Clinical trial · Observational
COVID19 OutcomeS in Myeloma and the Impact of VaCcines
Monitoring SARS-CoV-2 Vaccines and COVID-19 Related Outcomes in Individuals With Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient Reported Outcomes | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Diagnosis of multiple myeloma and currently receiving active treatment for any phase of the disease
- description
- Diagnosis of multiple myeloma must meet the International Myeloma Working Group criteria.
- interventionNames
- Other: Patient Reported Outcomes
Primary outcomes (3)
- measure
- Feasibility of Obtaining Baseline Clinical and PRO Data Capture From 200 Consented Patients.
- timeFrame
- At Baseline
- description
- Proportion of consented participants who provide responses for the PRO instruments \& proportion of participants who permission access to clinical data through the EHR.
- measure
- Feasibility of Obtaining 30-day Clinical and PRO Data Capture From 200 Consented Patients.
- timeFrame
- 30 days after enrollment
- description
- Proportion of consented participants who provide responses for the PRO instruments \& proportion of participants who permission access to clinical data through the EHR.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDWood 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
- DERIVEDZorger 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