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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
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 belowSelect...
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:Select...
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
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
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.
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Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,103 Previous Clinical Trials
359,402 Total Patients Enrolled
3 Trials studying Stem Cell Transplant Complications
280 Patients Enrolled for Stem Cell Transplant Complications
Christina Dieli-Conwright, PhD, MPHPrincipal InvestigatorDana-Farber Cancer Institute
4 Previous Clinical Trials
1,853 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18 years old.I have multiple myeloma and am on the waiting list for my first stem cell transplant.You currently do less than 60 minutes of exercise that makes you sweat and breathe harder each week.I plan to have a stem cell transplant using my own cells at Dana-Farber Cancer Institute.Women of child-bearing potential must agree to a pregnancy test and use contraception before entering the study, and for six months afterwardsI have a health condition that could worsen with exercise, as advised by my doctor.I have had spinal surgery or surgery for broken bones due to disease within the last six weeks.I am not receiving treatment for any other cancer.You possess the acumen to interpret and agree to a legally binding agreement of consent.I am cleared by my doctor to do both moderate and intense workouts.I have spinal issues that prevent me from exercising.I am at high risk for a serious fracture in a bone that supports weight.You are not able or not willing to do regular exercise.You do more than 60 minutes of intense exercise each week.You are fluent in English.I have had recent heart problems, including unstable angina or a heart attack.I am cleared by my doctor to do both aerobic and resistance exercises.You are available to journey to Dana-Farber Cancer Institute for necessary data collection.You do not exercise for at least 60 minutes a week at a moderate to vigorous level.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise Group (PARE)
- Group 2: Waitlist Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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