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Recruiting NCT05706766

NCT05706766 Prehabilitation Exercise Training in Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation

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Clinical Trial Summary
NCT ID NCT05706766
Status Recruiting
Phase
Sponsor Dana-Farber Cancer Institute
Condition Multiple Myeloma
Study Type INTERVENTIONAL
Enrollment 30 participants
Start Date 2023-06-29
Primary Completion 2026-12-31

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
PAREWaitlist Control Group

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 30 participants in total. It began in 2023-06-29 with a primary completion date of 2026-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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)

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Contact & Investigator

Central Contact

Christina Dieli-Conwright, PhD, MPH

✉ christinam_dieli-conwright@dfci.harvard.edu

📞 617-582-8321

Principal Investigator

Christina Dieli-Conwright, PhD, MPH

PRINCIPAL INVESTIGATOR

Dana-Farber Cancer Institute

Frequently Asked Questions

Who can join the NCT05706766 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05706766 currently recruiting?

Yes, NCT05706766 is actively recruiting participants. Contact the research team at christinam_dieli-conwright@dfci.harvard.edu for enrollment information.

Where is the NCT05706766 trial being conducted?

This trial is being conducted at Boston, United States, Boston, United States.

Who is sponsoring the NCT05706766 clinical trial?

NCT05706766 is sponsored by Dana-Farber Cancer Institute. The principal investigator is Christina Dieli-Conwright, PhD, MPH at Dana-Farber Cancer Institute. The trial plans to enroll 30 participants.

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