COVID19 OutcomeS in Myeloma and the Impact of VaCcines

NCT05831787 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 201

Last updated 2026-05-18

Study results available
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Summary

The COVID-19 pandemic has had an outsized impact on individuals with underlying social and medical vulnerability, leading to increased rates of severe disease, hospitalization, and death in these groups. Participants with underlying immune compromise, such as those with multiple myeloma, represent one such group. The advent of vaccines against SARS-CoV-2 has significantly limited morbidity and mortality across all groups, but the effectiveness of vaccination in individuals who are less likely to mount sufficient antibody response is uncertain. For this reason, booster vaccines have been recommended for those with underlying immune compromise. However, several key gaps remain in our understanding of how to best protect these individuals.

There is a dearth of real-world evidence about the effectiveness of vaccination and boosters in patients who are immunocompromised, and very little information specifically about the recently approved mRNA boosters. Additionally, rates of vaccination and booster uptake in the United States remain low. A rapid, decentralized method of ascertaining information related to booster vaccine response and adverse events related to vaccines and COVID-19 infection is critical not only to answer questions about the booster vaccines, but to develop an infrastructure for answering similar questions about future vaccines or other diseases.

Conditions

Interventions

OTHER

Patient Reported Outcomes

Patients will be asked to complete baseline, 30-day, and 6-month clinical and patient reported outcome health surveys.

Sponsors & Collaborators

  • ModernaTX, Inc.

    collaborator INDUSTRY
  • ASH Research Collaborative

    lead OTHER

Principal Investigators

  • William Wood, MD, MPH · UNC-Chapel Hill

  • Saad Usmani, MD,MBA,FACP · Memorial Sloan Kettering Cancer Center

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-23
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05831787 on ClinicalTrials.gov