Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma
PANORAMA-1
A Multicenter, Randomized, Double Blind, Placebo Controlled Phase III Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma
2 other identifiers
interventional
767
33 countries
204
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 multiple-myeloma
Started Dec 2009
204 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2009
CompletedFirst Posted
Study publicly available on registry
December 2, 2009
CompletedStudy Start
First participant enrolled
December 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2015
CompletedResults Posted
Study results publicly available
October 23, 2015
CompletedMarch 17, 2020
March 1, 2020
5.6 years
November 30, 2009
March 23, 2015
March 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression-free Survival Events in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.
45 months
Progression Free Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.
45 months
Secondary Outcomes (9)
Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone
45 months
Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone
45 months
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.
45 months
Time to Response Per Investigator Assessment (mEBMT Criteria) of Response Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.
45 months
Duration of Response Per Investigator Assessment (mEBMT Criteria) Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.
45 months
- +4 more secondary outcomes
Study Arms (2)
Panobinostat + Bortezomib + Dexamethasone
EXPERIMENTALPlacebo + Bortezomib + Dexamethasone
PLACEBO COMPARATORInterventions
Panobinostat was administered 3x week ( 2 weeks on 1 week off)
Bortezomib was administered 2 x week ( 2weeks on 1 week off)
Dexamethasone was adminstered on day of Bortezomib and the day after Bortezomib administration
Placebo was administered 3x week ( 2 weeks on 1 week off)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (210)
Novartis Investigative Site
Phoenix, Arizona, United States
Novartis Investigative Site
Anaheim, California, 92801, United States
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Concord, California, 94520, United States
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Los Angeles, California, 90027, United States
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San Diego, California, 92120, United States
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Stanford, California, 94304, United States
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Boca Raton, Florida, 33486, United States
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Lake Worth, Florida, 33467, United States
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Miami Shores, Florida, 33138, United States
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Athens, Georgia, 30607, United States
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Atlanta, Georgia, 30322, United States
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Marietta, Georgia, 30060, United States
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Marywood, Illinois, 60153, United States
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Quincy, Illinois, 62301, United States
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New Orleans, Louisiana, 70115, United States
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Baltimore, Maryland, 21229, United States
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Rockville, Maryland, 20850, United States
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Boston, Massachusetts, 02215, United States
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Southfield, Michigan, United States
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Edina, Minnesota, 55435, United States
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Minneapolis, Minnesota, 55404, United States
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Columbia, Missouri, 65201, United States
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East Orange, New Jersey, 07018-1095, United States
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Mount Kisco, New York, 10549, United States
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Durham, North Carolina, 27710, United States
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Bismarck, North Dakota, 58501, United States
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Dayton, Ohio, 45429, United States
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Middletown, Ohio, 45042, United States
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Pittsburgh, Pennsylvania, 15224, United States
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East Providence, Rhode Island, 02915, United States
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Nashville, Tennessee, 37203, United States
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Nashville, Tennessee, 37232, United States
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Amarillo, Texas, 79106, United States
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Houston, Texas, 77030, United States
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Kennewick, Washington, 99336, United States
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Seattle, Washington, 98104, United States
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Walla Walla, Washington, 33962, United States
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Morgantown, West Virginia, 26506, United States
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La Plata, Buenos Aires, B1900AWT, Argentina
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Buenos Aires, C1114AAN, Argentina
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Córdoba, X5000JHQ, Argentina
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St Leonards, New South Wales, 2065, Australia
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Herston, Queensland, 4029, Australia
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Woolloongabba, Queensland, 4102, Australia
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Franston, Victoria, 3199, Australia
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Nedlands, Western Australia, 6009, Australia
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Perth, Western Australia, 6000, Australia
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Linz, A-4010, Austria
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Vienna, A-1090, Austria
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Jette, Brussels Capital, 1090, Belgium
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Brussels, 1200, Belgium
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Hasselt, 3500, Belgium
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Brasília, Federal District, 70710-904, Brazil
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Rio de Janeiro, Rio de Janeiro, 20.211-030, Brazil
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Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil
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Rio de Janeiro, Rio de Janeiro, 22640-102, Brazil
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Barretos, São Paulo, 14784 400, Brazil
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Campinas, São Paulo, 13083-970, Brazil
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São Paulo, São Paulo, 01224-000, Brazil
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São Paulo, São Paulo, 05403 000, Brazil
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Halifax, Nova Scotia, B3H 1V7, Canada
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Hamilton, Ontario, L8V 5C2, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Greenfield Park, Quebec, J4V 2H1, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Beijing, Beijing Municipality, 100730, China
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Nanning, Guangxi, 530021, China
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Nanjing, Jiangsu, 210029, China
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Suzhou, Jiangsu, 215006, China
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Chengdu, Sichuan, 610041, China
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Tianjin, Tianjin Municipality, 300020, China
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Hangzhou, Zhejiang, 310003, China
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Beijing, 100020, China
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Beijing, 100044, China
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Shanghai, 200003, China
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Olomouc, CZE, 775 20, Czechia
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Aalborg, DK-9100, Denmark
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Aarhus, DK-8000, Denmark
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Copenhagen, DK-2100, Denmark
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Odense, DK 5000, Denmark
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Vejle, DK-7100, Denmark
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Alexandria, 21131, Egypt
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Giza, 11451, Egypt
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HUS Helsinki, FIN-00029, Finland
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Turku, FIN-20521, Finland
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Blois, 41016, France
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Dijon, 21034, France
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Lille, 59037, France
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Limoges, 87042, France
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Nantes, 44035, France
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Paris, 75231, France
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Pierre-Bénite, 69310, France
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Strasbourg, 67085, France
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Vandœuvre-lès-Nancy, 54511, France
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Aachen, 52074, Germany
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Bad Saarow, 15526, Germany
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Bamberg, 96049, Germany
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Berlin, 13353, Germany
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Bremen, 28177, Germany
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Dresden, 01307, Germany
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Duisburg, 47166, Germany
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Erlangen, 91054, Germany
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Frankfurt, 60590, Germany
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Hamburg, 22763, Germany
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Jena, 07740, Germany
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Kiel, 24105, Germany
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Magdeburg, 39120, Germany
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München, 81737, Germany
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Rostock, 18057, Germany
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Ulm, 89081, Germany
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Würzburg, 97080, Germany
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Thessaloniki, GR, 570 10, Greece
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Athens, 115 28, 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, 91120, Israel
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Kfar Saba, 4428164, Israel
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Petah Tikva, 49100, Israel
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Ramat Gan, 5265601, Israel
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San Giovanni Rotondo, FG, 71013, Italy
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Lecce, LE, 73100, Italy
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Milan, MI, 20133, Italy
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Pescara, PE, 65124, Italy
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Pisa, PI, 56126, Italy
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Pavia, PV, 27100, Italy
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Reggio Calabria, RC, 89124, Italy
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Roma, RM, 00144, Italy
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Roma, RM, 00161, Italy
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Pagani, SA, 84016, Italy
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Verona, VR, 37134, Italy
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Napoli, 80131, Italy
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Nagoya, Aichi-ken, 460-0001, Japan
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Nagoya, Aichi-ken, 467-8602, Japan
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Matsuyama, Ehime, 790-8524, Japan
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Fukuoka, Fukuoka, 812-8582, Japan
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Ōgaki, Gifu, 503-8502, Japan
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Shibukawa, Gunma, 377-8511, Japan
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Kure, Hiroshima, 737-0023, Japan
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Higashiibaraki-gun, Ibaraki, 311-3193, Japan
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Okayama, Okayama-ken, 701-1192, Japan
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Suita, Osaka, 565 0871, Japan
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Shibuya City, Tokyo, 150-8935, Japan
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Hiroshima, 734-8551, Japan
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Niigata, 951-8566, Japan
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Osaka, 545-8586, Japan
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Beirut, 6301, Lebanon
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San Luis Potosí City, 78218, Mexico
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Rotterdam, 3015 CE, Netherlands
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Rotterdam, Netherlands
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Utrecht, 3584 CX, Netherlands
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Bergen, NO-5021, Norway
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Fredrikstad, NO-1603, Norway
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Kristiansand, NO-4605, Norway
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Oslo, 0407, Norway
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Skien, NO-3710, Norway
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Trondheim, 7006, Norway
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Warsaw, 02 776, Poland
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Warsaw, 02-097, Poland
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Saint Petersburg, 191024, Russia
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Saratov, 410028, Russia
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Singapore, 169608, Singapore
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Parktown, 2193, South Africa
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Pretoria, 0027, South Africa
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Suwon, Gyeonggi-do, 16499, South Korea
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Jeollanam-do, Jeollanam-do, 519763, South Korea
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Seoul, Seocho Gu, 06591, South Korea
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Busan, 49201, South Korea
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Busan, 602739, South Korea
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Incheon, 405 760, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 06351, South Korea
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Taegu, 41944, South Korea
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Córdoba, Andalusia, 14004, Spain
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Seville, Andalusia, 41013, Spain
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Donostia / San Sebastian, Basque Country, 20080, Spain
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Salamanca, Castille and León, 37007, Spain
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Barcelona, Catalonia, 08036, Spain
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Santiago de Compostela, Galicia, 15706, Spain
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Pamplona, Navarre, 31008, Spain
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San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain
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Valencia, Valencia, 46026, Spain
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Barcelona, 08041, Spain
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Gothenburg, SE-413 45, Sweden
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Linköping, SE-581 85, Sweden
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Luleå, SE-971 80, Sweden
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Stockholm, SE-118 83, Sweden
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Uppsala, SE-751 85, Sweden
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Kaohsiung City, 83301, Taiwan
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Taichung, 40447, Taiwan
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Taipei, 10048, Taiwan
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Taoyuan District, 333, Taiwan
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Istanbul, TUR, 34098, Turkey (Türkiye)
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Adana, 01330, Turkey (Türkiye)
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Ankara, 06100, Turkey (Türkiye)
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Aberdeen, Scotland, AB25 2ZN, United Kingdom
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Glasgow, Scotland, G12 0YN, United Kingdom
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London, EC1A 7BE, United Kingdom
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London, SE5 9RS, United Kingdom
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London, W12 0HS, United Kingdom
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London, WC1E 6HX, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Wolverhampton, WV10 0QP, United Kingdom
Related Publications (4)
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.
PMID: 27751707DERIVEDSan-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.
PMID: 27677481DERIVEDRichardson 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.
PMID: 26631116DERIVEDSan-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.
PMID: 25242045DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2009
First Posted
December 2, 2009
Study Start
December 21, 2009
Primary Completion
July 30, 2015
Study Completion
July 30, 2015
Last Updated
March 17, 2020
Results First Posted
October 23, 2015
Record last verified: 2020-03