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.
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.
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There are 204 Locations for this study
Phoenix Arizona, , United States
Anaheim California, 92801, United States
Concord California, 94520, United States
Los Angeles California, 90027, United States
San Diego California, 92120, United States
Stanford California, 94304, United States
Boca Raton Florida, 33486, United States
Lake Worth Florida, 33467, United States
Miami Shores Florida, 33138, United States
Athens Georgia, 30607, United States
Atlanta Georgia, 30322, United States
Marietta Georgia, 30060, United States
Marywood Illinois, 60153, United States
Quincy Illinois, 62301, United States
New Orleans Louisiana, 70115, United States
Baltimore Maryland, 21229, United States
Rockville Maryland, 20850, United States
Boston Massachusetts, 02215, United States
Southfield Michigan, , United States
Edina Minnesota, 55435, United States
Minneapolis Minnesota, 55404, United States
Columbia Missouri, 65201, United States
East Orange New Jersey, 07018, United States
Mount Kisco New York, 10549, United States
Durham North Carolina, 27710, United States
Bismarck North Dakota, 58501, United States
Dayton Ohio, 45429, United States
Middletown Ohio, 45042, United States
Pittsburgh Pennsylvania, 15224, United States
East Providence Rhode Island, 02915, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Amarillo Texas, 79106, United States
Houston Texas, 77030, United States
Kennewick Washington, 99336, United States
Seattle Washington, 98104, United States
Walla Walla Washington, 33962, United States
Morgantown West Virginia, 26506, United States
La Plata Buenos Aires, B1900, Argentina
Buenos Aires , C1114, Argentina
Cordoba , X5000, Argentina
St Leonards New South Wales, 2065, Australia
Herston Queensland, 4029, Australia
Woolloongabba Queensland, 4102, Australia
Franston Victoria, 3199, Australia
Nedlands Western Australia, 6009, Australia
Perth Western Australia, 6000, Australia
Linz , A-401, Austria
Wien , A-109, Austria
Jette Brussel, 1090, Belgium
Bruxelles , 1200, Belgium
Hasselt , 3500, Belgium
Brasilia DF, 70710, Brazil
Rio de Janeiro RJ, 20.21, Brazil
Rio de Janeiro RJ, 20551, Brazil
Rio de Janeiro RJ, 22640, Brazil
Barretos SP, 14784, Brazil
Campinas SP, 13083, Brazil
Sao Paulo SP, 05403, Brazil
São Paulo SP, 01224, Brazil
Halifax Nova Scotia, B3H 1, Canada
Hamilton Ontario, L8V 5, Canada
Toronto Ontario, M5G 2, Canada
Greenfield Park Quebec, J4V 2, Canada
Montreal Quebec, H1T 2, Canada
Beijing Beijing, 10073, China
Nanning Guangxi, 53002, China
Nanjing Jiangsu, 21002, China
Suzhou Jiangsu, 21500, China
Chengdu Sichuan, 61004, China
Tianjin Tianjin, 30002, China
Hangzhou Zhejiang, 31000, China
Beijing , 10002, China
Beijing , 10004, China
Shanghai , 20000, China
Shanghai , 20002, China
Brno Bohunice Czech Republic, 625 0, Czechia
Prague 2 Czech Republic, 128 0, Czechia
Olomouc CZE, 775 2, Czechia
Copenhagen , DK-21, Denmark
Odense , DK 50, Denmark
Vejle , DK-71, Denmark
Ã…lborg , DK-91, Denmark
Ã…rhus , DK-80, Denmark
Alexandria , 21131, Egypt
Giza , 11451, Egypt
HUS Helsinki , FIN-0, Finland
Turku , FIN-2, Finland
Blois Cedex , 41016, France
Dijon , 21034, France
Lille Cedex , 59037, France
Limoges cedex , 87042, France
Nantes , 44035, France
Paris , 75231, France
Pierre Benite , 69310, France
Strasbourg cedex , 67085, France
Vandoeuvre Les Nancy , 54511, France
Aachen , 52074, Germany
Bad Saarow , 15526, Germany
Bamberg , 96049, Germany
Berlin , 13353, Germany
Bremen , 28177, Germany
Dresden , 01307, Germany
Duisburg , 47166, Germany
Erlangen , 91054, Germany
Frankfurt , 60590, Germany
Hamburg , 22763, Germany
Jena , 07740, Germany
Kiel , 24105, Germany
Magdeburg , 39120, Germany
Muenchen , 81737, Germany
Rostock , 18057, Germany
Ulm , 89081, Germany
Wuerzburg , 97080, Germany
Thessaloniki GR, 570 1, Greece
Athens , 115 2, Greece
Hong Kong SAR , , Hong Kong
Hong Kong , , Hong Kong
New Territories , , Hong Kong
Jerusalem , 91120, Israel
Kfar Saba , 44281, Israel
Petach Tikva , 49100, Israel
Ramat Gan , 52656, Israel
San Giovanni Rotondo FG, 71013, Italy
Lecce LE, 73100, Italy
Milano MI, 20133, Italy
Pescara PE, 65124, Italy
Pisa PI, 56126, Italy
Pavia PV, 27100, Italy
Reggio Calabria RC, 89124, Italy
Roma RM, 00144, Italy
Roma RM, 00161, Italy
Pagani SA, 84016, Italy
Verona VR, 37134, Italy
Napoli , 80131, Italy
Nagoya-city Aichi, 467-8, Japan
Nagoya Aichi, 460-0, Japan
Matsuyama-city Ehime, 790-8, Japan
Fukuoka city Fukuoka, 812-8, Japan
Ogaki-city Gifu, 503-8, Japan
Shibukawa Gunma, 377-8, Japan
Kure-city Hiroshima, 737-0, Japan
Higashiibaraki-gun Ibaraki, 311-3, Japan
Okayama city Okayama, 701-1, Japan
Suita city Osaka, 565 0, Japan
Shibuya Tokyo, 150-8, Japan
Hiroshima , 734-8, Japan
Niigata , 951-8, Japan
Osaka , 545-8, Japan
Suwon si Gyeonggi Do, 16499, Korea, Republic of
Seoul Seocho Gu, 06591, Korea, Republic of
Busan , 49201, Korea, Republic of
Busan , 60273, Korea, Republic of
Incheon , 405 7, Korea, Republic of
Jeollanam-do , 51976, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06351, Korea, Republic of
Taegu , 41944, Korea, Republic of
Beirut , 6301, Lebanon
San Luis Potosà , 78218, Mexico
Rotterdam , 3015 , Netherlands
Rotterdam , , Netherlands
Utrecht , 3584 , Netherlands
Bergen , NO-50, Norway
Fredrikstad , NO-16, Norway
Kristiansand , NO-46, Norway
Oslo , 0407, Norway
Skien , NO-37, Norway
Trondheim , 7006, Norway
Warszawa , 02 77, Poland
Warszawa , 02-09, Poland
Saratov , 41002, Russian Federation
St Petersburg , 19102, Russian Federation
Singapore , 16960, Singapore
Parktown , 2193, South Africa
Pretoria , 0027, South Africa
Cordoba Andalucia, 14004, Spain
Sevilla Andalucia, 41013, Spain
Salamanca Castilla Y Leon, 37007, Spain
Barcelona Catalunya, 08036, Spain
Valencia Comunidad Valenciana, 46026, Spain
Santiago de Compostela Galicia, 15706, Spain
Pamplona Navarra, 31008, Spain
San Sebastian Pais Vasco, 20080, Spain
La Laguna Santa Cruz De Tenerife, 38320, Spain
Barcelona , 08041, Spain
Göteborg , SE-41, Sweden
Linköping , SE-58, Sweden
Luleå , SE-97, Sweden
Stockholm , SE-11, Sweden
Uppsala , SE-75, Sweden
Kaohsiung City , 83301, Taiwan
Taichung , 40447, Taiwan
Taipei , 10048, Taiwan
Taoyuan , 333, Taiwan
Bangkok , 10330, Thailand
Bangkok , 10400, Thailand
Bangkok , 10700, Thailand
Istanbul TUR, 34098, Turkey
Adana , 01330, Turkey
Ankara , 06100, Turkey
Aberdeen Scotland, AB25 , United Kingdom
Glasgow Scotland, G12 0, United Kingdom
London , EC1A , United Kingdom
London , SE5 9, United Kingdom
London , W12 0, United Kingdom
London , WC1E , United Kingdom
Manchester , M20 4, United Kingdom
Wolverhampton , WV10 , United Kingdom
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