Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma
NCT ID: NCT01023308
Last Updated: 2020-03-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
767 participants
INTERVENTIONAL
2009-12-21
2015-07-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Panobinostat + Bortezomib + Dexamethasone
Panobinostat
Panobinostat was administered 3x week ( 2 weeks on 1 week off)
Bortezomib
Bortezomib was administered 2 x week ( 2weeks on 1 week off)
Dexamethasone
Dexamethasone was adminstered on day of Bortezomib and the day after Bortezomib administration
Placebo + Bortezomib + Dexamethasone
Bortezomib
Bortezomib was administered 2 x week ( 2weeks on 1 week off)
Dexamethasone
Dexamethasone was adminstered on day of Bortezomib and the day after Bortezomib administration
Placebo
Placebo was administered 3x week ( 2 weeks on 1 week off)
Interventions
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Panobinostat
Panobinostat was administered 3x week ( 2 weeks on 1 week off)
Bortezomib
Bortezomib was administered 2 x week ( 2weeks on 1 week off)
Dexamethasone
Dexamethasone was adminstered on day of Bortezomib and the day after Bortezomib administration
Placebo
Placebo was administered 3x week ( 2 weeks on 1 week off)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient requires retreatment for multiple myeloma
3. Patient has measurable M component in serum or urine at study screening
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Phoenix, Arizona, United States
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Anaheim, California, United States
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Concord, California, United States
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Los Angeles, California, United States
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San Diego, California, United States
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Stanford, California, United States
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Boca Raton, Florida, United States
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Lake Worth, Florida, United States
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Miami Shores, Florida, United States
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Athens, Georgia, United States
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Atlanta, Georgia, United States
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Marietta, Georgia, United States
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Marywood, Illinois, United States
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Quincy, Illinois, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Rockville, Maryland, United States
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Boston, Massachusetts, United States
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Southfield, Michigan, United States
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Edina, Minnesota, United States
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Minneapolis, Minnesota, United States
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Columbia, Missouri, United States
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East Orange, New Jersey, United States
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Mount Kisco, New York, United States
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Durham, North Carolina, United States
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Bismarck, North Dakota, United States
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Dayton, Ohio, United States
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Middletown, Ohio, United States
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Pittsburgh, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Amarillo, Texas, United States
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Houston, Texas, United States
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Kennewick, Washington, United States
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Seattle, Washington, United States
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Walla Walla, Washington, United States
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Morgantown, West Virginia, United States
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La Plata, Buenos Aires, Argentina
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Buenos Aires, , Argentina
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Córdoba, , Argentina
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St Leonards, New South Wales, Australia
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Herston, Queensland, Australia
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Woolloongabba, Queensland, Australia
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Franston, Victoria, Australia
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Nedlands, Western Australia, Australia
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Perth, Western Australia, Australia
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Linz, , Austria
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Vienna, , Austria
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Jette, Brussels Capital, Belgium
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Brussels, , Belgium
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Hasselt, , Belgium
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Brasília, Federal District, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Barretos, São Paulo, Brazil
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Campinas, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Halifax, Nova Scotia, Canada
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Hamilton, Ontario, Canada
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Toronto, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Beijing, Beijing Municipality, China
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Nanning, Guangxi, China
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Nanjing, Jiangsu, China
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Suzhou, Jiangsu, China
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Chengdu, Sichuan, China
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Tianjin, Tianjin Municipality, China
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Hangzhou, Zhejiang, China
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Beijing, , China
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Beijing, , China
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Shanghai, , China
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Shanghai, , China
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Brno Bohunice, Czech Republic, Czechia
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Prague, Czech Republic, Czechia
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Olomouc, CZE, Czechia
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Aalborg, , Denmark
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Aarhus, , Denmark
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Copenhagen, , Denmark
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Odense, , Denmark
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Vejle, , Denmark
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Alexandria, , Egypt
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Giza, , Egypt
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HUS Helsinki, , Finland
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Turku, , Finland
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Blois, , France
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Dijon, , France
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Lille, , France
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Limoges, , France
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Nantes, , France
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Pierre-Bénite, , France
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Strasbourg, , France
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Vandœuvre-lès-Nancy, , France
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Aachen, , Germany
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Bad Saarow, , Germany
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Bamberg, , Germany
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Bremen, , Germany
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Dresden, , Germany
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Erlangen, , Germany
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Jena, , Germany
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Magdeburg, , Germany
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München, , Germany
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Rostock, , Germany
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Ulm, , Germany
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Würzburg, , Germany
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Thessaloniki, GR, Greece
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Athens, , Greece
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New Territories, Hong Kong, Hong Kong
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Hong Kong, , Hong Kong
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Hong Kong SAR, , Hong Kong
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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San Giovanni Rotondo, FG, Italy
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Lecce, LE, Italy
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Milan, MI, Italy
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Pescara, PE, Italy
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Pisa, PI, Italy
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Pavia, PV, Italy
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Reggio Calabria, RC, Italy
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Roma, RM, Italy
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Roma, RM, Italy
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Pagani, SA, Italy
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Verona, VR, Italy
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Napoli, , Italy
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Nagoya, Aichi-ken, Japan
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Nagoya, Aichi-ken, Japan
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Matsuyama, Ehime, Japan
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Fukuoka, Fukuoka, Japan
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Ōgaki, Gifu, Japan
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Shibukawa, Gunma, Japan
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Kure, Hiroshima, Japan
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Higashiibaraki-gun, Ibaraki, Japan
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Okayama, Okayama-ken, Japan
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Suita, Osaka, Japan
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Shibuya City, Tokyo, Japan
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Hiroshima, , Japan
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Niigata, , Japan
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Osaka, , Japan
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Beirut, , Lebanon
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San Luis Potosí City, , Mexico
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Rotterdam, , Netherlands
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Rotterdam, , Netherlands
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Utrecht, , Netherlands
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Bergen, , Norway
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Fredrikstad, , Norway
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Kristiansand, , Norway
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Oslo, , Norway
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Skien, , Norway
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Trondheim, , Norway
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Warsaw, , Poland
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Warsaw, , Poland
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Saint Petersburg, , Russia
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Saratov, , Russia
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Singapore, , Singapore
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Parktown, , South Africa
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Pretoria, , South Africa
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Suwon, Gyeonggi-do, South Korea
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Jeollanam-do, Jeollanam-do, South Korea
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Seoul, Seocho Gu, South Korea
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Busan, , South Korea
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Busan, , South Korea
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Incheon, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Taegu, , South Korea
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Córdoba, Andalusia, Spain
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Seville, Andalusia, Spain
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Donostia / San Sebastian, Basque Country, Spain
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Salamanca, Castille and León, Spain
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Barcelona, Catalonia, Spain
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Santiago de Compostela, Galicia, Spain
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Pamplona, Navarre, Spain
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San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
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Valencia, Valencia, Spain
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Barcelona, , Spain
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Gothenburg, , Sweden
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Linköping, , Sweden
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Luleå, , Sweden
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Stockholm, , Sweden
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Uppsala, , Sweden
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Istanbul, TUR, Turkey (Türkiye)
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Adana, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Aberdeen, Scotland, United Kingdom
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Glasgow, Scotland, United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Wolverhampton, , United Kingdom
Countries
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References
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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.
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.
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.
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.
Related Links
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Related Info
Other Identifiers
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2009-015507-52
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLBH589D2308
Identifier Type: -
Identifier Source: org_study_id
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