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

8. mars 2020 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

767

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, C1114AAN
        • Novartis Investigative Site
      • Cordoba, Argentina, X5000JHQ
        • Novartis Investigative Site
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina, B1900AWT
        • Novartis Investigative Site
  • Australia
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065
        • Novartis Investigative Site
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Novartis Investigative Site
      • Woolloongabba, Queensland, Australia, 4102
        • Novartis Investigative Site
    • Victoria
      • Franston, Victoria, Australia, 3199
        • Novartis Investigative Site
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Novartis Investigative Site
      • Perth, Western Australia, Australia, 6000
        • Novartis Investigative Site
  • Belgia
      • Bruxelles, Belgia, 1200
        • Novartis Investigative Site
      • Hasselt, Belgia, 3500
        • Novartis Investigative Site
    • Brussel
      • Jette, Brussel, Belgia, 1090
        • 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
  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Novartis Investigative Site
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M5G 2M9
        • Novartis Investigative Site
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H1T 2M4
        • Novartis Investigative Site
  • Danmark
      • Copenhagen, Danmark, DK-2100
        • Novartis Investigative Site
      • Odense, Danmark, DK 5000
        • Novartis Investigative Site
      • Vejle, Danmark, DK-7100
        • Novartis Investigative Site
      • Ålborg, Danmark, DK-9100
        • Novartis Investigative Site
      • Århus, Danmark, DK-8000
        • Novartis Investigative Site
  • Den russiske føderasjonen
      • Saratov, Den russiske føderasjonen, 410028
        • Novartis Investigative Site
      • St Petersburg, Den russiske føderasjonen, 191024
        • Novartis Investigative Site
  • Egypt
      • Alexandria, Egypt, 21131
        • Novartis Investigative Site
      • Giza, Egypt, 11451
        • Novartis Investigative Site
  • Finland
      • HUS Helsinki, Finland, FIN-00029
        • Novartis Investigative Site
      • Turku, Finland, FIN-20521
        • Novartis Investigative Site
  • Forente stater
    • Arizona
      • Phoenix, Arizona, Forente stater
        • Novartis Investigative Site
    • California
      • Anaheim, California, Forente stater, 92801
        • Novartis Investigative Site
      • Concord, California, Forente stater, 94520
        • Novartis Investigative Site
      • Los Angeles, California, Forente stater, 90027
        • Novartis Investigative Site
      • San Diego, California, Forente stater, 92120
        • Novartis Investigative Site
      • Stanford, California, Forente stater, 94304
        • Novartis Investigative Site
    • Florida
      • Boca Raton, Florida, Forente stater, 33486
        • Novartis Investigative Site
      • Lake Worth, Florida, Forente stater, 33467
        • Novartis Investigative Site
      • Miami Shores, Florida, Forente stater, 33138
        • Novartis Investigative Site
    • Georgia
      • Athens, Georgia, Forente stater, 30607
        • Novartis Investigative Site
      • Atlanta, Georgia, Forente stater, 30322
        • Novartis Investigative Site
      • Marietta, Georgia, Forente stater, 30060
        • Novartis Investigative Site
    • Illinois
      • Marywood, Illinois, Forente stater, 60153
        • Novartis Investigative Site
      • Quincy, Illinois, Forente stater, 62301
        • Novartis Investigative Site
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70115
        • Novartis Investigative Site
    • Maryland
      • Baltimore, Maryland, Forente stater, 21229
        • Novartis Investigative Site
      • Rockville, Maryland, Forente stater, 20850
        • Novartis Investigative Site
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02215
        • Novartis Investigative Site
    • Michigan
      • Southfield, Michigan, Forente stater
        • Novartis Investigative Site
    • Minnesota
      • Edina, Minnesota, Forente stater, 55435
        • Novartis Investigative Site
      • Minneapolis, Minnesota, Forente stater, 55404
        • Novartis Investigative Site
    • Missouri
      • Columbia, Missouri, Forente stater, 65201
        • Novartis Investigative Site
    • New Jersey
      • East Orange, New Jersey, Forente stater, 07018-1095
        • Novartis Investigative Site
    • New York
      • Mount Kisco, New York, Forente stater, 10549
        • Novartis Investigative Site
    • North Carolina
      • Durham, North Carolina, Forente stater, 27710
        • Novartis Investigative Site
    • North Dakota
      • Bismarck, North Dakota, Forente stater, 58501
        • Novartis Investigative Site
    • Ohio
      • Dayton, Ohio, Forente stater, 45429
        • Novartis Investigative Site
      • Middletown, Ohio, Forente stater, 45042
        • Novartis Investigative Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15224
        • Novartis Investigative Site
    • Rhode Island
      • East Providence, Rhode Island, Forente stater, 02915
        • Novartis Investigative Site
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37203
        • Novartis Investigative Site
      • Nashville, Tennessee, Forente stater, 37232
        • Novartis Investigative Site
    • Texas
      • Amarillo, Texas, Forente stater, 79106
        • Novartis Investigative Site
      • Houston, Texas, Forente stater, 77030
        • Novartis Investigative Site
    • Washington
      • Kennewick, Washington, Forente stater, 99336
        • Novartis Investigative Site
      • Seattle, Washington, Forente stater, 98104
        • Novartis Investigative Site
      • Walla Walla, Washington, Forente stater, 33962
        • Novartis Investigative Site
    • West Virginia
      • Morgantown, West Virginia, Forente stater, 26506
        • Novartis Investigative Site
  • Frankrike
      • Blois Cedex, Frankrike, 41016
        • Novartis Investigative Site
      • Dijon, Frankrike, 21034
        • Novartis Investigative Site
      • Lille Cedex, Frankrike, 59037
        • Novartis Investigative Site
      • Limoges cedex, Frankrike, 87042
        • Novartis Investigative Site
      • Nantes, Frankrike, 44035
        • Novartis Investigative Site
      • Paris, Frankrike, 75231
        • Novartis Investigative Site
      • Pierre Benite, Frankrike, 69310
        • Novartis Investigative Site
      • Strasbourg cedex, Frankrike, 67085
        • Novartis Investigative Site
      • Vandoeuvre Les Nancy, Frankrike, 54511
        • Novartis Investigative Site
  • Hellas
      • Athens, Hellas, 115 28
        • Novartis Investigative Site
    • GR
      • Thessaloniki, GR, Hellas, 570 10
        • Novartis Investigative Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Novartis Investigative Site
      • Hong Kong SAR, Hong Kong
        • Novartis Investigative Site
      • New Territories, Hong Kong
        • Novartis Investigative Site
  • 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
  • Italia
      • Napoli, Italia, 80131
        • Novartis Investigative Site
    • FG
      • San Giovanni Rotondo, FG, Italia, 71013
        • Novartis Investigative Site
    • LE
      • Lecce, LE, Italia, 73100
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italia, 20133
        • Novartis Investigative Site
    • PE
      • Pescara, PE, Italia, 65124
        • Novartis Investigative Site
    • PI
      • Pisa, PI, Italia, 56126
        • Novartis Investigative Site
    • PV
      • Pavia, PV, Italia, 27100
        • Novartis Investigative Site
    • RC
      • Reggio Calabria, RC, Italia, 89124
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italia, 00144
        • Novartis Investigative Site
      • Roma, RM, Italia, 00161
        • Novartis Investigative Site
    • SA
      • Pagani, SA, Italia, 84016
        • Novartis Investigative Site
    • VR
      • Verona, VR, Italia, 37134
        • Novartis Investigative Site
  • Japan
      • Hiroshima, Japan, 734-8551
        • Novartis Investigative Site
      • Niigata, Japan, 951-8566
        • Novartis Investigative Site
      • Osaka, Japan, 545-8586
        • Novartis Investigative Site
    • Aichi
      • Nagoya, Aichi, Japan, 460-0001
        • Novartis Investigative Site
      • Nagoya-city, Aichi, Japan, 467-8602
        • Novartis Investigative Site
    • Ehime
      • Matsuyama-city, Ehime, Japan, 790-8524
        • Novartis Investigative Site
    • Fukuoka
      • Fukuoka city, Fukuoka, Japan, 812-8582
        • Novartis Investigative Site
    • Gifu
      • Ogaki-city, Gifu, Japan, 503-8502
        • Novartis Investigative Site
    • Gunma
      • Shibukawa, Gunma, Japan, 377-8511
        • Novartis Investigative Site
    • Hiroshima
      • Kure-city, Hiroshima, Japan, 737-0023
        • Novartis Investigative Site
    • Ibaraki
      • Higashiibaraki-gun, Ibaraki, Japan, 311-3193
        • Novartis Investigative Site
    • Okayama
      • Okayama city, Okayama, Japan, 701-1192
        • Novartis Investigative Site
    • Osaka
      • Suita city, Osaka, Japan, 565 0871
        • Novartis Investigative Site
    • Tokyo
      • Shibuya, Tokyo, Japan, 150-8935
        • Novartis Investigative Site
  • Kina
      • Beijing, Kina, 100044
        • Novartis Investigative Site
      • Beijing, Kina, 100020
        • Novartis Investigative Site
      • Shanghai, Kina, 200003
        • Novartis Investigative Site
      • Shanghai, Kina, 200025
        • Novartis Investigative Site
    • Beijing
      • Beijing, Beijing, Kina, 100730
        • Novartis Investigative Site
    • Guangxi
      • Nanning, Guangxi, Kina, 530021
        • Novartis Investigative Site
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210029
        • Novartis Investigative Site
      • Suzhou, Jiangsu, Kina, 215006
        • Novartis Investigative Site
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • Novartis Investigative Site
    • Tianjin
      • Tianjin, Tianjin, Kina, 300020
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310003
        • Novartis Investigative Site
  • Korea, Republikken
      • Busan, Korea, Republikken, 49201
        • Novartis Investigative Site
      • Busan, Korea, Republikken, 602739
        • Novartis Investigative Site
      • Incheon, Korea, Republikken, 405 760
        • Novartis Investigative Site
      • Jeollanam-do, Korea, Republikken, 519763
        • Novartis Investigative Site
      • Seoul, Korea, Republikken, 03080
        • Novartis Investigative Site
      • Seoul, Korea, Republikken, 06351
        • Novartis Investigative Site
      • Seoul, Korea, Republikken, 03722
        • Novartis Investigative Site
      • Taegu, Korea, Republikken, 41944
        • Novartis Investigative Site
    • Gyeonggi Do
      • Suwon si, Gyeonggi Do, Korea, Republikken, 16499
        • Novartis Investigative Site
    • Seocho Gu
      • Seoul, Seocho Gu, Korea, Republikken, 06591
        • Novartis Investigative Site
  • Libanon
      • Beirut, Libanon, 6301
        • Novartis Investigative Site
  • Mexico
      • San Luis Potosí, Mexico, 78218
        • Novartis Investigative Site
  • Nederland
      • Rotterdam, Nederland, 3015 CE
        • Novartis Investigative Site
      • Rotterdam, Nederland
        • Novartis Investigative Site
      • Utrecht, Nederland, 3584 CX
        • Novartis Investigative Site
  • Norge
      • Bergen, Norge, NO-5021
        • Novartis Investigative Site
      • Fredrikstad, Norge, NO-1603
        • Novartis Investigative Site
      • Kristiansand, Norge, NO-4605
        • Novartis Investigative Site
      • Oslo, Norge, 0407
        • Novartis Investigative Site
      • Skien, Norge, NO-3710
        • Novartis Investigative Site
      • Trondheim, Norge, 7006
        • Novartis Investigative Site
  • Polen
      • Warszawa, Polen, 02 776
        • Novartis Investigative Site
      • Warszawa, Polen, 02-097
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 169608
        • Novartis Investigative Site
  • Spania
      • Barcelona, Spania, 08041
        • Novartis Investigative Site
    • Andalucia
      • Cordoba, Andalucia, Spania, 14004
        • Novartis Investigative Site
      • Sevilla, Andalucia, Spania, 41013
        • Novartis Investigative Site
    • Castilla Y Leon
      • Salamanca, Castilla Y Leon, Spania, 37007
        • Novartis Investigative Site
    • Catalunya
      • Barcelona, Catalunya, Spania, 08036
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spania, 46026
        • Novartis Investigative Site
    • Galicia
      • Santiago de Compostela, Galicia, Spania, 15706
        • Novartis Investigative Site
    • Navarra
      • Pamplona, Navarra, Spania, 31008
        • Novartis Investigative Site
    • Pais Vasco
      • San Sebastian, Pais Vasco, Spania, 20080
        • Novartis Investigative Site
    • Santa Cruz De Tenerife
      • La Laguna, Santa Cruz De Tenerife, Spania, 38320
        • Novartis Investigative Site
  • Storbritannia
      • London, Storbritannia, EC1A 7BE
        • Novartis Investigative Site
      • London, Storbritannia, W12 0HS
        • Novartis Investigative Site
      • London, Storbritannia, SE5 9RS
        • Novartis Investigative Site
      • London, Storbritannia, WC1E 6HX
        • Novartis Investigative Site
      • Manchester, Storbritannia, M20 4BX
        • Novartis Investigative Site
      • Wolverhampton, Storbritannia, WV10 0QP
        • Novartis Investigative Site
    • Scotland
      • Aberdeen, Scotland, Storbritannia, AB25 2ZN
        • Novartis Investigative Site
      • Glasgow, Scotland, Storbritannia, G12 0YN
        • Novartis Investigative Site
  • Sverige
      • Göteborg, Sverige, SE-413 45
        • Novartis Investigative Site
      • Linköping, Sverige, SE-581 85
        • Novartis Investigative Site
      • Luleå, Sverige, SE-971 80
        • Novartis Investigative Site
      • Stockholm, Sverige, SE-118 83
        • Novartis Investigative Site
      • Uppsala, Sverige, SE-751 85
        • Novartis Investigative Site
  • Sør-Afrika
      • Parktown, Sør-Afrika, 2193
        • Novartis Investigative Site
      • Pretoria, Sør-Afrika, 0027
        • Novartis Investigative Site
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Novartis Investigative Site
      • Taichung, Taiwan, 40447
        • Novartis Investigative Site
      • Taipei, Taiwan, 10048
        • Novartis Investigative Site
      • Taoyuan, Taiwan, 333
        • Novartis Investigative Site
  • Thailand
      • Bangkok, Thailand, 10330
        • Novartis Investigative Site
      • Bangkok, Thailand, 10700
        • Novartis Investigative Site
      • Bangkok, Thailand, 10400
        • Novartis Investigative Site
  • Tsjekkia
    • CZE
      • Olomouc, CZE, Tsjekkia, 775 20
        • Novartis Investigative Site
    • Czech Republic
      • Brno Bohunice, Czech Republic, Tsjekkia, 625 00
        • Novartis Investigative Site
      • Prague 2, Czech Republic, Tsjekkia, 128 08
        • Novartis Investigative Site
  • Tyrkia
      • Adana, Tyrkia, 01330
        • Novartis Investigative Site
      • Ankara, Tyrkia, 06100
        • Novartis Investigative Site
    • TUR
      • Istanbul, TUR, Tyrkia, 34098
        • Novartis Investigative Site
  • Tyskland
      • Aachen, Tyskland, 52074
        • Novartis Investigative Site
      • Bad Saarow, Tyskland, 15526
        • Novartis Investigative Site
      • Bamberg, Tyskland, 96049
        • Novartis Investigative Site
      • Berlin, Tyskland, 13353
        • Novartis Investigative Site
      • Bremen, Tyskland, 28177
        • Novartis Investigative Site
      • Dresden, Tyskland, 01307
        • Novartis Investigative Site
      • Duisburg, Tyskland, 47166
        • Novartis Investigative Site
      • Erlangen, Tyskland, 91054
        • Novartis Investigative Site
      • Frankfurt, Tyskland, 60590
        • Novartis Investigative Site
      • Hamburg, Tyskland, 22763
        • Novartis Investigative Site
      • Jena, Tyskland, 07740
        • Novartis Investigative Site
      • Kiel, Tyskland, 24105
        • Novartis Investigative Site
      • Magdeburg, Tyskland, 39120
        • Novartis Investigative Site
      • Muenchen, Tyskland, 81737
        • Novartis Investigative Site
      • Rostock, Tyskland, 18057
        • Novartis Investigative Site
      • Ulm, Tyskland, 89081
        • Novartis Investigative Site
      • Wuerzburg, Tyskland, 97080
        • Novartis Investigative Site
  • Østerrike
      • Linz, Østerrike, A-4010
        • Novartis Investigative Site
      • Wien, Østerrike, A-1090
        • Novartis Investigative Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Panobinostat + Bortezomib + Dexamethasone
Legemiddel: Panobinostat
Panobinostat was administered 3x week ( 2 weeks on 1 week off)
Andre navn:
  • LBH589
Legemiddel: Bortezomib
Bortezomib was administered 2 x week ( 2weeks on 1 week off)
Andre navn:
  • (Velcade®)
Legemiddel: Dexamethasone
Dexamethasone was adminstered on day of Bortezomib and the day after Bortezomib administration
Placebo komparator: Placebo + Bortezomib + Dexamethasone
Legemiddel: Bortezomib
Bortezomib was administered 2 x week ( 2weeks on 1 week off)
Andre navn:
  • (Velcade®)
Legemiddel: Dexamethasone
Dexamethasone was adminstered on day of Bortezomib and the day after Bortezomib administration
Legemiddel: Placebo
Placebo was administered 3x week ( 2 weeks on 1 week off)

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
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.
Tidsramme: 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.
Tidsramme: 45 months
45 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 45 months
45 months
European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

21. desember 2009

Primær fullføring (Faktiske)

30. juli 2015

Studiet fullført (Faktiske)

30. juli 2015

Datoer for studieregistrering

Først innsendt

30. november 2009

Først innsendt som oppfylte QC-kriteriene

1. desember 2009

Først lagt ut (Anslag)

2. desember 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. mars 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. mars 2020

Sist bekreftet

1. mars 2020

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Andre studie-ID-numre

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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