New York
North Carolina
UNC Lineberger Comprehensive Cancer Center University of North Carolina
Chapel Hill, NC
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.
This trial is currently open and accepting patients.
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.
The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.
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.
Observational Trial
Enrollment: 200 patients (estimated)
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Chapel Hill, NC
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