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

Venous Thromboembolism Clinical Trial

— MYELAXAT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02066454
• Other study ID #: DCIC 1320
• Secondary ID: 2013-003190-99
• Status: Recruiting
• Phase: Phase 3
• First received: February 14, 2014
• Last updated: December 8, 2014
• Start date: April 2014
• Est. completion date: July 2017

Study information

• Verified date: December 2014
• Source: University Hospital, Grenoble
• Contact: Brigitte PEGOURIE, MD
• Phone: 04 76 76 55 90
• Email: bpegourie[@]chu-grenoble.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: The Commission nationale de l’informatique et des libertés
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: July 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Myeloma
• Neoplasms, Plasma Cell
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Apixaban
2.5mg x 2 per day during 6 months

Locations

Country	Name	City	State
France	CHRA	Annecy
France	Ch La Cote Basque	Bayonne
France	Hia Percy	Clamart
France	Chu Hopital Henri Mondor	Creteil
France	Centre Hospitalier	Dunkerque
France	Chu Grenoble	Grenoble
France	Chd Vendee	La Roche Sur Yon
France	Clinique Victor Hugo	Le Mans
France	Chru Hopital Huriez	Lille
France	Hopital St Vincent - Ghicl	Lille
France	Centre Leon Berard	Lyon
France	Groupe Hospitalier Du Havre	Montivilliers
France	Hopital de L'Archet	Nice
France	Hopital Pitie Salpetriere	Paris
France	Ch de Perigueux	Perigueux
France	Chu Bordeaux	Pessac
France	Ch Lyon Sud	Pierre Benite
France	Chu Poitiers	Poitiers
France	Chru de Tours	Tours

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Celgene Corporation

Country where clinical trial is conducted

France, 

References & Publications (63)

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* Note: There are 63 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	7 months	Yes
Secondary	incidence of venous thromboembolic complications	incidence of venous thromboembolic complications, symptomatic and asymptomatic, according to the thrombotic risk stratification of patients (low or high risk)	7 months	Yes
Secondary	incidence of venous thromboembolic complications	incidence of venous thromboembolic complications, symptomatic and asymptomatic, according to the time of treatment with iMiDs (diagnosis or relapse)	7 months	Yes
Secondary	incidence of major and clinically relevant non major bleeding	incidence of major and clinically relevant non major bleeding according to the thrombotic risk strtification of patients (low or high risk)	7 months	Yes
Secondary	incidence of arterial cardiovascular events	incidence of arterial cardiovascular events (myocardial infarction, ischemic stroke, TIA)	7 months	Yes