Geriatric Assessment Guided Interventions to Accelerate Functional Recovery After CAR-T Therapy for Patients 60 Years and Older With B-cell Non-Hodgkin Lymphoma or Multiple Myeloma, GOCART Study

Conditions

• B-Cell Non-Hodgkin Lymphoma
• Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

60 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Best Practice — OTHER
  Undergo standard of care
• Cognitive Intervention — OTHER
  Receive delirium prevention education
• Comprehensive Geriatric Assessment — OTHER
  Undergo geriatric assessment
• Nutritional Intervention — OTHER
  Undergo nutritional optimization
• Physical Therapy — PROCEDURE
  Undergo physical function optimization
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Jun 23, 2023

Status verified

Oct 2025

Primary completion

Oct 5, 2026

Completion

Oct 5, 2026

Study Design

Enrollment

164 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Arm I (PT, cognitive education, nutrition education)
  Patients undergo GA before lymphodepleting chemotherapy and recommendations based on assessment results communicated to treating physicians. Patients receive PT and delirium prevention education prior to lymphodepletion, at least once before CAR-T therapy, at least 2 times a week while inpatient, and at least once every other week outpatient up to day 30. Additionally, patients receive personalized nutritional guidance from a registered dietician prior to lymphodepletion, prior to CAR-T therapy and at least once a week up to day 30.
• Active Comparator: Arm II (standard of care)
  Patients undergo GA and receive standard of care throughout study.

Primary Outcome Measure

Changes in Short Physical Performance Battery (SPPB) [ Time Frame: From baseline to day 30 after chimeric antigen receptor T-cell (CAR-T) infusion ]

Locations (1)

Find similar trials in Duarte, CA

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