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

Launched by DANA-FARBER CANCER INSTITUTE · Jan 30, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether a special exercise program can help patients with multiple myeloma who are getting ready for an autologous stem cell transplant (ASCT). The exercise program, called prehabilitation aerobic and resistance exercise (PARE), will be done at home with virtual supervision for eight weeks before the transplant. The goal is to see if this training improves strength, physical ability, and overall health for patients during this important time.

To be eligible for the study, participants must be at least 18 years old, have a diagnosis of multiple myeloma, and be scheduled for their first stem cell transplant at the Dana-Farber Cancer Institute. They should currently do less than an hour of moderate exercise each week and must be medically cleared to participate in a fitness program. Participants will either follow the exercise program or continue their regular activities for the duration of the study. It’s important to know that women who can become pregnant will need to take a pregnancy test and use contraception during the study. This trial is currently seeking new participants, so if you think you might qualify, you can consider reaching out for more information.

Gender

ALL

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.