Photo Credit: Jelena Stanojkovic
The ASH Research Collaborative developed the COSMIC study to address the risks severe COVID-19 complications pose to patients with multiple myeloma.
Patients with multiple myeloma, due to their immune-compromised state, face an elevated risk of severe COVID-19 complications. Addressing these risks, the ASH Research Collaborative developed the COVID-19 OutcomeS in Myeloma and the Impact of VacCines (COSMIC) study to fill gaps in evidence and evaluate outcomes related to COVID-19 infection, vaccination, and QOL in this vulnerable population. This prospective, decentralized study utilized a site-based provider network, demonstrating a novel approach to pandemic preparedness and real-world evidence generation.
“Data from the ASH Research Collaborative COVID-19 Registry for Hematology demonstrated that patients with multiple myeloma and other immune compromise had elevated risk for severe complications from COVID-19 infection,” Saad Usmani, MD, and colleagues explained during ASH 2024.
“To address current evidence gaps and 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 to investigate COVID-19 infections, vaccinations, and QOL in patients with multiple myeloma.”
Researchers implemented the COSMIC study across eight ASH Research Collaborative sites, utilizing an innovative recruitment strategy. Patients accessed the study through a QR code provided during routine clinical visits, allowing for seamless enrollment and consent. Participants could share EHR data and complete patient-reported outcomes (PROs) at baseline, Day 30, and Day 180. These PROs included validated QOL assessments (EORTC QLQ-C30 and MY20). Clinicians facilitated enrollment and shared best practices monthly, ensuring efficient study execution. The study’s primary objectives included assessing the feasibility of decentralized data collection and understanding the interplay between vaccination, infection, and QOL outcomes in patients with multiple myeloma.
Over 4 months, COSMIC accrued 200 participants, aged 29 to 93 years, with a median age of 67. The cohort included diverse demographics: 46% female, 69% non-Hispanic White, 17% non-Hispanic Black, and 8% Hispanic/Latino. At baseline, 57% of participants reported a history of COVID-19 infection, with 11% requiring hospitalization. Remarkably, 95% of patients reported receiving COVID-19 vaccinations, with a median of four doses. Additionally, 23% expressed openness to discussing annual booster vaccines with their healthcare provider.
The study revealed no significant differences in baseline QOL scores between patients with and without a history of COVID-19 infection (mean scores of 63.7 vs 65.8; P=0.57). Adjusted analyses showed no association between infection history and health-related quality of life (HRQOL) outcomes (OR=0.93; 95% CI: 0.78–1.10; P=0.38). These findings suggest that COVID-19 infection did not drastically impact the overall QOL in this population. By the 30-day follow-up, three additional patients reported new COVID-19 infections, and 18 received an additional vaccine dose, emphasizing the importance of continued surveillance and vaccination in this group.
The study demonstrated the ability to engage a demographically representative cohort, reinforcing the value of equitable research practices. As data collection continues, COSMIC represents a significant step toward advancing our understanding of how vaccination and infection intersect with QOL in immune-compromised patients while laying the groundwork for future preparedness initiatives.
“COSMIC is a prospective, decentralized study within a site-based provider network conducted by the ASH Research Collaborative Multiple Myeloma Program that demonstrates the feasibility of using an innovative evidence generation strategy to drive rapid accrual of patients to address a rapidly evolving area of need,” Dr. Usmani and team concluded.
“The COSMIC study also provides proof of concept that a real-world evidence generation network can play an important role in national pandemic preparedness and response. The COSMIC experience reinforces the ability to accrue diverse patient populations representing the demographic of [patients with] myeloma in the US.”
