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

Primary Purpose

Myeloma, Venous Thromboembolism

Status

Unknown status

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Apixaban

About this trial

This is an interventional treatment trial for Myeloma focused on measuring myeloma, antiXa anticoagulant, venous thromboembolic disease, iMiDs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apixaban

Arm Description

oral direct anti-Xa anticoagulant

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

incidence of venous thromboembolic complications

incidence of venous thromboembolic complications, symptomatic and asymptomatic, according to the time of treatment with iMiDs (diagnosis or relapse)

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)

incidence of arterial cardiovascular events

incidence of arterial cardiovascular events (myocardial infarction, ischemic stroke, TIA)

Full Information

NCT ID

NCT02066454

First Posted

February 14, 2014

Last Updated

December 8, 2014

Sponsor

University Hospital, Grenoble

Collaborators

Celgene Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02066454

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Unknown status

Study Start Date

April 2014 (undefined)

Primary Completion Date

January 2017 (Anticipated)

Study Completion Date

July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Grenoble

Collaborators

Celgene Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myeloma, Venous Thromboembolism

Keywords

myeloma, antiXa anticoagulant, venous thromboembolic disease, iMiDs

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Apixaban

Arm Type

Experimental

Arm Description

oral direct anti-Xa anticoagulant

Intervention Type

Drug

Intervention Name(s)

Apixaban

Other Intervention Name(s)

oral direct anti-Xa anticoagulant

Intervention Description

2.5mg x 2 per day during 6 months

Primary Outcome Measure Information:

Title

Description

Time Frame

7 months

Secondary Outcome Measure Information:

Title

incidence of venous thromboembolic complications

Description

incidence of venous thromboembolic complications, symptomatic and asymptomatic, according to the thrombotic risk stratification of patients (low or high risk)

Time Frame

7 months

Title

incidence of venous thromboembolic complications

Description

incidence of venous thromboembolic complications, symptomatic and asymptomatic, according to the time of treatment with iMiDs (diagnosis or relapse)

Time Frame

7 months

Title

incidence of major and clinically relevant non major bleeding

Description

incidence of major and clinically relevant non major bleeding according to the thrombotic risk strtification of patients (low or high risk)

Time Frame

7 months

Title

incidence of arterial cardiovascular events

Description

incidence of arterial cardiovascular events (myocardial infarction, ischemic stroke, TIA)

Time Frame

7 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Brigitte PEGOURIE, MD

Phone

04 76 76 55 90

bpegourie@chu-grenoble.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Gilles PERNOD, PHD

Phone

04 76 76 34 60

gpernod@chu-grenoble.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brigitte PEGOURIE, MD

Organizational Affiliation

Hospital University Grenoble

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gilles PERNOD, PHD

Organizational Affiliation

Hospital University Grenoble

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHRA

City

Annecy

ZIP/Postal Code

74374

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Frédérique ORSINI, MD

Phone

04 50 63 66 08

First Name & Middle Initial & Last Name & Degree

Frédérique ORSINI, MD

First Name & Middle Initial & Last Name & Degree

Pascale CONY-MAKHOUL, MD

First Name & Middle Initial & Last Name & Degree

Anne PARRY, MD

First Name & Middle Initial & Last Name & Degree

Bernadette CORRONT, MD

First Name & Middle Initial & Last Name & Degree

DAGUINDAU Nicolas, MD

Facility Name

Ch La Cote Basque

City

Bayonne

ZIP/Postal Code

64100

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anne BANOS, MD

Phone

05 59 44 38 32

abanos@ch-cotebasque.fr

First Name & Middle Initial & Last Name & Degree

Anne BANOS, MD

First Name & Middle Initial & Last Name & Degree

Carla ARAUJO, MD

Facility Name

Hia Percy

City

Clamart

ZIP/Postal Code

92141

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thierry DE REVEL, MD

Phone

01 41 46 63 01

thderevel@gmail.com

First Name & Middle Initial & Last Name & Degree

Thierry DE REVEL, MD

Facility Name

Chu Hopital Henri Mondor

City

Creteil

ZIP/Postal Code

94010

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karim BELHADJ-MERZOUG, MD

Phone

01 49 81 49 63

karim.belhadj@hmn.aphp.fr

First Name & Middle Initial & Last Name & Degree

Karim BELHADJ-MERZOUG, MD

Facility Name

Centre Hospitalier

City

Dunkerque

ZIP/Postal Code

59385

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marc WETTERWALD, MD

Phone

03 28 28 56 33

marc.wetterwald@ch-dunkerque.fr

First Name & Middle Initial & Last Name & Degree

Marc WETTERWALD, MD

Facility Name

Chu Grenoble

City

Grenoble

ZIP/Postal Code

38043

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brigitte PEGOURIE, MD

Phone

04 76 76 55 90

bpegourie@chu-grenoble.fr

First Name & Middle Initial & Last Name & Degree

Brigitte PEGOURIE, MD

First Name & Middle Initial & Last Name & Degree

Rémy GRESSIN, MD

First Name & Middle Initial & Last Name & Degree

Lysiane MOLINA, MD

First Name & Middle Initial & Last Name & Degree

Audrey SIMON, MD

First Name & Middle Initial & Last Name & Degree

Stéphane COURBY, MD

First Name & Middle Initial & Last Name & Degree

Claude-Eric BULABOIS, MD

First Name & Middle Initial & Last Name & Degree

Anne THIEBAUT, MD

First Name & Middle Initial & Last Name & Degree

Jean-Yves CAHN, PHD

Facility Name

Chd Vendee

City

La Roche Sur Yon

ZIP/Postal Code

85925

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mourad TIAB, MD

Phone

02 51 44 61 73

mourad.tiab@chd-vendee.fr

First Name & Middle Initial & Last Name & Degree

Mourad TIAB, MD

Facility Name

Clinique Victor Hugo

City

Le Mans

ZIP/Postal Code

72000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eric VOOG, MD

First Name & Middle Initial & Last Name & Degree

Eric VOOG, MD

Facility Name

Hopital St Vincent - Ghicl

City

Lille

ZIP/Postal Code

59020

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Manuel CLIQUENNOIS, MD

Phone

03 20 87 45 32

cliquennois.manuel@ghicl.net

First Name & Middle Initial & Last Name & Degree

Manuel CLIQUENNOIS, MD

Facility Name

Chru Hopital Huriez

City

Lille

ZIP/Postal Code

59037

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thierry FACON, MD

Phone

03 20 44 57 12

thierry.facon@chru-lille.fr

First Name & Middle Initial & Last Name & Degree

Thierry FACON, MD

First Name & Middle Initial & Last Name & Degree

Xavier LELEU, MD

Facility Name

Centre Leon Berard

City

Lyon

ZIP/Postal Code

69373

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Philippe REY, MD

Phone

04 78 78 67 95

philippe.rey@lyon.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Philippe REY, MD

First Name & Middle Initial & Last Name & Degree

Catherine SEBAN, MD

First Name & Middle Initial & Last Name & Degree

Pierre BIRON, MD

Facility Name

Groupe Hospitalier Du Havre

City

Montivilliers

ZIP/Postal Code

76290

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Charles ZARNITSKY, MD

Phone

02 32 73 33 78

charles.zarnitsky@ch-havre.fr

First Name & Middle Initial & Last Name & Degree

Charles ZARNITSKY, MD

Facility Name

Hopital de L'Archet

City

Nice

ZIP/Postal Code

06202

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean-Gabriel FUZIBET, MD

Phone

04 92 03 58 23

fuzibet.jg@chu-nice.fr

First Name & Middle Initial & Last Name & Degree

Jean-Gabriel FUZIBET, MD

Facility Name

Hopital Pitie Salpetriere

City

Paris

ZIP/Postal Code

75651

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Damien ROOS-WEIL, MD

Phone

01 42 16 28 34

damienroosweil@voila.fr

First Name & Middle Initial & Last Name & Degree

Damien ROOS-WEIL, MD

First Name & Middle Initial & Last Name & Degree

Véronique MOREL-MALEK, MD

Facility Name

Ch de Perigueux

City

Perigueux

ZIP/Postal Code

24000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Philippe RODON, MD

Phone

05 53 45 29 78

rodon.philippe@wanadoo.fr

First Name & Middle Initial & Last Name & Degree

Philippe RODON, MD

Facility Name

Chu Bordeaux

City

Pessac

ZIP/Postal Code

33604

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gérald MARIT, MD

Phone

05 57 65 65 11

gerald.marit@chu-bordeaux.fr

First Name & Middle Initial & Last Name & Degree

Gérald MARIT, MD

First Name & Middle Initial & Last Name & Degree

Axelle LASCAUX, MD

First Name & Middle Initial & Last Name & Degree

Sophie DIMICOLI-SALAZAR, MD

Facility Name

Ch Lyon Sud

City

Pierre Benite

ZIP/Postal Code

69310

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lionel KARLIN, MD

Phone

04 78 86 43 09

lionel.karlin@chu-lyon.fr

First Name & Middle Initial & Last Name & Degree

Lionel KARLIN, MD

Facility Name

Chu Poitiers

City

Poitiers

ZIP/Postal Code

86021

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Isabelle AZAIS, MD

Phone

05 49 44 44 65

i.azais@chu-poitiers.fr

First Name & Middle Initial & Last Name & Degree

Isabelle AZAIS, MD

Facility Name

Chru de Tours

City

Tours

ZIP/Postal Code

37000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lotfi BENBOUKER, MD

First Name & Middle Initial & Last Name & Degree

Lotfi BENBOUKER, MD

12. IPD Sharing Statement

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

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

Myeloma, Venous Thromboembolism

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