NCT05706766Recruiting
Prehabilitation Exercise Training in Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation
Prehabilitation Exercise Training in Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation: The PROTECT Trial
Source: ClinicalTrials.gov · Last updated 22 Jan 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 20 Jan 2023
- Start date
- 29 Jun 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Dana-Farber Cancer Institute
- Diseases
- Multiple myeloma
- NCT number
- NCT05706766
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 29 Jun 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- 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.
- Unable to travel to Dana-Farber Cancer Institute for necessary data collection.
Other
- Patients with known spinal instability, spinal cord compression or neurological deficits or contraindications that preclude exercise.
- 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.
- Participate in more than 60 minutes of structured moderate to vigorous intensity exercise/week.
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.