Spots Global Cancer Trial Database for Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma
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Trial Identification
Brief Title: Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma
Official Title: A Multicenter, Randomized, Double Blind, Placebo Controlled Phase III Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma
Study ID: NCT01023308
Conditions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Novartis Investigative Site, Phoenix, Arizona, United States
Novartis Investigative Site, Anaheim, California, United States
Novartis Investigative Site, Concord, California, United States
Novartis Investigative Site, Los Angeles, California, United States
Novartis Investigative Site, San Diego, California, United States
Novartis Investigative Site, Stanford, California, United States
Novartis Investigative Site, Boca Raton, Florida, United States
Novartis Investigative Site, Lake Worth, Florida, United States
Novartis Investigative Site, Miami Shores, Florida, United States
Novartis Investigative Site, Athens, Georgia, United States
Novartis Investigative Site, Atlanta, Georgia, United States
Novartis Investigative Site, Marietta, Georgia, United States
Novartis Investigative Site, Marywood, Illinois, United States
Novartis Investigative Site, Quincy, Illinois, United States
Novartis Investigative Site, New Orleans, Louisiana, United States
Novartis Investigative Site, Baltimore, Maryland, United States
Novartis Investigative Site, Rockville, Maryland, United States
Novartis Investigative Site, Boston, Massachusetts, United States
Novartis Investigative Site, Southfield, Michigan, United States
Novartis Investigative Site, Edina, Minnesota, United States
Novartis Investigative Site, Minneapolis, Minnesota, United States
Novartis Investigative Site, Columbia, Missouri, United States
Novartis Investigative Site, East Orange, New Jersey, United States
Novartis Investigative Site, Mount Kisco, New York, United States
Novartis Investigative Site, Durham, North Carolina, United States
Novartis Investigative Site, Bismarck, North Dakota, United States
Novartis Investigative Site, Dayton, Ohio, United States
Novartis Investigative Site, Middletown, Ohio, United States
Novartis Investigative Site, Pittsburgh, Pennsylvania, United States
Novartis Investigative Site, East Providence, Rhode Island, United States
Novartis Investigative Site, Nashville, Tennessee, United States
Novartis Investigative Site, Nashville, Tennessee, United States
Novartis Investigative Site, Amarillo, Texas, United States
Novartis Investigative Site, Houston, Texas, United States
Novartis Investigative Site, Kennewick, Washington, United States
Novartis Investigative Site, Seattle, Washington, United States
Novartis Investigative Site, Walla Walla, Washington, United States
Novartis Investigative Site, Morgantown, West Virginia, United States
Novartis Investigative Site, La Plata, Buenos Aires, Argentina
Novartis Investigative Site, Buenos Aires, , Argentina
Novartis Investigative Site, Cordoba, , Argentina
Novartis Investigative Site, St Leonards, New South Wales, Australia
Novartis Investigative Site, Herston, Queensland, Australia
Novartis Investigative Site, Woolloongabba, Queensland, Australia
Novartis Investigative Site, Franston, Victoria, Australia
Novartis Investigative Site, Nedlands, Western Australia, Australia
Novartis Investigative Site, Perth, Western Australia, Australia
Novartis Investigative Site, Linz, , Austria
Novartis Investigative Site, Wien, , Austria
Novartis Investigative Site, Jette, Brussel, Belgium
Novartis Investigative Site, Bruxelles, , Belgium
Novartis Investigative Site, Hasselt, , Belgium
Novartis Investigative Site, Brasilia, DF, Brazil
Novartis Investigative Site, Rio de Janeiro, RJ, Brazil
Novartis Investigative Site, Rio de Janeiro, RJ, Brazil
Novartis Investigative Site, Rio de Janeiro, RJ, Brazil
Novartis Investigative Site, Barretos, SP, Brazil
Novartis Investigative Site, Campinas, SP, Brazil
Novartis Investigative Site, Sao Paulo, SP, Brazil
Novartis Investigative Site, São Paulo, SP, Brazil
Novartis Investigative Site, Halifax, Nova Scotia, Canada
Novartis Investigative Site, Hamilton, Ontario, Canada
Novartis Investigative Site, Toronto, Ontario, Canada
Novartis Investigative Site, Greenfield Park, Quebec, Canada
Novartis Investigative Site, Montreal, Quebec, Canada
Novartis Investigative Site, Beijing, Beijing, China
Novartis Investigative Site, Nanning, Guangxi, China
Novartis Investigative Site, Nanjing, Jiangsu, China
Novartis Investigative Site, Suzhou, Jiangsu, China
Novartis Investigative Site, Chengdu, Sichuan, China
Novartis Investigative Site, Tianjin, Tianjin, China
Novartis Investigative Site, Hangzhou, Zhejiang, China
Novartis Investigative Site, Beijing, , China
Novartis Investigative Site, Beijing, , China
Novartis Investigative Site, Shanghai, , China
Novartis Investigative Site, Shanghai, , China
Novartis Investigative Site, Brno Bohunice, Czech Republic, Czechia
Novartis Investigative Site, Prague 2, Czech Republic, Czechia
Novartis Investigative Site, Olomouc, CZE, Czechia
Novartis Investigative Site, Copenhagen, , Denmark
Novartis Investigative Site, Odense, , Denmark
Novartis Investigative Site, Vejle, , Denmark
Novartis Investigative Site, Ålborg, , Denmark
Novartis Investigative Site, Århus, , Denmark
Novartis Investigative Site, Alexandria, , Egypt
Novartis Investigative Site, Giza, , Egypt
Novartis Investigative Site, HUS Helsinki, , Finland
Novartis Investigative Site, Turku, , Finland
Novartis Investigative Site, Blois Cedex, , France
Novartis Investigative Site, Dijon, , France
Novartis Investigative Site, Lille Cedex, , France
Novartis Investigative Site, Limoges cedex, , France
Novartis Investigative Site, Nantes, , France
Novartis Investigative Site, Paris, , France
Novartis Investigative Site, Pierre Benite, , France
Novartis Investigative Site, Strasbourg cedex, , France
Novartis Investigative Site, Vandoeuvre Les Nancy, , France
Novartis Investigative Site, Aachen, , Germany
Novartis Investigative Site, Bad Saarow, , Germany
Novartis Investigative Site, Bamberg, , Germany
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Bremen, , Germany
Novartis Investigative Site, Dresden, , Germany
Novartis Investigative Site, Duisburg, , Germany
Novartis Investigative Site, Erlangen, , Germany
Novartis Investigative Site, Frankfurt, , Germany
Novartis Investigative Site, Hamburg, , Germany
Novartis Investigative Site, Jena, , Germany
Novartis Investigative Site, Kiel, , Germany
Novartis Investigative Site, Magdeburg, , Germany
Novartis Investigative Site, Muenchen, , Germany
Novartis Investigative Site, Rostock, , Germany
Novartis Investigative Site, Ulm, , Germany
Novartis Investigative Site, Wuerzburg, , Germany
Novartis Investigative Site, Thessaloniki, GR, Greece
Novartis Investigative Site, Athens, , Greece
Novartis Investigative Site, Hong Kong SAR, , Hong Kong
Novartis Investigative Site, Hong Kong, , Hong Kong
Novartis Investigative Site, New Territories, , Hong Kong
Novartis Investigative Site, Jerusalem, , Israel
Novartis Investigative Site, Kfar Saba, , Israel
Novartis Investigative Site, Petach Tikva, , Israel
Novartis Investigative Site, Ramat Gan, , Israel
Novartis Investigative Site, San Giovanni Rotondo, FG, Italy
Novartis Investigative Site, Lecce, LE, Italy
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Pescara, PE, Italy
Novartis Investigative Site, Pisa, PI, Italy
Novartis Investigative Site, Pavia, PV, Italy
Novartis Investigative Site, Reggio Calabria, RC, Italy
Novartis Investigative Site, Roma, RM, Italy
Novartis Investigative Site, Roma, RM, Italy
Novartis Investigative Site, Pagani, SA, Italy
Novartis Investigative Site, Verona, VR, Italy
Novartis Investigative Site, Napoli, , Italy
Novartis Investigative Site, Nagoya-city, Aichi, Japan
Novartis Investigative Site, Nagoya, Aichi, Japan
Novartis Investigative Site, Matsuyama-city, Ehime, Japan
Novartis Investigative Site, Fukuoka city, Fukuoka, Japan
Novartis Investigative Site, Ogaki-city, Gifu, Japan
Novartis Investigative Site, Shibukawa, Gunma, Japan
Novartis Investigative Site, Kure-city, Hiroshima, Japan
Novartis Investigative Site, Higashiibaraki-gun, Ibaraki, Japan
Novartis Investigative Site, Okayama city, Okayama, Japan
Novartis Investigative Site, Suita city, Osaka, Japan
Novartis Investigative Site, Shibuya, Tokyo, Japan
Novartis Investigative Site, Hiroshima, , Japan
Novartis Investigative Site, Niigata, , Japan
Novartis Investigative Site, Osaka, , Japan
Novartis Investigative Site, Suwon si, Gyeonggi Do, Korea, Republic of
Novartis Investigative Site, Seoul, Seocho Gu, Korea, Republic of
Novartis Investigative Site, Busan, , Korea, Republic of
Novartis Investigative Site, Busan, , Korea, Republic of
Novartis Investigative Site, Incheon, , Korea, Republic of
Novartis Investigative Site, Jeollanam-do, , Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Taegu, , Korea, Republic of
Novartis Investigative Site, Beirut, , Lebanon
Novartis Investigative Site, San Luis Potosí, , Mexico
Novartis Investigative Site, Rotterdam, , Netherlands
Novartis Investigative Site, Rotterdam, , Netherlands
Novartis Investigative Site, Utrecht, , Netherlands
Novartis Investigative Site, Bergen, , Norway
Novartis Investigative Site, Fredrikstad, , Norway
Novartis Investigative Site, Kristiansand, , Norway
Novartis Investigative Site, Oslo, , Norway
Novartis Investigative Site, Skien, , Norway
Novartis Investigative Site, Trondheim, , Norway
Novartis Investigative Site, Warszawa, , Poland
Novartis Investigative Site, Warszawa, , Poland
Novartis Investigative Site, Saratov, , Russian Federation
Novartis Investigative Site, St Petersburg, , Russian Federation
Novartis Investigative Site, Singapore, , Singapore
Novartis Investigative Site, Parktown, , South Africa
Novartis Investigative Site, Pretoria, , South Africa
Novartis Investigative Site, Cordoba, Andalucia, Spain
Novartis Investigative Site, Sevilla, Andalucia, Spain
Novartis Investigative Site, Salamanca, Castilla Y Leon, Spain
Novartis Investigative Site, Barcelona, Catalunya, Spain
Novartis Investigative Site, Valencia, Comunidad Valenciana, Spain
Novartis Investigative Site, Santiago de Compostela, Galicia, Spain
Novartis Investigative Site, Pamplona, Navarra, Spain
Novartis Investigative Site, San Sebastian, Pais Vasco, Spain
Novartis Investigative Site, La Laguna, Santa Cruz De Tenerife, Spain
Novartis Investigative Site, Barcelona, , Spain
Novartis Investigative Site, Göteborg, , Sweden
Novartis Investigative Site, Linköping, , Sweden
Novartis Investigative Site, Luleå, , Sweden
Novartis Investigative Site, Stockholm, , Sweden
Novartis Investigative Site, Uppsala, , Sweden
Novartis Investigative Site, Kaohsiung City, , Taiwan
Novartis Investigative Site, Taichung, , Taiwan
Novartis Investigative Site, Taipei, , Taiwan
Novartis Investigative Site, Taoyuan, , Taiwan
Novartis Investigative Site, Bangkok, , Thailand
Novartis Investigative Site, Bangkok, , Thailand
Novartis Investigative Site, Bangkok, , Thailand
Novartis Investigative Site, Istanbul, TUR, Turkey
Novartis Investigative Site, Adana, , Turkey
Novartis Investigative Site, Ankara, , Turkey
Novartis Investigative Site, Aberdeen, Scotland, United Kingdom
Novartis Investigative Site, Glasgow, Scotland, United Kingdom
Novartis Investigative Site, London, , United Kingdom
Novartis Investigative Site, London, , United Kingdom
Novartis Investigative Site, London, , United Kingdom
Novartis Investigative Site, London, , United Kingdom
Novartis Investigative Site, Manchester, , United Kingdom
Novartis Investigative Site, Wolverhampton, , United Kingdom
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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