This clinical trial evaluates whether prehabilitation with aerobic and resistance exercise improves physical fitness and quality of life outcomes in older patients planning to undergo chimeric antigen receptor (CAR)-T therapy for multiple myeloma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). CAR-T therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. Large numbers of the CAR-T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. While CAR-T therapy is commonly used to treat multiple myeloma, it can result in toxicities that lead to hospitalization, nerve and muscle impairment, and decreased physical function. Prehabilitation programs use targeted interventions to improve functional status prior to medical or surgical treatments. In this study, patients participate in personalized aerobic and resistance prehabilitation activities in the weeks leading up to their CAR-T infusion. This program may improve physical fitness and quality of life, both prior to and after CAR-T infusion, in older patients with relapsed or refractory multiple myeloma.
Additional locations may be listed on ClinicalTrials.gov for NCT07045727.
Locations matching your search criteria
United States
Minnesota
Rochester
Mayo Clinic in RochesterStatus: Active
Contact: Nadine Abdallah
Phone: 480-574-2739
PRIMARY OBJECTIVES:
I. To evaluate the feasibility and acceptability of a 6-week home-based virtual prehabilitation program with remote monitoring in 20 patients ≥ 60 years with relapsed/refractory (R/R) multiple myeloma (MM) scheduled to receive CAR-T therapy at Mayo Clinic – Rochester.
II. Evaluate changes in muscle mass, grip strength, physical performance, frailty status, quality of life, and physical activity from pre-program to post-program (day -2 pre CAR-T) and day +30 post CAR-T in patients who complete the program.
EXPLORATORY OBJECTIVE:
I. Evaluate the feasibility and preliminary effects of isolating skeletal muscle-derived extracellular vesicles (EVs) from peripheral blood samples of older patients with R/R MM and characterize the proteomic profile of EVs at baseline, day -2 pre-CAR-T, and day +30 post CAR-T.
OUTLINE:
Patients receive a personalized exercise plan and use the Connected mHealth app to participate in aerobic and resistance training, according to exercise guidelines and their personalized plan, for 6 weeks. Patients also receive health coaching check-in calls weekly for 6 weeks. Patients also undergo collection of blood and urine samples throughout the study.
After completion of study intervention, patients are followed up 2 days prior to their standard of care CAR-T infusion (after prehabilitation program) and then 30 days after standard of care CAR-T infusion.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationMayo Clinic in Rochester
Principal InvestigatorNadine Abdallah
