(SAN DIEGO, Dec. 7, 2024) – Multiple myeloma affects approximately 180,000 individuals in the United States and is a cancer of the blood’s plasma cells, which produce disease- and infection-fighting antibodies, and leads to a compromised immune system. The COVID-19 pandemic significantly affected individuals diagnosed with multiple myeloma, who exhibited increased rates of severe COVID-19 infections, complications, hospitalizations, and death. Along with their colleagues, William A. Wood, MD, MPH, professor in the University of North Carolina at Chapel Hill’s Department of Medicine, and Saad Z. Usmani, MD, MBA, chief of the myeloma service at Memorial Sloan Kettering Cancer Center, developed a novel study design to address current COVID-19 data gaps in this population and provide proof of concept for a pandemic preparedness and response network.

Through the ASH Research Collaborative Multiple Myeloma Program, researchers conducted a prospective, decentralized study, examining “COVID-19 OutcomeS in Myeloma and the Impact of VaCcines” (COSMIC). Prospective patients joined the study via a QR code or site-specific link provided during usual clinical care, and study activities took place in the patient mobile app. Over four months, the team recruited 200 patients from eight participating ASH Research Collaborative sites. Patients completed study activities through the study portal at baseline, day 30, and day 180.

Of the participants, 57.5% opted to share their electronic health record data, which included disease and treatment-related clinical data, laboratory results, pathology reports, and imaging reports. Additionally, 196 patients provided demographic, COVID-19 infection, and vaccine data, and patient reported outcome (PRO) surveys at baseline; 195 provided baseline PRO data; and 150 provided further information at day 30 of the analysis. Age, sex, or race did not significantly impact a patient’s likelihood of providing data at day 30.

Of the 196 patients who reported COVID-19 data, 111 (57%) reported a history of COVID-19 infection at baseline, with 12 (11%) requiring hospitalization. Additionally, 186 (95%) patients reported a history of COVID-19 vaccination. The median number of COVID-19 vaccinations received was four. At day 30, three additional patients reported a COVID-19 infection, with an additional nine patients (12 total) reporting a COVID-19 infection at day 180. At day 30, eighteen patients reported additional COVID-19 vaccination, with another twelve patients (30 total) reporting additional COVID-19 vaccination by day 180. The researchers found that a patient’s history of COVID-19 infection was not significantly associated with their quality-of-life score.

The COSMIC study’s success in recruiting participants and rapidly generating real-world data suggests that a decentralized workflow within a site-based provider network is a feasible option quickly answering questions related to national pandemic preparedness and response, or other real-world evidence questions requiring patient-generated health data. The study remains ongoing.

Read more about the COSMIC study:

1972: Initial Results from the ASH Research Collaborative’s COVID-19 Outcomes in Myeloma and the Impact of Vaccines (COSMIC): A Decentralized, Real-World Evidence Study for Patients with Multiple Myeloma to Monitor Outcomes Related to COVID-19 Vaccines and Infections

2393: Feasibility and Implementation of the ASH Research Collaborative’s COVID-19 Outcomes in Myeloma and the Impact of Vaccines (COSMIC): A Decentralized, Real-World Evidence Study for Patients with Multiple Myeloma to Monitor Outcomes Related to COVID-19 Vaccines and Infections

About the ASH Research Collaborative

The ASH Research Collaborative (ASH RC) is a non-profit organization established by the American Society of Hematology (ASH)  to improve the lives of people affected by blood diseases by fostering collaborative partnerships to accelerate research and improve outcomes for individuals with hematologic diseases by advancing treatment developments and generating evidence to support clinical decisions and care.

Contact

Melissa McGue, American Society of Hematology
mmcgue@hematology.org
202-552-4927