Clinical trial NCT05831787: COVID19 OutcomeS in Myeloma and the Impact of VaCcines
Official title: Monitoring SARS-CoV-2 Vaccines and COVID-19 Related Outcomes in Individuals With Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Myeloma
Keywords: Myeloma
COVID-19
Vaccine
COSMIC
Lead sponsor: ASH Research Collaborative
Sponsor class: OTHER
Collaborators: name: ModernaTX, Inc.
First posted: 2023-04-26
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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

Primary outcomes:
measure: Feasibility of obtaining baseline clinical and PRO data capture from 200 consented patients.
timeFrame: At Baseline
measure: Feasibility of obtaining 30-day clinical and PRO data capture from 200 consented patients.
timeFrame: 30 days after enrollment
measure: Feasibility of obtaining 6-month clinical and PRO data capture from 200 consented patients.
timeFrame: 6 months after enrollment
Secondary outcomes:
measure: COVID Vaccine Prevalence
timeFrame: At Baseline
measure: COVID Booster Incidence
timeFrame: During 6 month study period
measure: PRO Review
timeFrame: During 6 month study period
measure: COVID-19 Infection baseline
timeFrame: At Baseline
measure: COVID-19 Infection on study
timeFrame: During 6 month study period
measure: Patient reported COVID 19 adverse events baseline
timeFrame: At Baseline
measure: Patient reported COVID 19 adverse events on study
timeFrame: During 6 month study period
measure: EHR COVID 19 adverse events baseline
timeFrame: At Baseline
measure: EHR COVID 19 adverse events on study
timeFrame: During 6 month study period
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Chapel Hill
country: United States
facility: UNC-Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC-Chapel Hill
name: William Wood, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial Sloan Kettering Cancer Center
name: Saad Usmani, MD,MBA,FACP
role: PRINCIPAL_INVESTIGATOR
References: