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

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Ixazomib; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 706
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Cordoba, Argentina, X5000JHQ
    • Sanatorio Allende S.A.
  • Santa Fe, Argentina, S3000ADL
    • Hospital Iturraspe
  • Ciudad Autonoma De BuenosAires
    • Buenos Aires, Ciudad Autonoma De BuenosAires, Argentina, B1629AHJ
      • Hospital Universitario Austral
    • Buenos Aires, Ciudad Autonoma De BuenosAires, Argentina, C1181ACH
      • Hospital Italiano de Buenos Aires
    • Buenos Aires, Ciudad Autonoma De BuenosAires, Argentina, C1431FWO
      • Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)
• Australia
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • St Vincents Hospital Melbourne - PPDS
    • Frankston, Victoria, Australia, 3199
      • Frankston Hospital
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
• Austria
  • Salzburg, Austria, 5020
    • Paracelsus Medizinische Privatuniversitat
  • Wels, Austria, 4600
    • Klinikum Wels-Grieskirchen GmbH
  • Wien, Austria, A-1090
    • Medizinische Universitat Wien (Medical University of Vienna)
  • Tirol
    • Innsbruck, Tirol, Austria, 6020
      • Universitätsklinikum Innsbruck
• Belgium
  • Brussels
    • Brussel, Brussels, Belgium, 1090
      • UZ Brussel
    • Brussel, Brussels, Belgium, 1090
      • Universitair Ziekenhuis Brussel - PIN
    • Bruxelles, Brussels, Belgium, 1200
      • Cliniques Universitaires Saint-Luc
• Brazil
  • Rio De Janeiro, Brazil, 20211-030
    • HEMORIO - Unidade de Pesquisa Clinica
  • Rio De Janeiro, Brazil, 21941-913
    • Fundação Antônio Prudente - AC Camargo Câncer Center
  • Rio de Janeiro, Brazil, 20231-050
    • Instituto Nacional de Câncer
  • Sao Jose Do Rio Preto, Brazil, 15090-000
    • Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto
  • Sao Paulo, Brazil, 08270-070
    • Hospital Santa Marcelina
  • Sao Paulo, Brazil, 01236-030
    • Instituto de Ensino e Pesquisa São Lucas
  • Sao Paulo, Brazil, 05652-900
    • Hospital Israelita Albert Einstein
  • Sao Paulo, Brazil, 01308-050
    • Hospital Sírio Libanês
  • Sao Paulo, Brazil, 05403-000
    • Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
  • Sao Paulo, Brazil, 01509-900
    • Ealing Hospital
  • Sao Paulo, Brazil, 04537-080
    • Clinica Sao Germano
  • Bahia
    • Salvador, Bahia, Brazil, 41253-196
      • Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet
  • Goias
    • Goiania, Goias, Brazil, 74605-020
      • Hospital das Clínicas da Universidade Federal de Goiás
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30130-100
      • Hospital Das Clinicas Da Ufmg
  • Parana
    • Curitiba, Parana, Brazil, 81520-060
      • Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
  • Rio Grande Do Norte
    • Natal, Rio Grande Do Norte, Brazil, 59040-150
      • Liga Norte Riograndense Contra O Cancer
  • Rio Grande Do Sul
    • Caxias Do Sul, Rio Grande Do Sul, Brazil, 95070-560
      • Universidade de Caxias do Sul
    • Ijui, Rio Grande Do Sul, Brazil, 98700-000
      • Associação Hospital de Caridade Ijuí
    • Passo Fundo, Rio Grande Do Sul, Brazil, 99010-260
      • American Oncology Partners of Maryland, PA
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-001
      • Hospital Moinhos de Vento
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
      • Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
      • Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90470-340
      • Mae de Deus Center Hospital Giovanni Battista
  • Santa Catarina
    • Joinville, Santa Catarina, Brazil, 89201260
      • Instituto Joinvilense de Hematologia e Oncologia
  • Sao Paulo
    • Barretos, Sao Paulo, Brazil, 14784-400
      • Fundação PIO XII
    • Campinas, Sao Paulo, Brazil, 13083-878
      • Universidade Estadual De Campinas
    • Jau, Sao Paulo, Brazil, 17210-120
      • Hospital Amaral Carvalho
    • Santo Andre, Sao Paulo, Brazil, 09060-650
      • Faculdade de Medicina do ABC
• Canada
  • Ontario
    • Barrie, Ontario, Canada, L4M 6M2
      • Royal Victoria Regional Health Centre
    • Brampton, Ontario, Canada, L6W 3J7
      • William Osler Health Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Hospital
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health center
• Chile
  • Santiago, Chile, 8380455
    • Instituto Nacional del Cancer
  • Santiago, Chile
    • Centro Internacional de Estudios Clinicos
  • Vina Del Mar, Chile, 2570017
    • Centro de Investigaciones Clinicas Vina del Mar
  • Araucanía
    • Temuco, Araucanía, Chile, 4800827
      • Hospital Amaral Carvalho
• China
  • Beijing, China, 100191
    • Peking University Third Hospital
  • Beijing, China
    • Peking Union Medical College Hospital
  • Beijing, China, 100020
    • Beijing Chaoyang Hospital Capital Medical University
  • Hangzhou, China, 310003
    • The First Affiliated Hospital, College of Medicine, Zhejiang University
  • Shanghai, China, 200001
    • Renji Hospital Shanghai Jiaotong University School of Medicine
  • Shanghai, China, 200003
    • Shanghai Chang Zheng Hospital
  • Shenyang, China, 110004
    • Hospital Sao Rafael
  • Taiyuan, China, 030001
    • Second Hospital of Shanxi Medical University
  • Wuhan, China, 430030
    • James Lind Centro de Investigacion Del Cancer
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Hospital de Clínicas de Passo Fundo
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Ruijin Hospital Shanghai Jiaotong University School of Medicine
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital, College of Medicine, Zhejiang University
• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia, 050034
      • Hospital Pablo Tobon Uribe
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia
      • Instituto Nacional de Cancerologia Colombia
  • Distrito Capital De Bogota
    • Bogota, Distrito Capital De Bogota, Colombia, 110311
      • Hospital Universitario San Ignacio
• Croatia
  • Rijeka, Croatia, 51000
    • Clinical Hospital Center Rijeka
  • Zagreb, Croatia, 10 000
    • Clinical Hospital Center Zagreb - PPDS
  • Grad Zagreb
    • Zagreb, Grad Zagreb, Croatia, 10000
      • Clinical Hospital Dubrava
• Czechia
  • Brno, Czechia, 625 00
    • Fakultni nemocnice Brno
  • Olomouc, Czechia, 775 20
    • Fakultni nemocnice Olomouc
  • Ostrava, Czechia, 708 52
    • Fakultni nemocnice Ostrava
  • Praha 2, Czechia, 128 08
    • Vseobecna Fakultni Nemocnice V Praze
  • Kralovehradeck Kraj
    • Hradec Kralove, Kralovehradeck Kraj, Czechia, 500 05
      • Fakultni nemocnice Hradec Kralove
  • Praha, Hlavni Mesto
    • Prague, Praha, Hlavni Mesto, Czechia, 100 34
      • Fakultni nemocnice Kralovske Vinohrady
• Denmark
  • Aarhus N, Denmark, DK-8200
    • Aarhus Universitetshospital Århus Sygehus
  • Holstebro, Denmark, 7500
    • Regionshospitalet Holstebro
  • Odense, Denmark, 5000
    • Odense Universitetshospital
  • Capital
    • København, Capital, Denmark, 2100
      • Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
• France
  • Dijon, France, 21079
    • CHRU Dijon Complexe Du Bocage
  • Lille, France, 59037
    • CHRU Lille
  • Lille, France, 59020
    • Hopital Saint Vincent de Paul Ghicl
  • Paris, France, 75015
    • Groupe Hospitalier Necker Enfants Malades
  • Paris, France, 75013
    • Hopital de la Pitie Salpetriere
  • Pessac, France, 33604
    • Hôpital Haut Lévêque
  • Poitiers, France, 86021
    • Hopital Jean Bernard
  • Rennes, France
    • CHRU Rennes
  • Hauts-de-Seine
    • Clamart, Hauts-de-Seine, France, 92140
      • Hôpital Antoine Béclère
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44093
      • Hotel Dieu
  • Meurthe-et-Moselle
    • Vandoeuvre-les-nancy, Meurthe-et-Moselle, France, 54511
      • CHRU Nancy
• Germany
  • Aschaffenburg, Germany, 63739
    • Onkologie aschaffenburg
  • Berlin, Germany, 12200
    • Charité - Universitätsmedizin Berlin
  • Berlin, Germany, 14195
    • Medizinisches Versorgungszentrum Onkologischer Schwerpunkt
  • Landshut, Germany, 84034
    • Klinikum Landshut
  • Munchen, Germany, 81675
    • Klinikum rechts der Isar der Technischen Universitat Munchen
  • Rosenheim, Germany, 83022
    • Praxis Pihusch Medizinisches Versorgungszentrum GbR
  • Wurzburg, Germany, 97080
    • Gemeinschaftspraxis Dr. med. R. Schlag & Dr. med. B. Schottker & Dr. med. J. Haas
  • Baden-Wurttemberg
    • Ulm, Baden-Wurttemberg, Germany, 89081
      • Universitätsklinikum Ulm
    • Villingen-Schwenningen, Baden-Wurttemberg, Germany, 78050
      • Schwarzwald Baar Klinkum Villingen-Schwenningen GmbH
  • Bayern
    • Augsburg, Bayern, Germany, 86150
      • Hamatologische Onkologische Gemeinschaftspraxis Dr. Brudler, Dr. Heinrich, Dr. Bangerter
    • Herrsching am Ammersee, Bayern, Germany, 82211
      • Internistisch Hamatologische und Internistische Praxis
    • Munchen, Bayern, Germany, 81377
      • LMU Klinikum der Universität München
  • Niedersachsen
    • Oldenburg, Niedersachsen, Germany, 26121
      • Pius Hospital Oldenburg
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45122
      • Universitätsklinikum Essen
    • Munster, Nordrhein-Westfalen, Germany, 48149
      • Gemeinschaftspraxis für Hämatologie und Onkologie
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Saarland
    • Homburg, Saarland, Germany, 66421
      • Universität des Saarlandes
• Greece
  • Athens, Greece, 10676
    • Evangelismos General Hospital of Athens
  • Ioannina, Greece, 45500
    • University General Hospital of Ioannina
  • Larissa, Greece, 41110
    • University General Hospital of Larissa
  • Thessaloniki, Greece, 54007
    • Theageneio Anticancer Oncology Hospital of Thessaloniki
  • Thessaloniki, Greece, 57010
    • Georgios Papanikolaou General Hospital of Thessaloniki
  • Attiki
    • Athens, Attiki, Greece, 115 28
      • University of Athens Medical School - Regional General Hospital Alexandra
• Hungary
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem
  • Budapest, Hungary, 1097
    • Klinika Hematologii, Szpital Uniwersytecki Nr 2 im. Jana Biziela w Bydgoszczy
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Szeged, Hungary, 6725
    • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
• Israel
  • Be'er Sheva, Israel, 84101
    • Shamir Medical Center Assaf Harofeh
  • Beer Yaakov, Israel, 70300
    • Rigshospitalet
  • Haifa, Israel, 33394
    • Bnai Zion Medical Center
  • Jerusalem, Israel, 91120
    • Hadassah Medical Center - PPDS
  • Kfar Saba, Israel, 44281
    • Meir Medical Center
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center - PPDS
  • Ramat Gan, Israel, 52621
    • Chaim Sheba Medical Center
  • Tel Aviv, Israel, 64239
    • Tel Aviv Sourasky Medical Center
  • Tel Aviv, Israel, 69710
    • Assuta Medical Centers
  • Tiberias, Israel, 15208
    • Baruch Padeh Poriya Medical Center
• Italy
  • Ancona, Italy, 60126
    • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
  • Firenze, Italy, 50139
    • Azienda Ospedaliera Universitaria Careggi
  • Parma, Italy, 43126
    • Azienda Ospedaliero Universitaria di Parma
  • Ravenna, Italy, 48100
    • Ospedale Santa Maria delle Croci
  • Torino, Italy, 10126
    • Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino
  • Campania
    • Napoli, Campania, Italy, 80131
      • AORN A Cardarelli
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
    • Rimini, Emilia-Romagna, Italy, 47900
      • Ospedale Infermi di Rimini
  • Liguria
    • Genova, Liguria, Italy, 16132
      • IRCCS Az. Osp. Universitaria San Martino- IST
  • Lombardia
    • Brescia, Lombardia, Italy, 25123
      • ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN
    • Milano, Lombardia, Italy, 20162
      • ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
  • Puglia
    • San Giovanni Rotondo, Puglia, Italy, 71013
      • Ospedale Casa Sollievo Della Sofferenza IRCCS
  • Sicilia
    • Catania, Sicilia, Italy, 95124
      • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
  • Toscana
    • Pisa, Toscana, Italy, 56216
      • Azienda Ospedaliero Universitaria Pisana
  • Umbria
    • Terni, Umbria, Italy, 05100
      • Azienda Ospedaliera S Maria Di Terni
• Japan
  • Fukuoka, Japan, 810-8563
    • National Hospital Organization Kyushu Medical Center
  • Fukushima-City, Japan, 960-1295
    • Fukushima Medical University Hospital
  • Ibaraki, Japan, 311-3193
    • National Hospital Organization Mito Medical Center
  • Kurume, Japan, 830-0011
    • Kurume University Hospital
  • Nagaizumi-chō, Japan, 4118777
    • Shizuoka Cancer Center
  • Nagoya, Japan, 467-8602
    • Nagoya City University Hospital
  • Nagoya, Japan, 453-8511
    • Japanese Red Cross Nagoya Daiichi Hospital
  • Narita-shi, Japan, 286-8523
    • Japanese Red Cross Narita Hospital
  • Niigata-city, Japan
    • Niigata Cancer Center Hospital
  • Osaka, Japan, 530-0012
    • Osaka Saiseikai Nakatsu Hospital
  • Tachikawa, Japan, 1900014
    • National Hospital Organization Disaster Medical Center
  • Toyohashi, Japan
    • Toyohashi Municipal Hospital
  • Yamanashi, Japan, 400-8506
    • Yamanashi Prefectural Central Hospital
  • Gihu
    • Ogaki, Gihu, Japan, 503-8502
      • Ogaki Municipal Hospital
  • Hyogo
    • Kobe-City, Hyogo, Japan, 650-0047
      • Kobe City Medical Center General Hospital
  • Ibaraki
    • Hitachi, Ibaraki, Japan, 317-0077
      • Hitachi General Hospital
  • Nara
    • Ikoma-City, Nara, Japan, 630-0293
      • Nara Hospital Kinki University Faculty of Medicine
  • Okayama
    • Okayama-city, Okayama, Japan, 701-1192
      • National Hospital Organization Okayama Medical Center
  • Tokyo
    • Bunkyo, Tokyo, Japan, 113-8431
      • Juntendo University Hospital
    • Shibuya-ku, Tokyo, Japan, 150-8935
      • Japanese Red Cross Medical Center
• Korea, Republic of
  • Incheon, Korea, Republic of, 405-760
    • Gachon University Gil Medical Center
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 137-701
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital Yonsei University Health System - PPDS
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center - PPDS
  • Gyeonggido
    • Goyang-si, Gyeonggido, Korea, Republic of, 10408
      • National Cancer Center
• Mexico
  • Mexico City, Mexico, 14000
    • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Oaxaca, Mexico, 68000
    • Oaxaca Site management Organization (OSMO) - PPDS
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44160
      • Centro de Investigacion Farmaceutica Especializada de Occidente, SC - PPDS
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64460
      • Hospital Universitario Dr. Jose Eleuterio Gonzalez
    • Monterrey, Nuevo Leon, Mexico, 64000
      • Hospital Y Clinica OCA Sociedad Anonima de Capital Variable
• Poland
  • Chorzow, Poland
    • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
  • Wroclaw, Poland, 50-367
    • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
  • Kujawsko-pomorskie
    • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-168
      • Shengjing Hospital of China Medical University
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 02-106
      • MTZ Clinical Research Sp z o o - PRATIA - PPDS
• Portugal
  • Almada, Portugal, 2801-951
    • Hospital Garcia de Orta
  • Braga, Portugal, 4710-243
    • Hospital de Braga
  • Lisboa, Portugal, 1400-038
    • Champalimaud Cancer Center
  • Porto, Portugal, 4200-072
    • Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
  • Porto, Portugal, 4099-001
    • Centro Hospitalar do Porto - Hospital de Santo António
  • Porto, Portugal, 4200-319
    • Centro Hospitalar de Sao Joao EPE
  • Lisboa
    • Lisbon, Lisboa, Portugal, 1099-023
      • Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.
• Russian Federation
  • Kirov, Russian Federation, 610027
    • State Medical and Preventive Treatment Institution Kirov Regional Clinical Oncology Dispensary
  • Pyatigorsk, Russian Federation, 357500
    • Stavropol Regional Clinical Oncology Centre Pyatigorsk Affiliate
  • Ryazan, Russian Federation, 390039
    • Ryazan Regional Clinical Hospital
  • St. Petersburg, Russian Federation, 193024
    • Russian Research Institute of Hematology and Blood Transfusion
  • St. Petersburg, Russian Federation, 197110
    • City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31
• Serbia
  • Belgrade, Serbia, 11080
    • Clinical Hospital Center ''Bezanijska Kosa''
  • Belgrade, Serbia, 11000
    • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
  • Kragujevac, Serbia, 34000
    • University Clinical Center Kragujevac
  • Nis, Serbia, 18000
    • Soroka University Medical Centre
• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital
  • Singapore, Singapore, 169608
    • Singapore General Hospital (SGH)
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2196
      • Medical Oncology Centre of Rosebank
    • Pretoria, Gauteng, South Africa, 0044
      • Albert Alberts Stem Cell Transplant Centre
    • Pretoria, Gauteng, South Africa, 0181
      • Mary Potter Oncology Centre
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28006
    • Hospital Universitario de la Princesa
  • Madrid, Spain, 28031
    • Hospital Universitario Infanta Leonor
  • Madrid, Spain, 28009
    • Hospital General Universitario Gregorio Maranon
  • Madrid, Spain, 28050
    • Hospital Universitario HM Sanchinarro CIOCC
  • Murcia, Spain, 30008
    • Hospital General Universitario Morales Meseguer
  • Salamanca, Spain, 37007
    • Complejo Asistencial Universitario de Salamanca H. Clinico
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe de Valencia
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitario Germans Trias i Pujol
  • Madrid, Communidad Delaware
    • Pozuelo De Alarcon, Madrid, Communidad Delaware, Spain, 28223
      • Hospital Universitario Quironsalud Madrid
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universidad Navarra
• Sweden
  • Lund, Sweden, SE-22185
    • Skanes Universitetssjukhus Lund
  • Sodermanlands Lan
    • Stockholm, Sodermanlands Lan, Sweden
      • Karolinska Universitetssjukhuset Solna
    • Stockholm, Sodermanlands Lan, Sweden
      • Karolinska Universitetssjukhuset Huddinge
  • Vastra Gotalands Lan
    • Goteborg, Vastra Gotalands Lan, Sweden
      • Sahlgrenska Universitetssjukhuset
• Switzerland
  • Thun, Switzerland, CH-3600
    • Spital STS AG
• Taiwan
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
• Thailand
  • Bangkok, Thailand, 10330
    • Chulalongkorn University
  • Chiangmai, Thailand, 50200
    • Maharaj Nakorn Chiang Mai Chiang Mai University
  • Krung Thep Maha Nakhon
    • Bangkok, Krung Thep Maha Nakhon, Thailand, 10400
      • Ramathibodi Hospital
• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe Universitesi Tip Fakultesi Hastanesi
  • Ankara, Turkey, 06590
    • Ankara University Medical Faculty PPDS
  • Istanbul, Turkey, 34093
    • Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
  • Izmir, Turkey, 35340
    • Dokuz Eylul University Medical Faculty
• United Kingdom
  • Bath, United Kingdom, BA1 3NG
    • Royal United Hospital
  • Belfast, United Kingdom, BT16 1RH
    • Ulster Hospital
  • Bristol, United Kingdom, BS10 5NB
    • Southmead Hospital
  • Cardiff, United Kingdom, CF14 4XW
    • University Clinical Center Nis
  • Isleworth, United Kingdom, TW7 6AF
    • West Middlesex University Hospital
  • Leicester, United Kingdom, LE1 5WW
    • Leicester Royal Infirmary
  • London, United Kingdom
    • Chelsea and Westminster NHS Trust
  • Manchester, United Kingdom, M13 9WL
    • Manchester Royal Infirmary - PPDS
  • Middlesex, United Kingdom, HA1 3UJ
    • Northwick Park Hospital
  • Oldham, United Kingdom, OL1 2JH
    • The Royal Oldham Hospital - PPDS
  • Southall, United Kingdom, UB1 3HW
    • University Clinical Center of Serbia - PPDS
  • Swansea, United Kingdom
    • Singleton Hospital - PPDS
  • Antrim
    • Belfast, Antrim, United Kingdom, BT9 7AB
      • Belfast City Hospital
  • Birmingham
    • West Malling, Birmingham, United Kingdom, B9 5SS
      • Birmingham Heartlands Hospital
  • Bristol, City Of
    • Bristol, Bristol, City Of, United Kingdom, BS2 8ED
      • Bristol Haematology and Oncology centre
  • Dorset
    • Bournemouth, Dorset, United Kingdom, BH7 7DW
      • Royal Bournemouth Hospital
  • Hampshire
    • Portsmouth, Hampshire, United Kingdom, PO6 3LY
      • Queen Alexandra Hospital
  • Kent
    • Canterbury, Kent, United Kingdom, CT1 3NG
      • Kent and Canterbury Hospital
  • London, City Of
    • London, London, City Of, United Kingdom, W12 0HS
      • Hammersmith Hospital
    • London, London, City Of, United Kingdom, SE5 9RS
      • Kings College Hospital
    • London, London, City Of, United Kingdom, EC1A 7BE
      • Barts Health NHS Trust
    • London, London, City Of, United Kingdom, NW1 2BU
      • University College London
    • Uxbridge, London, City Of, United Kingdom, UB8 3NN
      • Hillingdon Hospital
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 7LJ
      • Churchill Hospital
  • Staffordshire
    • Wolverhampton, Staffordshire, United Kingdom, WV10 0QP
      • New Cross Hospital
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • Royal Marsden Hospital - Surrey
• United States
  • California
    • Fountain Valley, California, United States, 92708
      • Robert A Moss MD FACP Inc
    • Los Angeles, California, United States, 90095
      • UCLA Medical Hematology and Oncology
    • Oceanside, California, United States, 92056
      • North County Oncology Medical Clinic Inc
    • Oxnard, California, United States, 93030
      • Ventura County Hematology Oncology Specialists
    • Redlands, California, United States, 92373
      • Emad Ibrahim, Md, Inc
    • San Jose, California, United States, 95124
      • Global Cancer Research Institute (GCRI), Inc.
    • Santa Maria, California, United States, 93454
      • Central Coast Medical Oncology Corporation
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute, Emory University
  • Illinois
    • Chicago, Illinois, United States, 60612
      • John H. Stroger Jr. Hospital of Cook County
  • Iowa
    • Sioux City, Iowa, United States, 51101
      • Siouxland Hematology - Oncology Associates LLP
  • Kentucky
    • Hazard, Kentucky, United States, 41701
      • Appalachian Regional Healthcare
  • Maine
    • Scarborough, Maine, United States, 04074
      • New England Cancer Specialists
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • Saint Agnes Hospital - Baltimore - Hunt - PPDS
    • Bethesda, Maryland, United States, 20817
      • University Hospital of Wales -
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center - PPDS
  • Michigan
    • Lansing, Michigan, United States, 48912
      • Herbert-Herman Cancer Center
  • New York
    • New York, New York, United States, 10021
      • New York Presbyterian Hospital - Weill-Cornell
    • New York, New York, United States, 10021
      • Clinical Research Alliance Inc
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Cancer Care of WNC PA
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Cancer Pavillion
  • Texas
    • Tyler, Texas, United States, 75701
      • HOPE Cancer Center of East Texas
  • Washington
    • Seattle, Washington, United States, 98109
      • Swedish Cancer Institute
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • W VA University Mary Babb Randolph Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult male or female participants 18 years or older with a confirmed diagnosis of symptomatic newly diagnosed multiple myeloma (NDMM) according to standard criteria.
2. 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.
3. Documented major response (PR, VGPR, CR) according to the International Myeloma Working Group (IMWG) uniform response criteria, version 2011, after this initial therapy.

4. 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.)
5. 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.
6. Complete documentation of the details of the initial therapy before randomization including cytogenetics and International Staging System (ISS) is available.
7. Eastern Cooperative Oncology Group Performance Status of 0 to 2.
8. Suitable venous access for the study-required blood sampling and consent for the specific amounts that will be taken.
9. Is willing and able to adhere to the study visit schedule and other protocol requirements including blood sampling and bone marrow aspiration.

10. 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:

1. Multiple myeloma that has relapsed after, or was not responsive to, initial therapy.
2. Prior SCT.
3. Radiotherapy within 14 days before randomization.
4. 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.
5. Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period.
6. Major surgery within 14 days before randomization.
7. Central nervous system involvement.
8. Infection requiring intravenous (IV) antibiotic therapy or other serious infection within 14 days before randomization.
9. 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.
10. 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.
11. 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.
12. Ongoing or active infection, known human immunodeficiency virus (HIV) positive, active hepatitis B or C infection.
13. 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).
14. Psychiatric illness or social situation that would limit compliance with study requirements.
15. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
16. 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.
17. Treatment with any investigational products within 30 days before randomization.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Ixazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.	Drug: Placebo; Ixazomib placebo-matching capsules.
Experimental: Ixazomib; Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.	Drug: Ixazomib; Ixazomib capsules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS)	PFS is defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause, as evaluated by an independent review committee (IRC) according to International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first. Per IMWG criteria, PD is defined as, increase of 25% of lowest response value in one or more of following criteria: serum M-component (absolute increase ≥0.5 g/ deciliter (dL)); or urine M-component (absolute increase ≥200 mg/24-hour); difference between involved and uninvolved free light chains (FLC) levels (absolute increase >10 mg/dL); or bone marrow plasma cell percentage (absolute plasma cell percentage ≥10%); development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma; or development of hypercalcemia (corrected serum calcium >11.5mg/dL).	From randomization until PD or death (up to 52 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS was measured as the time from the date of randomization to the date of death.	From the date of randomization and every 12 weeks after PD on next-line therapy until death (up to 88 months)
Percentage of Participants Who Achieve or Maintain Any Best Response Category During the Treatment Period	Response was assessed according to IMWG criteria based on IRC assessment. Best response included PR, VGPR and CR. PR= >=50% reduction of serum M protein and >=90% or <200 mg reduction urinary M protein in 24-hour, or >50% decrease in difference between involved and uninvolved FLC levels, or >50% reduction in bone marrow plasma cells, if bone marrow plasma cells >30% and >50% reduction in size of soft tissue plasmacytomas at baseline. VGPR= >90% reduction (<100 mg/24-hour) in serum M-protein + urine M-protein detectable by immunofixation but not on electrophoresis. Complete response= >5% plasma cells in myelogram with absence of paraprotein in serum and urine according to immunofixation.	Up to 27 months
Time to Progression (TTP)	TTP is defined as the time from the date of randomization to the date of first documentation of PD, using IMWG criteria.	From randomization until PD or death (up to 52 months)
Progression Free Survival 2 (PFS2)	PFS2 is defined as the time from the date of randomization to objective PD on next-line treatment using IMWG criteria, or death due to any cause, whichever occurred first.	From the date of randomization to every 12 weeks until second PD or death (up to 88 months)
Time to Next Line Therapy (TTNT)	TTNT is defined as the time from the date of randomization to the date of the first dose of next-line antineoplastic therapy.	From randomization until PD or death (up to 52 months)
Time to End of the Next-line of Therapy After Study Treatment	Time to end of the next line of therapy is defined as the time from the date of randomization to the date of last dose of the next line of antineoplastic therapy following study treatment.	From randomization until PD or death (up to 52 months)
Duration of Next-line Therapy	Duration of next-line therapy is defined as the time from the date of the first dose of the next line of antineoplastic therapy coming after study treatment to the date of the last dose.	From randomization until PD or death (up to 52 months)
Percentage of Participants Who Develop a New Primary Malignancy		From randomization until PD or death (up to 52 months)
Percentage of Participants With Conversion From Minimal Residual Disease (MRD) Positive to MRD Negative	Bone marrow aspirates and blood samples were sent to a central laboratory and were assessed for MRD using flow cytometry. MRD negativity was defined as absence of MRD and MRD positivity was defined as presence of MRD. MRD was assessed by 8-color flow cytometry with the IMWG recommended sensitivity of 10^-5.	Up to 52 months
Correlation of MRD Status With PFS and OS	PFS is defined as the time from the date of randomization to the date of first documentation of PD or death from any cause, as evaluated by an IRC according to IMWG criteria, or death due to any cause, whichever occurred first, assessed for up to 52 months in this outcome measure. OS was measured as the time from the date of randomization to the date of death, assessed for up to 52 months in this outcome measure. Participants with various types of known MRD status were pooled together for analysis of overall survival in this outcome measure.	From randomization up to 52 months
OS in a High-risk Population	High-risk population included but not be limited to participants carrying cytogenetic deletion (del)17, translocation [t](4;14), t(14;16). OS was measured as the time from the date of randomization to the date of death.	From the date of randomization and every 12 weeks after PD on next-line therapy until death (up to 88 months)
PFS in a High-risk Population	High-risk population included but not be limited to participants carrying del17, t(4;14), t(14;16). PFS was defined as the time from the date of randomization to the date of first documentation of PD or death from any cause.	From randomization until PD or death (up to 52 months)
Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status	ECOG performance status assesses a participant's performance status on a 6-point scale ranging from 0=fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=capable of only limited self-care, confined to bed/chair >50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=dead. Lower grades indicate improvement.	Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26, progression free survival follow-up (PFSFU)- Visit 37 and progressive disease follow-up (PDFU)- Visit 26 (cycle length=28 days)
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAEs were defined as events that occurred after administration of the first dose of ixazomib or placebo through 30 days after the last dose of ixazomib or placebo. A SAE means any untoward medical occurrence that resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was considered medically significant.	First dose of study drug through 30 days after last dose of study drug (up to 88 months)
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) as Measured by the Global Health Status (GHS)	The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The change from baseline in GHS (EORTC QLQ-C30) score is presented. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1=very poor to 7=excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall GHS.	Baseline, Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26 (cycle length=28 days)
Correlation Between Frailty Status and PFS and OS	Participant's frailty status is classified as fit, unfit or frail on the bases of 4 components: age, the Charlson comorbidity scoring system without age weighting, the Katz index of independence in activities of daily living, and the Lawton instrumental activities of daily living scale. The sum of the 4 frailty scores equals the total frailty score. A total frailty score of 0 corresponds to a frailty status of fit; a total score of 1, to unfit; and a total score of 2 or more, to frail. PFS is defined as the time from the date of randomization to the date of first documentation of PD or death from any cause, as evaluated by an IRC according to IMWG criteria, or death due to any cause, whichever occurs first, assessed for up to 52 months in this outcome measure. OS will be measured as the time from the date of randomization to the date of death, assessed for up to 52 months in this outcome measure.	From randomization up to 52 months
Pharmacokinetic Parameter: Plasma Concentration of Ixazomib	Plasma concentrations of the complete hydrolysis product of ixazomib citrate (ixazomib) were measured using a validated liquid chromatography-tandem mass spectrometry (LC/MS/MS) assay.	Cycle 1 (1 and 4 hours post-dose Day 1, Days 8 and 15 pre-dose); Cycle 2 and 5 (Days 1 and 8 pre-dose) and Cycles 3, 4, 6 to 10 (Day 1 pre-dose) (cycle length=28 days)
Time to Resolution of Peripheral Neuropathy (PN) Events	PN is defined as the event in the high-level term of peripheral neuropathies not elsewhere classified (NEC) according to the medical dictionary for regulatory activities (MedDRA). A PN event was considered as resolved if its final outcome was resolved with no subsequent PN event of the same preferred term occurring on the resolution date or the day before and after. Time to resolution was defined as the time from the initial onset date (inclusive) to the resolution date for resolved events.	Up to 52 months
Time to Improvement of PN Events	PN is defined as the event in the high-level term of peripheral neuropathies NEC according to the MedDRA. A PN event was considered as resolved if its final outcome was resolved with no subsequent PN event of the same preferred term occurring on the improvement date or the day before and after. Time to improvement was defined as the time from the initial onset date (inclusive) to the improvement of event.	Up to 52 months

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Medical Director, Takeda

Publications and helpful links

General Publications

• Dimopoulos MA, Spicka I, Quach H, Oriol A, Hajek R, Garg M, Beksac M, Bringhen S, Katodritou E, Chng WJ, Leleu X, Iida S, Mateos MV, Morgan G, Vorog A, Labotka R, Wang B, Palumbo A, Lonial S; TOURMALINE-MM4 study group. Ixazomib as Postinduction Maintenance for Patients With Newly Diagnosed Multiple Myeloma Not Undergoing Autologous Stem Cell Transplantation: The Phase III TOURMALINE-MM4 Trial. J Clin Oncol. 2020 Dec 1;38(34):4030-4041. doi: 10.1200/JCO.20.02060. Epub 2020 Oct 6. Erratum In: J Clin Oncol. 2022 Mar 10;40(8):919.

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2015
• Primary Completion (Actual): August 12, 2019
• Study Completion (Actual): August 26, 2022

Study Registration Dates

• First Submitted: December 5, 2014
• First Submitted That Met QC Criteria: December 8, 2014
• First Posted (Estimated): December 9, 2014

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protease Inhibitors; Ixazomib
• Other Study ID Numbers: C16021; SNCTP000001745 (Registry Identifier: SNCTP); U1111-1160-1702 (Registry Identifier: WHO); 2014-001394-13 (EudraCT Number); REec-2015-1414 (Registry Identifier: REec); JapicCTI-152873 (Registry Identifier: JapicCTI); 153300410A0048 (Registry Identifier: RNEC); 1046003327 (Registry Identifier: TCTIN); 15/NE/0167 (Registry Identifier: NRES); 182602 (Registry Identifier: HC-CTD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No