montreal Cognitive Assessment (MoCA). Cognitive impairment defined as MoCA score of \< 23 or unable to complete the MoCA due to cognitive impairment. The proportion of patients with cognitive impairment at day 30, irrespective of baseline cognition, will be compared between the two arms using Chi-square test.
Weight loss
Malnourishment will be measured using weight loss and dichotomized as \> 5% weight loss from baseline to day +30. The proportion of patients with over 5% weight loss from T1 to T2 will be compared between the two arms using Chi-square test.
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator