COVID19 OutcomeS in Myeloma and the Impact of VaCcines (COSMIC)

Monitoring SARS-CoV-2 Vaccines and COVID-19 Related Outcomes in Individuals With Multiple Myeloma

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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Other: Patient Reported Outcomes

Detailed Description

The purpose of this project is to implement and establish the feasibility of a decentralized real-world evidence study network for patients with multiple myeloma and to monitor outcomes related to COVID-19 infection in this immunosuppressed population. Subjects with multiple myeloma will be invited to participate. The electronic portal will handle all consenting activities. Participants will be asked to complete specific study procedures electronically, including permission for electronic health record (EHR) data transfer. Participants will be asked to complete electronic questionnaires periodically.

• Study Type: Observational
• Enrollment (Actual): 201

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • UNC-Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals with a diagnosis of multiple myeloma per the International Myeloma Working Group and currently receiving active treatment for any phase of the disease, including initial therapy, maintenance, or relapsed disease.

Description

Inclusion Criteria:

• Diagnosis of multiple myeloma per the International Myeloma Working Group and currently receiving active treatment for any phase of the disease, including initial therapy, maintenance, or relapsed disease.
• Access to the internet
• An active patient portal (or willingness to activate)
• Willing to electronically sign the study-specific informed consent and authorization form

Exclusion Criteria:

• Non-English speaking
• Lack of internet access
• Cognitive impairment precluding ability to provide informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diagnosis of multiple myeloma and currently receiving active treatment for any phase of the disease; Diagnosis of multiple myeloma must meet the International Myeloma Working Group criteria.	Other: Patient Reported Outcomes; Patients will be asked to complete baseline, 30-day, and 6-month clinical and patient reported outcome health surveys.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Obtaining Baseline Clinical and PRO Data Capture From 200 Consented Patients.	Proportion of consented participants who provide responses for the PRO instruments & proportion of participants who permission access to clinical data through the EHR.	At Baseline
Feasibility of Obtaining 30-day Clinical and PRO Data Capture From 200 Consented Patients.	Proportion of consented participants who provide responses for the PRO instruments & proportion of participants who permission access to clinical data through the EHR.	30 days after enrollment
Feasibility of Obtaining 6-month Clinical and PRO Data Capture From 200 Consented Patients.	proportion of consented participants who provide responses for the PRO instruments & proportion of participants who permission access to clinical data through the EHR.	6 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COVID Vaccine Prevalence	Percent of patients who enroll on the study platform who had previously received a SARS-CoV-2 booster	At Baseline
PRO Review	Among participants providing PROs, percentage for whom PROs were viewed by site personnel	During 6 month study period
COVID Booster Incidence	Percent of patients who enroll on the study platform who went on to receive a SARS-CoV-2 booster at 1 month follow up visit	30 Days after enrollment
COVID-19 Infection Baseline	Percentage of participants reporting COVID-19 infection confirmed by home-based or other testing	At Baseline
COVID-19 Infection on Study	Percentage of participants reporting COVID-19 infection confirmed by home-based or other testing	During 6 month study period
Patient Reported COVID 19 Related Outcomes at Baseline	Patient reported outcomes related to confirmed COVID-19 infection. COVID-19-related outcomes were assessed through a decentralized approach using patient-reported data collected via study questionnaires. Outcomes included participant-reported COVID-19 infection and related clinical events (e.g., hospitalization).	At Baseline
Patient Reported COVID 19 Related Outcomes on Study	Patient reported outcomes related to confirmed COVID-19 infection. COVID-19-related outcomes were assessed through a decentralized approach using patient-reported data collected via study questionnaires. Outcomes included participant-reported COVID-19 infection and related clinical events (e.g., hospitalization).	During 6 month study period
EHR COVID 19 Related Outcomes Baseline	Hospitalization related to COVID-19 was ascertained through electronic health record (EHR) data obtained with participant permission. COVID-19-related outcomes included COVID-19 infection and associated clinical events (e.g., hospitalization), as documented in the EHR.	At Baseline
EHR COVID 19 Related Outcomes on Study	Hospitalization related to COVID-19 was ascertained through electronic health record (EHR) data obtained with participant permission. COVID-19-related outcomes included COVID-19 infection and associated clinical events (e.g., hospitalization), as documented in the EHR.	During 6 month study period
COVID Booster Incidence	Percent of patients who enrolled on the study platform and subsequently received a SARS-CoV-2 booster by the 6-month follow-up visit. Booster vaccination status was assessed using a combination of patient-reported data collected through the study platform and available electronic health record (EHR) data	6 months after enrollment

Collaborators and Investigators

• Sponsor: ASH Research Collaborative
• Collaborators: ModernaTX, Inc.
• Investigators: Principal Investigator: William Wood, MD, MPH, UNC-Chapel Hill; Principal Investigator: Saad Usmani, MD,MBA,FACP, Memorial Sloan Kettering Cancer Center

Publications and helpful links

General Publications

• Zorger AM, Hirsch C, Baumann M, Feldmann M, Brockelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N. Vaccines for preventing infections in adults with haematological malignancies. Cochrane Database Syst Rev. 2025 May 21;5(5):CD015530. doi: 10.1002/14651858.CD015530.pub2.
• Wood WA, Kumar SK, Semmel EA, James S, Schroeder MA, Chung DJ, Rosenberg A, Zonder J, Rubinstein S, D'Souza A, Martin T, Chari A, Vij R, Nooka AK, Anderson KC, Neuberg DS, Richard S, Torres K, Weiss BM, Pederson L, Derkach A, Geyer S, Usmani SZ. Feasibility of decentralized real-world monitoring of SARS-CoV-2 booster vaccines and COVID-19 outcomes in myeloma. Blood Adv. 2026 May 12;10(9):3094-3102. doi: 10.1182/bloodadvances.2025018963.

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: April 20, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Vaccine; COVID-19; Myeloma; COSMIC
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lung Diseases; Hematologic Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; COVID-19; Multiple Myeloma; Neoplasms, Plasma Cell; Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Health Care Economics and Organizations; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Surveys and Questionnaires; Health Planning; Health Care Surveys; Health Services Research; Patient Outcome Assessment; Patient Reported Outcome Measures
• Other Study ID Numbers: ASH RC DH 2022-00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: There is no plan at this time. All study data will be stored in the ASH RC Data Hub.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No