RecruitingNot ApplicableNCT07045727

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

Prehabilitation in Patients With Multiple Myeloma Receiving CAR-T Therapy


Sponsor

Mayo Clinic

Enrollment

20 participants

Start Date

Aug 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 60 Years

Inclusion Criteria6

  • 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 Criteria5

  • 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

Interventions

PROCEDUREAccelerometry

Ancillary studies

OTHERAerobic Exercise

Participate in aerobic training program

PROCEDUREBiospecimen Collection

Undergo collection of blood and urine samples

OTHERElectronic Health Record Review

Ancillary studies

OTHERExercise Counseling

Receive health coaching check-in calls

OTHERInternet-Based Intervention

Use Connected mHealth app

OTHERInterview

Ancillary studies

OTHERPhysical Performance Testing

Ancillary studies

OTHERResistance Training

Participate in resistance training program

OTHERSurvey Administration

Ancillary studies

PROCEDURETailored Intervention

Receive personalized exercise plan


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT07045727


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