HSR21-070: Feasibility of Tracking Digital Activity, Sleep, and Patient-Reported Outcomes (PROs) in Newly Diagnosed Multiple Myeloma (NDMM) Patients (pts) Undergoing an In-Class Transition From Parenteral Bortezomib-Based Therapy to Oral Ixazomib-Lenalidomide-Dexamethasone (IRd) in the Ongoing Community-Based United States (US) MM-6 Study (NCT03173092)

Authors: Kirsten Stuber MSN, MBA, FNP-BC, AOCNP1, Habte A. Yimer MD1, Karin Choquette MSN, AGNP-C, CCRC2, Sudhir Manda MD, FACP2, Jennifer Clayton MSN, ACNP3, Saulius Girnius MD3, Joshua Richter MD4, Presley Whidden MS5, Kimberly Bogard PharmD, BCPS5, Dasha Cherepanov PhD5, and Stephen J. Noga MD, PhD5
View More View Less
  • 1 Texas Oncology - Tyler/US Oncology Research, Tyler, TX
  • | 2 Arizona Oncology, Tucson, AZ
  • | 3 Trihealth Cancer Institute, Cincinnati, OH
  • | 4 Tisch Cancer Institute: Icahn School of Medicine at Mount Sinai, New York, NY
  • | 5 Millennium Pharmaceuticals, Inc., Cambridge, MA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited

Background: US MM-6 is evaluating in-class transition from parenteral bortezomib-based induction to all-oral IRd in US community NDMM pts, with the aim of increasing proteasome-inhibitor-based treatment duration while maintaining quality of life (QoL) and improving outcomes. We evaluated the feasibility of digital actigraphy (monitoring activity/rest) and electronic PRO (ePRO) data collection using wearable and mobile devices in an older MM pt population (median age 73 years). Methods: Transplant-ineligible/delayed NDMM pts are being enrolled to receive up to 39 28-day cycles of IRd after 3 cycles of bortezomib-based induction. To collect actigraphy data, pts wear digital activity trackers (Garmin Vivofit® 3) for ≥14 days of each 28-day cycle (≥12 hours/day). At the end of each cycle, site research coordinators launch ePRO questionnaires that pts complete using mobile devices, self-reporting QoL, neuropathy symptoms, treatment satisfaction, and monthly medication adherence. Results: As of 06/01/20, 101 pts had been treated; 46% were aged ≥75 years and 95% had ≥1 ongoing comorbidity, including renal/urinary disorders (38% of pts), cardiac disorders (29%), and peripheral neuropathy (14%). Pts had completed up to 31 IRd cycles (median 8). Actigraphy data (Figure) were available through 04/30/20 for 79 pts (∼40% aged ≥75 years), accounting for 12,937 days of data on which pts complied with device-wearing requirements out of 14,096 days (92%) during which any data were recorded; up to 51 compliant pts were analyzed. ePRO questionnaires were completed by ∼50% of 101 pts. Self-reported QoL and treatment satisfaction indicated both were maintained during IRd treatment among pts completing questionnaires, with small mean changes in ePRO scores from end of cycle 1 to cycles 2–8; 78–92% of pts self-reported monthly medication adherence as ‘excellent’/’very good’ across cycles 1–8 (cycle ≥9 data not shown due to small sample sizes). Conclusions: Activity levels/sleep durations reported in US MM-6 are consistent with published evidence. Most pts self-report high medication adherence; ePRO results indicate no adverse impact on pts’ QoL/treatment satisfaction during IRd therapy. We demonstrate the feasibility of ongoing activity and ePRO tracking in a comorbid, elderly, community-based MM population. This could be valuable for prompting discussions/triggering changes in pt management, particularly in situations potentially requiring increased remote care/telemedicine.

Figure 1.
Figure 1.

Actigraphy: activity levels and sleep duration*

Citation: Journal of the National Comprehensive Cancer Network 19, 3.5; 10.6004/jnccn.2020.7746

Corresponding Author: Kirsten Stuber, MSN, MBA, FNP-BC, AOCNP