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

August 8, 2025 updated by: University Hospital, Grenoble

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Annecy, France, 74374
        • CHRA
      • Bayonne, France, 64100
        • Ch La Cote Basque
      • Clamart, France, 92141
        • HIA Percy
      • Creteil, France, 94010
        • CHU Hôpital Henri Mondor
      • Dunkerque, France, 59385
        • Centre Hospitalier
      • Grenoble, France, 38043
        • CHU Grenoble
      • La Roche Sur Yon, France, 85925
        • CHD Vendee
      • Le Mans, France, 72000
        • Clinique Victor Hugo
      • Lille, France, 59037
        • Chru Hopital Huriez
      • Lille, France, 59020
        • Hopital St Vincent - Ghicl
      • Lyon, France, 69373
        • Centre Leon Berard
      • Montivilliers, France, 76290
        • Groupe Hospitalier du Havre
      • Nice, France, 06202
        • Hôpital de l'Archet
      • Paris, France, 75651
        • Hôpital Pitie Salpétrière
      • Perigueux, France, 24000
        • CH de Périgueux
      • Pessac, France, 33604
        • CHU Bordeaux
      • Pierre Benite, France, 69310
        • CH Lyon Sud
      • Poitiers, France, 86021
        • CHU Poitiers
      • Tours, France, 37000
        • CHRU De Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Apixaban
oral direct anti-Xa anticoagulant
Drug: Apixaban
2.5mg x 2 per day during 6 months
Other Names:
  • oral direct anti-Xa anticoagulant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

Celgene

Investigators

  • Principal Investigator: Brigitte PEGOURIE, MD, Hospital University Grenoble
  • Principal Investigator: Gilles PERNOD, PHD, Hospital University Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2014

Primary Completion (Actual)

July 12, 2016

Study Completion (Actual)

July 12, 2016

Study Registration Dates

First Submitted

February 14, 2014

First Submitted That Met QC Criteria

February 14, 2014

First Posted (Estimated)

February 19, 2014

Study Record Updates

Last Update Posted (Actual)

August 13, 2025

Last Update Submitted That Met QC Criteria

August 8, 2025

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC 1320
  • 2013-003190-99 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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