Multiple Myeloma
Conditions
Keywords
Myeloma, COVID-19, Vaccine, COSMIC
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.
Interventions
OTHERPatient Reported Outcomes
Patients will be asked to complete baseline, 30-day, and 6-month clinical and patient reported outcome health surveys.
Sponsors
ASH Research Collaborative
ModernaTX, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Obtaining Baseline Clinical and PRO Data Capture From 200 Consented Patients. | 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 30-day Clinical and PRO Data Capture From 200 Consented Patients. | 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 6-month Clinical and PRO Data Capture From 200 Consented Patients. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| COVID Vaccine Prevalence | At Baseline | Percent of patients who enroll on the study platform who had previously received a SARS-CoV-2 booster |
| COVID Booster Incidence | 30 Days after enrollment | Percent of patients who enroll on the study platform who went on to receive a SARS-CoV-2 booster at 1 month follow up visit |
| PRO Review | During 6 month study period | Among participants providing PROs, percentage for whom PROs were viewed by site personnel |
| COVID-19 Infection Baseline | At Baseline | Percentage of participants reporting COVID-19 infection confirmed by home-based or other testing |
| COVID-19 Infection on Study | During 6 month study period | Percentage of participants reporting COVID-19 infection confirmed by home-based or other testing |
| Patient Reported COVID 19 Related Outcomes at Baseline | At Baseline | Patient reported outcomes related to confirmed COVID-19 infection. COVID-19-related outcomes were assessed through a decentralized approach using patient-reported data collected via study questionnaires. Outcomes included participant-reported COVID-19 infection and related clinical events (e.g., hospitalization). |
| Patient Reported COVID 19 Related Outcomes on Study | During 6 month study period | Patient reported outcomes related to confirmed COVID-19 infection. COVID-19-related outcomes were assessed through a decentralized approach using patient-reported data collected via study questionnaires. Outcomes included participant-reported COVID-19 infection and related clinical events (e.g., hospitalization). |
| EHR COVID 19 Related Outcomes Baseline | At Baseline | Hospitalization related to COVID-19 was ascertained through electronic health record (EHR) data obtained with participant permission. COVID-19-related outcomes included COVID-19 infection and associated clinical events (e.g., hospitalization), as documented in the EHR. |
| EHR COVID 19 Related Outcomes on Study | During 6 month study period | Hospitalization related to COVID-19 was ascertained through electronic health record (EHR) data obtained with participant permission. COVID-19-related outcomes included COVID-19 infection and associated clinical events (e.g., hospitalization), as documented in the EHR. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORWilliam Wood, MD, MPH
UNC-Chapel Hill
PRINCIPAL_INVESTIGATORSaad Usmani, MD,MBA,FACP
Memorial Sloan Kettering Cancer Center
Participant flow
Recruitment details
The enrollment goal was 200 patients; however, an additional patient electronically consented after the enrollment goal was met prior to the study platform being deactivated. The additional patient did not complete any study activities, and the IRB was notified.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 120 Participants |
| Age, Categorical Between 18 and 65 years | 76 Participants |
| Age, Continuous | 66.1 years STANDARD_DEVIATION 10.21 |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic or Latina/Latino | 15 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic, Black | 34 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic, White | 143 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 4 Participants |
| Region of Enrollment United States | 196 participants |
| Sex: Female, Male Female | 90 Participants |
| Sex: Female, Male Male | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
None listed