Vaccines and COVID-19 in Multiple Myeloma

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Other: Patient Reported Outcomes


Participation Criteria
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Eligibility Criteria
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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. Consented to participate in the ASH Research Collaborative Data Hub's Multiple Myeloma program (electronic consent provided through ASH Research Collaborative Portal). Access to the internet. Willing to electronically sign the study-specific consent and authorization form through the ASH Research Collaborative Portal. Exclusion Criteria: Non-English or Spanish speaking Lack of internet access Cognitive impairment precluding ability to provide informed consent.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 | 
| COVID Booster Incidence | Percent of patients who enroll on the study platform who went on to receive a SARS-CoV-2 booster after enrollment | During 6 month study period | 
| PRO Review | Among participants providing PROs, percentage for whom PROs were viewed by site personnel | During 6 month study period | 
| 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 adverse events baseline | Patient reported adverse events related to confirmed COVID-19 infection | At Baseline | 
| Patient reported COVID 19 adverse events on study | Patient reported adverse events related to confirmed COVID-19 infection | During 6 month study period | 
| EHR COVID 19 adverse events baseline | Hospitalization related to COVID-19 as ascertained by full EHR data transmission provided by permission from the participant | At Baseline | 
| EHR COVID 19 adverse events on study | Hospitalization or death related to COVID-19 as ascertained by full EHR data transmission provided by permission from the participant | During 6 month study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myeloma, COVID-19, Vaccine