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

8 de março de 2020 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

767

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Panobinostat + Bortezomib + Dexamethasone
Medicamento: Panobinostat
Panobinostat was administered 3x week ( 2 weeks on 1 week off)
Outros nomes:
  • LBH589
Medicamento: Bortezomib
Bortezomib was administered 2 x week ( 2weeks on 1 week off)
Outros nomes:
  • (Velcade®)
Medicamento: Dexamethasone
Dexamethasone was adminstered on day of Bortezomib and the day after Bortezomib administration
Comparador de Placebo: Placebo + Bortezomib + Dexamethasone
Medicamento: Bortezomib
Bortezomib was administered 2 x week ( 2weeks on 1 week off)
Outros nomes:
  • (Velcade®)
Medicamento: Dexamethasone
Dexamethasone was adminstered on day of Bortezomib and the day after Bortezomib administration
Medicamento: Placebo
Placebo was administered 3x week ( 2 weeks on 1 week off)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
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.
Prazo: 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.
Prazo: 45 months
45 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone
Prazo: 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
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 45 months
45 months
European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Novartis Pharmaceuticals

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

21 de dezembro de 2009

Conclusão Primária (Real)

30 de julho de 2015

Conclusão do estudo (Real)

30 de julho de 2015

Datas de inscrição no estudo

Enviado pela primeira vez

30 de novembro de 2009

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de dezembro de 2009

Primeira postagem (Estimativa)

2 de dezembro de 2009

Atualizações de registro de estudo

Última Atualização Postada (Real)

17 de março de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de março de 2020

Última verificação

1 de março de 2020

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

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