Vaccines and COVID-19 in Multiple Myeloma
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | 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.
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Outcome Measures
Primary Outcome Measures
- Feasibility of obtaining baseline clinical and PRO data capture from 200 consented patients. [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.
- Feasibility of obtaining 30-day clinical and PRO data capture from 200 consented patients. [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.
- Feasibility of obtaining 6-month clinical and PRO data capture from 200 consented patients. [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 Outcome Measures
- COVID Vaccine Prevalence [At Baseline]
Percent of patients who enroll on the study platform who had previously received a SARS-CoV-2 booster
- COVID Booster Incidence [During 6 month study period]
Percent of patients who enroll on the study platform who went on to receive a SARS-CoV-2 booster after enrollment
- PRO Review [During 6 month study period]
Among participants providing PROs, percentage for whom PROs were viewed by site personnel
- COVID-19 Infection baseline [At Baseline]
Percentage of participants reporting COVID-19 infection confirmed by home-based or other testing
- COVID-19 Infection on study [During 6 month study period]
Percentage of participants reporting COVID-19 infection confirmed by home-based or other testing
- Patient reported COVID 19 adverse events baseline [At Baseline]
Patient reported adverse events related to confirmed COVID-19 infection
- Patient reported COVID 19 adverse events on study [During 6 month study period]
Patient reported adverse events related to confirmed COVID-19 infection
- EHR COVID 19 adverse events baseline [At Baseline]
Hospitalization related to COVID-19 as ascertained by full EHR data transmission provided by permission from the participant
- EHR COVID 19 adverse events on study [During 6 month study period]
Hospitalization or death related to COVID-19 as ascertained by full EHR data transmission provided by permission from the participant
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Consented to participate in the ASH Research Collaborative Data Hub's Multiple Myeloma program (electronic consent provided through ASH Research Collaborative Portal).
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Access to the internet.
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Willing to electronically sign the study-specific consent and authorization form through the ASH Research Collaborative Portal.
Exclusion Criteria:
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Non-English or Spanish speaking
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Lack of internet access
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Cognitive impairment precluding ability to provide informed consent.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- ASH Research Collaborative
- ModernaTX, Inc.
Investigators
- Principal Investigator: William Wood, MD, MPH, UNC-Chapel Hill
- Principal Investigator: Saad Usmani, MD,MBA,FACP, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ASH RC DH 2022-00001