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

8. marts 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

767

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Panobinostat + Bortezomib + Dexamethasone
Medicin: Panobinostat
Panobinostat was administered 3x week ( 2 weeks on 1 week off)
Andre navne:
  • LBH589
Medicin: Bortezomib
Bortezomib was administered 2 x week ( 2weeks on 1 week off)
Andre navne:
  • (Velcade®)
Medicin: Dexamethasone
Dexamethasone was adminstered on day of Bortezomib and the day after Bortezomib administration
Placebo komparator: Placebo + Bortezomib + Dexamethasone
Medicin: Bortezomib
Bortezomib was administered 2 x week ( 2weeks on 1 week off)
Andre navne:
  • (Velcade®)
Medicin: Dexamethasone
Dexamethasone was adminstered on day of Bortezomib and the day after Bortezomib administration
Medicin: Placebo
Placebo was administered 3x week ( 2 weeks on 1 week off)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
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.
Tidsramme: 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.
Tidsramme: 45 months
45 months

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novartis Pharmaceuticals

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

21. december 2009

Primær færdiggørelse (Faktiske)

30. juli 2015

Studieafslutning (Faktiske)

30. juli 2015

Datoer for studieregistrering

Først indsendt

30. november 2009

Først indsendt, der opfyldte QC-kriterier

1. december 2009

Først opslået (Skøn)

2. december 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. marts 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. marts 2020

Sidst verificeret

1. marts 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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