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Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma (PANORAMA-1)

2020年3月8日 更新者：Novartis Pharmaceuticals

A Multicenter, Randomized, Double Blind, Placebo Controlled Phase III Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma

Panobinostat (LBH589) is a highly potent pan-deacetylase inhibitor (pan-DACi), inclusive of HDAC6, which disrupts aggresome function, promotes accumulation of cytotoxic misfolded protein aggregates and triggers myeloma cell death. Combination of pan-DAC and protease inhibition by co-treatment with panobinostat (PAN) and bortezomib (BTZ) has demonstrated synergistic cytotoxicity in vitro and in vivo in pre-clinical experiments. Furthermore, clinical experience in advanced multiple myeloma (MM) patients treated by oral panobinostat and i.v bortezomib ± dexamethasone showed very encouraging results for efficacy and manageable toxicity profile.

Given the medical need for improved treatment strategies for patients with previously treated and relapsed MM, the purpose of this prospective, multinational, randomized, double-blind, placebo-controlled, parallel group Phase III study is to compare the results in progression-free survival of 2 combination therapies, panobinostat with bortezomib and dexamethasone or placebo with bortezomib and dexamethasone, in patients with previously treated MM whose disease has recurred or progressed.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

767

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

  • 中国
      • Beijing、中国、100044
        • Novartis Investigative Site
      • Beijing、中国、100020
        • Novartis Investigative Site
      • Shanghai、中国、200003
        • Novartis Investigative Site
      • Shanghai、中国、200025
        • Novartis Investigative Site
    • Beijing
      • Beijing、Beijing、中国、100730
        • Novartis Investigative Site
    • Guangxi
      • Nanning、Guangxi、中国、530021
        • Novartis Investigative Site
    • Jiangsu
      • Nanjing、Jiangsu、中国、210029
        • Novartis Investigative Site
      • Suzhou、Jiangsu、中国、215006
        • Novartis Investigative Site
    • Sichuan
      • Chengdu、Sichuan、中国、610041
        • Novartis Investigative Site
    • Tianjin
      • Tianjin、Tianjin、中国、300020
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310003
        • Novartis Investigative Site
  • 丹麦
      • Copenhagen、丹麦、DK-2100
        • Novartis Investigative Site
      • Odense、丹麦、DK 5000
        • Novartis Investigative Site
      • Vejle、丹麦、DK-7100
        • Novartis Investigative Site
      • Ålborg、丹麦、DK-9100
        • Novartis Investigative Site
      • Århus、丹麦、DK-8000
        • Novartis Investigative Site
  • 以色列
      • Jerusalem、以色列、91120
        • Novartis Investigative Site
      • Kfar Saba、以色列、4428164
        • Novartis Investigative Site
      • Petach Tikva、以色列、49100
        • Novartis Investigative Site
      • Ramat Gan、以色列、5265601
        • Novartis Investigative Site
  • 俄罗斯联邦
      • Saratov、俄罗斯联邦、410028
        • Novartis Investigative Site
      • St Petersburg、俄罗斯联邦、191024
        • Novartis Investigative Site
  • 加拿大
    • Nova Scotia
      • Halifax、Nova Scotia、加拿大、B3H 1V7
        • Novartis Investigative Site
    • Ontario
      • Hamilton、Ontario、加拿大、L8V 5C2
        • Novartis Investigative Site
      • Toronto、Ontario、加拿大、M5G 2M9
        • Novartis Investigative Site
    • Quebec
      • Greenfield Park、Quebec、加拿大、J4V 2H1
        • Novartis Investigative Site
      • Montreal、Quebec、加拿大、H1T 2M4
        • Novartis Investigative Site
  • 南非
      • Parktown、南非、2193
        • Novartis Investigative Site
      • Pretoria、南非、0027
        • Novartis Investigative Site
  • 台湾
      • Kaohsiung City、台湾、83301
        • Novartis Investigative Site
      • Taichung、台湾、40447
        • Novartis Investigative Site
      • Taipei、台湾、10048
        • Novartis Investigative Site
      • Taoyuan、台湾、333
        • Novartis Investigative Site
  • 埃及
      • Alexandria、埃及、21131
        • Novartis Investigative Site
      • Giza、埃及、11451
        • Novartis Investigative Site
  • 墨西哥
      • San Luis Potosí、墨西哥、78218
        • Novartis Investigative Site
  • 大韩民国
      • Busan、大韩民国、49201
        • Novartis Investigative Site
      • Busan、大韩民国、602739
        • Novartis Investigative Site
      • Incheon、大韩民国、405 760
        • Novartis Investigative Site
      • Jeollanam-do、大韩民国、519763
        • Novartis Investigative Site
      • Seoul、大韩民国、03080
        • Novartis Investigative Site
      • Seoul、大韩民国、06351
        • Novartis Investigative Site
      • Seoul、大韩民国、03722
        • Novartis Investigative Site
      • Taegu、大韩民国、41944
        • Novartis Investigative Site
    • Gyeonggi Do
      • Suwon si、Gyeonggi Do、大韩民国、16499
        • Novartis Investigative Site
    • Seocho Gu
      • Seoul、Seocho Gu、大韩民国、06591
        • Novartis Investigative Site
  • 奥地利
      • Linz、奥地利、A-4010
        • Novartis Investigative Site
      • Wien、奥地利、A-1090
        • Novartis Investigative Site
  • 巴西
    • DF
      • Brasilia、DF、巴西、70710-904
        • Novartis Investigative Site
    • RJ
      • Rio de Janeiro、RJ、巴西、20.211-030
        • Novartis Investigative Site
      • Rio de Janeiro、RJ、巴西、20551-030
        • Novartis Investigative Site
      • Rio de Janeiro、RJ、巴西、22640-102
        • Novartis Investigative Site
    • SP
      • Barretos、SP、巴西、14784 400
        • Novartis Investigative Site
      • Campinas、SP、巴西、13083-970
        • Novartis Investigative Site
      • Sao Paulo、SP、巴西、05403 000
        • Novartis Investigative Site
      • São Paulo、SP、巴西、01224-000
        • Novartis Investigative Site
  • 希腊
      • Athens、希腊、115 28
        • Novartis Investigative Site
    • GR
      • Thessaloniki、GR、希腊、570 10
        • Novartis Investigative Site
  • 德国
      • Aachen、德国、52074
        • Novartis Investigative Site
      • Bad Saarow、德国、15526
        • Novartis Investigative Site
      • Bamberg、德国、96049
        • Novartis Investigative Site
      • Berlin、德国、13353
        • Novartis Investigative Site
      • Bremen、德国、28177
        • Novartis Investigative Site
      • Dresden、德国、01307
        • Novartis Investigative Site
      • Duisburg、德国、47166
        • Novartis Investigative Site
      • Erlangen、德国、91054
        • Novartis Investigative Site
      • Frankfurt、德国、60590
        • Novartis Investigative Site
      • Hamburg、德国、22763
        • Novartis Investigative Site
      • Jena、德国、07740
        • Novartis Investigative Site
      • Kiel、德国、24105
        • Novartis Investigative Site
      • Magdeburg、德国、39120
        • Novartis Investigative Site
      • Muenchen、德国、81737
        • Novartis Investigative Site
      • Rostock、德国、18057
        • Novartis Investigative Site
      • Ulm、德国、89081
        • Novartis Investigative Site
      • Wuerzburg、德国、97080
        • Novartis Investigative Site
  • 意大利
      • Napoli、意大利、80131
        • Novartis Investigative Site
    • FG
      • San Giovanni Rotondo、FG、意大利、71013
        • Novartis Investigative Site
    • LE
      • Lecce、LE、意大利、73100
        • Novartis Investigative Site
    • MI
      • Milano、MI、意大利、20133
        • Novartis Investigative Site
    • PE
      • Pescara、PE、意大利、65124
        • Novartis Investigative Site
    • PI
      • Pisa、PI、意大利、56126
        • Novartis Investigative Site
    • PV
      • Pavia、PV、意大利、27100
        • Novartis Investigative Site
    • RC
      • Reggio Calabria、RC、意大利、89124
        • Novartis Investigative Site
    • RM
      • Roma、RM、意大利、00144
        • Novartis Investigative Site
      • Roma、RM、意大利、00161
        • Novartis Investigative Site
    • SA
      • Pagani、SA、意大利、84016
        • Novartis Investigative Site
    • VR
      • Verona、VR、意大利、37134
        • Novartis Investigative Site
  • 挪威
      • Bergen、挪威、NO-5021
        • Novartis Investigative Site
      • Fredrikstad、挪威、NO-1603
        • Novartis Investigative Site
      • Kristiansand、挪威、NO-4605
        • Novartis Investigative Site
      • Oslo、挪威、0407
        • Novartis Investigative Site
      • Skien、挪威、NO-3710
        • Novartis Investigative Site
      • Trondheim、挪威、7006
        • Novartis Investigative Site
  • 捷克语
    • CZE
      • Olomouc、CZE、捷克语、775 20
        • Novartis Investigative Site
    • Czech Republic
      • Brno Bohunice、Czech Republic、捷克语、625 00
        • Novartis Investigative Site
      • Prague 2、Czech Republic、捷克语、128 08
        • Novartis Investigative Site
  • 新加坡
      • Singapore、新加坡、169608
        • Novartis Investigative Site
  • 日本
      • Hiroshima、日本、734-8551
        • Novartis Investigative Site
      • Niigata、日本、951-8566
        • Novartis Investigative Site
      • Osaka、日本、545-8586
        • Novartis Investigative Site
    • Aichi
      • Nagoya、Aichi、日本、460-0001
        • Novartis Investigative Site
      • Nagoya-city、Aichi、日本、467-8602
        • Novartis Investigative Site
    • Ehime
      • Matsuyama-city、Ehime、日本、790-8524
        • Novartis Investigative Site
    • Fukuoka
      • Fukuoka city、Fukuoka、日本、812-8582
        • Novartis Investigative Site
    • Gifu
      • Ogaki-city、Gifu、日本、503-8502
        • Novartis Investigative Site
    • Gunma
      • Shibukawa、Gunma、日本、377-8511
        • Novartis Investigative Site
    • Hiroshima
      • Kure-city、Hiroshima、日本、737-0023
        • Novartis Investigative Site
    • Ibaraki
      • Higashiibaraki-gun、Ibaraki、日本、311-3193
        • Novartis Investigative Site
    • Okayama
      • Okayama city、Okayama、日本、701-1192
        • Novartis Investigative Site
    • Osaka
      • Suita city、Osaka、日本、565 0871
        • Novartis Investigative Site
    • Tokyo
      • Shibuya、Tokyo、日本、150-8935
        • Novartis Investigative Site
  • 比利时
      • Bruxelles、比利时、1200
        • Novartis Investigative Site
      • Hasselt、比利时、3500
        • Novartis Investigative Site
    • Brussel
      • Jette、Brussel、比利时、1090
        • Novartis Investigative Site
  • 法国
      • Blois Cedex、法国、41016
        • Novartis Investigative Site
      • Dijon、法国、21034
        • Novartis Investigative Site
      • Lille Cedex、法国、59037
        • Novartis Investigative Site
      • Limoges cedex、法国、87042
        • Novartis Investigative Site
      • Nantes、法国、44035
        • Novartis Investigative Site
      • Paris、法国、75231
        • Novartis Investigative Site
      • Pierre Benite、法国、69310
        • Novartis Investigative Site
      • Strasbourg cedex、法国、67085
        • Novartis Investigative Site
      • Vandoeuvre Les Nancy、法国、54511
        • Novartis Investigative Site
  • 波兰
      • Warszawa、波兰、02 776
        • Novartis Investigative Site
      • Warszawa、波兰、02-097
        • Novartis Investigative Site
  • 泰国
      • Bangkok、泰国、10330
        • Novartis Investigative Site
      • Bangkok、泰国、10700
        • Novartis Investigative Site
      • Bangkok、泰国、10400
        • Novartis Investigative Site
  • 澳大利亚
    • New South Wales
      • St Leonards、New South Wales、澳大利亚、2065
        • Novartis Investigative Site
    • Queensland
      • Herston、Queensland、澳大利亚、4029
        • Novartis Investigative Site
      • Woolloongabba、Queensland、澳大利亚、4102
        • Novartis Investigative Site
    • Victoria
      • Franston、Victoria、澳大利亚、3199
        • Novartis Investigative Site
    • Western Australia
      • Nedlands、Western Australia、澳大利亚、6009
        • Novartis Investigative Site
      • Perth、Western Australia、澳大利亚、6000
        • Novartis Investigative Site
  • 火鸡
      • Adana、火鸡、01330
        • Novartis Investigative Site
      • Ankara、火鸡、06100
        • Novartis Investigative Site
    • TUR
      • Istanbul、TUR、火鸡、34098
        • Novartis Investigative Site
  • 瑞典
      • Göteborg、瑞典、SE-413 45
        • Novartis Investigative Site
      • Linköping、瑞典、SE-581 85
        • Novartis Investigative Site
      • Luleå、瑞典、SE-971 80
        • Novartis Investigative Site
      • Stockholm、瑞典、SE-118 83
        • Novartis Investigative Site
      • Uppsala、瑞典、SE-751 85
        • Novartis Investigative Site
  • 美国
    • Arizona
      • Phoenix、Arizona、美国
        • Novartis Investigative Site
    • California
      • Anaheim、California、美国、92801
        • Novartis Investigative Site
      • Concord、California、美国、94520
        • Novartis Investigative Site
      • Los Angeles、California、美国、90027
        • Novartis Investigative Site
      • San Diego、California、美国、92120
        • Novartis Investigative Site
      • Stanford、California、美国、94304
        • Novartis Investigative Site
    • Florida
      • Boca Raton、Florida、美国、33486
        • Novartis Investigative Site
      • Lake Worth、Florida、美国、33467
        • Novartis Investigative Site
      • Miami Shores、Florida、美国、33138
        • Novartis Investigative Site
    • Georgia
      • Athens、Georgia、美国、30607
        • Novartis Investigative Site
      • Atlanta、Georgia、美国、30322
        • Novartis Investigative Site
      • Marietta、Georgia、美国、30060
        • Novartis Investigative Site
    • Illinois
      • Marywood、Illinois、美国、60153
        • Novartis Investigative Site
      • Quincy、Illinois、美国、62301
        • Novartis Investigative Site
    • Louisiana
      • New Orleans、Louisiana、美国、70115
        • Novartis Investigative Site
    • Maryland
      • Baltimore、Maryland、美国、21229
        • Novartis Investigative Site
      • Rockville、Maryland、美国、20850
        • Novartis Investigative Site
    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • Novartis Investigative Site
    • Michigan
      • Southfield、Michigan、美国
        • Novartis Investigative Site
    • Minnesota
      • Edina、Minnesota、美国、55435
        • Novartis Investigative Site
      • Minneapolis、Minnesota、美国、55404
        • Novartis Investigative Site
    • Missouri
      • Columbia、Missouri、美国、65201
        • Novartis Investigative Site
    • New Jersey
      • East Orange、New Jersey、美国、07018-1095
        • Novartis Investigative Site
    • New York
      • Mount Kisco、New York、美国、10549
        • Novartis Investigative Site
    • North Carolina
      • Durham、North Carolina、美国、27710
        • Novartis Investigative Site
    • North Dakota
      • Bismarck、North Dakota、美国、58501
        • Novartis Investigative Site
    • Ohio
      • Dayton、Ohio、美国、45429
        • Novartis Investigative Site
      • Middletown、Ohio、美国、45042
        • Novartis Investigative Site
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15224
        • Novartis Investigative Site
    • Rhode Island
      • East Providence、Rhode Island、美国、02915
        • Novartis Investigative Site
    • Tennessee
      • Nashville、Tennessee、美国、37203
        • Novartis Investigative Site
      • Nashville、Tennessee、美国、37232
        • Novartis Investigative Site
    • Texas
      • Amarillo、Texas、美国、79106
        • Novartis Investigative Site
      • Houston、Texas、美国、77030
        • Novartis Investigative Site
    • Washington
      • Kennewick、Washington、美国、99336
        • Novartis Investigative Site
      • Seattle、Washington、美国、98104
        • Novartis Investigative Site
      • Walla Walla、Washington、美国、33962
        • Novartis Investigative Site
    • West Virginia
      • Morgantown、West Virginia、美国、26506
        • Novartis Investigative Site
  • 芬兰
      • HUS Helsinki、芬兰、FIN-00029
        • Novartis Investigative Site
      • Turku、芬兰、FIN-20521
        • Novartis Investigative Site
  • 英国
      • London、英国、EC1A 7BE
        • Novartis Investigative Site
      • London、英国、W12 0HS
        • Novartis Investigative Site
      • London、英国、SE5 9RS
        • Novartis Investigative Site
      • London、英国、WC1E 6HX
        • Novartis Investigative Site
      • Manchester、英国、M20 4BX
        • Novartis Investigative Site
      • Wolverhampton、英国、WV10 0QP
        • Novartis Investigative Site
    • Scotland
      • Aberdeen、Scotland、英国、AB25 2ZN
        • Novartis Investigative Site
      • Glasgow、Scotland、英国、G12 0YN
        • Novartis Investigative Site
  • 荷兰
      • Rotterdam、荷兰、3015 CE
        • Novartis Investigative Site
      • Rotterdam、荷兰
        • Novartis Investigative Site
      • Utrecht、荷兰、3584 CX
        • Novartis Investigative Site
  • 西班牙
      • Barcelona、西班牙、08041
        • Novartis Investigative Site
    • Andalucia
      • Cordoba、Andalucia、西班牙、14004
        • Novartis Investigative Site
      • Sevilla、Andalucia、西班牙、41013
        • Novartis Investigative Site
    • Castilla Y Leon
      • Salamanca、Castilla Y Leon、西班牙、37007
        • Novartis Investigative Site
    • Catalunya
      • Barcelona、Catalunya、西班牙、08036
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Valencia、Comunidad Valenciana、西班牙、46026
        • Novartis Investigative Site
    • Galicia
      • Santiago de Compostela、Galicia、西班牙、15706
        • Novartis Investigative Site
    • Navarra
      • Pamplona、Navarra、西班牙、31008
        • Novartis Investigative Site
    • Pais Vasco
      • San Sebastian、Pais Vasco、西班牙、20080
        • Novartis Investigative Site
    • Santa Cruz De Tenerife
      • La Laguna、Santa Cruz De Tenerife、西班牙、38320
        • Novartis Investigative Site
  • 阿根廷
      • Buenos Aires、阿根廷、C1114AAN
        • Novartis Investigative Site
      • Cordoba、阿根廷、X5000JHQ
        • Novartis Investigative Site
    • Buenos Aires
      • La Plata、Buenos Aires、阿根廷、B1900AWT
        • Novartis Investigative Site
  • 香港
      • Hong Kong、香港
        • Novartis Investigative Site
      • Hong Kong SAR、香港
        • Novartis Investigative Site
      • New Territories、香港
        • Novartis Investigative Site
  • 黎巴嫩
      • Beirut、黎巴嫩、6301
        • Novartis Investigative Site

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

18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

Inclusion Criteria:

  1. Patient has a previous diagnosis of multiple myeloma.
  2. Patient requires retreatment for multiple myeloma
  3. Patient has measurable M component in serum or urine at study screening

Exclusion Criteria:

  1. Patient who has progressed under all prior lines of anti MM therapy
  2. Patient who has been treated by bortezomib before, and did not reach at least a minor response under this therapy, or progressed under it or within 60 days of last dose
  3. Patient has shown intolerance to bortezomib or to dexamethasone or components of these drugs or has any contraindication to one or the other drug , following locally applicable prescribing information
  4. Patient received prior treatment with DAC inhibitors including panobinostat
  5. Patient has impaired cardiac function, or a prolonged QTc interval at screening ECG
  6. Patient taking medications with relative risk of prolonging the QT interval or inducing Torsade de pointes
  7. Female patient who is pregnant or breast feeding or with childbearing potential and not willing to use a double method of contraception up to 3 months after the end of study treatment. Male patient who is not willing to use a barrier method of contraception up to 3 months after the end of study treatment.

Other protocol-defined inclusion/exclusion criteria may apply.

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：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Panobinostat + Bortezomib + Dexamethasone
药品：Panobinostat
Panobinostat was administered 3x week ( 2 weeks on 1 week off)
其他名称：
  • LBH589
药品：Bortezomib
Bortezomib was administered 2 x week ( 2weeks on 1 week off)
其他名称：
  • (Velcade®)
药品：Dexamethasone
Dexamethasone was adminstered on day of Bortezomib and the day after Bortezomib administration
安慰剂比较：Placebo + Bortezomib + Dexamethasone
药品：Bortezomib
Bortezomib was administered 2 x week ( 2weeks on 1 week off)
其他名称：
  • (Velcade®)
药品：Dexamethasone
Dexamethasone was adminstered on day of Bortezomib and the day after Bortezomib administration
药品：Placebo
Placebo was administered 3x week ( 2 weeks on 1 week off)

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Progression-free Survival Events in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.
大体时间：45 months
45 months
Progression Free Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.
大体时间：45 months
45 months

次要结果测量

结果测量
措施说明
大体时间
Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone
大体时间：45 months
Number of OS events
45 months
Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone
大体时间：45 months
survival time in months
45 months
Overall Response Rate in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.
大体时间：45 months
Best overall response based on mEBMT criteria per investigator assessment
45 months
Time to Response Per Investigator Assessment (mEBMT Criteria) of Response Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.
大体时间：45 months
45 months
Duration of Response Per Investigator Assessment (mEBMT Criteria) Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.
大体时间：45 months
45 months
Time to Progression/Relapse Per Investigator Assessment (mEBMT Criteria) Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.
大体时间：45 months
45 months
European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group
大体时间：12, 24 and 48 weeks
Higher values in the disease symptoms and side effects of treatment scores indicate worsening. Higher scores in the future perspective and body image scores indicate improvement. LS Means and SEM are estimated from the repeated measures model. Following factors and covariates are included in the repeated measurement model: time, treatment, treatment by time interaction, number of prior lines of anti-MM therapy (1/ 2 and 3), prior use of BTZ (Yes/ No), baseline score.Disease Symptom is the sum of 20 questions, total score ranges from 0 (best possible outcome) to 100 (worst possible outcome)", All subscales of EORTC QLQ-MY20 have the same score range of 0 -100. Decrease in symptom scores from baseline indicate improvement in symptoms.
12, 24 and 48 weeks
European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group
大体时间：12, 24 and 48 weeks
The EORTC QLQ-C30 measures functional dimensions (physical, role, emotional, cognitive, and social), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), six single-item symptom scales (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact) and a global health status/QoL scale. Disease Symptom is the sum of 30 questions, total score ranges from 0 (best possible outcome) to 100 (worst possible outcome)", All subscales of EORTC QLQ-C30 have the same score range of 0 -100. For global health status and other functional scales,an increase from baseline indicates improvement of QoL. Whereas for symptoms scales, fatigue, dyspnea, insomnia, appetite loss, constipation and diarrhea, decrease in scores from baseline indicate improvement in symptoms.
12, 24 and 48 weeks
Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group
大体时间：12, 24 and 48 weeks
Chronic Illness Therapy (FACIT) Measurement System and focuses on four general quality of life domains for physical well being, functional well-being, social/family well-being, and emotional well-being, and includes additional items to characterize treatment-related neurotoxicity. Higher subscales/total scores represent higher QOL. In the case of the neurotoxicity subscale, lower scores correspond to higher neurotoxicity. The recall period referenced in the questionnaire is the past 7 days.Ranges for FACT-G subscales are as follows:.PWB, scale 0 -28, , NtxS scale 0-44, FACT/GOG-Ntx trial outcome index scale is 0-100 and FACT-G scale is also scaled 0-100. An increase from baseline in these scores indicate improvement.
12, 24 and 48 weeks

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Novartis Pharmaceuticals

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研究记录日期

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研究主要日期

学习开始 (实际的)

2009年12月21日

初级完成 (实际的)

2015年7月30日

研究完成 (实际的)

2015年7月30日

研究注册日期

首次提交

2009年11月30日

首先提交符合 QC 标准的

2009年12月1日

首次发布 (估计)

2009年12月2日

研究记录更新

最后更新发布 (实际的)

2020年3月17日

上次提交的符合 QC 标准的更新

2020年3月8日

最后验证

2020年3月1日

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其他研究编号

  • CLBH589D2308
  • 2009-015507-52 (EudraCT编号)

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