Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT05706766
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05706766
Study Brief:
Protocol Section:
NCT05706766