N/A
N=201
COVID19 OutcomeS in Myeloma and the Impact of VaCcines
Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT05831787 ↗Enrolled (actual)
201
Serious AEs
—
Results posted
May 2026
Primary outcome: Primary: Feasibility of Obtaining Baseline Clinical and PRO Data Capture From 200 Consented Patients. — 196 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Patient Reported Outcomes (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- ASH Research Collaborative
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Obtaining Baseline Clinical and PRO Data Capture From 200 Consented Patients. |
196 | — |
| PRIMARY Feasibility of Obtaining 30-day Clinical and PRO Data Capture From 200 Consented Patients. |
162 | — |
| PRIMARY Feasibility of Obtaining 6-month Clinical and PRO Data Capture From 200 Consented Patients. |
159 | — |
| SECONDARY COVID Vaccine Prevalence |
186 | — |
| SECONDARY COVID Booster Incidence |
39 | — |
| SECONDARY PRO Review |
196 | — |
| SECONDARY COVID-19 Infection Baseline |
111 | — |
| SECONDARY COVID-19 Infection on Study |
18 | — |
| SECONDARY Patient Reported COVID 19 Related Outcomes at Baseline |
— | — |
| SECONDARY Patient Reported COVID 19 Related Outcomes on Study |
— | — |
| SECONDARY EHR COVID 19 Related Outcomes Baseline |
— | — |
| SECONDARY EHR COVID 19 Related Outcomes on Study |
12 | — |
| SECONDARY COVID Booster Incidence |
39 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT05831787). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.