COVID19 OutcomeS in Myeloma and the Impact of VaCcines

NCT05831787 | Active Not Recruiting

• 1 other identifier: ASH RC DH 2022-00001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Multiple Myeloma

Keywords

Myeloma; COVID-19; Vaccine; COSMIC

Outcome Measures

Primary Outcomes (3)

• Feasibility of obtaining baseline clinical and PRO data capture from 200 consented patients.

  Proportion of consented participants who provide responses for the PRO instruments \& proportion of participants who permission access to clinical data through the EHR.

  At Baseline

• Feasibility of obtaining 30-day clinical and PRO data capture from 200 consented patients.

  Proportion of consented participants who provide responses for the PRO instruments \& proportion of participants who permission access to clinical data through the EHR.

  30 days after enrollment

• Feasibility of obtaining 6-month clinical and PRO data capture from 200 consented patients.

  proportion of consented participants who provide responses for the PRO instruments \& proportion of participants who permission access to clinical data through the EHR.

  6 months after enrollment

Secondary Outcomes (9)

• COVID Vaccine Prevalence

  At Baseline

• COVID Booster Incidence

  During 6 month study period

• PRO Review

  During 6 month study period

• COVID-19 Infection baseline

  At Baseline

• COVID-19 Infection on study

  During 6 month study period

Study Arms (1)

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.

Other: Patient Reported Outcomes

Interventions

Patient Reported Outcomes OTHER

Patients will be asked to complete baseline, 30-day, and 6-month clinical and patient reported outcome health surveys.

Diagnosis of multiple myeloma and currently receiving active treatment for any phase of the disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with a 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.

You may qualify if:

• 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

You may not qualify if:

• Non-English speaking
• Lack of internet access
• Cognitive impairment precluding ability to provide informed consent

Sponsors & Collaborators

• ASH Research Collaborative: lead
• ModernaTX, Inc.: collaborator

Study Sites (2)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

UNC-Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell; COVID-19

Interventions

Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• William Wood, MD, MPH

  UNC-Chapel Hill

  PRINCIPAL INVESTIGATOR

• Saad Usmani, MD,MBA,FACP

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: April 26, 2023
• Study Start: January 23, 2024
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: June 17, 2024

Record last verified: 2024-06

Locations

US (2)