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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.

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

Useful links and downloads for this trial

Clinicaltrials.gov

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