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NCT05831787 · REGISTRY CONDITION SEARCH

COVID19 OutcomeS in Myeloma and the Impact of VaCcines

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
Not reported
Status at capture
COMPLETED
Registry last update
2026-05-18

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

COVID Vaccine Prevalence

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outcome · POSTED

COVID Booster Incidence

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outcome · POSTED

PRO Review

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outcome · POSTED

COVID-19 Infection Baseline

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outcome · POSTED

COVID-19 Infection on Study

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outcome · POSTED

Patient Reported COVID 19 Related Outcomes at Baseline

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outcome · POSTED

Patient Reported COVID 19 Related Outcomes on Study

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outcome · POSTED

EHR COVID 19 Related Outcomes Baseline

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outcome · POSTED

EHR COVID 19 Related Outcomes on Study

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outcome · POSTED

COVID Booster Incidence

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
false
sampling Method
NON_PROBABILITY_SAMPLE
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
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.
Treatment arms and interventions
arm Groups
  1. description
    Diagnosis of multiple myeloma must meet the International Myeloma Working Group criteria.
    intervention Names
    1. Other: Patient Reported Outcomes
    label
    Diagnosis of multiple myeloma and currently receiving active treatment for any phase of the disease
interventions
  1. arm Group Labels
    1. Diagnosis of multiple myeloma and currently receiving active treatment for any phase of the disease
    description
    Patients will be asked to complete baseline, 30-day, and 6-month clinical and patient reported outcome health surveys.
    name
    Patient Reported Outcomes
    type
    OTHER
Study design
observational Model
COHORT
time Perspective
PROSPECTIVE
Enrollment
count
201
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Proportion of consented participants who provide responses for the PRO instruments \& proportion of participants who permission access to clinical data through the EHR.
    measure
    Feasibility of Obtaining Baseline Clinical and PRO Data Capture From 200 Consented Patients.
    time Frame
    At Baseline
  2. description
    Proportion of consented participants who provide responses for the PRO instruments \& proportion of participants who permission access to clinical data through the EHR.
    measure
    Feasibility of Obtaining 30-day Clinical and PRO Data Capture From 200 Consented Patients.
    time Frame
    30 days after enrollment
  3. description
    proportion of consented participants who provide responses for the PRO instruments \& proportion of participants who permission access to clinical data through the EHR.
    measure
    Feasibility of Obtaining 6-month Clinical and PRO Data Capture From 200 Consented Patients.
    time Frame
    6 months after enrollment
secondary Outcomes
  1. description
    Percent of patients who enroll on the study platform who had previously received a SARS-CoV-2 booster
    measure
    COVID Vaccine Prevalence
    time Frame
    At Baseline
  2. description
    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
    measure
    COVID Booster Incidence
    time Frame
    30 Days after enrollment
  3. description
    Among participants providing PROs, percentage for whom PROs were viewed by site personnel
    measure
    PRO Review
    time Frame
    During 6 month study period
  4. description
    Percentage of participants reporting COVID-19 infection confirmed by home-based or other testing
    measure
    COVID-19 Infection Baseline
    time Frame
    At Baseline
  5. description
    Percentage of participants reporting COVID-19 infection confirmed by home-based or other testing
    measure
    COVID-19 Infection on Study
    time Frame
    During 6 month study period
  6. description
    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).
    measure
    Patient Reported COVID 19 Related Outcomes at Baseline
    time Frame
    At Baseline
  7. description
    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).
    measure
    Patient Reported COVID 19 Related Outcomes on Study
    time Frame
    During 6 month study period
  8. description
    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.
    measure
    EHR COVID 19 Related Outcomes Baseline
    time Frame
    At Baseline
  9. description
    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.
    measure
    EHR COVID 19 Related Outcomes on Study
    time Frame
    During 6 month study period
  10. description
    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
    measure
    COVID Booster Incidence
    time Frame
    6 months after enrollment
Full study description
brief 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.
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.
Source references
references
  1. citation
    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.
    pmid
    41734388
    type
    DERIVED
  2. citation
    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.
    pmid
    40396505
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice