Monitoring SARS-CoV-2 Vaccines and COVID-19 Related Outcomes in Individuals With Multiple Myeloma
| Registry | NCT05831787, acronym COSMIC |
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| Status | Completed |
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| Study type | Observational |
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| Enrollment | 201 (Actual) |
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| Sponsor | ASH Research Collaborative (Other); collaborators: ModernaTX, Inc. |
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| Conditions | Multiple Myeloma |
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| Interventions | Patient Reported Outcomes (Other) |
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| Dates | start 2024-01-23, primary completion 2024-12-31, completion 2024-12-31, first posted 2023-04-26, last updated 2026-05-18 |
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| Locations | 2 sites in United States |
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-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.
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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Diagnosis of multiple myeloma and currently receiving active treatment for any phase of the disease | | Other: Patient Reported Outcomes | Diagnosis of multiple myeloma must meet the International Myeloma Working Group criteria. |
- Patient Reported Outcomes (Other): Patients will be asked to complete baseline, 30-day, and 6-month clinical and patient reported outcome health surveys.
+Outcome measures
Primary outcomes
- 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 outcomes
- 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.
- COVID Booster Incidence [6 months after enrollment]: Percent of patients who enrolled on the study platform and subsequently received a SARS-CoV-2 booster by the 6-month follow-up visit. Booster vaccination status was assessed using a combination of patient-reported data collected through the study platform and available electronic health record (EHR) data
+Eligibility
Sex: All
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
+Posted results
Participant flow
| Milestone | Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease |
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| Started | 201 |
| Completed | 196 |
| Not completed | 5 |
Outcome results
- Feasibility of Obtaining Baseline Clinical and PRO Data Capture From 200 Consented Patients. (Primary), Count of participants, Participants: Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease 196
- Feasibility of Obtaining 30-day Clinical and PRO Data Capture From 200 Consented Patients. (Primary), Count of participants, Participants: Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease 162
- Feasibility of Obtaining 6-month Clinical and PRO Data Capture From 200 Consented Patients. (Primary), Count of participants, Participants: Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease 159
- COVID Vaccine Prevalence (Secondary), Count of participants, Participants: Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease 186
- COVID Booster Incidence (Secondary), Count of participants, Participants: Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease 18
- PRO Review (Secondary), Count of participants, Participants: Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease 196
- COVID-19 Infection Baseline (Secondary), Count of participants, Participants: Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease 111
- COVID-19 Infection on Study (Secondary), Count of participants, Participants: Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease 18
- Patient Reported COVID 19 Related Outcomes at Baseline (Secondary), Count of participants, Participants: Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease 0
- Patient Reported COVID 19 Related Outcomes on Study (Secondary), Count of participants, Participants: Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease 0
- EHR COVID 19 Related Outcomes Baseline (Secondary), Count of participants, Participants: Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease 0
- EHR COVID 19 Related Outcomes on Study (Secondary), Count of participants, Participants: Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease 12
- COVID Booster Incidence (Secondary), Count of participants, Participants: Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease 39
Adverse events
Time frame: Per protocol, in this observational study, adverse events were not monitored or assessed; therefore, there are no adverse event results to report over the 6 month study timeframe.
| Arm | Deaths | Serious adverse events | Other adverse events |
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| Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease | 0 | 0 | 0 |
Limitations and caveats: We acknowledge several limitations. We did not enroll consecutive patients or assess representativeness, limiting generalizability. Lack of Spanish materials and reliance on a patient portal requiring internet and digital literacy may contribute to disparities. PRO data use in decision-making was not studied. COVID-19 status was mainly self-reported, so misclassification is possible
+Locations (2)
| Facility | City | Country | Status |
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| Memorial Sloan Kettering Cancer Center | New York, New York | United States | |
| UNC-Chapel Hill | Chapel Hill, North Carolina | United States | |
+Publications
- Results publication: Wood WA, Kumar SK, Semmel EA, James S, Schroeder MA, Chung DJ, Rosenberg A, Zonder J, Rubinstein S, D'Souza A, Martin T, Chari A, Vij R, Nooka AK, Anderson KC, Neuberg DS, Richard S, Torres K, Weiss BM, Pederson L, Derkach A, Geyer S, Usmani SZ. Feasibility of decentralized real-world monitoring of SARS-CoV-2 booster vaccines and COVID-19 outcomes in myeloma. Blood Adv. 2026 May 12;10(9):3094-3102. doi: 10.1182/bloodadvances.2025018963. PMID 41734388
- Results publication: Zorger AM, Hirsch C, Baumann M, Feldmann M, Brockelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N. Vaccines for preventing infections in adults with haematological malignancies. Cochrane Database Syst Rev. 2025 May 21;5(5):CD015530. doi: 10.1002/14651858.CD015530.pub2. PMID 40396505
+Study documents
+Investigators