Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma (PANORAMA-1)
8 de marzo de 2020 actualizado 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
767
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Aachen, Alemania, 52074
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Bad Saarow, Alemania, 15526
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Bamberg, Alemania, 96049
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Berlin, Alemania, 13353
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Bremen, Alemania, 28177
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Dresden, Alemania, 01307
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Duisburg, Alemania, 47166
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Erlangen, Alemania, 91054
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Frankfurt, Alemania, 60590
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Hamburg, Alemania, 22763
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Jena, Alemania, 07740
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Kiel, Alemania, 24105
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Magdeburg, Alemania, 39120
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Muenchen, Alemania, 81737
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Rostock, Alemania, 18057
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Ulm, Alemania, 89081
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Wuerzburg, Alemania, 97080
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Buenos Aires, Argentina, C1114AAN
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Cordoba, Argentina, X5000JHQ
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Buenos Aires
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La Plata, Buenos Aires, Argentina, B1900AWT
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New South Wales
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St Leonards, New South Wales, Australia, 2065
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Queensland
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Herston, Queensland, Australia, 4029
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Woolloongabba, Queensland, Australia, 4102
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Victoria
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Franston, Victoria, Australia, 3199
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Western Australia
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Nedlands, Western Australia, Australia, 6009
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Perth, Western Australia, Australia, 6000
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Linz, Austria, A-4010
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Wien, Austria, A-1090
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DF
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Brasilia, DF, Brasil, 70710-904
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RJ
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Rio de Janeiro, RJ, Brasil, 20.211-030
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Rio de Janeiro, RJ, Brasil, 20551-030
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Rio de Janeiro, RJ, Brasil, 22640-102
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SP
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Barretos, SP, Brasil, 14784 400
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Campinas, SP, Brasil, 13083-970
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Sao Paulo, SP, Brasil, 05403 000
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CZE
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Czech Republic
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Seoul, Corea, república de, 03080
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Seoul, Corea, república de, 06351
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Taegu, Corea, república de, 41944
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Gyeonggi Do
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Suwon si, Gyeonggi Do, Corea, república de, 16499
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Seocho Gu
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Seoul, Seocho Gu, Corea, república de, 06591
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Copenhagen, Dinamarca, DK-2100
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Odense, Dinamarca, DK 5000
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Vejle, Dinamarca, DK-7100
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Alexandria, Egipto, 21131
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Illinois
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Marywood, Illinois, Estados Unidos, 60153
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Louisiana
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Maryland
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
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Michigan
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Southfield, Michigan, Estados Unidos
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Minnesota
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Edina, Minnesota, Estados Unidos, 55435
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Minneapolis, Minnesota, Estados Unidos, 55404
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Missouri
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Columbia, Missouri, Estados Unidos, 65201
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New Jersey
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East Orange, New Jersey, Estados Unidos, 07018-1095
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New York
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Mount Kisco, New York, Estados Unidos, 10549
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
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North Dakota
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Ohio
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15224
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Rhode Island
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Texas
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Amarillo, Texas, Estados Unidos, 79106
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Washington
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Kennewick, Washington, Estados Unidos, 99336
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Seattle, Washington, Estados Unidos, 98104
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West Virginia
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Morgantown, West Virginia, Estados Unidos, 26506
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Saratov, Federación Rusa, 410028
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St Petersburg, Federación Rusa, 191024
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HUS Helsinki, Finlandia, FIN-00029
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Turku, Finlandia, FIN-20521
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Blois Cedex, Francia, 41016
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Dijon, Francia, 21034
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Lille Cedex, Francia, 59037
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Limoges cedex, Francia, 87042
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Nantes, Francia, 44035
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Paris, Francia, 75231
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Athens, Grecia, 115 28
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GR
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Thessaloniki, GR, Grecia, 570 10
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Hong Kong, Hong Kong
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Jerusalem, Israel, 91120
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Kfar Saba, Israel, 4428164
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Petach Tikva, Israel, 49100
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Ramat Gan, Israel, 5265601
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Napoli, Italia, 80131
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FG
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San Giovanni Rotondo, FG, Italia, 71013
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LE
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Lecce, LE, Italia, 73100
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MI
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Milano, MI, Italia, 20133
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PE
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Pescara, PE, Italia, 65124
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PI
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Pisa, PI, Italia, 56126
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PV
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Pavia, PV, Italia, 27100
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RC
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Reggio Calabria, RC, Italia, 89124
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RM
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Roma, RM, Italia, 00144
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Roma, RM, Italia, 00161
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SA
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Pagani, SA, Italia, 84016
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VR
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Verona, VR, Italia, 37134
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Hiroshima, Japón, 734-8551
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Niigata, Japón, 951-8566
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Osaka, Japón, 545-8586
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Aichi
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Nagoya, Aichi, Japón, 460-0001
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Nagoya-city, Aichi, Japón, 467-8602
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Ehime
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Matsuyama-city, Ehime, Japón, 790-8524
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Fukuoka
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Fukuoka city, Fukuoka, Japón, 812-8582
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Gifu
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Ogaki-city, Gifu, Japón, 503-8502
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Gunma
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Shibukawa, Gunma, Japón, 377-8511
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Hiroshima
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Kure-city, Hiroshima, Japón, 737-0023
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Ibaraki
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Higashiibaraki-gun, Ibaraki, Japón, 311-3193
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Okayama
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Okayama city, Okayama, Japón, 701-1192
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Osaka
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Suita city, Osaka, Japón, 565 0871
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Tokyo
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Shibuya, Tokyo, Japón, 150-8935
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Beirut, Líbano, 6301
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San Luis Potosí, México, 78218
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Bergen, Noruega, NO-5021
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Fredrikstad, Noruega, NO-1603
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Kristiansand, Noruega, NO-4605
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Oslo, Noruega, 0407
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Skien, Noruega, NO-3710
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Trondheim, Noruega, 7006
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Adana, Pavo, 01330
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Ankara, Pavo, 06100
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TUR
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Istanbul, TUR, Pavo, 34098
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Rotterdam, Países Bajos, 3015 CE
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Rotterdam, Países Bajos
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Utrecht, Países Bajos, 3584 CX
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Warszawa, Polonia, 02 776
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Warszawa, Polonia, 02-097
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Beijing, Porcelana, 100044
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Shanghai, Porcelana, 200003
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Shanghai, Porcelana, 200025
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Beijing
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Beijing, Beijing, Porcelana, 100730
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Guangxi
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Nanning, Guangxi, Porcelana, 530021
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Jiangsu
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Nanjing, Jiangsu, Porcelana, 210029
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Suzhou, Jiangsu, Porcelana, 215006
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Sichuan
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Chengdu, Sichuan, Porcelana, 610041
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Tianjin
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Tianjin, Tianjin, Porcelana, 300020
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Zhejiang
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Hangzhou, Zhejiang, Porcelana, 310003
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London, Reino Unido, EC1A 7BE
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London, Reino Unido, W12 0HS
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London, Reino Unido, SE5 9RS
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London, Reino Unido, WC1E 6HX
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Manchester, Reino Unido, M20 4BX
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Wolverhampton, Reino Unido, WV10 0QP
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Scotland
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Aberdeen, Scotland, Reino Unido, AB25 2ZN
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Glasgow, Scotland, Reino Unido, G12 0YN
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Singapore, Singapur, 169608
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Parktown, Sudáfrica, 2193
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Pretoria, Sudáfrica, 0027
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Göteborg, Suecia, SE-413 45
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Linköping, Suecia, SE-581 85
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Luleå, Suecia, SE-971 80
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Stockholm, Suecia, SE-118 83
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Uppsala, Suecia, SE-751 85
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Bangkok, Tailandia, 10330
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Bangkok, Tailandia, 10700
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Bangkok, Tailandia, 10400
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Kaohsiung City, Taiwán, 83301
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Taichung, Taiwán, 40447
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Taipei, Taiwán, 10048
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Taoyuan, Taiwán, 333
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Patient has a previous diagnosis of multiple myeloma.
- Patient requires retreatment for multiple myeloma
- Patient has measurable M component in serum or urine at study screening
Exclusion Criteria:
- Patient who has progressed under all prior lines of anti MM therapy
- 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
- 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
- Patient received prior treatment with DAC inhibitors including panobinostat
- Patient has impaired cardiac function, or a prolonged QTc interval at screening ECG
- Patient taking medications with relative risk of prolonging the QT interval or inducing Torsade de pointes
- 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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Panobinostat + Bortezomib + Dexamethasone
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Panobinostat was administered 3x week ( 2 weeks on 1 week off)
Otros nombres:
Bortezomib was administered 2 x week ( 2weeks on 1 week off)
Otros nombres:
Dexamethasone was adminstered on day of Bortezomib and the day after Bortezomib administration
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Comparador de placebos: Placebo + Bortezomib + Dexamethasone
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Bortezomib was administered 2 x week ( 2weeks on 1 week off)
Otros nombres:
Dexamethasone was adminstered on day of Bortezomib and the day after Bortezomib administration
Placebo was administered 3x week ( 2 weeks on 1 week off)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
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.
Periodo de tiempo: 45 months
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45 months
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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.
Periodo de tiempo: 45 months
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45 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone
Periodo de tiempo: 45 months
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Number of OS events
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45 months
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Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone
Periodo de tiempo: 45 months
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survival time in months
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45 months
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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.
Periodo de tiempo: 45 months
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Best overall response based on mEBMT criteria per investigator assessment
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45 months
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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.
Periodo de tiempo: 45 months
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45 months
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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.
Periodo de tiempo: 45 months
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45 months
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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.
Periodo de tiempo: 45 months
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45 months
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European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group
Periodo de tiempo: 12, 24 and 48 weeks
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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.
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12, 24 and 48 weeks
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European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group
Periodo de tiempo: 12, 24 and 48 weeks
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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.
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12, 24 and 48 weeks
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Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group
Periodo de tiempo: 12, 24 and 48 weeks
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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.
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12, 24 and 48 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- San-Miguel JF, Einsele H, Moreau P. The Role of Panobinostat Plus Bortezomib and Dexamethasone in Treating Relapsed or Relapsed and Refractory Multiple Myeloma: A European Perspective. Adv Ther. 2016 Nov;33(11):1896-1920. doi: 10.1007/s12325-016-0413-7. Epub 2016 Sep 27.
- San-Miguel JF, Hungria VT, Yoon SS, Beksac M, Dimopoulos MA, Elghandour A, Jedrzejczak WW, Gunther A, Nakorn TN, Siritanaratkul N, Schlossman RL, Hou J, Moreau P, Lonial S, Lee JH, Einsele H, Sopala M, Bengoudifa BR, Binlich F, Richardson PG. Overall survival of patients with relapsed multiple myeloma treated with panobinostat or placebo plus bortezomib and dexamethasone (the PANORAMA 1 trial): a randomised, placebo-controlled, phase 3 trial. Lancet Haematol. 2016 Nov;3(11):e506-e515. doi: 10.1016/S2352-3026(16)30147-8. Epub 2016 Oct 14.
- Richardson PG, Hungria VT, Yoon SS, Beksac M, Dimopoulos MA, Elghandour A, Jedrzejczak WW, Guenther A, Nakorn TN, Siritanaratkul N, Schlossman RL, Hou J, Moreau P, Lonial S, Lee JH, Einsele H, Sopala M, Bengoudifa BR, Corrado C, Binlich F, San-Miguel JF. Panobinostat plus bortezomib and dexamethasone in previously treated multiple myeloma: outcomes by prior treatment. Blood. 2016 Feb 11;127(6):713-21. doi: 10.1182/blood-2015-09-665018. Epub 2015 Dec 2. Erratum In: Blood. 2016 Jun 30;127(26):3460.
- San-Miguel JF, Hungria VT, Yoon SS, Beksac M, Dimopoulos MA, Elghandour A, Jedrzejczak WW, Gunther A, Nakorn TN, Siritanaratkul N, Corradini P, Chuncharunee S, Lee JJ, Schlossman RL, Shelekhova T, Yong K, Tan D, Numbenjapon T, Cavenagh JD, Hou J, LeBlanc R, Nahi H, Qiu L, Salwender H, Pulini S, Moreau P, Warzocha K, White D, Blade J, Chen W, de la Rubia J, Gimsing P, Lonial S, Kaufman JL, Ocio EM, Veskovski L, Sohn SK, Wang MC, Lee JH, Einsele H, Sopala M, Corrado C, Bengoudifa BR, Binlich F, Richardson PG. Panobinostat plus bortezomib and dexamethasone versus placebo plus bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma: a multicentre, randomised, double-blind phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1195-206. doi: 10.1016/S1470-2045(14)70440-1. Epub 2014 Sep 18. Erratum In: Lancet Oncol. 2015 Jan;16(1):e6.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
21 de diciembre de 2009
Finalización primaria (Actual)
30 de julio de 2015
Finalización del estudio (Actual)
30 de julio de 2015
Fechas de registro del estudio
Enviado por primera vez
30 de noviembre de 2009
Primero enviado que cumplió con los criterios de control de calidad
1 de diciembre de 2009
Publicado por primera vez (Estimar)
2 de diciembre de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de marzo de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
8 de marzo de 2020
Última verificación
1 de marzo de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Neoplasias
- Trastornos linfoproliferativos
- Trastornos inmunoproliferativos
- Enfermedades hematológicas
- Trastornos hemorrágicos
- Trastornos hemostáticos
- Paraproteinemias
- Trastornos de proteínas en sangre
- Mieloma múltiple
- Neoplasias De Células Plasmáticas
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes Autonómicos
- Agentes del sistema nervioso periférico
- Inhibidores de enzimas
- Agentes antiinflamatorios
- Agentes antineoplásicos
- Antieméticos
- Agentes Gastrointestinales
- Glucocorticoides
- Hormonas
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Agentes Antineoplásicos Hormonales
- Inhibidores de histona desacetilasa
- Dexametasona
- Bortezomib
- Panobinostat
Otros números de identificación del estudio
- CLBH589D2308
- 2009-015507-52 (Número EudraCT)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .