Informations générales (source: ClinicalTrials.gov)

NCT02066454 Statut inconnu
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 (MYELAXAT)
Interventional
  • Myélome multiple
  • Thromboembolie
  • Tumeurs à plasmocytes
  • Thromboembolisme veineux
Phase 3
University Hospital, Grenoble (Voir sur ClinicalTrials)
avril 2014
juillet 2017
29 juin 2024
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
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Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Henri Mondor-Albert Chenevier Karim BELHADJ-MERZOUG, MD En recrutement IDF Contact (sur clinicalTrials)
AP-HP - Hôpital La Pitié-Salpêtrière Damien ROOS-WEIL, MD En recrutement IDF Contact (sur clinicalTrials)
HIA PERCY Thierry DE REVEL, MD En recrutement IDF Contact (sur clinicalTrials)
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centre Hospitalier - 59385 - Dunkerque - France Marc WETTERWALD, MD En recrutement Contact (sur clinicalTrials)
Ch de Perigueux - 24000 - Perigueux - France Philippe RODON, MD En recrutement Contact (sur clinicalTrials)
Ch La Cote Basque - 64100 - Bayonne - France Anne BANOS, MD En recrutement Contact (sur clinicalTrials)
Ch Lyon Sud - 69310 - Pierre Benite - France Lionel KARLIN, MD En recrutement Contact (sur clinicalTrials)
CHRA - 74374 - Annecy - France Frédérique ORSINI, MD En recrutement Contact (sur clinicalTrials)
Chru de Tours - 37000 - Tours - France Lotfi BENBOUKER, MD En recrutement Contact (sur clinicalTrials)
Chru Hopital Huriez - 59037 - Lille - France Thierry FACON, MD En recrutement Contact (sur clinicalTrials)
Chu Bordeaux - 33604 - Pessac - France Gérald MARIT, MD En recrutement Contact (sur clinicalTrials)
Chu Grenoble - 38043 - Grenoble - France Brigitte PEGOURIE, MD En recrutement Contact (sur clinicalTrials)
Chu Poitiers - 86021 - Poitiers - France Isabelle AZAIS, MD En recrutement Contact (sur clinicalTrials)
Hopital de L'Archet - 06202 - Nice - France Jean-Gabriel FUZIBET, MD En recrutement Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centre Leon Berard - 69373 - Lyon - France Philippe REY, MD En recrutement Contact (sur clinicalTrials)
Chd Vendee - 85925 - La Roche Sur Yon - France Mourad TIAB, MD En recrutement Contact (sur clinicalTrials)
Clinique Victor Hugo - 72000 - Le Mans - France Eric VOOG, MD En recrutement Contact (sur clinicalTrials)
Groupe Hospitalier Du Havre - 76290 - Montivilliers - France Charles ZARNITSKY, MD En recrutement Contact (sur clinicalTrials)
Hopital St Vincent - Ghicl - 59020 - Lille - France Manuel CLIQUENNOIS, MD En recrutement Contact (sur clinicalTrials)

Critères

Tous
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


- 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