Prehabilitation Exercise Training in Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation

NCT05706766 | Recruiting

• 1 other identifier: 22-403
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this research study is to investigate whether a virtual, home-based, prehabilitation aerobic and resistance exercise (PARE) training program implemented 8 weeks prior to receiving autologous stem cell transplant (ASCT) for multiple myeloma participants will improve muscular strength, physical capacity, patient reported outcomes, and cardiometabolic health outcomes. The names of the study interventions involved in this study are:

• Prehabilitative aerobic and resistance exercise (PARE) (virtually supervised 8-week aerobic and resistance exercise program)
• Waitlist control (8-week normal activity behavior)

Conditions

Multiple Myeloma; Stem Cell Transplant Complications

Keywords

Multiple Myeloma; Autologous Stem Cell Transplant; Aerobic Exercise Program; Resistance Exercise Program

Outcome Measures

Primary Outcomes (1)

• Difference in Muscular Strength

  The primary analysis is a mean difference in percent change between the intervention (PARE) and the control (Waitlist) groups in lower leg muscle strength measured through leg press.

  Pre-transplant (Week 9, post-intervention), and post-transplant (Week 14-15, 30 Day Post-ASCT Follow-Up)

Secondary Outcomes (3)

• Difference in Physical Capacity

  up to 9 months

• Difference in Patient Reported Outcomes

  up to 9 months

• Difference in Cardiometabolic Health Outcomes

  up to 9 months

Study Arms (2)

Exercise Group (PARE)

EXPERIMENTAL

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.

Behavioral: PARE

Waitlist Control Group

ACTIVE COMPARATOR

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.

Behavioral: Waitlist Control Group

Interventions

PARE BEHAVIORAL

Aerobic and resistance exercise program via Zoom platform.

Also known as: Prehabilitation Aerobic and Resistance Exercise training program

Exercise Group (PARE)

Waitlist Control Group BEHAVIORAL

Normal Activities.

Waitlist Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years old.
• All patients will have a diagnosis of multiple myeloma, referral to DFCI transplant team, and assigned to the autologous transplantation waiting list for a first transplant.
• Planning to receive autologous stem cell transplant after 8 weeks with or without concurrent neoadjuvant treatments at Dana-Farber Cancer Institute.
• Medical clearance to perform moderate-vigorous intensity aerobic and resistance exercise intervention and fitness testing by their treating physician or a certified clinical exercise physiologist.
• Speak English.
• Currently participate in less than or equal to 60 minutes of structured moderate-vigorous intensity exercise/week.
• Willing to travel to Dana-Farber Cancer Institute for necessary data collection.
• Ability to understand and the willingness to sign a written informed consent document.
• The effects of exercise on the developing fetus are unknown. For this reason, women of child-bearing potential must agree to undergo a pregnancy test and to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.

You may not qualify if:

• History of unstable angina, abnormal resting ECG and/or unstable angina or a heart attack in the previous month to allow safe completion of the cardiopulmonary exercise test (CPET) or VO2peak test.
• Patients with known spinal instability, spinal cord compression or neurological deficits or contraindications that preclude exercise.
• Those who have had recent (within six weeks) spinal surgery or other intervention surgery for pathological fractures.
• Those deemed unsuitable to partake by the transplant or study team.
• Patients at high-risk of impending pathologic fracture of a weight-bearing bone (including spine, hip/femur and humerus) as determined by physician.
• Unable or unwilling to undertake an exercise program on a regular basis.
• Pre-existing musculoskeletal or cardiorespiratory disease, or metabolic diseases that could exacerbate with exercise, in addition to other conditions deemed unsafe by physician.
• Patients with other active malignancies requiring active therapy.
• Participate in more than 60 minutes of structured moderate to vigorous intensity exercise/week.
• Unable to travel to Dana-Farber Cancer Institute for necessary data collection.
• Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (2)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Related Publications (1)

• Normann AJ, Mo CC, Wilson RL, Perez M, Cutler C, Uno H, Thompson LV, Skinner TL, Richardson PG, Marinac CR, Dieli-Conwright CM. Prehabilitation Exercise Training to Target Improved Muscle Strength in Pretransplant Patients Diagnosed With Multiple Myeloma: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2024 Dec 19;13:e64905. doi: 10.2196/64905.

  PMID: 39701583 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Christina Dieli-Conwright, PhD, MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Dieli-Conwright, PhD, MPH

CONTACT

617-582-8321; christinam_dieli-conwright@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: January 31, 2023
• Study Start: June 29, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (2)