COVID-19 Infection and Multiple Myeloma

NCT ID: NCT04492371

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1054 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2024-03-01

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.

Conditions

Multiple Myeloma; Covid19; Corona Virus Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

• Multiple Myeloma patients
• COVID-19 infection

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione EMN Italy Onlus

OTHER

Sponsor Role: collaborator

Stichting European Myeloma Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

General Hopspital Vienna/Medical University

Vienna, , Austria

UCL Saint-Luc

Brussels, , Belgium

University Hospital Ostrava

Ostrava, , Czechia

University Hospital Würzburg

Würzburg, , Germany

Alexandra Clinical Terapeutics

Athens, , Greece

AOU Consorziale Policlinico di Bari

Bari, , Italy

Amsterdam UMC

Amsterdam, , Netherlands

St James's University Hospital

Leeds, , United Kingdom

Countries

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

Other Identifiers

EMN-COVID

Identifier Type: -

Identifier Source: org_study_id