COVID-19 Infection and Multiple Myeloma

Multiple Myeloma Clinical Trial

— EMN-COVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04492371
• Other study ID #: EMN-COVID
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2024
• Source: Stichting European Myeloma Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1054
• Est. completion date: March 1, 2024
• Est. primary completion date: August 18, 2022
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Multiple Myeloma patients

• COVID-19 infection

Related Conditions & MeSH terms

• Communicable Diseases
• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• Covid19
• Infections
• Multiple Myeloma
• Neoplasms, Plasma Cell

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Stichting European Myeloma Network	Fondazione EMN Italy Onlus

Countries where clinical trial is conducted

Austria,  Belgium,  Czechia,  Germany,  Greece,  Italy,  Netherlands,  United Kingdom, 

Outcome

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