This pilot research trial studies a mobile wearable health device in bio-monitoring patients with newly diagnosed multiple myeloma receiving induction chemotherapy. Tracking health status with a wearable device may allow doctors to more consistently assess health status and improve the quality of the data collected in an easier way.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03006315.
PRIMARY OBJECTIVE:
I. To determine the feasibility of using mobile wearable health devices in bio-monitoring of newly diagnosed multiple myeloma patients receiving initial induction chemotherapy and autologous stem cell transplant (ASCT).
SECONDARY OBJECTIVES:
I. To describe bio-monitoring data measurements (levels of activity and duration of sleep) during the four cycles of induction chemotherapy.
II. To describe bio-monitoring data measurements with the following patient-related outcome measures: mobile health quality of life assessments and mobile Brief Pain Inventory (BPI) assessments.
III. To describe the association of bio-monitoring data measurements with the following changes in routine clinical oncology care: change in primary chemotherapy regimen, change in supportive care regimen (pain meds, antibiotics, anti-emetics, etc).
IV. To describe the bio-monitoring data measurements with the following clinical data endpoints: clinical responses, serious adverse events (grade 3 or 4 adverse events, hospitalizations, death).
OUTLINE:
Patients undergo bio-monitoring using Garmin Vivofit3 wearable device at baseline (1-7 days prior to receiving induction chemotherapy) and during induction chemotherapy for up to 6 cycles. Patients continuing with ASCT undergo bio-monitoring using Garmin Vivofit3 wearable device for up to 90 days post ASCT. Patients receive an instructional manual and tutorial session on how to operate and synchronize the device and download the Garmin mobile and Medidata mobile applications (apps).
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorNeha S. Korde