COVID-19 Infection and Multiple Myeloma
- Conditions
- Multiple MyelomaCorona Virus InfectionCovid19
- Registration Number
- NCT04492371
- Lead Sponsor
- Stichting European Myeloma Network
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1054
- Multiple Myeloma patients
- COVID-19 infection
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Costs related to COVID-19 1 years Costs related to Covid in terms of health resource needs.
Laboratory values collected at hospitalization 1 years Evaluate if recurring haematological and chemistry values are related to infection onset, better or poorer outcome.
Nature of COVID19 1 years The duration of infection.
COVID-19 infection in myeloma patient subgroups 1 years Number of infection in each myeloma patient subgroups and evaluation of the number of recovery per subgroup.
Systemic anti-cancer therapy subgroup 1 years Number of infection recovery for each systemic anti-cancer subgroup.
Incidence of COVID-19 infection in frail patients 1 years Number of frail patients with COVID-19 infection and resolution of it.
Infection outcome in different countries 1 years Number of infection and outcome per country.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
St James's University Hospital
🇬🇧Leeds, United Kingdom
University Hospital Ostrava
🇨🇿Ostrava, Czechia
AOU Consorziale Policlinico di Bari
🇮🇹Bari, Italy
University Hospital Würzburg
🇩🇪Würzburg, Germany
UCL Saint-Luc
🇧🇪Brussels, Belgium
Alexandra Clinical Terapeutics
🇬🇷Athens, Greece
Amsterdam UMC
🇳🇱Amsterdam, Netherlands
General Hopspital Vienna/Medical University
🇦🇹Vienna, Austria