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Trial Title:
COVID19 OutcomeS in Myeloma and the Impact of VaCcines
NCT ID:
NCT05831787
Condition:
Multiple Myeloma
Conditions: Official terms:
COVID-19
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
Myeloma
COVID-19
Vaccine
COSMIC
Study type:
Observational [Patient Registry]
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Patient Reported Outcomes
Description:
Patients will be asked to complete baseline, 30-day, and 6-month clinical and patient
reported outcome health surveys.
Arm group label:
Diagnosis of multiple myeloma and currently receiving active treatment for any phase of the disease
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Facility:
Name:
UNC-Chapel Hill
Address:
City:
Chapel Hill
Zip:
27514
Country:
United States
Start date:
January 23, 2024
Completion date:
January 31, 2025
Lead sponsor:
Agency:
ASH Research Collaborative
Agency class:
Other
Collaborator:
Agency:
ModernaTX, Inc.
Agency class:
Industry
Source:
ASH Research Collaborative
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05831787
