Exercise program for multiple myeloma patients before stem cell transplant
Prehabilitation Exercise Training in Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation: The PROTECT Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT05706766 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a diagnosis of multiple myeloma who are scheduled for autologous stem cell transplantation.
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.
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 performed: Other studies have shown positive outcomes with prehabilitation exercise programs in cancer patients, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Boston, Massachusetts and 1 other locations
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Christina Dieli-Conwright, PhD, MPH — Dana-Farber Cancer Institute
- Study coordinator: Christina Dieli-Conwright, PhD, MPH
- Email: christinam_dieli-conwright@dfci.harvard.edu
- Phone: 617-582-8321
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.