Clinical trial NCT02066454: Evaluation of the Use of Apixaban in Prevnetion of Thromboembolic Disease in Patients With Myeloma Trated With iMiDs
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Myeloma
Venous Thromboembolism
Keywords: myeloma
antiXa anticoagulant
venous thromboembolic disease
iMiDs
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2014-02-19
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 7 months
Secondary outcomes:
measure: incidence of venous thromboembolic complications
timeFrame: 7 months
measure: incidence of venous thromboembolic complications
timeFrame: 7 months
measure: incidence of major and clinically relevant non major bleeding
timeFrame: 7 months
measure: incidence of arterial cardiovascular events
timeFrame: 7 months
Other outcomes:
Locations:
city: Annecy
country: France
facility: CHRA
city: Bayonne
country: France
facility: Ch La Cote Basque
city: Clamart
country: France
facility: Hia Percy
city: Creteil
country: France
facility: Chu Hopital Henri Mondor
city: Dunkerque
country: France
facility: Centre Hospitalier
city: Grenoble
country: France
facility: Chu Grenoble
city: La Roche Sur Yon
country: France
facility: Chd Vendee
city: Le Mans
country: France
facility: Clinique Victor Hugo
city: Lille
country: France
facility: Hopital St Vincent - Ghicl
city: Lille
country: France
facility: Chru Hopital Huriez
city: Lyon
country: France
facility: Centre Leon Berard
city: Montivilliers
country: France
facility: Groupe Hospitalier Du Havre
city: Nice
country: France
facility: Hopital de L'Archet
city: Paris
country: France
facility: Hopital Pitie Salpetriere
city: Perigueux
country: France
facility: Ch de Perigueux
city: Pessac
country: France
facility: Chu Bordeaux
city: Pierre Benite
country: France
facility: Ch Lyon Sud
city: Poitiers
country: France
facility: Chu Poitiers
city: Tours
country: France
facility: Chru de Tours
Study officials:
affiliation: Hospital University Grenoble
name: Brigitte PEGOURIE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital University Grenoble
name: Gilles PERNOD, PHD
role: PRINCIPAL_INVESTIGATOR
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