Clinical trial · Interventional
Evaluation of the Use of Apixaban in Prevnetion of Thromboembolic Disease in Patients With Myeloma Trated With iMiDs
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
NCT02066454CI-TRIAL-00093576MYELAXATcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
| Venous Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apixaban | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Apixaban
- description
- oral direct anti-Xa anticoagulant
- interventionNames
- Drug: Apixaban
Primary outcomes (1)
- measure
- 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
- timeFrame
- 7 months
- description
- 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 outcomes (4)
- measure
- incidence of venous thromboembolic complications
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (64)
- BACKGROUNDAgnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Porcari A, Raskob GE, Weitz JI; AMPLIFY-EXT Investigators. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):699-708. doi: 10.1056/NEJMoa1207541. Epub 2012 Dec 8. PMID 23216615
- BACKGROUNDAnagnostopoulos A, Weber D, Rankin K, Delasalle K, Alexanian R. Thalidomide and dexamethasone for resistant multiple myeloma. Br J Haematol. 2003 Jun;121(5):768-71. doi: 10.1046/j.1365-2141.2003.04345.x. PMID 12780791
- BACKGROUNDAttal M, Lauwers-Cances V, Marit G, Caillot D, Moreau P, Facon T, Stoppa AM, Hulin C, Benboubker L, Garderet L, Decaux O, Leyvraz S, Vekemans MC, Voillat L, Michallet M, Pegourie B, Dumontet C, Roussel M, Leleu X, Mathiot C, Payen C, Avet-Loiseau H, Harousseau JL; IFM Investigators. Lenalidomide maintenance after stem-cell transplantation for multiple myeloma. N Engl J Med. 2012 May 10;366(19):1782-91. doi: 10.1056/NEJMoa1114138. PMID 22571202
- BACKGROUNDBarlogie B, Desikan R, Eddlemon P, Spencer T, Zeldis J, Munshi N, Badros A, Zangari M, Anaissie E, Epstein J, Shaughnessy J, Ayers D, Spoon D, Tricot G. Extended survival in advanced and refractory multiple myeloma after single-agent thalidomide: identification of prognostic factors in a phase 2 study of 169 patients. Blood. 2001 Jul 15;98(2):492-4. doi: 10.1182/blood.v98.2.492. PMID 11435324
- BACKGROUNDBaz R, Li L, Kottke-Marchant K, Srkalovic G, McGowan B, Yiannaki E, Karam MA, Faiman B, Jawde RA, Andresen S, Zeldis J, Hussein MA. The role of aspirin in the prevention of thrombotic complications of thalidomide and anthracycline-based chemotherapy for multiple myeloma. Mayo Clin Proc. 2005 Dec;80(12):1568-74. doi: 10.4065/80.12.1568. PMID 16342649
- BACKGROUNDBlom JW, Doggen CJ, Osanto S, Rosendaal FR. Malignancies, prothrombotic mutations, and the risk of venous thrombosis. JAMA. 2005 Feb 9;293(6):715-22. doi: 10.1001/jama.293.6.715.