Clinical trial NCT04492371: COVID-19 Infection and Multiple Myeloma
Official title: COVID-19 INFECTION IN MULTIPLE MYELOMA PATIENTS: AN EUROPEAN OBSERVATIONAL STUDY
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Covid19
Corona Virus Infection
Lead sponsor: European Myeloma Network B.V.
Sponsor class: NETWORK
Collaborators: name: Fondazione EMN Italy Onlus
First posted: 2020-07-30
Enrollment: 1054
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Multiple Myeloma patients with COVID-19 infection

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

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.

Eligibility criteria: Inclusion Criteria:

* Multiple Myeloma patients
* COVID-19 infection

Primary outcomes:
measure: Nature of COVID19
timeFrame: 1 years
measure: Costs related to COVID-19
timeFrame: 1 years
measure: Systemic anti-cancer therapy subgroup
timeFrame: 1 years
measure: Laboratory values collected at hospitalization
timeFrame: 1 years
measure: COVID-19 infection in myeloma patient subgroups
timeFrame: 1 years
measure: Incidence of COVID-19 infection in frail patients
timeFrame: 1 years
measure: Infection outcome in different countries
timeFrame: 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: General Hopspital Vienna/Medical University
city: Brussels
country: Belgium
facility: UCL Saint-Luc
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
city: Würzburg
country: Germany
facility: University Hospital Würzburg
city: Athens
country: Greece
facility: Alexandra Clinical Terapeutics
city: Bari
country: Italy
facility: AOU Consorziale Policlinico di Bari
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Leeds
country: United Kingdom
facility: St James's University Hospital
Study officials:
References: