Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

8 marzo 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

767

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Panobinostat + Bortezomib + Dexamethasone
Droga: Panobinostat
Panobinostat was administered 3x week ( 2 weeks on 1 week off)
Altri nomi:
  • LBH589
Droga: Bortezomib
Bortezomib was administered 2 x week ( 2weeks on 1 week off)
Altri nomi:
  • (Velcade®)
Droga: Dexamethasone
Dexamethasone was adminstered on day of Bortezomib and the day after Bortezomib administration
Comparatore placebo: Placebo + Bortezomib + Dexamethasone
Droga: Bortezomib
Bortezomib was administered 2 x week ( 2weeks on 1 week off)
Altri nomi:
  • (Velcade®)
Droga: Dexamethasone
Dexamethasone was adminstered on day of Bortezomib and the day after Bortezomib administration
Droga: Placebo
Placebo was administered 3x week ( 2 weeks on 1 week off)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
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.
Lasso di tempo: 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.
Lasso di tempo: 45 months
45 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 45 months
45 months
European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Novartis Pharmaceuticals

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

21 dicembre 2009

Completamento primario (Effettivo)

30 luglio 2015

Completamento dello studio (Effettivo)

30 luglio 2015

Date di iscrizione allo studio

Primo inviato

30 novembre 2009

Primo inviato che soddisfa i criteri di controllo qualità

1 dicembre 2009

Primo Inserito (Stima)

2 dicembre 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 marzo 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 marzo 2020

Ultimo verificato

1 marzo 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Panobinostat

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Benin

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi