EMN-COVID

Title

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

Overview / Summary

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. 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. 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. 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. This observational study aims to collect data on the outcomes of COVID19 infection in MM patients across Europe.

Study details

Objectives are:

• To characterize the nature of COVID19 in MM patients (duration, health resource needs)
• To define the severity of disease, outcomes and any association with Systemic anti-cancer therapy (SACT)
• To define laboratory values associated with the disease incidence and outcomes.
• To define myeloma patient subgroups where the disease has a greater representation, and whether there are differences in outcomes
• To define the role of frailty (calculated using mIMWG frailty score) in delineating those at greater risk
• To define if the variation in government/social strategies have had an association with outcomes utilizing inter-country datasets

Countries currently active and enrolling patients include:

  • Czech Republic
  • Greece
  • Italy

Patient eligibility criteria

  • Multiple myeloma patients infected by (SARS-CoV-2).
  • No exclusion criteria apply.
  • The study will enroll a minimum of 1000 patients with COVID19 diagnosis.

Publications

No publications connected to this trial at the moment