Prehabilitation With Aerobic and Resistance Exercise for Improving Physical Fitness and Quality of Life Outcomes in Older Patients Undergoing CAR-T Therapy for Relapsed or Refractory Multiple Myeloma

Mayo Clinic

Status

Enrolling

Conditions

Refractory Multiple Myeloma

Recurrent Multiple Myeloma

Treatments

Other: Internet-Based Intervention

Other: Exercise Counseling

Other: Aerobic Exercise

Procedure: Tailored Intervention

Procedure: Accelerometry

Other: Survey Administration

Procedure: Biospecimen Collection

Other: Physical Performance Testing

Other: Resistance Training

Other: Interview

Other: Electronic Health Record Review

Study type

Interventional

Funder types

Other

Identifiers

NCT07045727

25-001845 (Other Identifier)

NCI-2025-04165 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Multiple myeloma diagnosis
Females and males ≥ 60 years of age
Eastern Cooperative Oncology Group (ECOG) score of < 3
Scheduled for a CAR T therapy transfusion
Apheresis date at least 7 days prior to date of enrollment
Primary hematologist attending physician clearance for exercise

Exclusion criteria

Females or males < 60 years of age
Any hematological cancer other than multiple myeloma
Evidence of an absolute contraindication [e.g., heart insufficiency > New York Heart Association (NYHA) III or uncertain arrhythmia; uncontrolled hypertension; reduced standing or walking ability for exercise]
Other comorbidities that preclude participation in the exercise as deemed by physical therapist or physical medicine and rehabilitation (PM&R) physician
Active infections, active bleeding disorders, and cytopenias at risk for further adverse events deemed by hematologist-oncologist

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Supportive care (aerobic and resistance training)

Experimental group

Description:

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.

Treatment: