Real-World Mapping Antithrombotic Regimens in MM Patients on Treatment
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto
About this trial
The goal of this observational study is to learn about antithrombotic regimens in Multiple myeloma patients. The main question it aims to answer is the efficacy of different types of thromboprophylaxis (antiplatelet agents, heparins, oral anticoagulants) in preventing venous thromboembolism (VTE).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age equal to or greater than 18 years of age.
New diagnosis of symptomatic MM according to the CRAB or the SLIM criteria of the International Myeloma Working Group
First active treatment for MM started after recruitment in the study
Signed informed consent
Disqualifiers
Patients having had thrombosis within 6 months before diagnosis of MM
Patients with need of combined antithrombotic regimens (i.e. VKA or DOAC or LMWK and one or two antiplatelet drugs)
Ongoing first active treatment for MM initiated before the starting of the study.
Trial population
Adult patients with a newly diagnosis of symptomatic Multiple myeloma treated at the Italian haematological Centers of the GIMEMA network. Patients will be enrolled prior to any treatment for MM.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Rate of venous thromboembolism according to different thromboprophylaxis strategies
Efficacy of different thromboprophylaxis strategies vs no thromboprophylaxis in terms of rate of VTE in patients newly diagnosed: 1. Comparison of VTE rate in patients treated with antiplatelet agents vs no thromboprophylaxis 2. Comparison of VTE rate in patients treated with heparins vs no thromboprophylaxis 3. Comparison of VTE rate in patients treated with oral anticoagulants vs no thromboprophylaxis.
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov