COVID-19 Infection and Multiple Myeloma (EMN-COVID)
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|ClinicalTrials.gov Identifier: NCT04492371|
Recruitment Status : Recruiting
First Posted : July 30, 2020
Last Update Posted : July 30, 2020
|Condition or disease|
|Multiple Myeloma Covid19 Corona Virus Infection|
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|
|Estimated Enrollment :||500 participants|
|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|
- Nature of COVID19 [ Time Frame: 1 years ]The duration of infection.
- Costs related to COVID-19 [ Time Frame: 1 years ]Costs related to Covid in terms of health resource needs.
- Systemic anti-cancer therapy subgroup [ Time Frame: 1 years ]Number of infection recovery for each systemic anti-cancer subgroup.
- 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.
- 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.
- Incidence of COVID-19 infection in frail patients [ Time Frame: 1 years ]Number of frail patients with COVID-19 infection and resolution of it.
- Infection outcome in different countries [ Time Frame: 1 years ]Number of infection and outcome per country.
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
|Contact: Mario Boccadoro, Prof.||+firstname.lastname@example.org|
|General Hopspital Vienna/Medical University||Not yet recruiting|
|Contact: Maria Krauth, Prof.|
|UCL Saint-Luc||Not yet recruiting|
|Contact: Marie-Christiane Vekemans, Prof.|
|University Hospital Ostrava||Not yet recruiting|
|Contact: Roman Hajek, Prof.|
|University Hospital Würzburg||Not yet recruiting|
|Contact: Hermann Einsele, Prof.|
|Alexandra Clinical Terapeutics||Recruiting|
|Contact: Evangelos Terpos, Prof.|
|AOU Consorziale Policlinico di Bari||Active, not recruiting|
|Amsterdam UMC||Not yet recruiting|
|Contact: Sonja Zweegman, Prof.|
|St James's University Hospital||Not yet recruiting|
|Leeds, United Kingdom|
|Contact: Gordon Cook, Prof.|