COVID19 OutcomeS in Myeloma and the Impact of VaCcines

Multiple Myeloma Clinical Trial

— COSMIC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05831787
• Other study ID #: ASH RC DH 2022-00001
• Status: Active, not recruiting
• Start date: January 23, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: June 2024
• Source: ASH Research Collaborative
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: January 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• Patient Reported Outcomes
Patients will be asked to complete baseline, 30-day, and 6-month clinical and patient reported outcome health surveys.

Locations

Country	Name	City	State
United States	UNC-Chapel Hill	Chapel Hill	North Carolina
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
ASH Research Collaborative	ModernaTX, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	COVID Vaccine Prevalence	Percent of patients who enroll on the study platform who had previously received a SARS-CoV-2 booster	At Baseline
Secondary	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
Secondary	PRO Review	Among participants providing PROs, percentage for whom PROs were viewed by site personnel	During 6 month study period
Secondary	COVID-19 Infection baseline	Percentage of participants reporting COVID-19 infection confirmed by home-based or other testing	At Baseline
Secondary	COVID-19 Infection on study	Percentage of participants reporting COVID-19 infection confirmed by home-based or other testing	During 6 month study period
Secondary	Patient reported COVID 19 adverse events baseline	Patient reported adverse events related to confirmed COVID-19 infection	At Baseline
Secondary	Patient reported COVID 19 adverse events on study	Patient reported adverse events related to confirmed COVID-19 infection	During 6 month study period
Secondary	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
Secondary	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