Trial results for a study investigating COVID-19 outcomes and vaccine impact in patients with Multiple Myeloma were posted on ClinicalTrials.gov on 2026-05-18, reporting that baseline data was captured from 196 participants out of 201 enrolled.
Background
Multiple myeloma is a cancer of plasma cells, which are a type of white blood cell found in the bone marrow. Individuals with multiple myeloma often have compromised immune systems, making them particularly vulnerable to infections. The COVID-19 pandemic presented a significant health challenge for this patient population, with concerns about increased rates of severe disease, hospitalization, and mortality. While vaccines against SARS-CoV-2 have been effective in limiting morbidity and mortality across the general population, their effectiveness in immunocompromised individuals, such as those with multiple myeloma, has been a subject of ongoing investigation. Understanding the prevalence of vaccination, booster uptake, and infection rates, as well as the feasibility of collecting relevant clinical and patient-reported outcome (PRO) data, is crucial for informing care strategies for these vulnerable patients.
Trial design
This completed observational study enrolled 201 participants with Multiple Myeloma who were currently receiving active treatment for any phase of the disease. The primary objective was to assess the feasibility of obtaining baseline, 30-day, and 6-month clinical and PRO data capture from these consented patients. The study also aimed to characterize COVID-19 vaccine prevalence, booster incidence, and infection rates both at baseline and during the study period. No specific interventions were tested, as the trial focused on data collection and outcome observation within this patient group.
Key results
The trial results provided several key measurements related to data capture feasibility, COVID-19 vaccination, and infection rates in participants with multiple myeloma:
- Feasibility of Obtaining Baseline Clinical and PRO Data Capture From 200 Consented Patients: 196 Participants
- Feasibility of Obtaining 30-day Clinical and PRO Data Capture From 200 Consented Patients: 162 Participants
- Feasibility of Obtaining 6-month Clinical and PRO Data Capture From 200 Consented Patients: 159 Participants
- COVID Vaccine Prevalence: 186 Participants
- COVID Booster Incidence: 18 Participants
- PRO Review: 196 Participants
- COVID-19 Infection Baseline: 111 Participants
- COVID-19 Infection on Study: 18 Participants
- Patient Reported COVID 19 Related Outcomes at Baseline: 0 Participants
- Patient Reported COVID 19 Related Outcomes on Study: 0 Participants
- EHR COVID 19 Related Outcomes Baseline: 0 Participants
- EHR COVID 19 Related Outcomes on Study: 12 Participants
What this means
The posted results indicate a high degree of success in capturing baseline clinical and patient-reported outcome (PRO) data from individuals with multiple myeloma, with 196 out of 201 enrolled participants providing this information. While data capture rates decreased over time to 162 participants at 30 days and 159 at 6 months, these figures still demonstrate substantial feasibility for longitudinal follow-up in this population. The study also revealed high COVID-19 vaccine prevalence, with 186 participants having received a vaccine, though booster incidence was lower at 18 participants. Regarding COVID-19 infection, 111 participants reported a prior infection at baseline, with an additional 18 infections occurring during the study period. Notably, patient-reported COVID-19 related outcomes were recorded as 0 at both baseline and on study, suggesting either a lack of specific PRO instruments used for these outcomes or no reported events via that method. However, EHR-derived COVID-19 related outcomes showed 12 events on study, highlighting the utility of electronic health records for capturing clinical data in this context. These findings underscore the feasibility of conducting observational studies to gather critical health data in immunocompromised patient groups and provide insights into their vaccination status and infection experiences during the pandemic.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05831787, titled "COVID19 OutcomeS in Myeloma and the Impact of VaCcines", were posted on 2026-05-18 on clinicaltrials.gov.
