Exercise Program for Multiple Myeloma

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Other cancers, Heart insufficiency, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a specific exercise program can help older patients with multiple myeloma improve physical fitness and quality of life before undergoing CAR-T therapy. CAR-T modifies immune cells to target cancer cells but can cause side effects like muscle weakness and reduced physical function. Participants will follow a personalized exercise plan, including aerobic and resistance training, to determine its effectiveness in addressing these issues. The study seeks individuals aged 60 or older, diagnosed with multiple myeloma, and scheduled for CAR-T therapy. As an unphased trial, it offers a unique opportunity to contribute to research that may enhance patient care and quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this exercise program is safe for older patients with multiple myeloma?

A previous study found that regular aerobic and strength exercises are safe, with no harmful effects reported. This was especially true when patients followed the exercise program after treatments like autologous stem cell transplantation (ASCT). These results suggest that performing such exercises before starting CAR-T therapy can be safe for patients. The exercises aim to boost physical fitness and quality of life, potentially helping older patients with multiple myeloma feel better and stronger before their treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how a personalized exercise program might support patients with multiple myeloma, a type of blood cancer. Unlike typical treatments such as chemotherapy, which directly target cancer cells, this approach focuses on improving patients' overall well-being through aerobic and resistance training. By using the Connected mHealth app and health coaching, it aims to enhance physical fitness, potentially improving quality of life and resilience during treatment. This trial seeks to discover if exercise can be a valuable complement to existing therapies like CAR-T, offering a holistic avenue for patient care.

What evidence suggests that prehabilitation with aerobic and resistance exercise is effective for improving outcomes in multiple myeloma patients undergoing CAR-T therapy?

Research has shown that aerobic and resistance exercises before treatment can enhance well-being and physical fitness in people with multiple myeloma. In this trial, participants in the supportive care arm will receive a personalized exercise plan and use the Connected mHealth app for aerobic and resistance training over 6 weeks. Studies have found that these exercise programs strengthen muscles and improve heart health, which is crucial for older patients undergoing treatments like CAR-T therapy. This type of exercise can also reduce fatigue and boost overall well-being. Evidence suggests that patients who exercise before medical treatments often recover better and function more effectively afterward. These findings highlight the potential benefits of exercise for those facing the challenges of multiple myeloma treatment. ^{1 2 3 6 7}

Who Is on the Research Team?

Nadine H. Abdallah, MD

Principal Investigator

Mayo Clinic

Diane K. Ehlers, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for older patients with multiple myeloma that has either relapsed or is refractory, who are preparing to undergo CAR-T therapy. Participants should be able to engage in aerobic and resistance exercises as part of a prehabilitation program aimed at improving their physical fitness before treatment.

Inclusion Criteria

My apheresis was done at least 7 days before enrolling.

Primary hematologist attending physician clearance for exercise

I am 60 years old or older.

Exclusion Criteria

I am under 60 years old.

My cancer is a blood cancer, but not multiple myeloma.

My doctor says I have health issues that prevent me from exercising.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants engage in personalized aerobic and resistance exercise prehabilitation activities for 6 weeks prior to CAR-T infusion

6 weeks

Weekly health coaching check-in calls

CAR-T Therapy

Participants undergo CAR-T cell infusion for treatment of multiple myeloma

1 day

Follow-up

Participants are monitored for safety and effectiveness after CAR-T infusion

30 days

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• CAR-T Therapy
• Prehabilitation with Aerobic and Resistance Exercise

Trial Overview The study tests if a prehabilitation program consisting of personalized aerobic and resistance exercises can enhance physical fitness and quality of life in patients before they receive CAR-T therapy. The intervention includes exercise counseling, performance testing, tailored activities, and monitoring through internet-based tools.

How Is the Trial Designed?

Group I: Supportive care (aerobic and resistance training) Experimental Treatment 11 Interventions

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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11695955/

Prehabilitation Exercise Training to Target Improved ... Physical fitness outcomes, such as muscle strength and cardiovascular fitness, along with quality of life and fatigue, are improved in patients with multiple ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-02679

Prehabilitation Aerobic and Resistance Exercise Training ... Participating in PARE prior to ASCT may improve muscle strength, physical function, post-transplant outcomes and quality of life in patients with multiple ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0031940621000730

Feasibility and benefits of a structured prehabilitation ... Evidence supports the benefits of exercise-based rehabilitation in promoting recovery in myeloma patients following autologous stem-cell transplantation (ASCT).

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07045727

Prehabilitation With Aerobic and Resistance Exercise for ... This clinical trial evaluates whether prehabilitation with aerobic and resistance exercise improves physical fitness and quality of life outcomes in older ...

5. trialx.com trialx.com/clinical-trials/listings/307723/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/?&radius=50

Refractory Multiple Myeloma ) ( NCT07045727 ) This clinical trial evaluates whether prehabilitation with aerobic and resistance exercise improves physical fitness and quality of life outcomes in older ...

6. dana-farber.org dana-farber.org/clinical-trials/22-403

Prehabilitation Exercise Training in Multiple Myeloma ... The goal of this research study is to investigate whether a virtual, home-based, prehabilitation aerobic and resistance exercise (PARE) training program ...

7. trialx.com trialx.com/clinical-trials/listings/248646/prehabilitation-exercise-training-in-multiple-myeloma-patients-undergoing-autologous-stem-cell-transplantation/

Prehabilitation Exercise Training in Multiple Myeloma ... The goal of this research study is to investigate whether a virtual, home-based, prehabilitation aerobic and resistance exercise (PARE) training ...