在接受 iMiDs 治疗的骨髓瘤患者中使用阿哌沙班预防血栓栓塞性疾病的评估 (MYELAXAT)
2014年12月8日 更新者:University Hospital, Grenoble
评估使用口服直接抗 Xa 抗凝剂阿哌沙班预防接受 IMiD 治疗的骨髓瘤患者的静脉血栓栓塞性疾病:一项初步研究
评估:
- 静脉血栓栓塞事件 (VTE) 的发生率
- 出血并发症的发生率,在接受 IMiDs 治疗并需要血栓预防 6 个月的骨髓瘤患者群体中,在预防方案中使用口服抗 Xa 抗凝剂阿哌沙班 2.5 mg x2/天
研究概览
详细说明
MYELAXAT 试验是多中心、开放性试验,旨在评估静脉血栓栓塞事件 (VTE) 的发生率和出血并发症的发生率。
所有接受 iMiDs 治疗并需要血栓预防 6 个月的骨髓瘤患者,在预防方案中使用口服抗 Xa 抗凝剂阿哌沙班,2.5 mg x2/天
研究类型
介入性
注册 (预期的)
105
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
-
Annecy、法国、74374
- 招聘中
- CHRA
-
接触:
- Frédérique ORSINI, MD
- 电话号码:04 50 63 66 08
-
首席研究员:
- Frédérique ORSINI, MD
-
副研究员:
- Pascale CONY-MAKHOUL, MD
-
副研究员:
- Anne Parry, MD
-
副研究员:
- Bernadette CORRONT, MD
-
副研究员:
- DAGUINDAU Nicolas, MD
-
Bayonne、法国、64100
- 招聘中
- Ch La Cote Basque
-
首席研究员:
- Anne Banos, MD
-
接触:
- Anne BANOS, MD
- 电话号码:05 59 44 38 32
- 邮箱:abanos@ch-cotebasque.fr
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副研究员:
- Carla ARAUJO, MD
-
Clamart、法国、92141
- 招聘中
- HIA Percy
-
接触:
- Thierry DE REVEL, MD
- 电话号码:01 41 46 63 01
- 邮箱:thderevel@gmail.com
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首席研究员:
- Thierry DE REVEL, MD
-
Creteil、法国、94010
- 招聘中
- CHU Hôpital Henri Mondor
-
接触:
- Karim BELHADJ-MERZOUG, MD
- 电话号码:01 49 81 49 63
- 邮箱:karim.belhadj@hmn.aphp.fr
-
首席研究员:
- Karim BELHADJ-MERZOUG, MD
-
Dunkerque、法国、59385
- 招聘中
- Centre Hospitalier
-
接触:
- Marc WETTERWALD, MD
- 电话号码:03 28 28 56 33
- 邮箱:marc.wetterwald@ch-dunkerque.fr
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首席研究员:
- Marc WETTERWALD, MD
-
Grenoble、法国、38043
- 招聘中
- Chu Grenoble
-
接触:
- Brigitte PEGOURIE, MD
- 电话号码:04 76 76 55 90
- 邮箱:bpegourie@chu-grenoble.fr
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首席研究员:
- Brigitte PEGOURIE, MD
-
副研究员:
- Rémy GRESSIN, MD
-
副研究员:
- Lysiane MOLINA, MD
-
副研究员:
- Audrey SIMON, MD
-
副研究员:
- Stéphane COURBY, MD
-
副研究员:
- Claude-Eric BULABOIS, MD
-
副研究员:
- Anne THIEBAUT, MD
-
副研究员:
- Jean-Yves CAHN, PHD
-
La Roche Sur Yon、法国、85925
- 招聘中
- CHD Vendée
-
首席研究员:
- Mourad TIAB, MD
-
接触:
- Mourad TIAB, MD
- 电话号码:02 51 44 61 73
- 邮箱:mourad.tiab@chd-vendee.fr
-
Le Mans、法国、72000
- 招聘中
- Clinique Victor Hugo
-
Lille、法国、59020
- 招聘中
- Hopital St Vincent - Ghicl
-
接触:
- Manuel CLIQUENNOIS, MD
- 电话号码:03 20 87 45 32
- 邮箱:cliquennois.manuel@ghicl.net
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首席研究员:
- Manuel CLIQUENNOIS, MD
-
Lille、法国、59037
- 招聘中
- CHRU Hôpital HURIEZ
-
接触:
- Thierry FACON, MD
- 电话号码:03 20 44 57 12
- 邮箱:thierry.facon@chru-lille.fr
-
副研究员:
- Xavier LELEU, MD
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Lyon、法国、69373
- 招聘中
- Centre Leon Berard
-
副研究员:
- Pierre BIRON, MD
-
接触:
- Philippe REY, MD
- 电话号码:04 78 78 67 95
- 邮箱:philippe.rey@lyon.unicancer.fr
-
首席研究员:
- Philippe REY, MD
-
副研究员:
- Catherine SEBAN, MD
-
Montivilliers、法国、76290
- 招聘中
- Groupe Hospitalier Du Havre
-
接触:
- Charles ZARNITSKY, MD
- 电话号码:02 32 73 33 78
- 邮箱:charles.zarnitsky@ch-havre.fr
-
首席研究员:
- Charles ZARNITSKY, MD
-
Nice、法国、06202
- 招聘中
- Hopital de l'Archet
-
接触:
- Jean-Gabriel FUZIBET, MD
- 电话号码:04 92 03 58 23
- 邮箱:fuzibet.jg@chu-nice.fr
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Paris、法国、75651
- 招聘中
- Hopital Pitie Salpetriere
-
接触:
- Damien ROOS-WEIL, MD
- 电话号码:01 42 16 28 34
- 邮箱:damienroosweil@voila.fr
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首席研究员:
- Damien ROOS-WEIL, MD
-
副研究员:
- Véronique MOREL-MALEK, MD
-
Perigueux、法国、24000
- 招聘中
- CH de Périgueux
-
接触:
- Philippe RODON, MD
- 电话号码:05 53 45 29 78
- 邮箱:rodon.philippe@wanadoo.fr
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Pessac、法国、33604
- 招聘中
- CHU Bordeaux
-
接触:
- Gérald MARIT, MD
- 电话号码:05 57 65 65 11
- 邮箱:gerald.marit@chu-bordeaux.fr
-
副研究员:
- Axelle LASCAUX, MD
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Pierre Benite、法国、69310
- 招聘中
- CH Lyon sud
-
接触:
- Lionel KARLIN, MD
- 电话号码:04 78 86 43 09
- 邮箱:lionel.karlin@chu-lyon.fr
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Poitiers、法国、86021
- 招聘中
- CHU Poitiers
-
接触:
- Isabelle AZAIS, MD
- 电话号码:05 49 44 44 65
- 邮箱:i.azais@chu-poitiers.fr
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Tours、法国、37000
- 招聘中
- CHRU de Tours
-
接触:
- Lotfi BENBOUKER, MD
-
首席研究员:
- Lotfi BENBOUKER, MD
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
16年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准:
- 18岁以上患者(男性/女性)
- 所有连续接受一线治疗或复发的骨髓瘤患者 - 使用 IMiD(MPT、美法仑 - 泼尼松 - 沙利度胺;来那度胺 - 地塞米松)。
和
- 需要使用阿司匹林或低分子肝素 (LMWH) 预防静脉血栓栓塞事件至少 6 个月的患者 至少,2/3 的患者将接受来那度胺-地塞米松治疗。
- 书面知情同意书
- 隶属于法国社会保障体系或同等机构的患者
排除标准:
- 需要根治性抗凝治疗(肝素、LMWH、维生素 K 拮抗剂、达比加群、利伐沙班、阿哌沙班)治疗相关疾病(过去 6 个月内有机械瓣膜、心房颤动或静脉血栓栓塞性疾病)的患者。
- 术后需要使用抗凝剂进行预防性治疗的患者
- 需要抗血小板治疗的患者(阿司匹林、氯吡格雷、普拉格雷、替格瑞洛或双重抗血小板治疗)
- 活动性出血或出血风险高的患者(溃疡病、过去 6 个月内有颅内出血、未控制的高血压)
- 在过去 30 天内接受过外科手术的患者可能会面临出血风险
- 活动性肝病(肝炎、肝硬化)
- 严重肾功能不全(使用 Cockcroft 方程式的肌酐清除率 < 30 ml/mn)
- 已知对阿哌沙班的过敏反应
- 使用抗凝治疗的禁忌症
禁止合并治疗
- CYP3A4 和 P-gp 抑制剂:唑类抗真菌药(酮康唑、伊曲康唑、伏立康唑、泊沙康唑)、HIV 蛋白酶抑制剂(利托那韦、茚地那韦、奈非那韦、阿扎那韦、沙奎那韦)、特异性大环内酯类抗生素(克拉霉素、泰利霉素)
- 其他抗血栓治疗:水杨酸盐衍生物(阿司匹林,含阿司匹林的产品),抗血小板治疗,肝素(普通肝素,低分子肝素,danaparoide sodique,fondaparinux),水蛭素,口服抗凝剂(维生素K拮抗剂,利伐沙班,达比加群)
- AST 或 ALT 率 > 正常上限 3 倍的患者
- 胆红素率 > 1.5 倍正常上限的患者
- 血小板率 < 75 G/l 的患者
- 肌酐清除率 (Cockcroft) < 30 ml/mn 的患者
- 超声筛查偶然发现近端深静脉血栓形成
- 患者拒绝或无法提供信息的书面同意
- 研究者认为患者无法遵守方案要求
- 预期寿命少于 6 个月
- 被监禁的病人
- 6个月内怀孕或怀孕的可能性
- 没有可靠避孕措施的育龄女性
- 生态学 > 2
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:阿哌沙班
口服直接抗 Xa 抗凝剂
|
6 个月期间每天 2.5 毫克 x 2
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
总 VTE 和 VTE 相关死亡。大出血和临床相关的非大出血 - 根据国际血栓形成和止血学会定义的大出血和临床相关的非大出血
大体时间:7个月
|
总 VTE(致死性或非致死性肺栓塞、有症状的下肢远端或近端 DVT,以及双侧加压超声检测到的无症状近端 DVT)和 VTE 相关死亡。 - 根据国际血栓形成和止血学会定义的大出血和临床相关的非大出血 |
7个月
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
静脉血栓栓塞并发症的发生率
大体时间:7个月
|
根据患者的血栓风险分层(低风险或高风险),有症状和无症状的静脉血栓栓塞并发症的发生率
|
7个月
|
静脉血栓栓塞并发症的发生率
大体时间:7个月
|
根据 iMiD 治疗的时间(诊断或复发),有症状和无症状的静脉血栓栓塞并发症的发生率
|
7个月
|
大出血和临床相关非大出血的发生率
大体时间:7个月
|
根据患者的血栓形成风险分层(低风险或高风险)的大出血和临床相关非大出血的发生率
|
7个月
|
动脉心血管事件的发生率
大体时间:7个月
|
动脉心血管事件(心肌梗塞、缺血性中风、TIA)的发生率
|
7个月
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Brigitte PEGOURIE, MD、Hospital University Grenoble
- 首席研究员:Gilles PERNOD, PHD、Hospital University Grenoble
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Rajkumar SV, Hayman SR, Lacy MQ, Dispenzieri A, Geyer SM, Kabat B, Zeldenrust SR, Kumar S, Greipp PR, Fonseca R, Lust JA, Russell SJ, Kyle RA, Witzig TE, Gertz MA. Combination therapy with lenalidomide plus dexamethasone (Rev/Dex) for newly diagnosed myeloma. Blood. 2005 Dec 15;106(13):4050-3. doi: 10.1182/blood-2005-07-2817. Epub 2005 Aug 23.
- Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x.
- Dimopoulos 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. Erratum In: N Engl J Med. 2009 Jul 30;361(5):544.
- Facon 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.
- Sie P, Samama CM, Godier A, Rosencher N, Steib A, Llau JV, Van der Linden P, Pernod G, Lecompte T, Gouin-Thibault I, Albaladejo P; Working Group on Perioperative Haemostasis; French Study Group on Thrombosis and Haemostasis. Surgery and invasive procedures in patients on long-term treatment with direct oral anticoagulants: thrombin or factor-Xa inhibitors. Recommendations of the Working Group on Perioperative Haemostasis and the French Study Group on Thrombosis and Haemostasis. Arch Cardiovasc Dis. 2011 Dec;104(12):669-76. doi: 10.1016/j.acvd.2011.09.001. Epub 2011 Oct 29.
- Rajkumar SV, Blood E, Vesole D, Fonseca R, Greipp PR; Eastern Cooperative Oncology Group. Phase III clinical trial of thalidomide plus dexamethasone compared with dexamethasone alone in newly diagnosed multiple myeloma: a clinical trial coordinated by the Eastern Cooperative Oncology Group. J Clin Oncol. 2006 Jan 20;24(3):431-6. doi: 10.1200/JCO.2005.03.0221. Epub 2005 Dec 19.
- Singhal S, Mehta J, Desikan R, Ayers D, Roberson P, Eddlemon P, Munshi N, Anaissie E, Wilson C, Dhodapkar M, Zeddis J, Barlogie B. Antitumor activity of thalidomide in refractory multiple myeloma. N Engl J Med. 1999 Nov 18;341(21):1565-71. doi: 10.1056/NEJM199911183412102. Erratum In: N Engl J Med 2000 Feb 3;342(5):364.
- Anagnostopoulos 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.
- Rajkumar SV, Gertz MA, Lacy MQ, Dispenzieri A, Fonseca R, Geyer SM, Iturria N, Kumar S, Lust JA, Kyle RA, Greipp PR, Witzig TE. Thalidomide as initial therapy for early-stage myeloma. Leukemia. 2003 Apr;17(4):775-9. doi: 10.1038/sj.leu.2402866.
- 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.
- Rajkumar SV, Jacobus S, Callander NS, Fonseca R, Vesole DH, Williams ME, Abonour R, Siegel DS, Katz M, Greipp PR; Eastern Cooperative Oncology Group. Lenalidomide plus high-dose dexamethasone versus lenalidomide plus low-dose dexamethasone as initial therapy for newly diagnosed multiple myeloma: an open-label randomised controlled trial. Lancet Oncol. 2010 Jan;11(1):29-37. doi: 10.1016/S1470-2045(09)70284-0. Epub 2009 Oct 21. Erratum In: Lancet Oncol. 2010 Jan;11(1):14.
- Palumbo A, Bringhen S, Caravita T, Merla E, Capparella V, Callea V, Cangialosi C, Grasso M, Rossini F, Galli M, Catalano L, Zamagni E, Petrucci MT, De Stefano V, Ceccarelli M, Ambrosini MT, Avonto I, Falco P, Ciccone G, Liberati AM, Musto P, Boccadoro M; Italian Multiple Myeloma Network, GIMEMA. Oral melphalan and prednisone chemotherapy plus thalidomide compared with melphalan and prednisone alone in elderly patients with multiple myeloma: randomised controlled trial. Lancet. 2006 Mar 11;367(9513):825-31. doi: 10.1016/S0140-6736(06)68338-4.
- Palumbo A, Bringhen S, Liberati AM, Caravita T, Falcone A, Callea V, Montanaro M, Ria R, Capaldi A, Zambello R, Benevolo G, Derudas D, Dore F, Cavallo F, Gay F, Falco P, Ciccone G, Musto P, Cavo M, Boccadoro M. Oral melphalan, prednisone, and thalidomide in elderly patients with multiple myeloma: updated results of a randomized controlled trial. Blood. 2008 Oct 15;112(8):3107-14. doi: 10.1182/blood-2008-04-149427. Epub 2008 May 27.
- Rajkumar SV, Hayman S, Gertz MA, Dispenzieri A, Lacy MQ, Greipp PR, Geyer S, Iturria N, Fonseca R, Lust JA, Kyle RA, Witzig TE. Combination therapy with thalidomide plus dexamethasone for newly diagnosed myeloma. J Clin Oncol. 2002 Nov 1;20(21):4319-23. doi: 10.1200/JCO.2002.02.116.
- Weber D, Rankin K, Gavino M, Delasalle K, Alexanian R. Thalidomide alone or with dexamethasone for previously untreated multiple myeloma. J Clin Oncol. 2003 Jan 1;21(1):16-9. doi: 10.1200/JCO.2003.03.139.
- Attal 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.
- Barlogie 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.
- Baz 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.
- Blom 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.
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研究记录日期
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研究主要日期
学习开始
2014年4月1日
初级完成 (预期的)
2017年1月1日
研究完成 (预期的)
2017年7月1日
研究注册日期
首次提交
2014年2月14日
首先提交符合 QC 标准的
2014年2月14日
首次发布 (估计)
2014年2月19日
研究记录更新
最后更新发布 (估计)
2014年12月9日
上次提交的符合 QC 标准的更新
2014年12月8日
最后验证
2014年12月1日
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