Multiple Myeloma Clinical Trial

A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT)

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Adult male or female participants 18 years or older with a confirmed diagnosis of symptomatic newly diagnosed multiple myeloma (NDMM) according to standard criteria.
Completed 6 to 12 months (± 2 weeks) of initial therapy, during which the participant was treated to best response, defined as the best response maintained for 2 cycles after the M-protein nadir is reached.
Documented major response (PR, VGPR, CR) according to the International Myeloma Working Group (IMWG) uniform response criteria, version 2011, after this initial therapy.

Female participants who:

Are postmenopausal for at least 1 year before the screening visit, OR
Are surgically sterile, OR
If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 90 days after the last dose of study drug, OR
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.)

Male participants, even if surgically sterilized (that is, status postvasectomy), who:

Agree to practice effective barrier contraception during the entire study Treatment period and through 90 days after the last dose of study drug, OR
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
Complete documentation of the details of the initial therapy before randomization including cytogenetics and International Staging System (ISS) is available.
Eastern Cooperative Oncology Group Performance Status of 0 to 2.
Suitable venous access for the study-required blood sampling and consent for the specific amounts that will be taken.
Is willing and able to adhere to the study visit schedule and other protocol requirements including blood sampling and bone marrow aspiration.

Must meet the following clinical laboratory criteria at study entry:

Absolute neutrophil count (ANC) greater than or equal to (≥) 1,000 per cubic millimeter (/mm^3) without growth factor support and platelet count ≥75,000/mm^3. Platelet transfusions to help participants meet eligibility criteria are not allowed within 3 days before randomization.
Total bilirubin less than or equal to (≤) 1.5*the upper limit of the normal range (ULN).
Alanine aminotransferase and aspartate aminotransferase ≤ 3*ULN.
Calculated creatinine clearance ≥ 30 milliliter per minute (mL/min) (using the Cockcroft-Gault equation).

Exclusion Criteria:

Multiple myeloma that has relapsed after, or was not responsive to, initial therapy.
Prior SCT.
Radiotherapy within 14 days before randomization.
Diagnosed or treated for another malignancy within 5 years before randomization or previous diagnosis with another malignancy. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period.
Major surgery within 14 days before randomization.
Central nervous system involvement.
Infection requiring intravenous (IV) antibiotic therapy or other serious infection within 14 days before randomization.
Diagnosis of Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes syndrome (POEMS), plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome.
Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, uncontrolled congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.
Systemic treatment with strong cytochrome P450 3A (CYP3A) inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital) or St. John's wort within 14 days before randomization.
Ongoing or active infection, known human immunodeficiency virus (HIV) positive, active hepatitis B or C infection.
Comorbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens (example, PN that is Grade 1 with pain or Grade 2 or higher of any cause).
Psychiatric illness or social situation that would limit compliance with study requirements.
Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
Inability to swallow oral medication, inability or unwillingness to comply with the drug administration requirements, or gastrointestinal (GI) procedure that could interfere with the oral absorption or tolerance of treatment.
Treatment with any investigational products within 30 days before randomization.

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

706

Study ID:

NCT02312258

Recruitment Status:

Completed

Sponsor:

Takeda

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There are 255 Locations for this study

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Robert A Moss MD FACP Inc
Fountain Valley California, 92708, United States
UCLA Medical Hematology and Oncology
Los Angeles California, 90095, United States
North County Oncology Medical Clinic Inc
Oceanside California, 92056, United States
Ventura County Hematology Oncology Specialists
Oxnard California, 93030, United States
Emad Ibrahim, MD, Inc
Redlands California, 92373, United States
Global Cancer Research Institute (GCRI), Inc.
San Jose California, 95124, United States
Central Coast Medical Oncology Corporation
Santa Maria California, 93454, United States
Winship Cancer Institute, Emory University
Atlanta Georgia, 30322, United States
John H. Stroger Jr. Hospital of Cook County
Chicago Illinois, 60612, United States
Siouxland Hematology - Oncology Associates LLP
Sioux City Iowa, 51101, United States
Appalachian Regional Healthcare
Hazard Kentucky, 41701, United States
New England Cancer Specialists
Scarborough Maine, 04074, United States
Saint Agnes Hospital - Baltimore - Hunt - PPDS
Baltimore Maryland, 21229, United States
University Hospital of Wales -
Bethesda Maryland, 20817, United States
Tufts Medical Center - PPDS
Boston Massachusetts, 02111, United States
Herbert-Herman Cancer Center
Lansing Michigan, 48912, United States
Clinical Research Alliance Inc
New York New York, 10021, United States
New York Presbyterian Hospital - Weill-Cornell
New York New York, 10021, United States
Cancer Care of WNC PA
Asheville North Carolina, 28801, United States
UPMC Cancer Pavillion
Pittsburgh Pennsylvania, 15232, United States
HOPE Cancer Center of East Texas
Tyler Texas, 75701, United States
Swedish Cancer Institute
Seattle Washington, 98109, United States
W VA University Mary Babb Randolph Cancer Center
Morgantown West Virginia, 26506, United States
Hospital Universitario Austral
Buenos Aires Ciudad Autonoma De BuenosAires, B1629, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires Ciudad Autonoma De BuenosAires, C1181, Argentina
Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)
Buenos Aires Ciudad Autonoma De BuenosAires, C1431, Argentina
Sanatorio Allende S.A.
Cordoba , X5000, Argentina
Hospital Iturraspe
Santa Fe , S3000, Argentina
St Vincents Hospital Melbourne - PPDS
Fitzroy Victoria, 3065, Australia
Frankston Hospital
Frankston Victoria, 3199, Australia
The Alfred Hospital
Melbourne Victoria, 3004, Australia
Universitatsklinikum Innsbruck
Innsbruck Tirol, 6020, Austria
Paracelsus Medizinische Privatuniversitat
Salzburg , 5020, Austria
Klinikum Wels-Grieskirchen GmbH
Wels , 4600, Austria
Medizinische Universitat Wien (Medical University of Vienna)
Wien , A-109, Austria
Universitair Ziekenhuis Brussel - PIN
Brussel Brussels, 1090, Belgium
UZ Brussel
Brussel Brussels, 1090, Belgium
Cliniques Universitaires Saint-Luc
Bruxelles Brussels, 1200, Belgium
Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet
Salvador Bahia, 41253, Brazil
Hospital Das Clinicas Da Universidade Federal de Goias
Goiania Goias, 74605, Brazil
Hospital Das Clinicas Da UFMG
Belo Horizonte Minas Gerais, 30130, Brazil
Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner
Curitiba Parana, 81520, Brazil
Liga Norte Riograndense Contra O Cancer
Natal Rio Grande Do Norte, 59040, Brazil
Universidade de Caxias do Sul
Caxias Do Sul Rio Grande Do Sul, 95070, Brazil
Associacao Hospital de Caridade Ijui
Ijui Rio Grande Do Sul, 98700, Brazil
American Oncology Partners of Maryland, PA
Passo Fundo Rio Grande Do Sul, 99010, Brazil
Hospital Moinhos de Vento
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Mae de Deus Center Hospital Giovanni Battista
Porto Alegre Rio Grande Do Sul, 90470, Brazil
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Instituto Joinvilense de Hematologia E Oncologia
Joinville Santa Catarina, 89201, Brazil
Fundacao PIO XII
Barretos Sao Paulo, 14784, Brazil
Universidade Estadual de Campinas
Campinas Sao Paulo, 13083, Brazil
Hospital Amaral Carvalho
Jau Sao Paulo, 17210, Brazil
Faculdade de Medicina Do ABC
Santo Andre Sao Paulo, 09060, Brazil
HEMORIO - Unidade de Pesquisa Clinica
Rio De Janeiro , 20211, Brazil
Instituto Nacional de Cancer
Rio de Janeiro , 20231, Brazil
Fundação Antônio Prudente - AC Camargo Câncer Center
Rio De Janeiro , 21941, Brazil
Hospital de Base Da Faculdade de Medicina de Sao Jose Do Rio Preto
Sao Jose Do Rio Preto , 15090, Brazil
Instituto de Ensino E Pesquisa Sao Lucas
Sao Paulo , 01236, Brazil
Hospital Sirio Libanes
Sao Paulo , 01308, Brazil
Ealing Hospital
Sao Paulo , 01509, Brazil
Clinica Sao Germano
Sao Paulo , 04537, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Sao Paulo , 05403, Brazil
Hospital Israelita Albert Einstein
Sao Paulo , 05652, Brazil
Hospital Santa Marcelina
Sao Paulo , 08270, Brazil
Royal Victoria Regional Health Centre
Barrie Ontario, L4M 6, Canada
William Osler Health Centre
Brampton Ontario, L6W 3, Canada
Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada
McGill University Health Center
Montreal Quebec, H4A 3, Canada
Hospital Amaral Carvalho
Temuco Araucanía, 48008, Chile
Instituto Nacional Del Cancer
Santiago , 83804, Chile
Centro Internacional de Estudios Clinicos
Santiago , , Chile
Centro de Investigaciones Clinicas Vina del Mar
Vina Del Mar , 25700, Chile
Hospital de Clinicas de Passo Fundo
Nanjing Jiangsu, 21002, China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai Shanghai, 20002, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou Zhejiang, 31000, China
Beijing Chaoyang Hospital Capital Medical University
Beijing , 10002, China
Peking University Third Hospital
Beijing , 10019, China
Peking Union Medical College Hospital
Beijing , , China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou , 31000, China
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai , 20000, China
Shanghai Chang Zheng Hospital
Shanghai , 20000, China
Hospital São Rafael
Shenyang , 11000, China
Second Hospital of Shanxi Medical University
Taiyuan , 03000, China
James Lind Centro de Investigación del Cáncer
Wuhan , 43003, China
Hospital Pablo Tobon Uribe
Medellin Antioquia, 05003, Colombia
Instituto Nacional de Cancerologia Colombia
Bogota Cundinamarca, , Colombia
Hospital Universitario San Ignacio
Bogota Distrito Capital De Bogota, 11031, Colombia
Clinical Hospital Dubrava
Zagreb Grad Zagreb, 10000, Croatia
Clinical Hospital Center Rijeka
Rijeka , 51000, Croatia
Clinical Hospital Center Zagreb - PPDS
Zagreb , 10 00, Croatia
Fakultni nemocnice Hradec Kralove
Hradec Kralove Kralovehradeck Kraj, 500 0, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague Praha, Hlavni Mesto, 100 3, Czechia
Fakultni nemocnice Brno
Brno , 625 0, Czechia
Fakultni nemocnice Olomouc
Olomouc , 775 2, Czechia
Fakultni nemocnice Ostrava
Ostrava , 708 5, Czechia
Vseobecna fakultni nemocnice v Praze
Praha 2 , 128 0, Czechia
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
København Capital, 2100, Denmark
Aarhus Universitetshospital Århus Sygehus
Aarhus N , DK-82, Denmark
Regionshospitalet Holstebro
Holstebro , 7500, Denmark
Odense Universitetshospital
Odense , 5000, Denmark
Hopital Antoine Beclere
Clamart Hauts-de-Seine, 92140, France
Hotel Dieu
Nantes Loire-Atlantique, 44093, France
CHRU Nancy
Vandoeuvre-les-nancy Meurthe-et-Moselle, 54511, France
CHRU Dijon Complexe Du Bocage
Dijon , 21079, France
Hopital Saint Vincent de Paul GHICL
Lille , 59020, France
CHRU Lille
Lille , 59037, France
Hopital de la Pitie Salpetriere
Paris , 75013, France
Groupe Hospitalier Necker Enfants Malades
Paris , 75015, France
Hopital Haut Leveque
Pessac , 33604, France
Hopital Jean Bernard
Poitiers , 86021, France
CHRU Rennes
Rennes , , France
Universitatsklinikum Ulm
Ulm Baden-Wurttemberg, 89081, Germany
Schwarzwald Baar Klinkum Villingen-Schwenningen GmbH
Villingen-Schwenningen Baden-Wurttemberg, 78050, Germany
Hamatologische Onkologische Gemeinschaftspraxis Dr. Brudler, Dr. Heinrich, Dr. Bangerter
Augsburg Bayern, 86150, Germany
Internistisch Hamatologische und Internistische Praxis
Herrsching am Ammersee Bayern, 82211, Germany
LMU Klinikum der Universitat Munchen
Munchen Bayern, 81377, Germany
Pius Hospital Oldenburg
Oldenburg Niedersachsen, 26121, Germany
Universitatsklinikum Essen
Essen Nordrhein-Westfalen, 45122, Germany
Gemeinschaftspraxis fur Hamatologie und Onkologie
Munster Nordrhein-Westfalen, 48149, Germany
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
Mainz Rheinland-Pfalz, 55131, Germany
Universitat Des Saarlandes
Homburg Saarland, 66421, Germany
Onkologie Aschaffenburg
Aschaffenburg , 63739, Germany
Charite - Universitatsmedizin Berlin
Berlin , 12200, Germany
Medizinisches Versorgungszentrum Onkologischer Schwerpunkt
Berlin , 14195, Germany
Klinikum Landshut
Landshut , 84034, Germany
Klinikum rechts der Isar der Technischen Universitat Munchen
Munchen , 81675, Germany
Praxis Pihusch Medizinisches Versorgungszentrum GbR
Rosenheim , 83022, Germany
Gemeinschaftspraxis Dr. med. R. Schlag & Dr. med. B. Schottker & Dr. med. J. Haas
Wurzburg , 97080, Germany
University of Athens Medical School - Regional General Hospital Alexandra
Athens Attiki, 115 2, Greece
Evangelismos General Hospital of Athens
Athens , 10676, Greece
University General Hospital of Ioannina
Ioannina , 45500, Greece
University General Hospital of Larissa
Larissa , 41110, Greece
Theageneio Anticancer Oncology Hospital of Thessaloniki
Thessaloniki , 54007, Greece
Georgios Papanikolaou General Hospital of Thessaloniki
Thessaloniki , 57010, Greece
Semmelweis Egyetem
Budapest , 1083, Hungary
Klinika Hematologii, Szpital Uniwersytecki Nr 2 im. Jana Biziela w Bydgoszczy
Budapest , 1097, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen , 4032, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged , 6725, Hungary
Shamir Medical Center Assaf Harofeh
Be'er Sheva , 84101, Israel
Rigshospitalet
Beer Yaakov , 70300, Israel
Bnai Zion Medical Center
Haifa , 33394, Israel
Hadassah Medical Center - PPDS
Jerusalem , 91120, Israel
Meir Medical Center
Kfar Saba , 44281, Israel
Rabin Medical Center - PPDS
Petah Tikva , 49100, Israel
Chaim Sheba Medical Center
Ramat Gan , 52621, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv , 64239, Israel
Assuta Medical Centers
Tel Aviv , 69710, Israel
Baruch Padeh Poriya Medical Center
Tiberias , 15208, Israel
AORN A Cardarelli
Napoli Campania, 80131, Italy
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
Bologna Emilia-Romagna, 40138, Italy
Ospedale Infermi di Rimini
Rimini Emilia-Romagna, 47900, Italy
IRCCS Az. Osp. Universitaria San Martino- IST
Genova Liguria, 16132, Italy
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN
Brescia Lombardia, 25123, Italy
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
Milano Lombardia, 20162, Italy
Ospedale Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo Puglia, 71013, Italy
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Catania Sicilia, 95124, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa Toscana, 56216, Italy
Azienda Ospedaliera S Maria Di Terni
Terni Umbria, 05100, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
Ancona , 60126, Italy
Azienda Ospedaliera Universitaria Careggi
Firenze , 50139, Italy
Azienda Ospedaliero Universitaria di Parma
Parma , 43126, Italy
Ospedale Santa Maria Delle Croci
Ravenna , 48100, Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino
Torino , 10126, Italy
Ogaki Municipal Hospital
Ogaki Gihu, 503-8, Japan
Kobe City Medical Center General Hospital
Kobe-City Hyogo, 650-0, Japan
Hitachi General Hospital
Hitachi Ibaraki, 317-0, Japan
Nara Hospital Kinki University Faculty of Medicine
Ikoma-City Nara, 630-0, Japan
National Hospital Organization Okayama Medical Center
Okayama-city Okayama, 701-1, Japan
Juntendo University Hospital
Bunkyo Tokyo, 113-8, Japan
Japanese Red Cross Medical Center
Shibuya-ku Tokyo, 150-8, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka , 810-8, Japan
Fukushima Medical University Hospital
Fukushima-City , 960-1, Japan
National Hospital Organization Mito Medical Center
Ibaraki , 311-3, Japan
Kurume University Hospital
Kurume , 830-0, Japan
Shizuoka Cancer Center
Nagaizumi-chō , 41187, Japan
Japanese Red Cross Nagoya Daiichi Hospital
Nagoya , 453-8, Japan
Nagoya City University Hospital
Nagoya , 467-8, Japan
Japanese Red Cross Narita Hospital
Narita-shi , 286-8, Japan
Niigata Cancer Center Hospital
Niigata-city , , Japan
Osaka Saiseikai Nakatsu Hospital
Osaka , 530-0, Japan
National Hospital Organization Disaster Medical Center
Tachikawa , 19000, Japan
Toyohashi Municipal Hospital
Toyohashi , , Japan
Yamanashi Prefectural Central Hospital
Yamanashi , 400-8, Japan
National Cancer Center
Goyang-si Gyeonggido, 10408, Korea, Republic of
Gachon University Gil Medical Center
Incheon , 405-7, Korea, Republic of
Seoul National University Hospital
Seoul , 110-7, Korea, Republic of
Severance Hospital Yonsei University Health System - PPDS
Seoul , 120-7, Korea, Republic of
Samsung Medical Center - PPDS
Seoul , 135-7, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul , 137-7, Korea, Republic of
Centro de Investigacion Farmaceutica Especializada de Occidente, SC - PPDS
Guadalajara Jalisco, 44160, Mexico
Hospital Y Clinica OCA Sociedad Anonima de Capital Variable
Monterrey Nuevo Leon, 64000, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey Nuevo Leon, 64460, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City , 14000, Mexico
Oaxaca Site management Organization (OSMO) - PPDS
Oaxaca , 68000, Mexico
Shengjing Hospital of China Medical University
Bydgoszcz Kujawsko-pomorskie, 85-16, Poland
MTZ Clinical Research Sp z o o - PRATIA - PPDS
Warszawa Mazowieckie, 02-10, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Chorzow , , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
Wroclaw , 50-36, Poland
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.
Lisbon Lisboa, 1099-, Portugal
Hospital Garcia de Orta
Almada , 2801-, Portugal
Hospital de Braga
Braga , 4710-, Portugal
Champalimaud Cancer Center
Lisboa , 1400-, Portugal
Centro Hospitalar do Porto - Hospital de Santo Antonio
Porto , 4099-, Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
Porto , 4200-, Portugal
Centro Hospitalar de Sao Joao EPE
Porto , 4200-, Portugal
State Medical and Preventive Treatment Institution Kirov Regional Clinical Oncology Dispensary
Kirov , 61002, Russian Federation
Stavropol Regional Clinical Oncology Centre Pyatigorsk Affiliate
Pyatigorsk , 35750, Russian Federation
Ryazan Regional Clinical Hospital
Ryazan , 39003, Russian Federation
Russian Research Institute of Hematology and Blood Transfusion
St. Petersburg , 19302, Russian Federation
City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31
St. Petersburg , 19711, Russian Federation
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Belgrade , 11000, Serbia
Clinical Hospital Center ''Bezanijska Kosa''
Belgrade , 11080, Serbia
University Clinical Center Kragujevac
Kragujevac , 34000, Serbia
Soroka University Medical Centre
Nis , 18000, Serbia
National University Hospital
Singapore , 11907, Singapore
Singapore General Hospital (SGH)
Singapore , 16960, Singapore
Medical Oncology Centre of Rosebank
Johannesburg Gauteng, 2196, South Africa
Albert Alberts Stem Cell Transplant Centre
Pretoria Gauteng, 0044, South Africa
Mary Potter Oncology Centre
Pretoria Gauteng, 0181, South Africa
Hospital Universitario Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo De Alarcon Madrid, Communidad Delaware, 28223, Spain
Clinica Universidad Navarra
Pamplona Navarra, 31008, Spain
Hospital Clinic de Barcelona
Barcelona , 08036, Spain
Hospital de La Santa Creu i Sant Pau
Barcelona , 08041, Spain
Hospital Universitario de La Princesa
Madrid , 28006, Spain
Hospital General Universitario Gregorio Maranon
Madrid , 28009, Spain
Hospital Universitario Infanta Leonor
Madrid , 28031, Spain
Hospital Universitario La Paz
Madrid , 28046, Spain
Hospital Universitario HM Sanchinarro CIOCC
Madrid , 28050, Spain
Hospital General Universitario Morales Meseguer
Murcia , 30008, Spain
Complejo Asistencial Universitario de Salamanca H. Clinico
Salamanca , 37007, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia , 46026, 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 , SE-22, Sweden
Spital STS AG
Thun , CH-36, Switzerland
Kaohsiung Medical University Hospital
Kaohsiung , 807, Taiwan
Taichung Veterans General Hospital
Taichung , 40705, Taiwan
National Taiwan University Hospital
Taipei , 100, Taiwan
Ramathibodi Hospital
Bangkok Krung Thep Maha Nakhon, 10400, Thailand
Chulalongkorn University
Bangkok , 10330, Thailand
Maharaj Nakorn Chiang Mai Chiang Mai University
Chiangmai , 50200, Thailand
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara , 06100, Turkey
Ankara University Medical Faculty PPDS
Ankara , 06590, Turkey
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
Istanbul , 34093, Turkey
Dokuz Eylul University Medical Faculty
Izmir , 35340, Turkey
Belfast City Hospital
Belfast Antrim, BT9 7, United Kingdom
Birmingham Heartlands Hospital
West Malling Birmingham, B9 5S, United Kingdom
Bristol Haematology and Oncology Centre
Bristol Bristol, City Of, BS2 8, United Kingdom
Royal Bournemouth Hospital
Bournemouth Dorset, BH7 7, United Kingdom
Queen Alexandra Hospital
Portsmouth Hampshire, PO6 3, United Kingdom
Kent and Canterbury Hospital
Canterbury Kent, CT1 3, United Kingdom
Barts Health NHS Trust
London London, City Of, EC1A , United Kingdom
University College London
London London, City Of, NW1 2, United Kingdom
Kings College Hospital
London London, City Of, SE5 9, United Kingdom
Hammersmith Hospital
London London, City Of, W12 0, United Kingdom
Hillingdon Hospital
Uxbridge London, City Of, UB8 3, United Kingdom
Churchill Hospital
Oxford Oxfordshire, OX3 7, United Kingdom
New Cross Hospital
Wolverhampton Staffordshire, WV10 , United Kingdom
Royal Marsden Hospital - Surrey
Sutton Surrey, SM2 5, United Kingdom
Royal United Hospital
Bath , BA1 3, United Kingdom
Ulster Hospital
Belfast , BT16 , United Kingdom
Southmead Hospital
Bristol , BS10 , United Kingdom
University Clinical Center Nis
Cardiff , CF14 , United Kingdom
West Middlesex University Hospital
Isleworth , TW7 6, United Kingdom
Leicester Royal Infirmary
Leicester , LE1 5, United Kingdom
Chelsea and Westminster NHS Trust
London , , United Kingdom
Manchester Royal Infirmary - PPDS
Manchester , M13 9, United Kingdom
Northwick Park Hospital
Middlesex , HA1 3, United Kingdom
The Royal Oldham Hospital - PPDS
Oldham , OL1 2, United Kingdom
University Clinical Center of Serbia - PPDS
Southall , UB1 3, United Kingdom
Singleton Hospital - PPDS
Swansea , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

706

Study ID:

NCT02312258

Recruitment Status:

Completed

Sponsor:


Takeda

How clear is this clinincal trial information?

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