65 岁以下多发性骨髓瘤患者的 GEM05 (GEM05MENOS65)
VBMCP-VBAD/Velcade 与沙利度胺/地塞米松与 Velcade/沙利度胺/地塞米松诱导治疗后继以自体造血干细胞支持的高剂量强化治疗和维持治疗的全国性、开放标签、多中心、随机、比较 III 期研究65 岁以下未经治疗的多发性骨髓瘤患者的干扰素-a 对比沙利度胺对比沙利度胺/万珂
研究概览
详细说明
将包括总共多达 390 名 ≤ 65 岁的诊断为多发性骨髓瘤且有症状的患者,这些患者既往未接受过 MM 化疗。
患者将在最多三个研究阶段的预定访视中接受评估:治疗前、治疗和随访。
预处理包括筛选和基线访问。 在提供知情同意书后,将对患者进行研究资格评估,然后将患者随机分配 (1:1:1) 接受 VBMCP-VBAD+Velcade(A 组)或沙利度胺+地塞米松(B 组)或沙利度胺+地塞米松+Velcade (丙组)。 他们都将接受长达 24 周的诱导治疗。
4 周后,没有进展或不可接受的毒性,将动员干细胞进行自体移植。 移植后三个月,患者将再次随机(1:1:1)接受维持治疗:干扰素-a(M1组)或沙利度胺(M2组)或沙利度胺+万珂(M3组),为期三年。
一旦治疗期结束,将进行跟进。 在此期间,我们将每三个月评估一次反应、无进展生存期和全球生存期。
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
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Albacete、西班牙
- Complejo Hospitalario Universitario de Albacete
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Alcorcón、西班牙
- Fundacion Hospital Alcorcón
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Alicante、西班牙
- Hospital General de Alicante
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Avila、西班牙
- Hospital Ntra. Sra. Sonsoles
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Badajoz、西班牙
- Hospital Regional Universitario Infanta Cristina
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Badalona、西班牙
- Hospital de Badalona Germans Trias i Pujol
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Barcelona、西班牙
- Hospital del Mar
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Barcelona、西班牙
- Hospital de la Santa Creu i Sant Pau
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Barcelona、西班牙
- Hospital Vall d'Hebron
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Barcelona、西班牙
- Hospital Clinic I Provincial de Barcelona
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Bilbao、西班牙
- Hospital de Cruces
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Bilbao、西班牙
- Basurtuko Ospitalea
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Ciudad Real、西班牙
- Hospital Nuestra Señora de Alarcos
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Cuenca、西班牙
- Hospital Virgen de la Luz
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Cáceres、西班牙
- Hospital Virgen del Puerto
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Donostia、西班牙
- Hospital Donostia
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Elda、西班牙
- Hospital General de Elda
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Getafe、西班牙
- Hospital Universitario de Getafe
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Guadalajara、西班牙
- Hospital General de Guadalajara
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Huesca、西班牙
- Hospital de San Jorge
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Lanzarote、西班牙
- Hospital General de Lanzarote
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Leon、西班牙
- Complejo Hospitalario León
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Lugo、西班牙
- Complexo Hospitalario Xeral-Calde
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Madrid、西班牙
- Hospital Ramon y Cajal
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Madrid、西班牙
- Hospital Clínico San Carlos de Madrid
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Madrid、西班牙
- Hospital 12 de Octubre
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Madrid、西班牙
- Fundación Jiménez Díaz
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Madrid、西班牙
- Hospital Universitario La Paz
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Madrid、西班牙
- Hospital Universitario de La Princesa
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Madrid、西班牙
- Clínica Puerta de Hierro
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Madrid、西班牙
- Clínica Moncloa
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Madrid、西班牙
- Clinica Ruber
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Madrid、西班牙
- Hospital Central de la Defensa
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Martorell、西班牙
- Fundación Hospital Sant Joan de Déu de Martorell
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Murcia、西班牙
- Hospital General Morales Meseguer
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Murcia、西班牙
- Hospital Santa Maria del Rosell
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Murcia、西班牙
- Hospital Virgen del Castillo de Yecla
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Mérida、西班牙
- Hospital de Mérida
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Oviedo、西班牙
- Hospital Central de Asturias
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Palencia、西班牙
- Hospital del Río Carrión
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Palma de Gran Canaria、西班牙
- Hospital de Gran Canaria Doctor Negrin
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Palma de Mallorca、西班牙
- Hospital Son Llatzer
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Palma de Mallorca、西班牙
- Complejo Asistencial Son Dureta
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Palma de Mallorca、西班牙
- Hospital Verge del Toro
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Pamplona、西班牙
- Hospital de Navarra
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Pamplona、西班牙
- Hospital Virgen del Camino
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Pontevedra、西班牙
- Complejo Hospitalario de Pontevedra_Hospital Montecelo
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Pontevedra、西班牙
- Complejo Hospitalario de Pontevedra_Hospital Provincial
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Sagunto、西班牙
- Hospital de Sagunto
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Salamanca、西班牙
- Hospital Clinico De Salamanca
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San Pedro de Alcántara、西班牙
- Hospital San Pedro de Alcántara
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Sant Pere de Ribes、西班牙
- Clínica Sant Camil
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Santander、西班牙
- Hospital Universitario Marqués de Valdecilla
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Santiago de Compostela、西班牙
- Complejo Hospitalario Universitario de Santiago
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Segovia、西班牙
- Hospital General de Segovia
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Tarragona、西班牙
- Hospital Joan XXIII
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Tenerife、西班牙
- Hospital Universitario de Canarias
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Toledo、西班牙
- Hospital Virgen de la Salud
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Toledo、西班牙
- Hospital Nuestra Señora del Prado
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Valencia、西班牙
- Hospital Arnau de Vilanova
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Valencia、西班牙
- Fundación Instituto Valenciano de Oncología
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Valencia、西班牙
- Hospital la Fe
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Valencia、西班牙
- Hospital Clínic
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Valencia、西班牙
- Hospital Dr. Peset
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Valencia、西班牙
- Hospital Francesc de Borja
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Valencia、西班牙
- Hospital General Básico de la Defensa
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Valladolid、西班牙
- Hospital Clínico de Valladolid
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Vigo、西班牙
- Complejo Hospitalario Universitario de Vigo
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Vinaros、西班牙
- Comarcal de Vinaros
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Vitoria、西班牙
- Hospital Txagorritxu
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Vizcaya、西班牙
- Hospital de Galdakao
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Zamora、西班牙
- Hospital Virgen de la Concha
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Zaragoza、西班牙
- Hospital Miguel Servet
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Zaragoza、西班牙
- Hospital Clinico Lozano Blesa
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Aragón
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Zaragoza、Aragón、西班牙
- Hospital Royo Villanova
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Barcelona
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Manresa、Barcelona、西班牙
- Xarxa assistencial de Manresa
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Sabadell、Barcelona、西班牙
- Corporacio Sanitaria Parc Tauli
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Castellón
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Castello、Castellón、西班牙
- Hospital General de Castellon
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Navarra
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Pamplona、Navarra、西班牙
- Clinica Universitaria de Navarra
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
纳入标准:
- 必须能够遵守协议要求
- 在进行任何不属于正常医疗护理的研究相关程序之前,必须自愿签署知情同意书,
- 年龄 <65 岁并且可能进行自体移植。
- 患者最近被诊断患有有症状的多发性骨髓瘤,之前未接受过任何针对多发性骨髓瘤的化疗。
- 患者患有可测量的疾病,定义为可量化的血清单克隆蛋白值,并且在适用的情况下,尿液轻链排泄量≥ 200 mg/24 小时。
- 心电图 < 2。
- El 患者的预期寿命 > 3 个月.
在开始诱导治疗之前,患者具有以下实验室值:
- 血小板计数≥50000/mm3,血红蛋白≥8g/dl,中性粒细胞绝对计数≥1000/mm3。 如果它们是由于骨髓浸润,则允许较低的值。
- 校正血清钙<14mg/dl。
- 天冬氨酸转氨酶 (AST):≤ 2.5 x 正常上限。
- 丙氨酸转氨酶 (ALT): ≤ 2.5 x 正常上限。
- 总胆红素:≤1.5 x 正常值上限。
- 血清肌酐≤ 2 mg/dl。
- 对于纳入沙利度胺分支的患者:育龄妇女不得发生性行为,除非她们在第一次给药前 4 周开始使用两种抗避孕药,在整个研究期间直至最后一次给药后 4 周。
排除标准:
- 非分泌型骨髓瘤。
- 患者之前接受过多发性骨髓瘤的治疗,但在开始治疗前接受紧急类固醇剂量或双膦酸盐或放疗除外。
- 入组前 14 天内患有 < 2 级周围神经病变的患者。
- 患者在入组前 4 周内接受过大手术。
- 患者对硼替佐米、硼或甘露醇或沙利度胺过敏。
- 患者在入组前 30 天内接受过其他研究药物。
- 已知患者对人类免疫缺陷病毒 (HIV)、乙型肝炎表面抗原阳性或活动性丙型肝炎感染呈血清反应阳性。
- 患者在入组后 6 个月内发生心肌梗塞或患有纽约心脏协会 (NYHA) III 级或 IV 级心力衰竭、不受控制的心绞痛、严重不受控制的室性心律失常,或急性缺血或主动传导系统异常的心电图证据。
- 患者因任何原因参加了另一项临床研究和/或正在接受研究药物。
- 怀孕或哺乳期妇女。
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:A
VBMCP/VBAD + Velcade VBMCP 的四个交替周期:长春新碱,0.03 mg/Kg (iv) 第 1 天,BCNU,0.5 mg/Kg iv,第 1 天,环磷酰胺,10 mg/Kg iv,第 1 天,Melfalán,0 ,25 mg/Kg 口服第 1 至 4 天泼尼松,1 mg/Kg 口服第 1 至 4 天;第 5 至 8 天口服 0.5 mg/Kg,第 9 至 12 天口服 0.25 mg/Kg。 VBAD:长春新碱,第 1 天静脉注射 1mg,BCNU,第 1 天静脉注射 30mg/m2,阿霉素,第 1 天静脉注射 40mg/m2 地塞米松,第 1 至 4、9 至 12 和 17 至 20 天口服 40mg。 VBMCP 和 VBAD 之间的间隔为 5 周,VBAD 和 VBMCP 之间的间隔为 4 周。 患者将接受两个周期的 VBMCP 和两个周期的 VBAD。 在最后一个 VBAD 周期 4 周后,患者将接受两个周期的 Velcade,每周两次静脉注射 1.3 mg/m2(第 1、4、8 和 11 天),随后 10 天不进行治疗 |
VBMCP:长春新碱,0.03 mg/Kg(iv)第 1 天,BCNU,0.5 mg/Kg iv,第 1 天,环磷酰胺,10 mg/Kg iv,第 1 天,美法仑,0.25 mg/Kg,第 1 天口服4 泼尼松,1 mg/Kg 口服,第 1 至 4 天;第 5 至 8 天口服 0.5 mg/Kg,第 9 至 12 天口服 0.25 mg/Kg。 VBAD:长春新碱,第 1 天静脉注射 1mg,BCNU,第 1 天静脉注射 30mg/m2,阿霉素,第 1 天静脉注射 40mg/m2 地塞米松,第 1 至 4、9 至 12 和 17 至 20 天口服 40mg。 |
实验性的:乙
沙利度胺/地塞米松 4 周的六个周期。沙利度胺第 1 天,周期 1(50 毫克/天 v.o)。 如果毒性 < 2 级,第 15 天的剂量为 100 mg/天,第 1 个周期,第 1 天的剂量为 200 mg/天,第 2 个周期。 地塞米松:40 毫克/天 v.o. 第 1 至 4 天和第 9 至 12 天,期间未治疗 16 天 |
沙利度胺第 1 天,周期 1(50 毫克/天 v.o)。 如果毒性 < 2 级,第 15 天的剂量为 100 mg/天,第 1 个周期,第 1 天的剂量为 200 mg/天,第 2 个周期。 地塞米松:40 毫克/天 v.o. 第 1 至 4 天和第 9 至 12 天,期间未治疗 16 天 |
实验性的:C
沙利度胺:第 1 周期第 1 天(50 mg/天)。如果毒性 < 2 级,则在第 15 天第 1 周期增加剂量(100 mg/天)和第 2 周期第 1 天(200 mg de Thalidomide)。 地塞米松:40 mg/天 v.o 第 1 至 4 天和第 8 至 11 天,期间有 17 天不治疗。 Velcade:1.3 mg/m2 iv,每周两次(第 1、4、8 和 11 天),期间有 17 天不治疗。 |
沙利度胺:第 1 周期第 1 天(50 mg/天)。如果毒性 < 2 级,则在第 15 天第 1 周期增加剂量(100 mg/天),在第 1 周期第 2 天增加剂量(200 mg de Thalidomide)。 地塞米松:40 mg/天 v.o 第 1 至 4 天和第 8 至 11 天,期间有 17 天不治疗。 Velcade:1.3 mg/m2 每周两次静脉注射(第 1、4、8 和 11 天),期间有 17 天不治疗 |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
主要目的是比较三种诱导治疗的安全性和有效性:VBMCP-VBAD / Velcade 与 Thalidomide / Dexamethasone 与 Velcade / Thalidomide / Dexamethasone。
大体时间:2年
|
2年
|
次要结果测量
结果测量 |
大体时间 |
---|---|
评估治疗后干细胞动员的能力,以便进行自体移植。否则,本研究想比较维持治疗的安全性和有效性:干扰素 a-2b 与沙利度胺
大体时间:2年
|
2年
|
合作者和调查者
调查人员
- 首席研究员:Bladé Joan, Dr、Hospital Clinic of Barcelona
出版物和有用的链接
一般刊物
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研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
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- 2005-001110-41
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VBMCP/VBAD/万珂的临床试验
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Millennium Pharmaceuticals, Inc.Johnson & Johnson Pharmaceutical Research & Development, L.L.C.完全的
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Millennium Pharmaceuticals, Inc.完全的
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The Rogosin InstituteWeill Medical College of Cornell University完全的
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Spectrum Health HospitalsMillennium Pharmaceuticals, Inc.完全的
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Millennium Pharmaceuticals, Inc.完全的
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Prof. Dr. Clemens SchmittCharite University, Berlin, Germany; Janssen-Cilag Ltd.主动,不招人