A Phase 3 interventional study of Apixaban in Myeloma and Venous Thromboembolism, sponsored by University Hospital, Grenoble. Completed at 19 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-13.
Sponsored by University Hospital, Grenoble · Phase 3, Interventional, and Treatment
To evaluate:
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
2,306 studies on the registry are indexed under Neoplasms, Plasma Cell; 246 are open to participants now.
This study's enrollment of 108 is above the median of 39 across 1,823 interventional studies indexed under Neoplasms, Plasma Cell.
Browse Neoplasms, Plasma Cell studies →University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
Counted across the registry records on this site, refreshed daily.
AND
- who require prevention of venous thromboembolic events with Aspirin or Low molecular Weight Heparin (LMWH) for a minimum duration of 6 months At least, 2/3 of patients will be treated with Lenalidomide-Dexamethasone.
Exclusion Criteria:
Prohibited concomitant treatment
oral direct anti-Xa anticoagulant
Drug: Apixaban
2.5mg x 2 per day during 6 months
Also known as: oral direct anti-Xa anticoagulant
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
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble