이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2020년 3월 8일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

767

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Panobinostat + Bortezomib + Dexamethasone
의약품: Panobinostat
Panobinostat was administered 3x week ( 2 weeks on 1 week off)
다른 이름들:
  • LBH589
의약품: Bortezomib
Bortezomib was administered 2 x week ( 2weeks on 1 week off)
다른 이름들:
  • (Velcade®)
의약품: Dexamethasone
Dexamethasone was adminstered on day of Bortezomib and the day after Bortezomib administration
위약 비교기: Placebo + Bortezomib + Dexamethasone
의약품: Bortezomib
Bortezomib was administered 2 x week ( 2weeks on 1 week off)
다른 이름들:
  • (Velcade®)
의약품: Dexamethasone
Dexamethasone was adminstered on day of Bortezomib and the day after Bortezomib administration
의약품: Placebo
Placebo was administered 3x week ( 2 weeks on 1 week off)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
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.
기간: 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.
기간: 45 months
45 months

2차 결과 측정

결과 측정
측정값 설명
기간
Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone
기간: 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
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 45 months
45 months
European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Novartis Pharmaceuticals

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2009년 12월 21일

기본 완료 (실제)

2015년 7월 30일

연구 완료 (실제)

2015년 7월 30일

연구 등록 날짜

최초 제출

2009년 11월 30일

QC 기준을 충족하는 최초 제출

2009년 12월 1일

처음 게시됨 (추정)

2009년 12월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 3월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 3월 8일

마지막으로 확인됨

2020년 3월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

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

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

다발성 골수종에 대한 임상 시험

Panobinostat에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Equatorial Guinea

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다