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OpenTrials
Completed

NCT Number: NCT05831787

COVID19 OutcomeS in Myeloma and the Impact of VaCcines

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders COVID-19 Cardiovascular Diseases Coronaviridae Infections Coronavirus Infections Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Infections Lung Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Nidovirales Infections Paraproteinemias Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Vascular Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient reported outcomes

Other

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

Primary outcomes

  1. Feasibility of Obtaining Baseline Clinical and PRO Data Capture From 200 Consented Patients.

    Time frame: At Baseline

    Proportion of consented participants who provide responses for the PRO instruments & proportion of participants who permission access to clinical data through the EHR.

  2. Feasibility of Obtaining 30-day Clinical and PRO Data Capture From 200 Consented Patients.

    Time frame: 30 days after enrollment

    Proportion of consented participants who provide responses for the PRO instruments & proportion of participants who permission access to clinical data through the EHR.

  3. Feasibility of Obtaining 6-month Clinical and PRO Data Capture From 200 Consented Patients.

    Time frame: 6 months after enrollment

    proportion of consented participants who provide responses for the PRO instruments & proportion of participants who permission access to clinical data through the EHR.

Secondary outcomes

  1. COVID Vaccine Prevalence

    Time frame: At Baseline

    Percent of patients who enroll on the study platform who had previously received a SARS-CoV-2 booster

  2. COVID Booster Incidence

    Time frame: 30 Days after enrollment

    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

  3. PRO Review

    Time frame: During 6 month study period

    Among participants providing PROs, percentage for whom PROs were viewed by site personnel

  4. COVID-19 Infection Baseline

    Time frame: At Baseline

    Percentage of participants reporting COVID-19 infection confirmed by home-based or other testing

  5. COVID-19 Infection on Study

    Time frame: During 6 month study period

    Percentage of participants reporting COVID-19 infection confirmed by home-based or other testing

  6. Patient Reported COVID 19 Related Outcomes at Baseline

    Time frame: 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).

  7. Patient Reported COVID 19 Related Outcomes on Study

    Time frame: During 6 month study period

    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).

  8. EHR COVID 19 Related Outcomes Baseline

    Time frame: At 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.

  9. EHR COVID 19 Related Outcomes on Study

    Time frame: During 6 month study period

    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.

  10. COVID Booster Incidence

    Time frame: 6 months after enrollment

    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

Sponsors and collaborators

Lead sponsor

ASH Research Collaborative

Other

Collaborators

  • ModernaTX, Inc.

Registry information

Official study title

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

Acronym: COSMIC

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 26, 2023
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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