COVID-19 Infection and Multiple Myeloma (EMN-COVID)

COVID-19 INFECTION IN MULTIPLE MYELOMA PATIENTS: AN EUROPEAN OBSERVATIONAL STUDY

Collect in an observational study the outcomes of COVID19 infection in MM patients across Europe.

Study Overview

• Status: Completed
• Conditions: Covid19; Multiple Myeloma; Corona Virus Infection

Detailed Description

Coronavirus Disease 2019 (COVID-19), caused by a novel coronavirus (SARS-CoV-2), is a highly contagious disease that appeared in Wuhan, Hubei province of China in December 2019. It has now spread to multiple countries through infected persons travelling mainly by air. Most of the infected patients have mild symptoms including fever, fatigue and cough. But in severe cases, patients can progress rapidly and develop the acute respiratory distress syndrome, septic shock, metabolic acidosis and coagulopathy including a disseminated intravascular coagulation (DIC).

Multiple myeloma (MM) is a mature B-cell malignancy largely affecting the older patient with a median age at presentation of 70 years. The general performance status (PS) and the presence of comorbidity can identify a group of patients with poor tolerance to treatment, as well as risks of both bacterial and viral infection. MM patients have benefited significantly from therapeutic developments, however, the host response biology of the older person, coupled with a distinct disease biology overlay induces immune dysfunction. For example, the impact of aging on the human immune system is well documented. In MM it has long-since been understood that there is a spectrum of immune dysregulation, an important host factor considered in the "Hallmarks of cancer" theory. In addition, the delivery of anti-MM therapy includes immune modulating agents such as steroids, proteasome inhibitors and CD38-directed therapy though not all immune modulation is necessarily detrimental.

As such, myeloma patients are considered a higher risk in the current pandemic with SARS-COVID19. However, it is not clear whether this is actually the case, and the risk may not be different to population in general. Equally it may be sub-groups of patients who are at risk e.g. on treatment versus stable response (plateau), frailty. AS such, this proposal aims to collect in an observational study, the outcomes of COVID19 infection in MM patients across Europe.

• Study Type: Observational
• Enrollment (Actual): 1054

Contacts and Locations

• Study Contact: Name: Mario Boccadoro, Prof.; Phone Number: +390110243236; Email: clinicaltrialoffice@emnitaly.org

Study Locations

• Austria
  • Vienna, Austria
    • General Hopspital Vienna/Medical University
• Belgium
  • Brussels, Belgium
    • UCL Saint-Luc
• Czechia
  • Ostrava, Czechia
    • University Hospital Ostrava
• Germany
  • Würzburg, Germany
    • University Hospital Würzburg
• Greece
  • Athens, Greece
    • Alexandra Clinical Terapeutics
• Italy
  • Bari, Italy
    • AOU Consorziale Policlinico di Bari
• Netherlands
  • Amsterdam, Netherlands
    • Amsterdam UMC
• United Kingdom
  • Leeds, United Kingdom
    • St James's University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Multiple Myeloma patients with COVID-19 infection

Description

Inclusion Criteria:

• Multiple Myeloma patients
• COVID-19 infection

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nature of COVID19	The duration of infection.	1 years
Costs related to COVID-19	Costs related to Covid in terms of health resource needs.	1 years
Systemic anti-cancer therapy subgroup	Number of infection recovery for each systemic anti-cancer subgroup.	1 years
Laboratory values collected at hospitalization	Evaluate if recurring haematological and chemistry values are related to infection onset, better or poorer outcome.	1 years
COVID-19 infection in myeloma patient subgroups	Number of infection in each myeloma patient subgroups and evaluation of the number of recovery per subgroup.	1 years
Incidence of COVID-19 infection in frail patients	Number of frail patients with COVID-19 infection and resolution of it.	1 years
Infection outcome in different countries	Number of infection and outcome per country.	1 years

Collaborators and Investigators

• Sponsor: Stichting European Myeloma Network
• Collaborators: Fondazione EMN Italy Onlus

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): August 18, 2022
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (Actual): July 30, 2020

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; COVID-19; Coronavirus Infections; Multiple Myeloma; Neoplasms, Plasma Cell; Infections; Communicable Diseases
• Other Study ID Numbers: EMN-COVID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No