Truly COSMIC: An ASH Research Collaborative First

The ASH Research Collaborative (ASH RC) was established in 2017 to enhance outcomes for patients with blood diseases through innovative research, collaboration, and data sharing. Building on the success of its sickle cell disease initiatives, the Collaborative launched the Multiple Myeloma (MM) Research Network, bringing together leading academic institutions to conduct patient-focused, decentralized research. The ASH RC created the MM Data Hub Program¹  to address key gaps in real-world data (RWD) by enabling timely and actionable evidence generation for patients with MM, with a multicenter network of 12 U.S.-based academic medical centers collecting and analyzing RWD. Participating centers contribute data through electronic case report forms and direct electronic health record (EHR) imports. To date, 8,824 patients have been enrolled, with 2,825 having complete data for analysis. The data covers diagnosis trends, patient demographics, and outcomes.

One of the ASH RC’s flagship projects, the COVID-19 Outcomes in Myeloma and the Impact of Vaccines (COSMIC) study, serves as a proof-of-concept protocol addressing the data gaps in COVID-19 outcomes among individuals with MM, which compromises the immune system and puts patients at heightened risk for severe COVID-19 complications. Conducted under the ASH RC Multiple Myeloma Program, the study provided vital insights into how the pandemic and vaccination affected this vulnerable population. Results were presented at the 66th ASH Annual Meeting in San Diego, with abstracts shared widely with the research community.^1,2 

Over four months in 2024, the COSMIC study enrolled 200 patients across eight ASH RC sites — completing recruitment well ahead of schedule. Recruitment primarily occurred during clinic visits, using QR codes and site-specific links, with all study activities conducted via a mobile app. Patients were virtually assessed at baseline, day 30, and day 180, focusing on COVID-19 infection history, vaccination status, and patient-reported outcomes (PROs) related to quality of life (QOL).

The results revealed that 57% of participants reported a history of COVID-19 infection at baseline, with 12 patients requiring hospitalization. Most participants (95%) had received at least one COVID-19 vaccine, with a median of four doses per patient. Patient engagement was high throughout the study, with 97% completing the baseline visit, 81% at day 30, and 82% at day 180. Among 196 participants, 57.5% consented to share their EHRs, contributing clinical data, lab results, and imaging reports.

By day 180, 12 additional COVID-19 infections were reported. Importantly, a history of COVID-19 infection was not significantly associated with QOL scores. Vaccination rates rose during the study period, with 18 patients receiving additional doses by day 30, and 30 patients receiving boosters by day 180. The study’s collaboration with Moderna ensured regular progress tracking through quarterly meetings. PROs offered valuable insights into participants’ well-being. Investigators noted that while QOL scoring reports were helpful, they were challenging to apply in real-time during clinical visits. To address this, the study team developed visual summaries of PRO data for easier interpretation and discussion with patients.

The COSMIC study demonstrated the feasibility and effectiveness of decentralized, patient-centered research, even as we were emerging from the global COVID pandemic. Of the 200 enrolled patients, 164 completed their final study visit. As the study concludes, efforts are underway to finalize a patient-facing summary and communicate the results to participants and the broader public. A wrap-up letter is being developed to thank participants and provide an overview of key findings. Data analysis continues, with plans for future publications. The COSMIC study highlights how decentralized research can improve patient engagement and data collection while offering a robust model for future pandemic preparedness and response efforts.