RECRUITING

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

Conditions

Recurrent Multiple Myeloma Refractory Multiple Myeloma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prehabilitation in Patients With Multiple Myeloma Receiving CAR-T Therapy

Quick Facts

Study Start:2025-08-18

Study Completion:2026-09-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07045727

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Clinical Trials Referral Office

CONTACT

855-776-0015

mayocliniccancerstudies@mayo.edu

Principal Investigator

Nadine H. Abdallah, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Diane K. Ehlers, PhD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Nadine H. Abdallah, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic
Diane K. Ehlers, PhD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-18

Study Completion Date2026-09-15

Study Record Updates

Study Start Date2025-08-18

Study Completion Date2026-09-15

Terms related to this study

Additional Relevant MeSH Terms

Recurrent Multiple Myeloma
Refractory Multiple Myeloma