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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07045727
Status
Recruiting
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Conditions

  • Recurrent Multiple Myeloma
  • Refractory Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Accelerometry — PROCEDURE
    Ancillary studies
  • Aerobic Exercise — OTHER
    Participate in aerobic training program
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood and urine samples
  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Exercise Counseling — OTHER
    Receive health coaching check-in calls
  • Internet-Based Intervention — OTHER
    Use Connected mHealth app
  • Interview — OTHER
    Ancillary studies
  • Physical Performance Testing — OTHER
    Ancillary studies
  • Resistance Training — OTHER
    Participate in resistance training program
  • Survey Administration — OTHER
    Ancillary studies
  • Tailored Intervention — PROCEDURE
    Receive personalized exercise plan

Study Details

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.

Key Dates

Start date
Aug 18, 2025
Status verified
Mar 2026
Primary completion
Sep 15, 2026
Completion
Sep 15, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Supportive care (aerobic and resistance training)
    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.

Primary Outcome Measure

Enrollment rate [ Time Frame: Up to 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Nadine H. Abdallah, MD (PRINCIPAL_INVESTIGATOR)
Diane K. Ehlers, PhD (PRINCIPAL_INVESTIGATOR)

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