Multiple MyelomaEMN-COVIDNCT04492371
COVID-19 Infection and Multiple Myeloma
An observational study of Multiple Myeloma and Covid19, run by Stichting European Myeloma Network at 8 sites in 8 countries.
Trial summary
Collect in an observational study the outcomes of COVID19 infection in MM patients across Europe. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Multiple Myeloma, Covid19, Corona Virus Infection
- How many people
- 1,054 participants
- Where
- 8 sitesin 8 countries
- Study dates
- 1 Jul 2020to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Adult, Older adult
Study population: Multiple Myeloma patients with COVID-19 infection
Who may be able to join
- Multiple Myeloma patients
- COVID-19 infection
Who cannot join
None listed.
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
About this study
Official title: COVID-19 INFECTION IN MULTIPLE MYELOMA PATIENTS: AN EUROPEAN OBSERVATIONAL STUDY
Collect in an observational study the outcomes of COVID19 infection in MM patients across Europe.
Read the 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
- Medical subject headings
- Multiple Myeloma, COVID-19, Coronavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Nature of COVID19
The duration of infection.
Measured: 1 years
Costs related to COVID-19
Costs related to Covid in terms of health resource needs.
Measured: 1 years
Systemic anti-cancer therapy subgroup
Number of infection recovery for each systemic anti-cancer subgroup.
Measured: 1 years
Laboratory values collected at hospitalization
Evaluate if recurring haematological and chemistry values are related to infection onset, better or poorer outcome.
Measured: 1 years
COVID-19 infection in myeloma patient subgroups
Number of infection in each myeloma patient subgroups and evaluation of the number of recovery per subgroup.
Measured: 1 years
Incidence of COVID-19 infection in frail patients
Number of frail patients with COVID-19 infection and resolution of it.
Measured: 1 years
Infection outcome in different countries
Number of infection and outcome per country.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start1 Jul 2020
- Primary completion18 Aug 2022
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,054 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stichting European Myeloma Network
- Sponsor type
- Research network
- Collaborators
- Fondazione EMN Italy Onlus
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492371
- Sponsor's protocol ID
- EMN-COVID
- Acronym
- EMN-COVID
- Status last verified
- Mar 2024
- First submitted
- 28 Jul 2020
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 INFECTION IN MULTIPLE MYELOMA PATIENTS: AN EUROPEAN OBSERVATIONAL STUDY
- ClinicalTrials.gov ID
- NCT04492371
- Acronym / sponsor ID
- EMN-COVID / EMN-COVID
- Conditions
- Multiple Myeloma, Covid19, Corona Virus Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,054 participants (actual)
- Lead sponsor
- Stichting European Myeloma NetworkResearch network
- Collaborators
- Fondazione EMN Italy Onlus
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 18 Aug 2022 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Multiple Myeloma patients with COVID-19 infection
Key inclusion criteria (2 listed)
- Multiple Myeloma patients
- COVID-19 infection
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nature of COVID19
Time frame: 1 years
The duration of infection.
Costs related to COVID-19
Time frame: 1 years
Costs related to Covid in terms of health resource needs.
Systemic anti-cancer therapy subgroup
Time frame: 1 years
Number of infection recovery for each systemic anti-cancer subgroup.
Laboratory values collected at hospitalization
Time frame: 1 years
Evaluate if recurring haematological and chemistry values are related to infection onset, better or poorer outcome.
COVID-19 infection in myeloma patient subgroups
Time frame: 1 years
Number of infection in each myeloma patient subgroups and evaluation of the number of recovery per subgroup.
Incidence of COVID-19 infection in frail patients
Time frame: 1 years
Number of frail patients with COVID-19 infection and resolution of it.
Infection outcome in different countries
Time frame: 1 years
Number of infection and outcome per country.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and Covid19, run by Stichting European Myeloma Network at 8 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Austria, Belgium, Czechia, Germany, Greece and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nature of COVID19 (time frame: 1 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.