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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04492371
Recruitment Status : Recruiting
First Posted : July 30, 2020
Last Update Posted : July 30, 2020
Sponsor:
Collaborator:
Fondazione EMN Italy Onlus
Information provided by (Responsible Party):
European Myeloma Network

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

Condition or disease
Multiple Myeloma Covid19 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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: COVID-19 INFECTION IN MULTIPLE MYELOMA PATIENTS: AN EUROPEAN OBSERVATIONAL STUDY
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021





Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Multiple Myeloma patients with COVID-19 infection
Criteria

Inclusion Criteria:

  • Multiple Myeloma patients
  • COVID-19 infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04492371


Contacts
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Contact: Mario Boccadoro, Prof. +390110243236 clinicaltrialoffice@emnitaly.org

Locations
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Austria
General Hopspital Vienna/Medical University Not yet recruiting
Vienna, Austria
Contact: Maria Krauth, Prof.         
Belgium
UCL Saint-Luc Not yet recruiting
Brussels, Belgium
Contact: Marie-Christiane Vekemans, Prof.         
Czechia
University Hospital Ostrava Not yet recruiting
Ostrava, Czechia
Contact: Roman Hajek, Prof.         
Germany
University Hospital Würzburg Not yet recruiting
Würzburg, Germany
Contact: Hermann Einsele, Prof.         
Greece
Alexandra Clinical Terapeutics Recruiting
Athens, Greece
Contact: Evangelos Terpos, Prof.         
Italy
AOU Consorziale Policlinico di Bari Active, not recruiting
Bari, Italy
Netherlands
Amsterdam UMC Not yet recruiting
Amsterdam, Netherlands
Contact: Sonja Zweegman, Prof.         
United Kingdom
St James's University Hospital Not yet recruiting
Leeds, United Kingdom
Contact: Gordon Cook, Prof.         
Sponsors and Collaborators
European Myeloma Network
Fondazione EMN Italy Onlus
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Responsible Party: European Myeloma Network
ClinicalTrials.gov Identifier: NCT04492371    
Other Study ID Numbers: EMN-COVID
First Posted: July 30, 2020    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases