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
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  • 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 J Natl Compr Canc Netw 19, 3.5; 10.6004/jnccn.2020.7746

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