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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Panobinostat; Drug: Bortezomib; Drug: Dexamethasone; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 767
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Panobinostat + Bortezomib + Dexamethasone	Drug: Panobinostat; Panobinostat was administered 3x week ( 2 weeks on 1 week off); Other Names: LBH589; Drug: Bortezomib; Bortezomib was administered 2 x week ( 2weeks on 1 week off); Other Names: (Velcade®); Drug: Dexamethasone; Dexamethasone was adminstered on day of Bortezomib and the day after Bortezomib administration
Placebo Comparator: Placebo + Bortezomib + Dexamethasone	Drug: Bortezomib; Bortezomib was administered 2 x week ( 2weeks on 1 week off); Other Names: (Velcade®); Drug: Dexamethasone; Dexamethasone was adminstered on day of Bortezomib and the day after Bortezomib administration; Drug: Placebo; Placebo was administered 3x week ( 2 weeks on 1 week off)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	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.	45 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

General Publications

• 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.
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Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2009
• Primary Completion (Actual): July 30, 2015
• Study Completion (Actual): July 30, 2015

Study Registration Dates

• First Submitted: November 30, 2009
• First Submitted That Met QC Criteria: December 1, 2009
• First Posted (Estimate): December 2, 2009

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 8, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Bortezomib; Combination; relapsed; Myeloma; Panobinostat; DACi; LBH589D; Velcade®; Combination,
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Histone Deacetylase Inhibitors; Dexamethasone; Bortezomib; Panobinostat
• Other Study ID Numbers: CLBH589D2308; 2009-015507-52 (EudraCT Number)