Trial record 6 of 439 for:    Open Studies | "Anticoagulants"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by University Hospital, Grenoble
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT02066454
First received: February 14, 2014
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

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

Condition Intervention Phase
Myeloma
Venous Thromboembolism
Drug: Apixaban
Phase 3

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

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

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 [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
    incidence of arterial cardiovascular events (myocardial infarction, ischemic stroke, TIA)


Estimated Enrollment: 105
Study Start Date: April 2014
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Apixaban
oral direct anti-Xa anticoagulant
Drug: Apixaban
2.5mg x 2 per day during 6 months
Other Name: oral direct anti-Xa anticoagulant

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02066454

Contacts
Contact: Brigitte PEGOURIE, MD 04 76 76 55 90 bpegourie@chu-grenoble.fr
Contact: Gilles PERNOD, PHD 04 76 76 34 60 gpernod@chu-grenoble.fr

Locations
France
CHRA Not yet recruiting
Annecy, France, 74374
Contact: Frédérique ORSINI, MD    04 50 63 66 08      
Principal Investigator: Frédérique ORSINI, MD         
Sub-Investigator: Pascale CONY-MAKHOUL, MD         
Sub-Investigator: Anne PARRY, MD         
Sub-Investigator: Bernadette CORRONT, MD         
Sub-Investigator: DAGUINDAU Nicolas, MD         
Ch La Cote Basque Not yet recruiting
Bayonne, France, 64100
Contact: Anne BANOS, MD    05 59 44 38 32    abanos@ch-cotebasque.fr   
Principal Investigator: Anne BANOS, MD         
Sub-Investigator: Carla ARAUJO, MD         
Hia Percy Not yet recruiting
Clamart, France, 92141
Contact: Thierry DE REVEL, MD    01 41 46 63 01    thderevel@gmail.com   
Principal Investigator: Thierry DE REVEL, MD         
Chu Hopital Henri Mondor Not yet recruiting
Creteil, France, 94010
Contact: Karim BELHADJ-MERZOUG, MD    01 49 81 49 63    karim.belhadj@hmn.aphp.fr   
Principal Investigator: Karim BELHADJ-MERZOUG, MD         
Centre Hospitalier Not yet recruiting
Dunkerque, France, 59385
Contact: Marc WETTERWALD, MD    03 28 28 56 33    marc.wetterwald@ch-dunkerque.fr   
Principal Investigator: Marc WETTERWALD, MD         
Chu Grenoble Not yet recruiting
Grenoble, France, 38043
Contact: Brigitte PEGOURIE, MD    04 76 76 55 90    bpegourie@chu-grenoble.fr   
Principal Investigator: Brigitte PEGOURIE, MD         
Sub-Investigator: Rémy GRESSIN, MD         
Sub-Investigator: Lysiane MOLINA, MD         
Sub-Investigator: Audrey SIMON, MD         
Sub-Investigator: Stéphane COURBY, MD         
Sub-Investigator: Claude-Eric BULABOIS, MD         
Sub-Investigator: Anne THIEBAUT, MD         
Sub-Investigator: Jean-Yves CAHN, PHD         
Chd Vendee Not yet recruiting
La Roche Sur Yon, France, 85925
Contact: Mourad TIAB, MD    02 51 44 61 73    mourad.tiab@chd-vendee.fr   
Principal Investigator: Mourad TIAB, MD         
Clinique Victor Hugo Not yet recruiting
Le Mans, France, 72000
Contact: Eric VOOG, MD         
Principal Investigator: Eric VOOG, MD         
Chru Hopital Huriez Not yet recruiting
Lille, France, 59037
Contact: Thierry FACON, MD    03 20 44 57 12    thierry.facon@chru-lille.fr   
Principal Investigator: Thierry FACON, MD         
Sub-Investigator: Xavier LELEU, MD         
Hopital St Vincent - Ghicl Not yet recruiting
Lille, France, 59020
Contact: Manuel CLIQUENNOIS, MD    03 20 87 45 32    cliquennois.manuel@ghicl.net   
Principal Investigator: Manuel CLIQUENNOIS, MD         
Centre Leon Berard Not yet recruiting
Lyon, France, 69373
Contact: Philippe REY, MD    04 78 78 67 95    philippe.rey@lyon.unicancer.fr   
Principal Investigator: Philippe REY, MD         
Sub-Investigator: Catherine SEBAN, MD         
Sub-Investigator: Pierre BIRON, MD         
Groupe Hospitalier Du Havre Not yet recruiting
Montivilliers, France, 76290
Contact: Charles ZARNITSKY, MD    02 32 73 33 78    charles.zarnitsky@ch-havre.fr   
Principal Investigator: Charles ZARNITSKY, MD         
Hopital de L'Archet Not yet recruiting
Nice, France, 06202
Contact: Jean-Gabriel FUZIBET, MD    04 92 03 58 23    fuzibet.jg@chu-nice.fr   
Principal Investigator: Jean-Gabriel FUZIBET, MD         
Hopital Pitie Salpetriere Not yet recruiting
Paris, France, 75651
Contact: Damien ROOS-WEIL, MD    01 42 16 28 34    damienroosweil@voila.fr   
Principal Investigator: Damien ROOS-WEIL, MD         
Sub-Investigator: Véronique MOREL-MALEK, MD         
Ch de Perigueux Not yet recruiting
Perigueux, France, 24000
Contact: Philippe RODON, MD    05 53 45 29 78    rodon.philippe@wanadoo.fr   
Principal Investigator: Philippe RODON, MD         
Chu Bordeaux Not yet recruiting
Pessac, France, 33604
Contact: Gérald MARIT, MD    05 57 65 65 11    gerald.marit@chu-bordeaux.fr   
Principal Investigator: Gérald MARIT, MD         
Sub-Investigator: Axelle LASCAUX, MD         
Sub-Investigator: Sophie DIMICOLI-SALAZAR, MD         
Ch Lyon Sud Not yet recruiting
Pierre Benite, France, 69310
Contact: Lionel KARLIN, MD    04 78 86 43 09    lionel.karlin@chu-lyon.fr   
Principal Investigator: Lionel KARLIN, MD         
Chu Poitiers Not yet recruiting
Poitiers, France, 86021
Contact: Isabelle AZAIS, MD    05 49 44 44 65    i.azais@chu-poitiers.fr   
Principal Investigator: Isabelle AZAIS, MD         
Chru de Tours Not yet recruiting
Tours, France, 37000
Contact: Lotfi BENBOUKER, MD         
Principal Investigator: Lotfi BENBOUKER, MD         
Sponsors and Collaborators
University Hospital, Grenoble
Celgene Corporation
Investigators
Principal Investigator: Brigitte PEGOURIE, MD Hospital University Grenoble
Principal Investigator: Gilles PERNOD, PHD Hospital University Grenoble
  More Information

Publications:
Leleu X, Daley L, Rodon P et al. MELISSE : Etude Multicentrique Prospective Observationelle pour definir les Facteurs de Risques de Thrombose dans le Myelome traite par les IMiDs. Congrès SFH, Paris, Mars 2011.
Palumbo A, Davies F, Kropff M et al. Consensus guidelines for the optimal management of adverse events in newly diagnosed, transplant-ineligible patients receiving melphalan and prednisone in combination with thalidomide (MPT) for the treatment of multiple myeloma. Ann Hematol 2010 89: 803-811
Turpie A G, Lassen MR, ; Eriksson BI, et al. Rivaroxaban for the prevention of venous thromboembolism after hip or knee arthroplasty. Pooled analysis of four studies. Thromb Haemost 2011; 105: 444-53

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02066454     History of Changes
Other Study ID Numbers: DCIC 1320, 2013-003190-99
Study First Received: February 14, 2014
Last Updated: March 14, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: The Commission nationale de l’informatique et des libertés

Keywords provided by University Hospital, Grenoble:
myeloma
antiXa anticoagulant
venous thromboembolic disease
iMiDs

Additional relevant MeSH terms:
Anticoagulants
Multiple Myeloma
Neoplasms, Plasma Cell
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Embolism and Thrombosis
Thrombosis
Heparin, Low-Molecular-Weight
Dalteparin
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 24, 2014