Evaluation of the Use of Apixaban in Prevnetion of Thromboembolic Disease in Patients With Myeloma Trated With iMiDs
Overview[ - collapse ][ - ]
| 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 | Myeloma Venous Thromboembolism |
| Intervention | Drug: Apixaban |
| Phase | Phase 3 |
| Sponsor | University Hospital, Grenoble |
| Responsible Party | University Hospital, Grenoble |
| ClinicalTrials.gov Identifier | NCT02066454 |
| First Received | February 14, 2014 |
| Last Updated | March 14, 2014 |
| Last verified | March 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | February 14, 2014 |
|---|---|
| Last Updated Date | March 14, 2014 |
| Start Date | April 2014 |
| Estimated Primary Completion Date | July 2017 |
| Current 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 |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Evaluation of the Use of Apixaban in Prevnetion of Thromboembolic Disease in Patients With Myeloma Trated With iMiDs |
|---|---|
| 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 |
| 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 |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition |
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| Intervention | Drug: Apixaban 2.5mg x 2 per day during 6 months Other Names: oral direct anti-Xa anticoagulant |
| Study Arm (s) | Experimental: Apixaban oral direct anti-Xa anticoagulant |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Not yet recruiting |
|---|---|
| Estimated Enrollment | 105 |
| Estimated Completion Date | July 2017 |
| Estimated Primary Completion Date | January 2017 |
| 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Brigitte PEGOURIE, MD 04 76 76 55 90 bpegourie@chu-grenoble.fr |
| Location Countries | France |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT02066454 |
|---|---|
| Other Study ID Numbers | DCIC 1320 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | University Hospital, Grenoble |
| Study Sponsor | University Hospital, Grenoble |
| Collaborators | Celgene Corporation |
| Investigators | Principal Investigator: Brigitte PEGOURIE, MD Hospital University GrenoblePrincipal Investigator: Gilles PERNOD, PHD Hospital University Grenoble |
| Verification Date | March 2014 |
Locations[ + expand ][ + ]
| CHRA | Annecy, France, 74374 Contact: Frédérique ORSINI, MD | 04 50 63 66 08Principal Investigator: Frédérique ORSINI, MD Not yet recruiting |
|---|---|
| Ch La Cote Basque | Bayonne, France, 64100 Contact: Anne BANOS, MD | 05 59 44 38 32 | abanos@ch-cotebasque.frPrincipal Investigator: Anne BANOS, MD Not yet recruiting |
| Hia Percy | Clamart, France, 92141 Contact: Thierry DE REVEL, MD | 01 41 46 63 01 | thderevel@gmail.comPrincipal Investigator: Thierry DE REVEL, MD Not yet recruiting |
| Chu Hopital Henri Mondor | Creteil, France, 94010 Contact: Karim BELHADJ-MERZOUG, MD | 01 49 81 49 63 | karim.belhadj@hmn.aphp.frPrincipal Investigator: Karim BELHADJ-MERZOUG, MD Not yet recruiting |
| Centre Hospitalier | Dunkerque, France, 59385 Contact: Marc WETTERWALD, MD | 03 28 28 56 33 | marc.wetterwald@ch-dunkerque.frPrincipal Investigator: Marc WETTERWALD, MD Not yet recruiting |
| Chu Grenoble | Grenoble, France, 38043 Contact: Brigitte PEGOURIE, MD | 04 76 76 55 90 | bpegourie@chu-grenoble.frPrincipal Investigator: Brigitte PEGOURIE, MD Not yet recruiting |
| Chd Vendee | La Roche Sur Yon, France, 85925 Contact: Mourad TIAB, MD | 02 51 44 61 73 | mourad.tiab@chd-vendee.frPrincipal Investigator: Mourad TIAB, MD Not yet recruiting |
| Clinique Victor Hugo | Le Mans, France, 72000 Contact: Eric VOOG, MDPrincipal Investigator: Eric VOOG, MD Not yet recruiting |
| Chru Hopital Huriez | Lille, France, 59037 Contact: Thierry FACON, MD | 03 20 44 57 12 | thierry.facon@chru-lille.frPrincipal Investigator: Thierry FACON, MD Not yet recruiting |
| Hopital St Vincent - Ghicl | Lille, France, 59020 Contact: Manuel CLIQUENNOIS, MD | 03 20 87 45 32 | cliquennois.manuel@ghicl.netPrincipal Investigator: Manuel CLIQUENNOIS, MD Not yet recruiting |
| Centre Leon Berard | Lyon, France, 69373 Contact: Philippe REY, MD | 04 78 78 67 95 | philippe.rey@lyon.unicancer.frPrincipal Investigator: Philippe REY, MD Not yet recruiting |
| Groupe Hospitalier Du Havre | Montivilliers, France, 76290 Contact: Charles ZARNITSKY, MD | 02 32 73 33 78 | charles.zarnitsky@ch-havre.frPrincipal Investigator: Charles ZARNITSKY, MD Not yet recruiting |
| Hopital de L'Archet | Nice, France, 06202 Contact: Jean-Gabriel FUZIBET, MD | 04 92 03 58 23 | fuzibet.jg@chu-nice.frPrincipal Investigator: Jean-Gabriel FUZIBET, MD Not yet recruiting |
| Hopital Pitie Salpetriere | Paris, France, 75651 Contact: Damien ROOS-WEIL, MD | 01 42 16 28 34 | damienroosweil@voila.frPrincipal Investigator: Damien ROOS-WEIL, MD Not yet recruiting |
| Ch de Perigueux | Perigueux, France, 24000 Contact: Philippe RODON, MD | 05 53 45 29 78 | rodon.philippe@wanadoo.frPrincipal Investigator: Philippe RODON, MD Not yet recruiting |
| Chu Bordeaux | Pessac, France, 33604 Contact: Gérald MARIT, MD | 05 57 65 65 11 | gerald.marit@chu-bordeaux.frPrincipal Investigator: Gérald MARIT, MD Not yet recruiting |
| Ch Lyon Sud | Pierre Benite, France, 69310 Contact: Lionel KARLIN, MD | 04 78 86 43 09 | lionel.karlin@chu-lyon.frPrincipal Investigator: Lionel KARLIN, MD Not yet recruiting |
| Chu Poitiers | Poitiers, France, 86021 Contact: Isabelle AZAIS, MD | 05 49 44 44 65 | i.azais@chu-poitiers.frPrincipal Investigator: Isabelle AZAIS, MD Not yet recruiting |
| Chru de Tours | Tours, France, 37000 Contact: Lotfi BENBOUKER, MDPrincipal Investigator: Lotfi BENBOUKER, MD Not yet recruiting |