Evaluation of the Use of Apixaban in Prevnetion of Thromboembolic Disease in Patients With Myeloma Trated With iMiDs

• Status: Unknown status
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Grenoble
• Collaborator: Celgene Corporation
• Treatments: Anticoagulants; Apixaban; Dalteparin; Heparin, Low-Molecular-Weight

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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