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Spots Global Cancer Trial Database for A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT)

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Trial Identification

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

Interventions

Placebo
Ixazomib

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Medical Director

Affiliation: Takeda

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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