MyelomaPhase 3MYELAXATNCT02066454
Evaluation of the Use of Apixaban in Prevnetion of Thromboembolic Disease in Patients With Myeloma Trated With iMiDs
A Phase 3 study testing Apixaban in people with Myeloma and Venous Thromboembolism, run by University Hospital, Grenoble at 19 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloma, Venous Thromboembolism
- What is being tested?
- Apixaban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 19 sitesFrance
- Study dates
- 5 Jun 2014to 12 Jul 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 24Show fewer
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
France19 sites
CHRA
Annecy, 74374
Ch La Cote Basque
Bayonne, 64100
Hia Percy
Clamart, 92141
Chu Hopital Henri Mondor
Créteil, 94010
Centre Hospitalier
Dunkirk, 59385
Chu Grenoble
Grenoble, 38043
Chd Vendee
La Roche-sur-Yon, 85925
Clinique Victor Hugo
Le Mans, 72000
Hopital St Vincent - Ghicl
Lille, 59020
Chru Hopital Huriez
Lille, 59037
Centre Leon Berard
Lyon, 69373
Groupe Hospitalier Du Havre
Montivilliers, 76290
Hopital de L'Archet
Nice, 06202
Hopital Pitie Salpetriere
Paris, 75651
Ch de Perigueux
Périgueux, 24000
Chu Bordeaux
Pessac, 33604
Ch Lyon Sud
Pierre-Bénite, 69310
Chu Poitiers
Poitiers, 86021
Chru de Tours
Tours, 37000
About this study
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
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
Read the 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
- Conditions
- Myeloma, Venous Thromboembolism
- Being tested
- Apixaban
- Keywords
- myeloma, antiXa anticoagulant, venous thromboembolic disease, iMiDs
- Medical subject headings
- Neoplasms, Plasma Cell, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Also called oral direct anti-Xa anticoagulant
2.5mg x 2 per day during 6 months
| Study group | Role | What they receive |
|---|---|---|
| Apixaban | Experimental | oral direct anti-Xa anticoagulant Receives: Drug: Apixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Measured: 7 months
Secondary outcomes (4)
incidence of venous thromboembolic complications
incidence of venous thromboembolic complications, symptomatic and asymptomatic, according to the thrombotic risk stratification of patients (low or high risk)
Measured: 7 months
incidence of venous thromboembolic complications
incidence of venous thromboembolic complications, symptomatic and asymptomatic, according to the time of treatment with iMiDs (diagnosis or relapse)
Measured: 7 months
incidence of major and clinically relevant non major bleeding
incidence of major and clinically relevant non major bleeding according to the thrombotic risk strtification of patients (low or high risk)
Measured: 7 months
incidence of arterial cardiovascular events
incidence of arterial cardiovascular events (myocardial infarction, ischemic stroke, TIA)
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study start5 Jun 2014
- Primary completion12 Jul 2016
- Study completion12 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (64)Papers the sponsor has linked to this study.
- Other trials for MyelomaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Sponsor
- Investigators
- Brigitte PEGOURIE, MD, Principal investigator, Hospital University GrenobleGilles PERNOD, PHD, Principal investigator, Hospital University Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066454
- Sponsor's protocol ID
- DCIC 1320
- Other IDs
- 2013-003190-99
- Acronym
- MYELAXAT
- Status last verified
- Mar 2015
- First submitted
- 14 Feb 2014
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Agnelli 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.
PubMed 23216615Anagnostopoulos 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.
PubMed 12780791Attal 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.
PubMed 22571202Barlogie 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.
PubMed 11435324Baz 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.
PubMed 16342649Blom 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.
PubMed 15701913Carrier M, Le Gal G, Tay J, Wu C, Lee AY. Rates of venous thromboembolism in multiple myeloma patients undergoing immunomodulatory therapy with thalidomide or lenalidomide: a systematic review and meta-analysis. J Thromb Haemost. 2011 Apr;9(4):653-63. doi: 10.1111/j.1538-7836.2011.04215.x.
PubMed 21255254Cavo M, Zamagni E, Tosi P, Cellini C, Cangini D, Tacchetti P, Testoni N, Tonelli M, de Vivo A, Palareti G, Tura S, Baccarani M. First-line therapy with thalidomide and dexamethasone in preparation for autologous stem cell transplantation for multiple myeloma. Haematologica. 2004 Jul;89(7):826-31.
PubMed 15257934Chen C, Reece DE, Siegel D, Niesvizky R, Boccia RV, Stadtmauer EA, Abonour R, Richardson P, Matous J, Kumar S, Bahlis NJ, Alsina M, Vescio R, Coutre SE, Pietronigro D, Knight RD, Zeldis JB, Rajkumar V. Expanded safety experience with lenalidomide plus dexamethasone in relapsed or refractory multiple myeloma. Br J Haematol. 2009 Jul;146(2):164-70. doi: 10.1111/j.1365-2141.2009.07728.x. Epub 2009 May 26.
PubMed 19545290Cohen AT, Davidson BL, Gallus AS, Lassen MR, Prins MH, Tomkowski W, Turpie AG, Egberts JF, Lensing AW; ARTEMIS Investigators. Efficacy and safety of fondaparinux for the prevention of venous thromboembolism in older acute medical patients: randomised placebo controlled trial. BMJ. 2006 Feb 11;332(7537):325-9. doi: 10.1136/bmj.38733.466748.7C. Epub 2006 Jan 26.
PubMed 16439370Cohen AT, Spiro TE, Buller HR, Haskell L, Hu D, Hull R, Mebazaa A, Merli G, Schellong S, Spyropoulos AC, Tapson V; MAGELLAN Investigators. Rivaroxaban for thromboprophylaxis in acutely ill medical patients. N Engl J Med. 2013 Feb 7;368(6):513-23. doi: 10.1056/NEJMoa1111096.
PubMed 23388003Connolly SJ, Eikelboom J, Joyner C, Diener HC, Hart R, Golitsyn S, Flaker G, Avezum A, Hohnloser SH, Diaz R, Talajic M, Zhu J, Pais P, Budaj A, Parkhomenko A, Jansky P, Commerford P, Tan RS, Sim KH, Lewis BS, Van Mieghem W, Lip GY, Kim JH, Lanas-Zanetti F, Gonzalez-Hermosillo A, Dans AL, Munawar M, O'Donnell M, Lawrence J, Lewis G, Afzal R, Yusuf S; AVERROES Steering Committee and Investigators. Apixaban in patients with atrial fibrillation. N Engl J Med. 2011 Mar 3;364(9):806-17. doi: 10.1056/NEJMoa1007432. Epub 2011 Feb 10.
PubMed 21309657Dimopoulos M, Spencer A, Attal M, Prince HM, Harousseau JL, Dmoszynska A, San Miguel J, Hellmann A, Facon T, Foa R, Corso A, Masliak Z, Olesnyckyj M, Yu Z, Patin J, Zeldis JB, Knight RD; Multiple Myeloma (010) Study Investigators. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med. 2007 Nov 22;357(21):2123-32. doi: 10.1056/NEJMoa070594.
PubMed 18032762Facon T, Mary JY, Hulin C, Benboubker L, Attal M, Pegourie B, Renaud M, Harousseau JL, Guillerm G, Chaleteix C, Dib M, Voillat L, Maisonneuve H, Troncy J, Dorvaux V, Monconduit M, Martin C, Casassus P, Jaubert J, Jardel H, Doyen C, Kolb B, Anglaret B, Grosbois B, Yakoub-Agha I, Mathiot C, Avet-Loiseau H; Intergroupe Francophone du Myelome. Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99-06): a randomised trial. Lancet. 2007 Oct 6;370(9594):1209-18. doi: 10.1016/S0140-6736(07)61537-2.
PubMed 17920916Goldhaber SZ, Leizorovicz A, Kakkar AK, Haas SK, Merli G, Knabb RM, Weitz JI; ADOPT Trial Investigators. Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. N Engl J Med. 2011 Dec 8;365(23):2167-77. doi: 10.1056/NEJMoa1110899. Epub 2011 Nov 13.
PubMed 22077144
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02066454
- Acronym / sponsor ID
- MYELAXAT / DCIC 1320
- Conditions
- Myeloma, Venous Thromboembolism
- Keywords
- myeloma, antiXa anticoagulant, venous thromboembolic disease, iMiDs
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- 5 Jun 2014 (actual)
- Primary completion
- 12 Jul 2016 (actual)
- Study completion
- 12 Jul 2016 (actual)
- First posted
- 19 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apixaban | Experimental | Drug: Apixabanoral direct anti-Xa anticoagulant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApixabanAlso: oral direct anti-Xa anticoagulant2.5mg x 2 per day during 6 months | Drug | Apixaban |
Primary outcome
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
4 secondary outcomes
incidence of venous thromboembolic complications
Time frame: 7 months
incidence of venous thromboembolic complications
Time frame: 7 months
incidence of major and clinically relevant non major bleeding
Time frame: 7 months
incidence of arterial cardiovascular events
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Background: PubMed 23216615Agnelli 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.
- Background: PubMed 12780791Anagnostopoulos 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.
- Background: PubMed 22571202Attal 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.
- Background: PubMed 11435324Barlogie 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.
- Background: PubMed 16342649Baz 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.
- Background: PubMed 15701913Blom 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.
- Background: PubMed 21255254Carrier M, Le Gal G, Tay J, Wu C, Lee AY. Rates of venous thromboembolism in multiple myeloma patients undergoing immunomodulatory therapy with thalidomide or lenalidomide: a systematic review and meta-analysis. J Thromb Haemost. 2011 Apr;9(4):653-63. doi: 10.1111/j.1538-7836.2011.04215.x.
- Background: PubMed 15257934Cavo M, Zamagni E, Tosi P, Cellini C, Cangini D, Tacchetti P, Testoni N, Tonelli M, de Vivo A, Palareti G, Tura S, Baccarani M. First-line therapy with thalidomide and dexamethasone in preparation for autologous stem cell transplantation for multiple myeloma. Haematologica. 2004 Jul;89(7):826-31.
- Background: PubMed 19545290Chen C, Reece DE, Siegel D, Niesvizky R, Boccia RV, Stadtmauer EA, Abonour R, Richardson P, Matous J, Kumar S, Bahlis NJ, Alsina M, Vescio R, Coutre SE, Pietronigro D, Knight RD, Zeldis JB, Rajkumar V. Expanded safety experience with lenalidomide plus dexamethasone in relapsed or refractory multiple myeloma. Br J Haematol. 2009 Jul;146(2):164-70. doi: 10.1111/j.1365-2141.2009.07728.x. Epub 2009 May 26.
- Background: PubMed 16439370Cohen AT, Davidson BL, Gallus AS, Lassen MR, Prins MH, Tomkowski W, Turpie AG, Egberts JF, Lensing AW; ARTEMIS Investigators. Efficacy and safety of fondaparinux for the prevention of venous thromboembolism in older acute medical patients: randomised placebo controlled trial. BMJ. 2006 Feb 11;332(7537):325-9. doi: 10.1136/bmj.38733.466748.7C. Epub 2006 Jan 26.
- Background: PubMed 23388003Cohen AT, Spiro TE, Buller HR, Haskell L, Hu D, Hull R, Mebazaa A, Merli G, Schellong S, Spyropoulos AC, Tapson V; MAGELLAN Investigators. Rivaroxaban for thromboprophylaxis in acutely ill medical patients. N Engl J Med. 2013 Feb 7;368(6):513-23. doi: 10.1056/NEJMoa1111096.
- Background: PubMed 21309657Connolly SJ, Eikelboom J, Joyner C, Diener HC, Hart R, Golitsyn S, Flaker G, Avezum A, Hohnloser SH, Diaz R, Talajic M, Zhu J, Pais P, Budaj A, Parkhomenko A, Jansky P, Commerford P, Tan RS, Sim KH, Lewis BS, Van Mieghem W, Lip GY, Kim JH, Lanas-Zanetti F, Gonzalez-Hermosillo A, Dans AL, Munawar M, O'Donnell M, Lawrence J, Lewis G, Afzal R, Yusuf S; AVERROES Steering Committee and Investigators. Apixaban in patients with atrial fibrillation. N Engl J Med. 2011 Mar 3;364(9):806-17. doi: 10.1056/NEJMoa1007432. Epub 2011 Feb 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigitte PEGOURIE, MD principal investigator
Hospital University Grenoble
Gilles PERNOD, PHD principal investigator
Hospital University Grenoble
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apixaban in people with Myeloma and Venous Thromboembolism, run by University Hospital, Grenoble at 19 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02066454, which also lists 64 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.