Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

Exercise program for multiple myeloma patients before stem cell transplant

Official title: Prehabilitation Exercise Training in Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation: The PROTECT Trial

Run by Dana-Farber Cancer Institute · NCT05706766 · Data updated 2026-11-12

This study tests if a home-based exercise program can help people with multiple myeloma get stronger and healthier before they have a stem cell transplant.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment30 (estimated)
SponsorDana-Farber Cancer Institute
Academic / other
Locations2 sites (Boston, Massachusetts and 1 other locations)
StatusRecruiting
StartedJune 29, 2023
Main results expectedDecember 31, 2026
Study endsJuly 31, 2027
Registry record updatedJanuary 22, 2026
Trial IDNCT05706766 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 with a diagnosis of multiple myeloma who are scheduled for autologous stem cell transplantation.

Probably not a fit

Patients who are already engaging in more than 60 minutes of structured moderate-vigorous exercise per week may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research investigates the effects of a virtual, home-based prehabilitation exercise program combining aerobic and resistance training for patients with multiple myeloma who are preparing for autologous stem cell transplantation. Participants will be randomly assigned to either the exercise group or a waitlist control group, with evaluations of muscle strength, physical fitness, and health outcomes conducted throughout the study. The exercise program lasts for 8 weeks prior to the transplant, while the control group will maintain their usual activity levels. The study aims to enroll approximately 30 participants at the Dana-Farber Cancer Institute.

Why it matters

Potential benefit: If successful, this program could enhance physical fitness and health outcomes for patients undergoing stem cell transplantation.

How similar studies have gone: Other studies have shown positive outcomes with prehabilitation exercise programs in cancer patients, suggesting potential success for this approach.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Dana Farber Cancer Institute
    Boston, Massachusetts, United States
    Recruiting
  • Dana-Farber Cancer Institute
    Boston, Massachusetts, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.