Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma (PANORAMA-1)
8 mars 2020 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
767
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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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, Australien, 2065
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Queensland
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Herston, Queensland, Australien, 4029
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Woolloongabba, Queensland, Australien, 4102
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Victoria
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Franston, Victoria, Australien, 3199
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Western Australia
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Nedlands, Western Australia, Australien, 6009
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Perth, Western Australia, Australien, 6000
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Bruxelles, Belgien, 1200
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Hasselt, Belgien, 3500
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Brussel
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Jette, Brussel, Belgien, 1090
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DF
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Brasilia, DF, Brasilien, 70710-904
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RJ
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Rio de Janeiro, RJ, Brasilien, 20.211-030
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Rio de Janeiro, RJ, Brasilien, 20551-030
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Rio de Janeiro, RJ, Brasilien, 22640-102
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SP
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Barretos, SP, Brasilien, 14784 400
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Campinas, SP, Brasilien, 13083-970
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Sao Paulo, SP, Brasilien, 05403 000
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São Paulo, SP, Brasilien, 01224-000
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Copenhagen, Danmark, DK-2100
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Odense, Danmark, DK 5000
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Vejle, Danmark, DK-7100
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Århus, Danmark, DK-8000
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Alexandria, Egypten, 21131
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Giza, Egypten, 11451
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HUS Helsinki, Finland, FIN-00029
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Turku, Finland, FIN-20521
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Thessaloniki, GR, Grekland, 570 10
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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, Italien, 80131
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FG
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San Giovanni Rotondo, FG, Italien, 71013
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LE
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Lecce, LE, Italien, 73100
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MI
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Milano, MI, Italien, 20133
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PE
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Pescara, PE, Italien, 65124
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PI
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PV
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RC
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Reggio Calabria, RC, Italien, 89124
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RM
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Roma, RM, Italien, 00144
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Roma, RM, Italien, 00161
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SA
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Pagani, SA, Italien, 84016
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Osaka, Japan, 545-8586
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Aichi
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Nagoya, Aichi, Japan, 460-0001
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Ehime
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Matsuyama-city, Ehime, Japan, 790-8524
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Fukuoka
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Fukuoka city, Fukuoka, Japan, 812-8582
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Gifu
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Ogaki-city, Gifu, Japan, 503-8502
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Gunma
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Shibukawa, Gunma, Japan, 377-8511
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Hiroshima
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Kure-city, Hiroshima, Japan, 737-0023
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Ibaraki
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Higashiibaraki-gun, Ibaraki, Japan, 311-3193
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Okayama
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Okayama city, Okayama, Japan, 701-1192
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Osaka
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Suita city, Osaka, Japan, 565 0871
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Tokyo
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Shibuya, Tokyo, Japan, 150-8935
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Adana, Kalkon, 01330
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Ankara, Kalkon, 06100
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TUR
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Istanbul, TUR, Kalkon, 34098
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Nova Scotia
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Halifax, Nova Scotia, Kanada, B3H 1V7
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Ontario
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Hamilton, Ontario, Kanada, L8V 5C2
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Toronto, Ontario, Kanada, M5G 2M9
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Quebec
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Greenfield Park, Quebec, Kanada, J4V 2H1
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Montreal, Quebec, Kanada, H1T 2M4
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Beijing, Kina, 100044
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Beijing, Kina, 100020
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Shanghai, Kina, 200003
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Beijing
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Guangxi
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Nanning, Guangxi, Kina, 530021
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Jiangsu
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Nanjing, Jiangsu, Kina, 210029
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Suzhou, Jiangsu, Kina, 215006
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Sichuan
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Chengdu, Sichuan, Kina, 610041
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Tianjin
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Tianjin, Tianjin, Kina, 300020
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310003
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Busan, Korea, Republiken av, 49201
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Busan, Korea, Republiken av, 602739
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Incheon, Korea, Republiken av, 405 760
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Jeollanam-do, Korea, Republiken av, 519763
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Seoul, Korea, Republiken av, 03080
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Seoul, Korea, Republiken av, 06351
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Seoul, Korea, Republiken av, 03722
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Taegu, Korea, Republiken av, 41944
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Gyeonggi Do
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Suwon si, Gyeonggi Do, Korea, Republiken av, 16499
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Seocho Gu
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Seoul, Seocho Gu, Korea, Republiken av, 06591
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Beirut, Libanon, 6301
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San Luis Potosí, Mexiko, 78218
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Rotterdam, Nederländerna, 3015 CE
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Rotterdam, Nederländerna
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Utrecht, Nederländerna, 3584 CX
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Bergen, Norge, NO-5021
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Fredrikstad, Norge, NO-1603
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Kristiansand, Norge, NO-4605
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Oslo, Norge, 0407
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Skien, Norge, NO-3710
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Trondheim, Norge, 7006
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Warszawa, Polen, 02 776
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Warszawa, Polen, 02-097
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Saratov, Ryska Federationen, 410028
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St Petersburg, Ryska Federationen, 191024
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Singapore, Singapore, 169608
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Andalucia
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Cordoba, Andalucia, Spanien, 14004
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Sevilla, Andalucia, Spanien, 41013
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Castilla Y Leon
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Salamanca, Castilla Y Leon, Spanien, 37007
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Catalunya
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Barcelona, Catalunya, Spanien, 08036
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Comunidad Valenciana
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Valencia, Comunidad Valenciana, Spanien, 46026
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Galicia
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Santiago de Compostela, Galicia, Spanien, 15706
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Navarra
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Pamplona, Navarra, Spanien, 31008
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Pais Vasco
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San Sebastian, Pais Vasco, Spanien, 20080
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Santa Cruz De Tenerife
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La Laguna, Santa Cruz De Tenerife, Spanien, 38320
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London, Storbritannien, EC1A 7BE
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London, Storbritannien, WC1E 6HX
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Manchester, Storbritannien, M20 4BX
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Wolverhampton, Storbritannien, WV10 0QP
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Scotland
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Aberdeen, Scotland, Storbritannien, AB25 2ZN
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Glasgow, Scotland, Storbritannien, G12 0YN
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Göteborg, Sverige, SE-413 45
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Linköping, Sverige, SE-581 85
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Stockholm, Sverige, SE-118 83
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Uppsala, Sverige, SE-751 85
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Bangkok, Thailand, 10700
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CZE
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Olomouc, CZE, Tjeckien, 775 20
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Czech Republic
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Brno Bohunice, Czech Republic, Tjeckien, 625 00
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Prague 2, Czech Republic, Tjeckien, 128 08
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Aachen, Tyskland, 52074
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Bad Saarow, Tyskland, 15526
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Bamberg, Tyskland, 96049
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Berlin, Tyskland, 13353
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Bremen, Tyskland, 28177
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Dresden, Tyskland, 01307
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Duisburg, Tyskland, 47166
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Erlangen, Tyskland, 91054
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Frankfurt, Tyskland, 60590
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Hamburg, Tyskland, 22763
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Kiel, Tyskland, 24105
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Magdeburg, Tyskland, 39120
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Muenchen, Tyskland, 81737
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Wuerzburg, Tyskland, 97080
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Panobinostat + Bortezomib + Dexamethasone
|
Panobinostat was administered 3x week ( 2 weeks on 1 week off)
Andra namn:
Bortezomib was administered 2 x week ( 2weeks on 1 week off)
Andra namn:
Dexamethasone was adminstered on day of Bortezomib and the day after Bortezomib administration
|
|
Placebo-jämförare: Placebo + Bortezomib + Dexamethasone
|
Bortezomib was administered 2 x week ( 2weeks on 1 week off)
Andra namn:
Dexamethasone was adminstered on day of Bortezomib and the day after Bortezomib administration
Placebo was administered 3x week ( 2 weeks on 1 week off)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
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.
Tidsram: 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.
Tidsram: 45 months
|
45 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone
Tidsram: 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
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 45 months
|
45 months
|
|
|
European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
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Publikationer och användbara länkar
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Allmänna publikationer
- 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.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
21 december 2009
Primärt slutförande (Faktisk)
30 juli 2015
Avslutad studie (Faktisk)
30 juli 2015
Studieregistreringsdatum
Först inskickad
30 november 2009
Först inskickad som uppfyllde QC-kriterierna
1 december 2009
Första postat (Uppskatta)
2 december 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 mars 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 mars 2020
Senast verifierad
1 mars 2020
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Hjärt-kärlsjukdomar
- Kärlsjukdomar
- Immunsystemets sjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Lymfoproliferativa störningar
- Immunproliferativa störningar
- Hematologiska sjukdomar
- Hemorragiska störningar
- Hemostatiska störningar
- Paraproteinemier
- Blodproteinstörningar
- Multipelt myelom
- Neoplasmer, Plasmacell
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Autonoma agenter
- Agenter från det perifera nervsystemet
- Enzyminhibitorer
- Antiinflammatoriska medel
- Antineoplastiska medel
- Antiemetika
- Gastrointestinala medel
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitut och hormonantagonister
- Antineoplastiska medel, hormonella
- Histon deacetylashämmare
- Dexametason
- Bortezomib
- Panobinostat
Andra studie-ID-nummer
- CLBH589D2308
- 2009-015507-52 (EudraCT-nummer)
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