Spots Global Cancer Trial Database for A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participants With Multiple Myeloma Following Autologous Stem Cell Transplant
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Trial Identification
Brief Title: A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participants With Multiple Myeloma Following Autologous Stem Cell Transplant
Official Title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Patients With Multiple Myeloma Following Autologous Stem Cell Transplant
Study ID: NCT02181413
Study Description
Brief Summary: The purpose of this study is to determine the effect of ixazomib citrate maintenance therapy on progression-free survival (PFS), compared to placebo, in participants with newly diagnosed multiple myeloma (NDMM) who have had a response (complete response \[CR\], very good partial response \[VGPR\], or partial response \[PR\]) to induction therapy followed by high-dose therapy (HDT) and autologous stem cell transplant (ASCT).
Detailed Description: The investigational drug being tested in this study is called ixazomib citrate. Ixazomib citrate is being tested to slow disease progression and improve overall survival in people who have NDMM and who have had any type of positive response to induction therapy followed by HDT and ASCT. This study will look at the effect ixazomib citrate has on the length of time that participants are free of progressive disease (PD) and their overall survival (OS). The study enrolled 656 participants. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need, or if the disease has progressed and the information is required for planning the next treatment): * Ixazomib citrate 3 mg for the first 4 cycles, then 4 mg for the remaining 22 cycles * Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has no active ingredient. All participants will be asked to take one capsule on Days 1, 8 and 15 of each 28-day cycle, for up to 26 cycles (approximately 24 months). This multi-center trial will be conducted globally. The overall time to participate in this study is up to 107 months. Participants will make 28 visits to the clinic during the treatment period and will continue to make visits after treatment has ended. During this initial follow up period, participants will be assessed for disease status with follow up every 12 weeks. After the next line of therapy begins, follow-up will occur every 12 weeks until death or termination of the study.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Mayo Clinic - PPDS, Rochester, Minnesota, United States
Montefiore Medical Center, Bronx, New York, United States
Penn State Health Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Baylor University Medical Center, Dallas, Texas, United States
West Virginia University Hospital, Morgantown, West Virginia, United States
Hospital Italiano de La Plata, La Plata, Buenos Aires, Argentina
Instituto de Hematologia Y Medicina Clinica Dr Ruben Davoli, Rosario, Santa Fe, Argentina
Sanatorio Britanico de Rosario, Rosario, Santa Fe, Argentina
Sanatorio Parque de Rosario, Rosario, Santa Fe, Argentina
Hospital Italiano de Buenos Aires, Ciudad Autonoma de Buenos Aires, , Argentina
Hospital Iturraspe, Santa Fe, , Argentina
St George Hospital, Kogarah, New South Wales, Australia
Calvary Mater Newcastle, Waratah, New South Wales, Australia
Westmead Hospital, Westmead, New South Wales, Australia
Icon Cancer Care South Brisbane, South Brisbane, Queensland, Australia
Gold Coast University Hospital, Southport, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
The Queen Elizabeth Hospital, Woodville South, South Australia, Australia
Austin Health, Heidelberg, Victoria, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Elisabethinen Hospital Linz, Linz, , Austria
Salzburger Landeskliniken, Salzburg, , Austria
Allgemeines Krankenhaus der Stadt Wien, Wien, , Austria
Klinik Ottakring (fruher: Wilhelminenspital), Wien, , Austria
Centre Hospitalier Jolimont-Lobbes, La Louviere, Hainaut, Belgium
Centre Hospitalier Universitaire Ambroise Pare, Mons, Hainaut, Belgium
UZ Gent, Gent, Oost-Vlaanderen, Belgium
AZ Sint-Jan AV, Brugge, West-Vlaanderen, Belgium
ZNA Middelheim, Antwerpen, , Belgium
ZNA Stuivenberg, Antwerpen, , Belgium
Hospital Das Clinicas Da Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil
Instituto de Oncologia Do Parana, Curitiba, Parana, Brazil
Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner, Curitiba, Parana, Brazil
Hospital de Clinicas de Passo Fundo, Passo Fundo, Rio Grande Do Sul, Brazil
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS, Porto Alegre, Rio Grande Do Sul, Brazil
Mae de Deus Center Hospital Giovanni Battista, Porto Alegre, Rio Grande Do Sul, Brazil
Centro de Pesquisas Oncologicas, Florianopolis, Santa Catarina, Brazil
Instituto Joinvilense de Hematologia E Oncologia, Joinville, Santa Catarina, Brazil
Hospital Amaral Carvalho, Jau, Sao Paulo, Brazil
Hospital de Base Da FAMERP, Sao Jose Do Rio Preto, Sao Paulo, Brazil
Instituto Nacional de Cancer, Rio De Janeiro, , Brazil
Universidade Federal do Rio de Janeiro - UFRJ, Rio de Janeiro, , Brazil
Irmandade Da Santa Casa de Misericordia de Sao Paulo, Sao Paulo, , Brazil
Hospital Israelita Albert Einstein, Sao Paulo, , Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, , Brazil
University Health Network, Toronto, Ontario, Canada
MUHC-Glen Site, Montreal, Quebec, Canada
Instituto Nacional de Cancerologia Colombia, Bogota, Cundinamarca, Colombia
Fundacion Valle Del Lili, Cali, Valle Del Cauca, Colombia
Hospital Pablo Tobon Uribe, Medellin, , Colombia
Fakultni nemocnice Hradec Kralove, Hradec Kralove, Kralovehradeck Kraj, Czechia
Fakultni nemocnice Brno, Brno, , Czechia
Fakultni nemocnice Olomouc, Olomouc, , Czechia
Fakultni nemocnice Ostrava, Ostrava, , Czechia
Vseobecna Fakultni Nemocnice V Praze, Praha 2, , Czechia
Fakultni nemocnice Kralovske Vinohrady, Praha, , Czechia
Herlev Hospital, Herlev, Capital, Denmark
Aalborg Universitetshospital, Aalborg, Nordjylland, Denmark
Aarhus Universitetshospital Arhus Sygehus, Aarhus N, , Denmark
Rigshospitalet, Copenhagen, , Denmark
Odense Universitetshospital, Odense, , Denmark
Sjallands Universitetshospital, Roskilde, Roskilde, , Denmark
Vejle Sygehus, Vejle, , Denmark
Hopital Antoine Beclere, Clamart, Hauts-de-Seine, France
Hotel Dieu - Nantes, Nantes, Loire-Atlantique, France
CHRU Lille, Lille, Nord, France
Hopital Universitaire Dupuytren, Limoges, , France
Groupe Hospitalier Necker Enfants Malades, Paris, , France
University Clinic Heidelberg, Heidelberg, Baden-Wurttemberg, Germany
Klinikum Mannheim Universitatsklinikum gGmbH, Mannheim, Baden-Wurttemberg, Germany
Universitatsklinikum Ulm, Ulm, Baden-Wurttemberg, Germany
LMU Klinikum der Universitat Munchen, Munchen, Bayern, Germany
Universitatsklinikum Wurzburg, Wurzburg, Bayern, Germany
Klinikum Darmstadt GmbH, Darmstadt, Hessen, Germany
Klinikum Frankfurt Hochst GmbH, Frankfurt am Main, Hessen, Germany
Pius Hospital Oldenburg, Oldenburg, Niedersachsen, Germany
Universitatsklinikum Bonn, Bonn, Nordrhein-Westfalen, Germany
Universitatsklinikum Essen, Essen, Nordrhein-Westfalen, Germany
Evangelisches Krankenhaus Essen Werden gGmbH, Essen, Nordrhein-Westfalen, Germany
Katholisches Krankenhaus Hagen gGmbH, Hagen, Nordrhein-Westfalen, Germany
Uniklinik Koln, Koln, Nordrhein-Westfalen, Germany
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz, Mainz, Rheinland-Pfalz, Germany
Universitatsklinikum Carl Gustav Carus an der TU Dresden, Dresden, Sachsen, Germany
Helios Klinikum Berlin-Buch, Berlin, , Germany
Charite - Universitatsmedizin Berlin, Berlin, , Germany
Asklepios Klinik St. Georg, Hamburg, , Germany
Universitatsklinikum Hamburg Eppendorf, Hamburg, , Germany
Asklepios Klinik Altona, Hamburg, , Germany
KRH Klinikum Siloah-Oststadt-Heidehaus, Hannover, , Germany
Klinikum der Stadt Ludwigshafen gGmbH, Ludwigshafen, , Germany
Universitatsklinikum Tubingen, Tubingen, , Germany
Evangelismos General Hospital of Athens, Athens, Attiki, Greece
Laiko General Hospital of Athens, Athens, Attiki, Greece
Alexandra Hospital, Athens, , Greece
Georgios Papanikolaou General Hospital of Thessaloniki, Thessaloniki, , Greece
Semmelweis Egyetem, Budapest, , Hungary
Del-pesti Centrumkorhaz- Orszagos Hematologiai es Infektologiai Intezet, Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont, Debrecen, , Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz, Kaposvar, , Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Szeged, , Hungary
Barzilai Medical Center, Ashkelon, , Israel
Soroka University Medical Centre, Be'er Sheva, , Israel
Bnai Zion Medical Center, Haifa, , Israel
Rambam Medical Center - PPDS, Haifa, , Israel
Lady Davis Carmel Medical Center, Haifa, , Israel
Shaare Zedek Medical Center, Jerusalem, , Israel
Hadassah Medical Center PPDS -, Jerusalem, , Israel
Galilee Medical Center, Nahariya, , Israel
Rabin Medical Center - PPDS, Petach Tikva, , Israel
Sheba Medical Center - PPDS, Ramat-Gan, , Israel
Kaplan Medical Center, Rehovot, , Israel
ZIV Medical Center, Safed, , Israel
Tel Aviv Sourasky Medical Center PPDS, Tel Aviv, , Israel
Shamir Medical Center Assaf Harofeh, Tzrifin, , Israel
Presidio Ospedaliero di Pescara, Pescara, Abruzzo, Italy
Azienda Ospedaliera San Camillo Forlanini, Roma, Lazio, Italy
Fondazione IRCCS Policlinico San Matteo di Pavia, Pavia, Lombardia, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi, Ancona, Marche, Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino, Torino, Piemonte, Italy
IRCCS Centro Di Riferimento Oncologico Della Basilicata, Rionero In Vulture, Potenza, Italy
Azienda Ospedaliera S Maria Di Terni, Terni, Umbria, Italy
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi, Bologna, , Italy
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN, Brescia, , Italy
Azienda Ospedaliera Universitaria Careggi, Firenze, , Italy
IRCCS Az. Osp. Universitaria San Martino- IST, Genova, , Italy
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l - PPDS, Meldola, , Italy
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda, Milano, , Italy
Ospedale Infermi di Rimini, Rimini, , Italy
Kobe City Medical Center General Hospital, Kobe-City, Hyogo, Japan
Iwate Medical University Hospital, Morioka-shi, Iwate, Japan
National Hospital Organization Sendai Medical Center, Sendai, Miyagi, Japan
Niigata Cancer Center Hospital, Niigata-shi, Niigata, Japan
National Hospital Organization Okayama Medical Center, Okayama-City, Okayama, Japan
Saitama Medical Center, Kawagoe-city, Saitama, Japan
Juntendo University Hospital, Bunkyo, Tokyo, Japan
Chiba University Hospital, Chiba, Tokyo, Japan
Japanese Red Cross Medical Center, Shibuya-ku, Tokyo, Japan
Keio University Hospital, Shinjuku-ku, Tokyo, Japan
Center Hospital of the National Center for Global Health and Medicine, Shinjuku, Tokyo, Japan
Kyushu University Hospital, Fukuoka-City, , Japan
Nagoya City University Hospital, Nagoya-City, , Japan
National Hospital Organization Nagoya Medical Center, Nagoya, , Japan
National Hospital Organaization Shibukawa Medical Center, Shibukawa, , Japan
National Hospital Organization Disaster Medical Center, Tachikawa, , Japan
Toyohashi Municipal Hospital, Toyohashi-City, , Japan
National Cancer Center, Goyang, Gyeonggido, Korea, Republic of
Chungnam National University Hospital, Daejeon, , Korea, Republic of
Gachon University Gil Medical Center Pharmacy, Incheon, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System - PPDS, Seoul, , Korea, Republic of
Samsung Medical Center - PPDS, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Asan Medical Center - PPDS, Seoul, , Korea, Republic of
Ewha Womans University Mokdong Hospital, Seoul, , Korea, Republic of
Centro de Investigacion Farmaceutica Especializada de Occidente, SC - PPDS, Guadalajara, Jalisco, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey, Nuevo Leon, Mexico
VU Medisch Centrum, Amsterdam, Noord-Holland, Netherlands
Albert Schweitzer Ziekenhuis, Dordrecht, Zuid-Holland, Netherlands
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
Erasmus MC, Rotterdam, , Netherlands
Universitair Medisch Centrum Utrecht, Utrecht, , Netherlands
Vestre Viken HF Sykehuset Asker Og Barum, Gjelta, Oppland, Norway
St. Olav's University Hospital, Trondheim, Sor-Trondelag, Norway
Oslo Universitetssykehus HF, Ulleval, Oslo, , Norway
Stavanger Universitetssykehus, Stavanger, , Norway
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu, Wroclaw, Dolnoslaskie, Poland
Wojskowy Instytut Medyczny, Warszawa, Mazowieckie, Poland
Uniwersyteckie Centrum Kliniczne, Gdansk, Pomorskie, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich, Chorzow, Slaskie, Poland
Szpital Specjalistyczny w Brzozowie, Brzozow, , Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Lodz, , Poland
Hospital de Braga, Braga, , Portugal
Centro Hospitalar E Universitario de Coimbra EPE, Coimbra, , Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS, Porto, , Portugal
Centro Hospitalar de Sao Joao, E.P.E., Porto, , Portugal
National University Hospital, Singapore, , Singapore
Singapore General Hospital (SGH), Singapore, , Singapore
Medical Oncology Centre of Rosebank, Johannesburg, Gauteng, South Africa
Mary Potter Oncology Centre, Pretoria, Gauteng, South Africa
Albert Alberts Stem Cell Transplant Centre, Pretoria, Gauteng, South Africa
Hospital Universitario Germans Trias i Pujol, Badalona, Barcelona, Spain
Hospital General Universitario Gregorio Maranon, Madrid, Madrid, Communidad Delaware, Spain
Clinica Universidad Navarra, Pamplona, Navarra, Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
C.H. Regional Reina Sofia - PPDS, Cordoba, , Spain
Institut Catala d'Oncologia Girona, Girona, , Spain
Hospital Universitario de La Princesa, Madrid, , Spain
Hospital Universitario La Paz - PPDS, Madrid, , Spain
Hospital Universitario HM Sanchinarro CIOCC, Madrid, , Spain
Hospital Universitario Puerta de Hierro - Majadahonda, Madrid, , Spain
Hospital General Universitario Morales Meseguer, Murcia, , Spain
Complejo Asistencial Universitario de Salamanca H. Clinico, Salamanca, , Spain
Hospital Universitario Virgen del Rocio - PPDS, Sevilla, , Spain
Helsingborg Lasarett, Helsingborg, Skane Lan, Sweden
Skanes Universitetssjukhus Lund, Lund, Skane Lan, Sweden
Sahlgrenska Universitetssjukhuset, Goteborg, Vastra Gotalands Lan, Sweden
Karolinska Universitetssjukhuset Huddinge, Stockholm, , Sweden
Akademiska Sjukhuset I Uppsala, Uppsala, , Sweden
Universitatsspital Basel, Basel, Basel-Stadt (de), Switzerland
Universitatsspital Zurich, Zurich, Zurich (de), Switzerland
Kaohsiung Medical University Hospital, Kaohsiung, , Taiwan
Chang Gung Medical Foundation-Kaoshiung Branch, Kaohsiung, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Chang Gung Medical Foundation Chiayi Chang Gung Memorial Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital, Linkou, Taoyuan City, , Taiwan
Chulalongkorn University, Bangkok, Krung Thep Maha Nakhon-Bangkok, Thailand
Phramongkutklao Hospital, Bangkok, Krung Thep Maha Nakhon-Bangkok, Thailand
Hacettepe Universitesi Tip Fakultesi Hastanesi, Ankara, , Turkey
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi, Ankara, , Turkey
Ankara University Medical Faculty PPDS, Ankara, , Turkey
Pamukkale Universitesi Tip Fakultesi Hastanesi, Denizli, , Turkey
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi, Istanbul, , Turkey
Erciyes Universitesi Tip Fakultesi Hastanesi, Kayseri, , Turkey
Karadeniz Technical University Faculty of Medicine, Trabzon, , Turkey
MNPE Kyiv Center of Bone Marrow Transplantation of executive body of Kyiv council, Kyiv, , Ukraine
Southampton General Hospital, Southampton, Hampshire, United Kingdom
Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre, London, London, City Of, United Kingdom
Kings College Hospital, London, London, City Of, United Kingdom
Imperial College Healthcare NHS Trust, London, London, City Of, United Kingdom
Churchill Hospital, Oxford, Oxfordshire, United Kingdom
Royal Marsden Hospital - Surrey, Sutton, Surrey, United Kingdom
St James University Hospital, Leeds, Yorkshire, United Kingdom
Royal Hallamshire Hospital, Sheffield, Yorkshire, United Kingdom
University Hospitals Leicester, Leicester, , United Kingdom
University College London Hospitals (UCLH), London, , United Kingdom
Singleton Hospital - PPDS, Swansea, , United Kingdom
Contact Details
Name: Study Director
Affiliation: Takeda
Role: STUDY_DIRECTOR
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