Abstract
Background: Exercise interventions remain understudied in the prehabilitation setting for patients with hematologic malignancies with limited evidence in patients with multiple myeloma undergoing autologous stem cell transplant (ASCT). Physical deconditioning and sarcopenia are common in patients with multiple myeloma undergoing ASCT, and exercise may serve as an effective strategy to mitigate the effects. This analysis presents preliminary recruitment outcomes and enrollment data for a virtually supervised prehabilitation exercise intervention implemented prior to transplant.Methods: The ongoing PROTECT Trial (NCT05706766) evaluates lower limb strength in patients with multiple myeloma undergoing ASCT following a virtually supervised, individualized prehabilitation exercise program. Eligible patients include adults (18 years and over) diagnosed with multiple myeloma who are scheduled to receive ASCT within 6-8 weeks following induction therapy, referred by Dana-Farber Cancer Institute (DFCI) transplant team, not pregnant, willing to travel to DFCI for data collection and who are sedentary, defined as participating in less than 60 minutes of structured exercise per week. Patients must also be cleared to by their treating physician to perform moderate-vigorous intensity aerobic and resistance exercise. Recruitment at Dana-Farber Cancer Institute involves treating oncologist referrals, electronic health record screening, transplant candidate lists, and recruitment discussions with patients during clinic visits. Following physician approval, eligible patients are contacted and screened for eligibility by the PI (A.N.), including a PARQ+ guided health history and Godin physical activity assessment. Descriptive statistics were used to summarize the volume of patients obtained from recruitment strategies and screening variables.Results: Patients receiving care at DFCI were screened for the PROTECT Trial (N=156) from June 2023 – August 2025 (currently ongoing). Of 156 screened for eligibility, 99 (63%) were ineligible. The primary reason for ineligibility was patients with scheduled transplants were less than the 6-8 week intervention window (n=40; 40%) and that did not have a transplant scheduled as part of their treatment plan (n=27; 27%). Of the 58 eligible patients, 11 patients consented, resulting in a 19% accrual rate. Among the 10 patients who completed baseline testing, randomization was evenly distributed across the exercise group (n=5) and control group (n=5). Among patients who declined to participate (n=47, 81%), the most common reasons were lack of time or scheduling conflicts (n=8, 14%) due to personal schedule and/or medical-related appointments; or could not be reached with no communication response received from voicemails or emails (n=6, 10%). Among enrolled participants, 20% were identified via direct oncologist referral, 80% from the Bone Marrow Transplant List managed by oncology nurse navigators, and 0% from the HSCT and Cellular Therapies Admit Schedule. The majority of enrolled patients (80%) reside in Massachusetts within a 2–3 hour driving radius of Boston and 20% are from out of state. Randomized participants had a mean age of 61±9 years old, an average BMI of 29.9±4.6 kg/m2, and diagnosed with Revised-International Staging System (R-ISS) Stage I (82%) Stage II (9%) Stage III (9%). The amendment to remove the 6-8 week timeline to transplant requirement, approved in November 2024, led to a 2.7-fold increase in accrual rates. Monthly accrual goals (1–2 patients) have been achieved in 7 of 24 months since the trial opened in June 2023. Conclusion: Recruitment strategies for the PROTECT Trial are multifaceted and require careful coordination with the transplant and myeloma teams alongside flexibility in enrollment timing pre-transplant due to the unpredictable ASCT timeline. Considerations for commute distance/transportation barriers to DFCI are critical to support adequate enrollment. Future studies should explore earlier engagement with patients (i.e. at time of diagnosis) and their oncology provider team to enhance feasibility and may inform prehabilitation recruitment strategies for other hematologic cancers involving transplant.
