Feasibility of Decentralized Real-World Monitoring of SARS-CoV-2 Booster Vaccines and COVID-19 Outcomes in Myeloma

Patients with multiple myeloma have an elevated risk for severe complications from SARS-CoV-2 (COVID-19) infection. To demonstrate proof of concept for a pandemic preparedness and response network, the ASH Research Collaborative Multiple Myeloma Program developed a prospective, decentralized study within a site-based provider network. In the COVID-19 OutcomeS in Myeloma and the Impact of VacCines (COSMIC) study, patients provided consent, optionally gave permission for electronic health record data collection, completed patient-reported outcomes at baseline, Day 30, and Day 180 through an electronic study portal, and were compensated for participation. Clinicians at participating sites facilitated study recruitment and shared best practices monthly to accelerate study execution. The COSMIC study rapidly accrued and consented 201 patients from eight participating sites over four months (1/22/2024 through 5/17/2024). Consented participants' ages ranged from 30 to 93 years, with median of 67 years; 46% were female, 69% were non-Hispanic White (NHW), 17% were non-Hispanic Black (NHB), and 8% were Hispanic/Latino. Patient-reported data completion was 97% at baseline, 81% at 1-month, and 79% at 6-months. At baseline, 55% of patients reported a history of COVID-19 infection and had received a median of 4 prior SARS-CoV-2 vaccines. For all patients, there were an additional 18 COVID-19 infections and 57 vaccines received during the 6-month observation period. There were no significant differences in HRQOL over time or by history of COVID-19 infection. COSMIC demonstrates the feasibility of using an innovative evidence generation strategy to drive rapid accrual of patients to address an evolving area of need.