Evaluation of the use of an oral direct anti-Xa anticoagulant, Apixaban in prevention of venous thromboembolic disease in patients treated with IMiDs during myeloma: a pilot study - MYELAXAT

CHU de Grenoble0 sitesSeptember 25, 2015

Overview

No summary available.

Registry

who.int

Start Date

September 25, 2015

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

CHU de Grenoble

•Patients (men/women) aged more than 18 years
•All consecutive patients, with myeloma, in first\-line treatment or in relapse, who are treated
•\-With IMiDs (MPT, Melphalan \-Prednisone \-Thalidomide ; Lenalidomide \- Dexamethasone).
•\-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.
•Written informed consent
•Patients affiliated to the French social security system or equivalent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•Patient who needs curative anticoagulant treatment (heparin, LMWH, vitamin K antagonists, Dabigatran, Rivaroxaban, Apixaban) for an associated disorder (mechanical valve, atrial fibrillation or venous thromboembolic disease in the previous 6 months).
•Patient who needs preventive treatment with an anticoagulant in a post\-operative context
•Patient who needs anti\-platelet treatment (Aspirin, Clopidogrel, Prasugrel, Ticagrelor or dual anti\-platelet therapy )
•Patient with active bleeding or at a high risk of bleeding (ulcer disease, intracranial bleeding in the previous 6 months, uncontrolled hypertension)
•Patient having undergone a surgical intervention within the past 30 days likely to expose them to an haemorrhagic risk
•Active hepatic disease (hepatitis, cirrhosis)
•Severe renal insufficiency (creatinine clearance using the Cockcroft equation \< 30 ml/mn)
•Known allergic reaction to Apixaban
•Contraindication to the use of an anticoagulant treatment
•Prohibited concomitant treatment