COVID19 OutcomeS in Myeloma and the Impact of VaCcines

Part of paid clinical trials in New York, New York.

Sponsor
ASH Research Collaborative
Study ID
NCT05831787
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Patient Reported Outcomes — OTHER
    Patients will be asked to complete baseline, 30-day, and 6-month clinical and patient reported outcome health surveys.

Study Details

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.

Key Dates

Start date
Jan 23, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
201 participants (actual)

Arms

  • Arm: Diagnosis of multiple myeloma and currently receiving active treatment for any phase of the disease
    Diagnosis of multiple myeloma must meet the International Myeloma Working Group criteria.

Primary Outcome Measure

Feasibility of Obtaining Baseline Clinical and PRO Data Capture From 200 Consented Patients. [ Time Frame: At Baseline ]

Locations (2)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
UNC-Chapel HillChapel HillNorth Carolina27514-

Find similar trials in New York, NY

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Memorial Sloan Kettering Cancer Center· New York, NYUNC-Chapel Hill· Chapel Hill, NC

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