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Completed

NCT Number: NCT04492371

COVID-19 Infection and Multiple Myeloma

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

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders COVID-19 Cardiovascular Diseases Corona Virus Infection Coronaviridae Infections Coronavirus Infections Covid19 Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Infections Lung Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Nidovirales Infections Paraproteinemias Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Vascular Diseases Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hopspital Vienna/Medical University, Vienna, Austria

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Multiple Myeloma patients
  • COVID-19 infection

Treatment and study plan

Primary outcomes

  1. Nature of COVID19

    Time frame: 1 years

    The duration of infection.

  2. Costs related to COVID-19

    Time frame: 1 years

    Costs related to Covid in terms of health resource needs.

  3. Systemic anti-cancer therapy subgroup

    Time frame: 1 years

    Number of infection recovery for each systemic anti-cancer subgroup.

  4. Laboratory values collected at hospitalization

    Time frame: 1 years

    Evaluate if recurring haematological and chemistry values are related to infection onset, better or poorer outcome.

  5. COVID-19 infection in myeloma patient subgroups

    Time frame: 1 years

    Number of infection in each myeloma patient subgroups and evaluation of the number of recovery per subgroup.

  6. Incidence of COVID-19 infection in frail patients

    Time frame: 1 years

    Number of frail patients with COVID-19 infection and resolution of it.

  7. Infection outcome in different countries

    Time frame: 1 years

    Number of infection and outcome per country.

Sponsors and collaborators

Lead sponsor

Stichting European Myeloma Network

Network

Collaborators

  • Fondazione EMN Italy Onlus

Registry information

Official study title

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

Acronym: EMN-COVID

Important dates

Study start
2020
Primary completion
2022
Study completion
2024
First posted
Jul 30, 2020
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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