Monitoring SARS-CoV-2 Vaccines and COVID-19 Related Outcomes in Individuals With Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 3
- 主要终点
- Feasibility of obtaining 30-day clinical and PRO data capture from 200 consented patients.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Non-English speaking
- •Lack of internet access
- •Cognitive impairment precluding ability to provide informed consent
结局指标
主要结局
Feasibility of obtaining 30-day clinical and PRO data capture from 200 consented patients.
时间窗: 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 baseline clinical and PRO data capture from 200 consented patients.
时间窗: 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 6-month clinical and PRO data capture from 200 consented patients.
时间窗: 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.
次要结局
- COVID Booster Incidence(During 6 month study period)
- COVID-19 Infection baseline(At Baseline)
- COVID-19 Infection on study(During 6 month study period)
- PRO Review(During 6 month study period)
- COVID Vaccine Prevalence(At Baseline)
- Patient reported COVID 19 adverse events on study(During 6 month study period)
- EHR COVID 19 adverse events on study(During 6 month study period)
- EHR COVID 19 adverse events baseline(At Baseline)
- Patient reported COVID 19 adverse events baseline(At Baseline)