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Prehabilitation Exercise for Multiple Myeloma

N/A

Recruiting

Led By Christina Dieli-Conwright, PhD, MPH

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Over 18 years old

Planning to receive autologous stem cell transplant after 8 weeks with or without concurrent neoadjuvant treatments at Dana-Farber Cancer Institute

Must not have

Other active malignancies requiring active therapy

Known spinal instability, spinal cord compression or neurological deficits or contraindications that preclude exercise

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 9 months

Awards & highlights

No Placebo-Only Group

Summary

This trial examines if a virtual, prehab exercise program prior to stem cell transplant for multiple myeloma can improve strength, capacity, patient outcomes and cardiometabolic health.

Who is the study for?

This trial is for adults over 18 with multiple myeloma who are on the autologous stem cell transplant waiting list at Dana-Farber Cancer Institute. They must exercise less than 60 minutes per week, be able to travel for data collection, and women must use contraception. Exclusions include unstable heart conditions, inability to comply with study requirements, spinal issues preventing exercise, other active cancers needing treatment.

What is being tested?

The study tests if an 8-week virtual home-based aerobic and resistance exercise program (PARE) before autologous stem cell transplantation can improve muscle strength, physical capacity, patient outcomes, and cardiometabolic health compared to a waitlist control group continuing normal activities.

What are the potential side effects?

Since this trial involves a prehabilitation exercise program rather than medication or invasive procedures, side effects may include typical exercise-related risks such as muscle soreness or strain but should generally be minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 years old.

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I plan to have a stem cell transplant using my own cells at Dana-Farber Cancer Institute.

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I am cleared by my doctor to do both moderate and intense workouts.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not receiving treatment for any other cancer.

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I have spinal issues that prevent me from exercising.

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I am at high risk for a serious fracture in a bone that supports weight.

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I have had recent heart problems, including unstable angina or a heart attack.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference in Muscular Strength

Secondary study objectives

Difference in Cardiometabolic Health Outcomes

Difference in Patient Reported Outcomes

Difference in Physical Capacity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Exercise Group (PARE)Experimental Treatment1 Intervention

Participants will be randomly assigned to the Exercise Group (PARE) and will complete study procedures as outlined: * 8 weeks of 3x weekly sessions of virtually supervised aerobic and resistance exercise performed at home using study-provided stationary bike, resistance equipment, heart-rate monitor, and a wi-fi enabled tablet. * Clinic visits at week 1, week 10, and 30 days post Autologous Stem Cell Transplantation (ASCT). * Questionnaires and surveys.

Group II: Waitlist Control GroupActive Control1 Intervention

Participants will be randomly assigned to the Waitlist Control Group and will complete study procedures as outlined: * 8 weeks of continuing with normal daily activities. * Option to participate in PARE exercise program after study completion. * 3 clinic visits with option of 5 visits. The two additional visits are for evaluation and testing for those who choose to participate in exercise program after study completion.

0 / 7Eligibility criteria met