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Brief Title: A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT)
Official Title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation
Study ID: NCT02312258
Brief Summary: The purpose of this study is to determine the effect of ixazomib maintenance therapy on progression free survival (PFS) compared with placebo, in participants with NDMM who have had a major response (complete response \[CR\], very good partial response \[VGPR\], or partial response \[PR\]) to initial therapy and who have not undergone SCT.
Detailed Description: The drug being tested in this study is called ixazomib citrate. Ixazomib citrate is being tested to slow progressive disease (PD) and improve overall survival in people who have NDMM who have had a major positive response to initial therapy and have not undergone SCT. This study will look at the effect of ixazomib citrate has on the length of time that participants are free of PD and their overall survival. The study will enrol approximately 700 participants. Participants will be randomly assigned (by chance, like flipping a coin) in 3:2 ratio to Ixazomib or matching placebo groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): * Ixazomib citrate initiates at 3 mg which will be escalated to 4 mg with cycle 5 day 1 * 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. The treatment period will be approximately 24 months (equivalent to 26 cycles) or until patients experience PD or unacceptable toxicities, whichever occurs first. This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 78 to 106 months. Participants will make 28 visits to the clinic during the treatment period and will continue to make follow-up visits every 4 weeks until the next line of therapy begins. Participants will also be contacted by telephone every 12 weeks after last treatment visit for a follow-up assessment.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Robert A Moss MD FACP Inc, Fountain Valley, California, United States
UCLA Medical Hematology and Oncology, Los Angeles, California, United States
North County Oncology Medical Clinic Inc, Oceanside, California, United States
Ventura County Hematology Oncology Specialists, Oxnard, California, United States
Emad Ibrahim, MD, Inc, Redlands, California, United States
Global Cancer Research Institute (GCRI), Inc., San Jose, California, United States
Central Coast Medical Oncology Corporation, Santa Maria, California, United States
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States
John H. Stroger Jr. Hospital of Cook County, Chicago, Illinois, United States
Siouxland Hematology - Oncology Associates LLP, Sioux City, Iowa, United States
Appalachian Regional Healthcare, Hazard, Kentucky, United States
New England Cancer Specialists, Scarborough, Maine, United States
Saint Agnes Hospital - Baltimore - Hunt - PPDS, Baltimore, Maryland, United States
University Hospital of Wales -, Bethesda, Maryland, United States
Tufts Medical Center - PPDS, Boston, Massachusetts, United States
Herbert-Herman Cancer Center, Lansing, Michigan, United States
Clinical Research Alliance Inc, New York, New York, United States
New York Presbyterian Hospital - Weill-Cornell, New York, New York, United States
Cancer Care of WNC PA, Asheville, North Carolina, United States
UPMC Cancer Pavillion, Pittsburgh, Pennsylvania, United States
HOPE Cancer Center of East Texas, Tyler, Texas, United States
Swedish Cancer Institute, Seattle, Washington, United States
W VA University Mary Babb Randolph Cancer Center, Morgantown, West Virginia, United States
Hospital Universitario Austral, Buenos Aires, Ciudad Autonoma De BuenosAires, Argentina
Hospital Italiano de Buenos Aires, Buenos Aires, Ciudad Autonoma De BuenosAires, Argentina
Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC), Buenos Aires, Ciudad Autonoma De BuenosAires, Argentina
Sanatorio Allende S.A., Cordoba, , Argentina
Hospital Iturraspe, Santa Fe, , Argentina
St Vincents Hospital Melbourne - PPDS, Fitzroy, Victoria, Australia
Frankston Hospital, Frankston, Victoria, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Universitatsklinikum Innsbruck, Innsbruck, Tirol, Austria
Paracelsus Medizinische Privatuniversitat, Salzburg, , Austria
Klinikum Wels-Grieskirchen GmbH, Wels, , Austria
Medizinische Universitat Wien (Medical University of Vienna), Wien, , Austria
Universitair Ziekenhuis Brussel - PIN, Brussel, Brussels, Belgium
UZ Brussel, Brussel, Brussels, Belgium
Cliniques Universitaires Saint-Luc, Bruxelles, Brussels, Belgium
Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet, Salvador, Bahia, Brazil
Hospital Das Clinicas Da Universidade Federal de Goias, Goiania, Goias, Brazil
Hospital Das Clinicas Da UFMG, Belo Horizonte, Minas Gerais, Brazil
Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner, Curitiba, Parana, Brazil
Liga Norte Riograndense Contra O Cancer, Natal, Rio Grande Do Norte, Brazil
Universidade de Caxias do Sul, Caxias Do Sul, Rio Grande Do Sul, Brazil
Associacao Hospital de Caridade Ijui, Ijui, Rio Grande Do Sul, Brazil
American Oncology Partners of Maryland, PA, Passo Fundo, Rio Grande Do Sul, Brazil
Hospital Moinhos de Vento, Porto Alegre, 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
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS), Porto Alegre, Rio Grande Do Sul, Brazil
Instituto Joinvilense de Hematologia E Oncologia, Joinville, Santa Catarina, Brazil
Fundacao PIO XII, Barretos, Sao Paulo, Brazil
Universidade Estadual de Campinas, Campinas, Sao Paulo, Brazil
Hospital Amaral Carvalho, Jau, Sao Paulo, Brazil
Faculdade de Medicina Do ABC, Santo Andre, Sao Paulo, Brazil
HEMORIO - Unidade de Pesquisa Clinica, Rio De Janeiro, , Brazil
Instituto Nacional de Cancer, Rio de Janeiro, , Brazil
Fundação Antônio Prudente - AC Camargo Câncer Center, Rio De Janeiro, , Brazil
Hospital de Base Da Faculdade de Medicina de Sao Jose Do Rio Preto, Sao Jose Do Rio Preto, , Brazil
Instituto de Ensino E Pesquisa Sao Lucas, Sao Paulo, , Brazil
Hospital Sirio Libanes, Sao Paulo, , Brazil
Ealing Hospital, Sao Paulo, , Brazil
Clinica Sao Germano, Sao Paulo, , Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, , Brazil
Hospital Israelita Albert Einstein, Sao Paulo, , Brazil
Hospital Santa Marcelina, Sao Paulo, , Brazil
Royal Victoria Regional Health Centre, Barrie, Ontario, Canada
William Osler Health Centre, Brampton, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
McGill University Health Center, Montreal, Quebec, Canada
Hospital Amaral Carvalho, Temuco, Araucanía, Chile
Instituto Nacional Del Cancer, Santiago, , Chile
Centro Internacional de Estudios Clinicos, Santiago, , Chile
Centro de Investigaciones Clinicas Vina del Mar, Vina Del Mar, , Chile
Hospital de Clinicas de Passo Fundo, Nanjing, Jiangsu, China
Ruijin Hospital Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, China
The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China
Beijing Chaoyang Hospital Capital Medical University, Beijing, , China
Peking University Third Hospital, Beijing, , China
Peking Union Medical College Hospital, Beijing, , China
The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, , China
Renji Hospital Shanghai Jiaotong University School of Medicine, Shanghai, , China
Shanghai Chang Zheng Hospital, Shanghai, , China
Hospital São Rafael, Shenyang, , China
Second Hospital of Shanxi Medical University, Taiyuan, , China
James Lind Centro de Investigación del Cáncer, Wuhan, , China
Hospital Pablo Tobon Uribe, Medellin, Antioquia, Colombia
Instituto Nacional de Cancerologia Colombia, Bogota, Cundinamarca, Colombia
Hospital Universitario San Ignacio, Bogota, Distrito Capital De Bogota, Colombia
Clinical Hospital Dubrava, Zagreb, Grad Zagreb, Croatia
Clinical Hospital Center Rijeka, Rijeka, , Croatia
Clinical Hospital Center Zagreb - PPDS, Zagreb, , Croatia
Fakultni nemocnice Hradec Kralove, Hradec Kralove, Kralovehradeck Kraj, Czechia
Fakultni nemocnice Kralovske Vinohrady, Prague, Praha, Hlavni Mesto, Czechia
Fakultni nemocnice Brno, Brno, , Czechia
Fakultni nemocnice Olomouc, Olomouc, , Czechia
Fakultni nemocnice Ostrava, Ostrava, , Czechia
Vseobecna fakultni nemocnice v Praze, Praha 2, , Czechia
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University), København, Capital, Denmark
Aarhus Universitetshospital Århus Sygehus, Aarhus N, , Denmark
Regionshospitalet Holstebro, Holstebro, , Denmark
Odense Universitetshospital, Odense, , Denmark
Hopital Antoine Beclere, Clamart, Hauts-de-Seine, France
Hotel Dieu, Nantes, Loire-Atlantique, France
CHRU Nancy, Vandoeuvre-les-nancy, Meurthe-et-Moselle, France
CHRU Dijon Complexe Du Bocage, Dijon, , France
Hopital Saint Vincent de Paul GHICL, Lille, , France
CHRU Lille, Lille, , France
Hopital de la Pitie Salpetriere, Paris, , France
Groupe Hospitalier Necker Enfants Malades, Paris, , France
Hopital Haut Leveque, Pessac, , France
Hopital Jean Bernard, Poitiers, , France
CHRU Rennes, Rennes, , France
Universitatsklinikum Ulm, Ulm, Baden-Wurttemberg, Germany
Schwarzwald Baar Klinkum Villingen-Schwenningen GmbH, Villingen-Schwenningen, Baden-Wurttemberg, Germany
Hamatologische Onkologische Gemeinschaftspraxis Dr. Brudler, Dr. Heinrich, Dr. Bangerter, Augsburg, Bayern, Germany
Internistisch Hamatologische und Internistische Praxis, Herrsching am Ammersee, Bayern, Germany
LMU Klinikum der Universitat Munchen, Munchen, Bayern, Germany
Pius Hospital Oldenburg, Oldenburg, Niedersachsen, Germany
Universitatsklinikum Essen, Essen, Nordrhein-Westfalen, Germany
Gemeinschaftspraxis fur Hamatologie und Onkologie, Munster, Nordrhein-Westfalen, Germany
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz, Mainz, Rheinland-Pfalz, Germany
Universitat Des Saarlandes, Homburg, Saarland, Germany
Onkologie Aschaffenburg, Aschaffenburg, , Germany
Charite - Universitatsmedizin Berlin, Berlin, , Germany
Medizinisches Versorgungszentrum Onkologischer Schwerpunkt, Berlin, , Germany
Klinikum Landshut, Landshut, , Germany
Klinikum rechts der Isar der Technischen Universitat Munchen, Munchen, , Germany
Praxis Pihusch Medizinisches Versorgungszentrum GbR, Rosenheim, , Germany
Gemeinschaftspraxis Dr. med. R. Schlag & Dr. med. B. Schottker & Dr. med. J. Haas, Wurzburg, , Germany
University of Athens Medical School - Regional General Hospital Alexandra, Athens, Attiki, Greece
Evangelismos General Hospital of Athens, Athens, , Greece
University General Hospital of Ioannina, Ioannina, , Greece
University General Hospital of Larissa, Larissa, , Greece
Theageneio Anticancer Oncology Hospital of Thessaloniki, Thessaloniki, , Greece
Georgios Papanikolaou General Hospital of Thessaloniki, Thessaloniki, , Greece
Semmelweis Egyetem, Budapest, , Hungary
Klinika Hematologii, Szpital Uniwersytecki Nr 2 im. Jana Biziela w Bydgoszczy, Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont, Debrecen, , Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Szeged, , Hungary
Shamir Medical Center Assaf Harofeh, Be'er Sheva, , Israel
Rigshospitalet, Beer Yaakov, , Israel
Bnai Zion Medical Center, Haifa, , Israel
Hadassah Medical Center - PPDS, Jerusalem, , Israel
Meir Medical Center, Kfar Saba, , Israel
Rabin Medical Center - PPDS, Petah Tikva, , Israel
Chaim Sheba Medical Center, Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Assuta Medical Centers, Tel Aviv, , Israel
Baruch Padeh Poriya Medical Center, Tiberias, , Israel
AORN A Cardarelli, Napoli, Campania, Italy
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi, Bologna, Emilia-Romagna, Italy
Ospedale Infermi di Rimini, Rimini, Emilia-Romagna, Italy
IRCCS Az. Osp. Universitaria San Martino- IST, Genova, Liguria, Italy
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN, Brescia, Lombardia, Italy
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda, Milano, Lombardia, Italy
Ospedale Casa Sollievo Della Sofferenza IRCCS, San Giovanni Rotondo, Puglia, Italy
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele, Catania, Sicilia, Italy
Azienda Ospedaliero Universitaria Pisana, Pisa, Toscana, Italy
Azienda Ospedaliera S Maria Di Terni, Terni, Umbria, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi, Ancona, , Italy
Azienda Ospedaliera Universitaria Careggi, Firenze, , Italy
Azienda Ospedaliero Universitaria di Parma, Parma, , Italy
Ospedale Santa Maria Delle Croci, Ravenna, , Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino, Torino, , Italy
Ogaki Municipal Hospital, Ogaki, Gihu, Japan
Kobe City Medical Center General Hospital, Kobe-City, Hyogo, Japan
Hitachi General Hospital, Hitachi, Ibaraki, Japan
Nara Hospital Kinki University Faculty of Medicine, Ikoma-City, Nara, Japan
National Hospital Organization Okayama Medical Center, Okayama-city, Okayama, Japan
Juntendo University Hospital, Bunkyo, Tokyo, Japan
Japanese Red Cross Medical Center, Shibuya-ku, Tokyo, Japan
National Hospital Organization Kyushu Medical Center, Fukuoka, , Japan
Fukushima Medical University Hospital, Fukushima-City, , Japan
National Hospital Organization Mito Medical Center, Ibaraki, , Japan
Kurume University Hospital, Kurume, , Japan
Shizuoka Cancer Center, Nagaizumi-chō, , Japan
Japanese Red Cross Nagoya Daiichi Hospital, Nagoya, , Japan
Nagoya City University Hospital, Nagoya, , Japan
Japanese Red Cross Narita Hospital, Narita-shi, , Japan
Niigata Cancer Center Hospital, Niigata-city, , Japan
Osaka Saiseikai Nakatsu Hospital, Osaka, , Japan
National Hospital Organization Disaster Medical Center, Tachikawa, , Japan
Toyohashi Municipal Hospital, Toyohashi, , Japan
Yamanashi Prefectural Central Hospital, Yamanashi, , Japan
National Cancer Center, Goyang-si, Gyeonggido, Korea, Republic of
Gachon University Gil Medical Center, 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
Centro de Investigacion Farmaceutica Especializada de Occidente, SC - PPDS, Guadalajara, Jalisco, Mexico
Hospital Y Clinica OCA Sociedad Anonima de Capital Variable, Monterrey, Nuevo Leon, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey, Nuevo Leon, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, , Mexico
Oaxaca Site management Organization (OSMO) - PPDS, Oaxaca, , Mexico
Shengjing Hospital of China Medical University, Bydgoszcz, Kujawsko-pomorskie, Poland
MTZ Clinical Research Sp z o o - PRATIA - PPDS, Warszawa, Mazowieckie, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich, Chorzow, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu, Wroclaw, , Poland
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E., Lisbon, Lisboa, Portugal
Hospital Garcia de Orta, Almada, , Portugal
Hospital de Braga, Braga, , Portugal
Champalimaud Cancer Center, Lisboa, , Portugal
Centro Hospitalar do Porto - Hospital de Santo Antonio, Porto, , Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS, Porto, , Portugal
Centro Hospitalar de Sao Joao EPE, Porto, , Portugal
State Medical and Preventive Treatment Institution Kirov Regional Clinical Oncology Dispensary, Kirov, , Russian Federation
Stavropol Regional Clinical Oncology Centre Pyatigorsk Affiliate, Pyatigorsk, , Russian Federation
Ryazan Regional Clinical Hospital, Ryazan, , Russian Federation
Russian Research Institute of Hematology and Blood Transfusion, St. Petersburg, , Russian Federation
City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31, St. Petersburg, , Russian Federation
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology, Belgrade, , Serbia
Clinical Hospital Center ''Bezanijska Kosa'', Belgrade, , Serbia
University Clinical Center Kragujevac, Kragujevac, , Serbia
Soroka University Medical Centre, Nis, , Serbia
National University Hospital, Singapore, , Singapore
Singapore General Hospital (SGH), Singapore, , Singapore
Medical Oncology Centre of Rosebank, Johannesburg, Gauteng, South Africa
Albert Alberts Stem Cell Transplant Centre, Pretoria, Gauteng, South Africa
Mary Potter Oncology Centre, Pretoria, Gauteng, South Africa
Hospital Universitario Germans Trias i Pujol, Badalona, Barcelona, Spain
Hospital Universitario Quironsalud Madrid, Pozuelo De Alarcon, Madrid, Communidad Delaware, Spain
Clinica Universidad Navarra, Pamplona, Navarra, Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital de La Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitario de La Princesa, Madrid, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Hospital Universitario Infanta Leonor, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario HM Sanchinarro CIOCC, Madrid, , Spain
Hospital General Universitario Morales Meseguer, Murcia, , Spain
Complejo Asistencial Universitario de Salamanca H. Clinico, Salamanca, , Spain
Hospital Universitari i Politecnic La Fe de Valencia, Valencia, , Spain
Karolinska Universitetssjukhuset Huddinge, Stockholm, Sodermanlands Lan, Sweden
Karolinska Universitetssjukhuset Solna, Stockholm, Sodermanlands Lan, Sweden
Sahlgrenska Universitetssjukhuset, Goteborg, Vastra Gotalands Lan, Sweden
Skanes Universitetssjukhus Lund, Lund, , Sweden
Spital STS AG, Thun, , Switzerland
Kaohsiung Medical University Hospital, Kaohsiung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Ramathibodi Hospital, Bangkok, Krung Thep Maha Nakhon, Thailand
Chulalongkorn University, Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Chiang Mai University, Chiangmai, , Thailand
Hacettepe Universitesi Tip Fakultesi Hastanesi, Ankara, , Turkey
Ankara University Medical Faculty PPDS, Ankara, , Turkey
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi, Istanbul, , Turkey
Dokuz Eylul University Medical Faculty, Izmir, , Turkey
Belfast City Hospital, Belfast, Antrim, United Kingdom
Birmingham Heartlands Hospital, West Malling, Birmingham, United Kingdom
Bristol Haematology and Oncology Centre, Bristol, Bristol, City Of, United Kingdom
Royal Bournemouth Hospital, Bournemouth, Dorset, United Kingdom
Queen Alexandra Hospital, Portsmouth, Hampshire, United Kingdom
Kent and Canterbury Hospital, Canterbury, Kent, United Kingdom
Barts Health NHS Trust, London, London, City Of, United Kingdom
University College London, London, London, City Of, United Kingdom
Kings College Hospital, London, London, City Of, United Kingdom
Hammersmith Hospital, London, London, City Of, United Kingdom
Hillingdon Hospital, Uxbridge, London, City Of, United Kingdom
Churchill Hospital, Oxford, Oxfordshire, United Kingdom
New Cross Hospital, Wolverhampton, Staffordshire, United Kingdom
Royal Marsden Hospital - Surrey, Sutton, Surrey, United Kingdom
Royal United Hospital, Bath, , United Kingdom
Ulster Hospital, Belfast, , United Kingdom
Southmead Hospital, Bristol, , United Kingdom
University Clinical Center Nis, Cardiff, , United Kingdom
West Middlesex University Hospital, Isleworth, , United Kingdom
Leicester Royal Infirmary, Leicester, , United Kingdom
Chelsea and Westminster NHS Trust, London, , United Kingdom
Manchester Royal Infirmary - PPDS, Manchester, , United Kingdom
Northwick Park Hospital, Middlesex, , United Kingdom
The Royal Oldham Hospital - PPDS, Oldham, , United Kingdom
University Clinical Center of Serbia - PPDS, Southall, , United Kingdom
Singleton Hospital - PPDS, Swansea, , United Kingdom
Name: Medical Director
Affiliation: Takeda
Role: STUDY_DIRECTOR