Actively Recruiting

Phase Not Applicable
Age: 60Years +
All Genders
ID07045727

Prehabilitation With Aerobic and Resistance Exercise for Older Patients Undergoing CAR-T Therapy for Relapsed or Refractory Multiple Myeloma

Led by Mayo Clinic · Updated on 2026-03-30

20

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether a personalized prehabilitation program with aerobic and resistance exercises can improve physical fitness and quality of life in older patients with relapsed or refractory multiple myeloma undergoing chimeric antigen receptor (CAR)-T therapy. CAR-T therapy modifies a patient's immune cells to attack cancer but can cause side effects like hospitalization and decreased physical function. This study focuses on patients aged 60 and older preparing for CAR-T treatment to see if exercise before therapy can help. Participants receive a tailored exercise plan through the Connected mHealth app to engage in aerobic and resistance training for six weeks before their CAR-T infusion. Weekly health coaching calls support patients during this period. Throughout the study, blood and urine samples are collected to monitor health and response. During the study, researchers assess muscle strength, muscle mass, physical performance, physical activity levels, frailty status, and quality of life at three points: before starting the exercise program, just before CAR-T infusion, and 30 days after infusion. The trial also monitors enrollment, retention, completion rates, patient satisfaction, and any adverse events up to 30 days post-infusion. The overall aim is to understand if this prehabilitation can enhance outcomes and well-being in this patient group.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with multiple myeloma
  • Age 60 years or older
  • Eastern Cooperative Oncology Group (ECOG) score less than 3
  • Scheduled for CAR-T therapy transfusion
  • Apheresis date at least 7 days before enrollment
  • Clearance from primary hematologist to participate in exercise
Not Eligible

You will not qualify if you...

  • Under 60 years of age
  • Any blood cancer other than multiple myeloma
  • Absolute contraindications such as severe heart failure (NYHA III or higher), uncertain arrhythmia, uncontrolled high blood pressure, or inability to stand or walk for exercise
  • Other medical conditions preventing exercise as determined by specialists
  • Active infections, bleeding disorders, or blood cell deficiencies that increase risk of adverse events

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 weeks

Participants receive a personalized exercise plan and use the Connected mHealth app to participate in aerobic and resistance training according to exercise guidelines and their plan. They also receive weekly health coaching check-in calls and undergo collection of blood and urine samples throughout the study.

Weekly visits for health coaching check-in calls and sample collection

Follow-up

Duration - Up to 30 days post-CAR-T infusion

Participants are assessed for changes in muscle strength, muscle mass, physical performance, quality of life, physical activity, and frailty status up to 30 days after CAR-T infusion.

3 visits: baseline prior to intervention, post-intervention two days before CAR-T infusion, and follow-up 30 days after CAR-T infusion

Trial Site Locations

Total: 1 location

1

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

C

Clinical Trials Referral Office

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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