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

Phase 1

• Conditions: Multiple myeloma; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2013-003190-99-FR
• Lead Sponsor: CHU de Grenoble

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-25
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 104
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified