Evaluation of the Use of Apixaban in Prevnetion of Thromboembolic Disease in Patients With Myeloma Trated With iMiDs
- Registration Number
- NCT02066454
- Lead Sponsor
- University Hospital, Grenoble
- Brief Summary
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
- Detailed Description
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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 105
- 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).
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.
- Written informed consent
- Patients affiliated to the French social security system or equivalent
-
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
- inhibitors of CYP3A4 and P-gp : azole antimycotic agents (ketoconazole, itraconazole, voriconazole, posaconazole), inhibitors of HIV protease (ritonavir, indinavir, nelfinavir, atazanavir, saquinavir), specific macrolide antibiotics (clarithromycine, telithromycine)
- other antithrombotic treatment : salicylate derivates (aspirin, products containing aspirin), antiplatelet therapy, heparin (unfractionated heparin, low molecular weight heparin, danaparoide sodique, fondaparinux), hirudines, oral anticoagulants (vitamin K antagonists, rivaroxaban, dabigatran)
-
Patient with AST or ALT rate > 3 times upper limit of normal
-
Patient with Bilirubin rate > 1.5 times upper limit of normal
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Patient with Platelets rate < 75 G/l
-
Patient with Creatinine Clearance (Cockcroft) < 30 ml/mn
-
Incidental finding of a proximal Deep Venous Thrombosis on the screening ultrasound
-
Patients refusing or unable to give a written consent of information
-
Patient unable to comply with the protocol requirement, in the investigator's opinion
-
Life expectancy less than 6 months
-
Incarcerated patients
-
Pregnancy or possibility of pregnancy within 6 months
-
Females of childbearing potential without reliable contraception
-
Ecog > 2
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Apixaban Apixaban oral direct anti-Xa anticoagulant
- Primary Outcome Measures
Name Time Method 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 7 months 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
- Secondary Outcome Measures
Name Time Method incidence of major and clinically relevant non major bleeding 7 months incidence of major and clinically relevant non major bleeding according to the thrombotic risk strtification of patients (low or high risk)
incidence of arterial cardiovascular events 7 months incidence of arterial cardiovascular events (myocardial infarction, ischemic stroke, TIA)
incidence of venous thromboembolic complications 7 months incidence of venous thromboembolic complications, symptomatic and asymptomatic, according to the time of treatment with iMiDs (diagnosis or relapse)
Trial Locations
- Locations (19)
Hia Percy
🇫🇷Clamart, France
Ch La Cote Basque
🇫🇷Bayonne, France
Chd Vendee
🇫🇷La Roche Sur Yon, France
Clinique Victor Hugo
🇫🇷Le Mans, France
CHRA
🇫🇷Annecy, France
Chu Bordeaux
🇫🇷Pessac, France
Ch Lyon Sud
🇫🇷Pierre Benite, France
Chu Poitiers
🇫🇷Poitiers, France
Centre Hospitalier
🇫🇷Dunkerque, France
Chu Grenoble
🇫🇷Grenoble, France
Hopital de L'Archet
🇫🇷Nice, France
Chru de Tours
🇫🇷Tours, France
Chu Hopital Henri Mondor
🇫🇷Creteil, France
Hopital St Vincent - Ghicl
🇫🇷Lille, France
Chru Hopital Huriez
🇫🇷Lille, France
Centre Leon Berard
🇫🇷Lyon, France
Hopital Pitie Salpetriere
🇫🇷Paris, France
Groupe Hospitalier Du Havre
🇫🇷Montivilliers, France
Ch de Perigueux
🇫🇷Perigueux, France