Multiple Myeloma Clinical Trial

Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma

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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

767

Study ID:

NCT01023308

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 204 Locations for this study

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Novartis Investigative Site
Phoenix Arizona, , United States
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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, 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, B1900, Argentina
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Buenos Aires , C1114, Argentina
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Cordoba , X5000, 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-401, Austria
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Wien , A-109, Austria
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Jette Brussel, 1090, Belgium
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Bruxelles , 1200, Belgium
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Hasselt , 3500, Belgium
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Brasilia DF, 70710, Brazil
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Rio de Janeiro RJ, 20.21, Brazil
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Rio de Janeiro RJ, 20551, Brazil
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Rio de Janeiro RJ, 22640, Brazil
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Barretos SP, 14784, Brazil
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Campinas SP, 13083, Brazil
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Sao Paulo SP, 05403, Brazil
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São Paulo SP, 01224, Brazil
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Halifax Nova Scotia, B3H 1, Canada
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Hamilton Ontario, L8V 5, Canada
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Toronto Ontario, M5G 2, Canada
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Greenfield Park Quebec, J4V 2, Canada
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Montreal Quebec, H1T 2, Canada
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Beijing Beijing, 10073, China
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Nanning Guangxi, 53002, China
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Nanjing Jiangsu, 21002, China
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Suzhou Jiangsu, 21500, China
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Chengdu Sichuan, 61004, China
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Tianjin Tianjin, 30002, China
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Hangzhou Zhejiang, 31000, China
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Beijing , 10002, China
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Beijing , 10004, China
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Shanghai , 20000, China
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Shanghai , 20002, China
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Brno Bohunice Czech Republic, 625 0, Czechia
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Prague 2 Czech Republic, 128 0, Czechia
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Olomouc CZE, 775 2, Czechia
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Copenhagen , DK-21, Denmark
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Odense , DK 50, Denmark
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Vejle , DK-71, Denmark
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Ã…lborg , DK-91, Denmark
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Ã…rhus , DK-80, Denmark
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Alexandria , 21131, Egypt
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Giza , 11451, Egypt
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HUS Helsinki , FIN-0, Finland
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Turku , FIN-2, Finland
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Blois Cedex , 41016, France
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Dijon , 21034, France
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Lille Cedex , 59037, France
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Limoges cedex , 87042, France
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Nantes , 44035, France
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Paris , 75231, France
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Pierre Benite , 69310, France
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Strasbourg cedex , 67085, France
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Vandoeuvre Les 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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Muenchen , 81737, Germany
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Rostock , 18057, Germany
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Ulm , 89081, Germany
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Wuerzburg , 97080, Germany
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Thessaloniki GR, 570 1, Greece
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Athens , 115 2, Greece
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Hong Kong SAR , , Hong Kong
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Hong Kong , , Hong Kong
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New Territories , , Hong Kong
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Jerusalem , 91120, Israel
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Kfar Saba , 44281, Israel
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Petach Tikva , 49100, Israel
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Ramat Gan , 52656, Israel
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San Giovanni Rotondo FG, 71013, Italy
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Lecce LE, 73100, Italy
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Milano 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-city Aichi, 467-8, Japan
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Nagoya Aichi, 460-0, Japan
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Matsuyama-city Ehime, 790-8, Japan
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Fukuoka city Fukuoka, 812-8, Japan
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Ogaki-city Gifu, 503-8, Japan
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Shibukawa Gunma, 377-8, Japan
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Kure-city Hiroshima, 737-0, Japan
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Higashiibaraki-gun Ibaraki, 311-3, Japan
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Okayama city Okayama, 701-1, Japan
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Suita city Osaka, 565 0, Japan
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Shibuya Tokyo, 150-8, Japan
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Hiroshima , 734-8, Japan
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Niigata , 951-8, Japan
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Osaka , 545-8, Japan
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Suwon si Gyeonggi Do, 16499, Korea, Republic of
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Seoul Seocho Gu, 06591, Korea, Republic of
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Busan , 49201, Korea, Republic of
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Busan , 60273, Korea, Republic of
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Incheon , 405 7, Korea, Republic of
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Jeollanam-do , 51976, Korea, Republic of
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Seoul , 03080, Korea, Republic of
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Seoul , 03722, Korea, Republic of
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Seoul , 06351, Korea, Republic of
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Taegu , 41944, Korea, Republic of
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Beirut , 6301, Lebanon
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San Luis Potosí , 78218, Mexico
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Rotterdam , 3015 , Netherlands
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Rotterdam , , Netherlands
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Utrecht , 3584 , Netherlands
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Bergen , NO-50, Norway
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Fredrikstad , NO-16, Norway
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Kristiansand , NO-46, Norway
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Oslo , 0407, Norway
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Skien , NO-37, Norway
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Trondheim , 7006, Norway
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Warszawa , 02 77, Poland
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Warszawa , 02-09, Poland
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Saratov , 41002, Russian Federation
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St Petersburg , 19102, Russian Federation
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Singapore , 16960, Singapore
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Parktown , 2193, South Africa
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Pretoria , 0027, South Africa
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Cordoba Andalucia, 14004, Spain
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Sevilla Andalucia, 41013, Spain
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Salamanca Castilla Y Leon, 37007, Spain
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Barcelona Catalunya, 08036, Spain
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Valencia Comunidad Valenciana, 46026, Spain
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Santiago de Compostela Galicia, 15706, Spain
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Pamplona Navarra, 31008, Spain
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San Sebastian Pais Vasco, 20080, Spain
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La Laguna Santa Cruz De Tenerife, 38320, Spain
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Barcelona , 08041, Spain
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Göteborg , SE-41, Sweden
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Linköping , SE-58, Sweden
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Luleå , SE-97, Sweden
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Stockholm , SE-11, Sweden
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Uppsala , SE-75, 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 , 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
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Adana , 01330, Turkey
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Ankara , 06100, Turkey
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Aberdeen Scotland, AB25 , United Kingdom
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Glasgow Scotland, G12 0, United Kingdom
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London , EC1A , United Kingdom
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London , SE5 9, United Kingdom
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London , W12 0, United Kingdom
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London , WC1E , United Kingdom
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Manchester , M20 4, United Kingdom
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Wolverhampton , WV10 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

767

Study ID:

NCT01023308

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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