To evaluate: * the incidence of venous thromboembolic event (VTE) * the incidence of hemorrhagic complications, In a population of patients with myeloma who are treated with IMiDs and require thromboprophylaxis for 6 months, using an oral anti-Xa anticoagulant, Apixaban, in a preventive scheme, 2.5 mg x2/day
MYELAXAT trial is multicentre, open trial which aims to evaluate the incidence of venous thromboembolic event (VTE) and the incidence of hemorrhagic complications. All patients with Myeloma treated with iMiDs and require thromboprophylaxis for 6 months, using an oral anti-Xa anticoagulant, Apixaban, in a preventive scheme, 2.5 mg x2/day
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
108
2.5mg x 2 per day during 6 months
CHRA
Annecy, France
Ch La Cote Basque
Bayonne, France
Hia Percy
Clamart, France
Total VTE and VTE-related death. Major and clinically relevant non major bleeding - Major and clinically relevant non major bleeding, defined according to International Society of Thrombosis and haemostasis
Total VTE (fatal or non fatal pulmonary embolism, symptomatic distal or proximal DVT of lower limbs, and asymptomatic proximal DVT detected by bilateral compression ultrasound) and VTE-related death. \- Major and clinically relevant non major bleeding, defined according to International Society of Thrombosis and haemostasis
Time frame: 7 months
incidence of venous thromboembolic complications
incidence of venous thromboembolic complications, symptomatic and asymptomatic, according to the thrombotic risk stratification of patients (low or high risk)
Time frame: 7 months
incidence of venous thromboembolic complications
incidence of venous thromboembolic complications, symptomatic and asymptomatic, according to the time of treatment with iMiDs (diagnosis or relapse)
Time frame: 7 months
incidence of major and clinically relevant non major bleeding
incidence of major and clinically relevant non major bleeding according to the thrombotic risk strtification of patients (low or high risk)
Time frame: 7 months
incidence of arterial cardiovascular events
incidence of arterial cardiovascular events (myocardial infarction, ischemic stroke, TIA)
Time frame: 7 months
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