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
10 other identifiers
interventional
706
33 countries
267
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 multiple-myeloma
Started Apr 2015
Typical duration for phase_3 multiple-myeloma
267 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2014
CompletedFirst Posted
Study publicly available on registry
December 9, 2014
CompletedStudy Start
First participant enrolled
April 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2019
CompletedResults Posted
Study results publicly available
November 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 26, 2022
CompletedSeptember 21, 2023
August 1, 2023
4.3 years
December 5, 2014
August 6, 2020
August 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (19)
Overall Survival (OS)
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
Up to 27 months
Time to Progression (TTP)
From randomization until PD or death (up to 52 months)
Progression Free Survival 2 (PFS2)
From the date of randomization to every 12 weeks until second PD or death (up to 88 months)
Time to Next Line Therapy (TTNT)
From randomization until PD or death (up to 52 months)
- +14 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORIxazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.
Ixazomib
EXPERIMENTALIxazomib 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- +6 more criteria
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (275)
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, B1629AHJ, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Ciudad Autonoma de BuenosAires, C1181ACH, Argentina
Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)
Buenos Aires, Ciudad Autonoma de BuenosAires, C1431FWO, Argentina
Sanatorio Allende S.A.
Córdoba, X5000JHQ, Argentina
Hospital Iturraspe
Santa Fe, S3000ADL, 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, Tyrol, 6020, Austria
Paracelsus Medizinische Privatuniversitat
Salzburg, 5020, Austria
Medizinische Universitat Wien (Medical University of Vienna)
Vienna, A-1090, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, 4600, Austria
Universitair Ziekenhuis Brussel - PIN
Brussels, Brussels Capital, 1090, Belgium
UZ Brussel
Brussels, Brussels Capital, 1090, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, 1200, Belgium
Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet
Salvador, Estado de Bahia, 41253-196, Brazil
Hospital Das Clinicas Da Universidade Federal de Goias
Goiânia, Goiás, 74605-020, Brazil
Hospital Das Clinicas Da UFMG
Belo Horizonte, Minas Gerais, 30130-100, Brazil
Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner
Curitiba, Paraná, 81520-060, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, Rio Grande do Norte, 59040-150, Brazil
Universidade de Caxias do Sul
Caxias do Sul, Rio Grande do Sul, 95070-560, Brazil
Associacao Hospital de Caridade Ijui
Ijuí, Rio Grande do Sul, 98700-000, Brazil
American Oncology Partners of Maryland, PA
Passo Fundo, Rio Grande do Sul, 99010-260, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035-001, Brazil
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Mae de Deus Center Hospital Giovanni Battista
Porto Alegre, Rio Grande do Sul, 90470-340, Brazil
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Instituto Joinvilense de Hematologia E Oncologia
Joinville, Santa Catarina, 89201260, Brazil
Fundacao PIO XII
Barretos, São Paulo, 14784-400, Brazil
Universidade Estadual de Campinas
Campinas, São Paulo, 13083-878, Brazil
Hospital Amaral Carvalho
Jaú, São Paulo, 17210-120, Brazil
Faculdade de Medicina Do ABC
Santo André, São Paulo, 09060-650, Brazil
HEMORIO - Unidade de Pesquisa Clinica
Rio de Janeiro, 20211-030, Brazil
Instituto Nacional de Cancer
Rio de Janeiro, 20231-050, Brazil
Fundação Antônio Prudente - AC Camargo Câncer Center
Rio de Janeiro, 21941-913, Brazil
Hospital de Base Da Faculdade de Medicina de Sao Jose Do Rio Preto
São José do Rio Preto, 15090-000, Brazil
Instituto de Ensino E Pesquisa Sao Lucas
São Paulo, 01236-030, Brazil
Hospital Sirio Libanes
São Paulo, 01308-050, Brazil
Ealing Hospital
São Paulo, 01509-900, Brazil
Clinica Sao Germano
São Paulo, 04537-080, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, 05403-000, Brazil
Hospital Israelita Albert Einstein
São Paulo, 05652-900, Brazil
Hospital Santa Marcelina
São Paulo, 08270-070, Brazil
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2, Canada
William Osler Health Centre
Brampton, Ontario, L6W 3J7, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
McGill University Health Center
Montreal, Quebec, H4A 3J1, Canada
Hospital Amaral Carvalho
Temuco, Región de la Araucanía, 4800827, Chile
Instituto Nacional Del Cancer
Santiago, 8380455, Chile
Centro Internacional de Estudios Clinicos
Santiago, Chile
Centro de Investigaciones Clinicas Vina del Mar
Viña del Mar, 2570017, Chile
Hospital de Clinicas de Passo Fundo
Nanjing, Jiangsu, 210029, China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003, China
Beijing Chaoyang Hospital Capital Medical University
Beijing, 100020, China
Peking University Third Hospital
Beijing, 100191, China
Peking Union Medical College Hospital
Beijing, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, 310003, China
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, 200001, China
Shanghai Chang Zheng Hospital
Shanghai, 200003, China
Hospital São Rafael
Shenyang, 110004, China
Second Hospital of Shanxi Medical University
Taiyuan, 030001, China
James Lind Centro de Investigación del Cáncer
Wuhan, 430030, China
Hospital Pablo Tobon Uribe
Medellín, Antioquia, 050034, Colombia
Hospital Universitario San Ignacio
Bogotá, Bogota D.C., 110311, Colombia
Instituto Nacional de Cancerologia Colombia
Bogota, Cundinamarca, Colombia
Clinical Hospital Dubrava
Zagreb, City of Zagreb, 10000, Croatia
Clinical Hospital Center Rijeka
Rijeka, 51000, Croatia
Clinical Hospital Center Zagreb - PPDS
Zagreb, 10 000, Croatia
Fakultni nemocnice Hradec Kralove
Hradec Králové, Kralovehradeck Kraj, 500 05, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Praha, Hlavni Mesto, 100 34, Czechia
Fakultni nemocnice Brno
Brno, 625 00, Czechia
Fakultni nemocnice Olomouc
Olomouc, 775 20, Czechia
Fakultni nemocnice Ostrava
Ostrava, 708 52, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 08, Czechia
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Copenhagen, Capital, 2100, Denmark
Aarhus Universitetshospital Århus Sygehus
Aarhus N, DK-8200, 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
Vandœuvre-lès-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, Bavaria, 86150, Germany
Internistisch Hamatologische und Internistische Praxis
Herrsching am Ammersee, Bavaria, 82211, Germany
LMU Klinikum der Universitat Munchen
München, Bavaria, 81377, Germany
Pius Hospital Oldenburg
Oldenburg, Lower Saxony, 26121, Germany
Universitatsklinikum Essen
Essen, North Rhine-Westphalia, 45122, Germany
Gemeinschaftspraxis fur Hamatologie und Onkologie
Münster, North Rhine-Westphalia, 48149, Germany
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
Mainz, Rhineland-Palatinate, 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
München, 81675, Germany
Praxis Pihusch Medizinisches Versorgungszentrum GbR
Rosenheim, 83022, Germany
Gemeinschaftspraxis Dr. med. R. Schlag & Dr. med. B. Schottker & Dr. med. J. Haas
Würzburg, 97080, Germany
University of Athens Medical School - Regional General Hospital Alexandra
Athens, Attica, 115 28, 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
Rigshospitalet
Beer Yaakov, 70300, Israel
Shamir Medical Center Assaf Harofeh
Beersheba, 84101, 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
Ospedale Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, Apulia, 71013, Italy
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
Genoa, Liguria, 16132, Italy
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN
Brescia, Lombardy, 25123, Italy
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
Milan, Lombardy, 20162, Italy
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Catania, Sicily, 95124, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, 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
Florence, 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
Ōgaki, Gihu, 503-8502, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047, Japan
Hitachi General Hospital
Hitachi, Ibaraki, 317-0077, Japan
Nara Hospital Kinki University Faculty of Medicine
Ikoma, Nara, 630-0293, Japan
National Hospital Organization Okayama Medical Center
Okayama, Okayama-ken, 701-1192, Japan
Juntendo University Hospital
Bunkyo, Tokyo, 113-8431, Japan
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo, 150-8935, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, 810-8563, Japan
Fukushima Medical University Hospital
Fukushima, 960-1295, Japan
National Hospital Organization Mito Medical Center
Ibaraki, 311-3193, Japan
Kurume University Hospital
Kurume, 830-0011, Japan
Shizuoka Cancer Center
Nagaizumi-chō, 4118777, Japan
Japanese Red Cross Nagoya Daiichi Hospital
Nagoya, 453-8511, Japan
Nagoya City University Hospital
Nagoya, 467-8602, Japan
Japanese Red Cross Narita Hospital
Narita-shi, 286-8523, Japan
Niigata Cancer Center Hospital
Niigata, Japan
Osaka Saiseikai Nakatsu Hospital
Osaka, 530-0012, Japan
National Hospital Organization Disaster Medical Center
Tachikawa, 1900014, Japan
Toyohashi Municipal Hospital
Toyohashi, Japan
Yamanashi Prefectural Central Hospital
Yamanashi, 400-8506, Japan
Centro de Investigacion Farmaceutica Especializada de Occidente, SC - PPDS
Guadalajara, Jalisco, 44160, Mexico
Hospital Y Clinica OCA Sociedad Anonima de Capital Variable
Monterrey, Nuevo León, 64000, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, 64460, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14000, Mexico
Oaxaca Site management Organization (OSMO) - PPDS
Oaxaca City, 68000, Mexico
Shengjing Hospital of China Medical University
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland
MTZ Clinical Research Sp z o o - PRATIA - PPDS
Warsaw, Masovian Voivodeship, 02-106, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Chorzów, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
Wroclaw, 50-367, Poland
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.
Lisbon, Lisbon District, 1099-023, Portugal
Hospital Garcia de Orta
Almada, 2801-951, Portugal
Hospital de Braga
Braga, 4710-243, Portugal
Champalimaud Cancer Center
Lisbon, 1400-038, Portugal
Centro Hospitalar do Porto - Hospital de Santo Antonio
Porto, 4099-001, Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
Porto, 4200-072, Portugal
Centro Hospitalar de Sao Joao EPE
Porto, 4200-319, Portugal
State Medical and Preventive Treatment Institution Kirov Regional Clinical Oncology Dispensary
Kirov, 610027, Russia
Stavropol Regional Clinical Oncology Centre Pyatigorsk Affiliate
Pyatigorsk, 357500, Russia
Ryazan Regional Clinical Hospital
Ryazan, 390039, Russia
Russian Research Institute of Hematology and Blood Transfusion
Saint Petersburg, 193024, Russia
City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31
Saint Petersburg, 197110, Russia
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
Niš, 18000, Serbia
National University Hospital
Singapore, 119074, Singapore
Singapore General Hospital (SGH)
Singapore, 169608, 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
National Cancer Center
Goyang-si, Gyeonggido, 10408, South Korea
Gachon University Gil Medical Center
Incheon, 405-760, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Severance Hospital Yonsei University Health System - PPDS
Seoul, 120-752, South Korea
Samsung Medical Center - PPDS
Seoul, 135-710, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 137-701, South Korea
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Communidad Delaware, 28223, Spain
Clinica Universidad Navarra
Pamplona, Navarre, 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, Södermanland County, Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, Södermanland County, Sweden
Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götaland County, Sweden
Skanes Universitetssjukhus Lund
Lund, SE-22185, Sweden
Spital STS AG
Thun, CH-3600, Switzerland
Kaohsiung Medical University Hospital
Kaohsiung City, 807, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Ramathibodi Hospital
Bangkok, Bangkok, 10400, Thailand
Chulalongkorn University
Bangkok, 10330, Thailand
Maharaj Nakorn Chiang Mai Chiang Mai University
Chiang Mai, 50200, Thailand
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, 06100, Turkey (Türkiye)
Ankara University Medical Faculty PPDS
Ankara, 06590, Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
Istanbul, 34093, Turkey (Türkiye)
Dokuz Eylul University Medical Faculty
Izmir, 35340, Turkey (Türkiye)
Belfast City Hospital
Belfast, Antrim, BT9 7AB, United Kingdom
Birmingham Heartlands Hospital
West Malling, Birmingham, B9 5SS, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, Bristol, City of, BS2 8ED, United Kingdom
Royal Bournemouth Hospital
Bournemouth, Dorset, BH7 7DW, United Kingdom
Queen Alexandra Hospital
Portsmouth, Hampshire, PO6 3LY, United Kingdom
Kent and Canterbury Hospital
Canterbury, Kent, CT1 3NG, United Kingdom
Barts Health NHS Trust
London, London, City of, EC1A 7BE, United Kingdom
University College London
London, London, City of, NW1 2BU, United Kingdom
Kings College Hospital
London, London, City of, SE5 9RS, United Kingdom
Hammersmith Hospital
London, London, City of, W12 0HS, United Kingdom
Hillingdon Hospital
Uxbridge, London, City of, UB8 3NN, United Kingdom
Churchill Hospital
Oxford, Oxfordshire, OX3 7LJ, United Kingdom
New Cross Hospital
Wolverhampton, Staffordshire, WV10 0QP, United Kingdom
Royal Marsden Hospital - Surrey
Sutton, Surrey, SM2 5PT, United Kingdom
Royal United Hospital
Bath, BA1 3NG, United Kingdom
Ulster Hospital
Belfast, BT16 1RH, United Kingdom
Southmead Hospital
Bristol, BS10 5NB, United Kingdom
University Clinical Center Nis
Cardiff, CF14 4XW, United Kingdom
West Middlesex University Hospital
Isleworth, TW7 6AF, United Kingdom
Leicester Royal Infirmary
Leicester, LE1 5WW, United Kingdom
Chelsea and Westminster NHS Trust
London, United Kingdom
Manchester Royal Infirmary - PPDS
Manchester, M13 9WL, United Kingdom
Northwick Park Hospital
Middlesex, HA1 3UJ, United Kingdom
The Royal Oldham Hospital - PPDS
Oldham, OL1 2JH, United Kingdom
University Clinical Center of Serbia - PPDS
Southall, UB1 3HW, United Kingdom
Singleton Hospital - PPDS
Swansea, United Kingdom
Related Publications (2)
Paiva B, Manrique I, Dimopoulos MA, Gay F, Min CK, Zweegman S, Spicka I, Teipel R, Mateos MV, Giuliani N, Cavo M, Hopkins CR, Fu W, Suryanarayan K, Vorog A, Li C, Wang B, Estevam J, Labotka R, Dash AB. MRD dynamics during maintenance for improved prognostication of 1280 patients with myeloma in the TOURMALINE-MM3 and -MM4 trials. Blood. 2023 Feb 9;141(6):579-591. doi: 10.1182/blood.2022016782.
PMID: 36130300DERIVEDDimopoulos 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.
PMID: 33021870DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2014
First Posted
December 9, 2014
Study Start
April 9, 2015
Primary Completion
August 12, 2019
Study Completion
August 26, 2022
Last Updated
September 21, 2023
Results First Posted
November 10, 2020
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- 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
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.