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

Grenoble Alpes University Hospital Center (CHU)

Status and phase

Completed

Phase 3

Conditions

Venous Thromboembolism

Myeloma

Treatments

Drug: Apixaban

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02066454

DCIC 1320

2013-003190-99 (EudraCT Number)

Details and patient eligibility

About

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

Full 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

Enrollment

108 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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