A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participants With Multiple Myeloma Following Autologous Stem Cell Transplant
A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Patients With Multiple Myeloma Following Autologous Stem Cell Transplant
8 other identifiers
interventional
656
32 countries
218
Brief Summary
The purpose of this study is to determine the effect of ixazomib citrate maintenance therapy on progression-free survival (PFS), compared to placebo, in participants with newly diagnosed multiple myeloma (NDMM) who have had a response (complete response \[CR\], very good partial response \[VGPR\], or partial response \[PR\]) to induction therapy followed by high-dose therapy (HDT) and autologous stem cell transplant (ASCT).
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 Jul 2014
Longer than P75 for phase_3 multiple-myeloma
218 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
June 27, 2014
CompletedFirst Posted
Study publicly available on registry
July 4, 2014
CompletedStudy Start
First participant enrolled
July 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 16, 2018
CompletedResults Posted
Study results publicly available
May 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 8, 2023
CompletedNovember 19, 2024
October 1, 2024
3.8 years
June 27, 2014
April 15, 2019
October 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
PFS was defined as the time from the date of randomization to the date of first documentation of PD, as evaluated by an independent review committee (IRC) according to International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurred first. PD was defined as ≥25% increase from lowest value in: serum/urine M component; participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved free light chain (FLC) levels must be \>10 milligrams per deciliter (mg/dL); participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must have been ≥10%; new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size increase; hypercalcemia development.
Randomization up to End of treatment (EOT) (24 months); thereafter followed up every 4 weeks (up to 45 months)
Secondary Outcomes (21)
Overall Survival (OS)
Randomization up to end of follow up period (up to 107 months)
Percentage of Participants With Any Best Response Category Before PD or Subsequent Therapy
Randomization up to EOT (up to 24 months) and thereafter every 4 weeks until initiation of the next line of therapy (up to 107 months)
Time to Progression (TTP)
Randomization up to PD (up to 107 months)
Second Progression Free Survival (PFS2)
Randomization up to EOT (24 months); thereafter followed up every 4 weeks until initiation of next-line therapy and then every 12 weeks until second progressive disease (PD2) or death (up to 107 months)
Time to Start of the Next Line of Therapy
Randomization up to 107 months
- +16 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORIxazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons.
Ixazomib Citrate
EXPERIMENTALIxazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who have had any dose reductions due to adverse events (AEs) would not be dose escalated.
Interventions
Eligibility Criteria
You may qualify if:
- Adult male or female participants 18 years or older with a confirmed diagnosis of symptomatic multiple myeloma according to standard criteria.
- Documented results of cytogenetics/ fluorescence in situ hybridization (FISH) obtained at any time before transplant, and International Staging System (ISS) staging at the time of diagnosis available.
- Underwent standard of care (SOC) induction therapy (induction therapy must include proteasome inhibitor (PI) and/or immunomodulating drugs (IMiD)-based regimens as primary therapy for multiple myeloma), followed by a single autologous stem cell transplant (ASCT) with a high-dose melphalan (200 mg/m\^2) conditioning regimen, within 12 months of diagnosis. Vincristine, Adriamycin \[doxorubicin\], and dexamethasone (VAD) is not an acceptable induction therapy for this trial.
- Started screening no earlier than 75 days after transplant, completed screening within 15 days, and randomized no later than 115 days after transplant.
- Must have not received post-ASCT consolidation therapy.
- Documented response to ASCT (PR, VGPR, CR/stringent complete response \[sCR\]) according to IMWG criteria.
- ECOG performance status of 0 to 2.
- Female participants who:
- 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, AND
- Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR
- Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence \[eg, calendar, ovulation, symptothermal, postovulation methods for the female partner\] and withdrawal are not acceptable methods of contraception.) Male participants, even if surgically sterilized (ie, 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, AND
- Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR
- Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence \[eg, calendar, ovulation, symptothermal, postovulation methods for the female partner\] 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.
- +7 more criteria
You may not qualify if:
- Multiple myeloma that has relapsed following primary therapy or is not responsive to primary therapy. For this study, stable disease following ASCT will be considered nonresponsive to primary therapy.
- Double (tandem) ASCT.
- Radiotherapy within 14 days before the first dose of study drug.
- Diagnosed or treated for another malignancy within 5 years before randomization or previously diagnosed with another malignancy with evidence of residual disease. 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, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome.
- Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic 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 use of Ginkgo biloba or St. John's wort within 14 days before randomization in the study.
- Active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive.
- Comorbid systemic illnesses or other severe concurrent disease which, 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 (eg, peripheral neuropathy that is Grade 1 with pain or Grade 2 or higher of any cause).
- Psychiatric illness/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 (227)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Mayo Clinic - PPDS
Rochester, Minnesota, 55905, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
West Virginia University Hospital
Morgantown, West Virginia, 26506, United States
Hospital Italiano de La Plata
La Plata, Buenos Aires, B1900AX, Argentina
Instituto de Hematologia Y Medicina Clinica Dr Ruben Davoli
Rosario, Santa Fe Province, 2000, Argentina
Sanatorio Britanico de Rosario
Rosario, Santa Fe Province, S2000CVB, Argentina
Sanatorio Parque de Rosario
Rosario, Santa Fe Province, S2000DSV, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, C1181ACH, Argentina
Hospital Iturraspe
Santa Fe, S3006FTP, Argentina
St George Hospital
Kogarah, New South Wales, 2217, Australia
Calvary Mater Newcastle
Waratah, New South Wales, 2298, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Icon Cancer Care South Brisbane
South Brisbane, Queensland, 4101, Australia
Gold Coast University Hospital
Southport, Queensland, 4215, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Elisabethinen Hospital Linz
Linz, 4020, Austria
Salzburger Landeskliniken
Salzburg, 5020, Austria
Allgemeines Krankenhaus der Stadt Wien
Vienna, 1090, Austria
Klinik Ottakring (fruher: Wilhelminenspital)
Vienna, 1160, Austria
Centre Hospitalier Jolimont-Lobbes
La Louvière, Hainaut, 7100, Belgium
Centre Hospitalier Universitaire Ambroise Pare
Mons, Hainaut, 7000, Belgium
UZ Gent
Ghent, Oost-Vlaanderen, 9000, Belgium
AZ Sint-Jan AV
Bruges, West-Vlaanderen, 8000, Belgium
ZNA Middelheim
Antwerp, 2020, Belgium
ZNA Stuivenberg
Antwerp, 2060, Belgium
Hospital Das Clinicas Da Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, 30130-100, Brazil
Instituto de Oncologia Do Parana
Curitiba, Paraná, 80530-010, Brazil
Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner
Curitiba, Paraná, 81520-060, Brazil
Hospital de Clinicas de Passo Fundo
Passo Fundo, Rio Grande do Sul, 99010-260, 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
Centro de Pesquisas Oncologicas
Florianópolis, Santa Catarina, 88034000, Brazil
Instituto Joinvilense de Hematologia E Oncologia
Joinville, Santa Catarina, 89201-260, Brazil
Hospital Amaral Carvalho
Jaú, São Paulo, 17210-080, Brazil
Hospital de Base Da FAMERP
São José do Rio Preto, São Paulo, 15090-000, Brazil
Instituto Nacional de Cancer
Rio de Janeiro, 20231-050, Brazil
Universidade Federal do Rio de Janeiro - UFRJ
Rio de Janeiro, 21941-913, Brazil
Irmandade Da Santa Casa de Misericordia de Sao Paulo
São Paulo, 01223-001, Brazil
Hospital Israelita Albert Einstein
São Paulo, 05651-901, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, 5403000, Brazil
University Health Network
Toronto, Ontario, M5G 2N2, Canada
MUHC-Glen Site
Montreal, Quebec, H4A 3J1, Canada
Instituto Nacional de Cancerologia Colombia
Bogota, Cundinamarca, Colombia
Fundacion Valle Del Lili
Cali, Valle del Cauca Department, Colombia
Hospital Pablo Tobon Uribe
Medellín, Colombia
Fakultni nemocnice Hradec Kralove
Hradec Králové, Kralovehradeck Kraj, 500 05, Czechia
Fakultni nemocnice Brno
Brno, 625 00, Czechia
Fakultni nemocnice Olomouc
Olomouc, 779 00, Czechia
Fakultni nemocnice Ostrava
Ostrava, 708 52, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, 128 08, Czechia
Herlev Hospital
Herlev, Capital, 2730, Denmark
Aalborg Universitetshospital
Aalborg, North Denmark, DK-9000, Denmark
Aarhus Universitetshospital Arhus Sygehus
Aarhus N, DK-8200, Denmark
Rigshospitalet
Copenhagen, 2100, Denmark
Odense Universitetshospital
Odense, 5000, Denmark
Sjallands Universitetshospital, Roskilde
Roskilde, DK-4000, Denmark
Vejle Sygehus
Vejle, DK-7100, Denmark
Hopital Antoine Beclere
Clamart, Hauts-de-Seine, 92140, France
Hotel Dieu - Nantes
Nantes, Loire-Atlantique, 44093, France
CHRU Lille
Lille, Nord, 59037, France
Hopital Universitaire Dupuytren
Limoges, 87042, France
Groupe Hospitalier Necker Enfants Malades
Paris, 75015, France
University Clinic Heidelberg
Heidelberg, Baden-Wurttemberg, 69120, Germany
Klinikum Mannheim Universitatsklinikum gGmbH
Mannheim, Baden-Wurttemberg, 68167, Germany
Universitatsklinikum Ulm
Ulm, Baden-Wurttemberg, 89081, Germany
LMU Klinikum der Universitat Munchen
München, Bavaria, 81377, Germany
Universitatsklinikum Wurzburg
Würzburg, Bavaria, 97080, Germany
Klinikum Darmstadt GmbH
Darmstadt, Hesse, 64283, Germany
Klinikum Frankfurt Hochst GmbH
Frankfurt am Main, Hesse, 65929, Germany
Pius Hospital Oldenburg
Oldenburg, Lower Saxony, 26121, Germany
Universitatsklinikum Bonn
Bonn, North Rhine-Westphalia, 53105, Germany
Uniklinik Koln
Cologne, North Rhine-Westphalia, 50937, Germany
Universitatsklinikum Essen
Essen, North Rhine-Westphalia, 45122, Germany
Evangelisches Krankenhaus Essen Werden gGmbH
Essen, North Rhine-Westphalia, 45239, Germany
Katholisches Krankenhaus Hagen gGmbH
Hagen, North Rhine-Westphalia, 58095, Germany
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
Mainz, Rhineland-Palatinate, 55131, Germany
Universitatsklinikum Carl Gustav Carus an der TU Dresden
Dresden, Saxony, 1307, Germany
Helios Klinikum Berlin-Buch
Berlin, 13125, Germany
Charite - Universitatsmedizin Berlin
Berlin, 13353, Germany
Asklepios Klinik St. Georg
Hamburg, 20099, Germany
Universitatsklinikum Hamburg Eppendorf
Hamburg, 20246, Germany
Asklepios Klinik Altona
Hamburg, 22763, Germany
KRH Klinikum Siloah-Oststadt-Heidehaus
Hanover, 30459, Germany
Klinikum der Stadt Ludwigshafen gGmbH
Ludwigshafen, 67063, Germany
Universitatsklinikum Tubingen
Tübingen, 72076, Germany
Evangelismos General Hospital of Athens
Athens, Attica, 10676, Greece
Laiko General Hospital of Athens
Athens, Attica, 11527, Greece
Alexandra Hospital
Athens, 11528, Greece
Georgios Papanikolaou General Hospital of Thessaloniki
Thessaloniki, 57010, Greece
Semmelweis Egyetem
Budapest, 1083, Hungary
Del-pesti Centrumkorhaz- Orszagos Hematologiai es Infektologiai Intezet
Budapest, 1097, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, 6725, Hungary
Barzilai Medical Center
Ashkelon, 78278, Israel
Soroka University Medical Centre
Beersheba, 84101, Israel
Bnai Zion Medical Center
Haifa, 31048, Israel
Rambam Medical Center - PPDS
Haifa, 31096, Israel
Lady Davis Carmel Medical Center
Haifa, 34362, Israel
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Hadassah Medical Center PPDS -
Jerusalem, 91120, Israel
Galilee Medical Center
Nahariya, 22100, Israel
Rabin Medical Center - PPDS
Petah Tikva, 49100, Israel
Sheba Medical Center - PPDS
Ramat Gan, 52621, Israel
Kaplan Medical Center
Rehovot, 76100, Israel
ZIV Medical Center
Safed, 13100, Israel
Tel Aviv Sourasky Medical Center PPDS
Tel Aviv, 64239, Israel
Shamir Medical Center Assaf Harofeh
Tzrifin, 70300, Israel
Presidio Ospedaliero di Pescara
Pescara, Abruzzo, 65100, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, Lazio, 152, Italy
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Lombardy, 27100, Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino
Turin, Piedmont, 10126, Italy
IRCCS Centro Di Riferimento Oncologico Della Basilicata
Rionero in Vulture, Potenza, 85028, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
Ancona, The Marches, 60020, Italy
Azienda Ospedaliera S Maria Di Terni
Terni, Umbria, 5100, Italy
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
Bologna, 40138, Italy
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN
Brescia, 25123, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, 50134, Italy
IRCCS Az. Osp. Universitaria San Martino- IST
Genova, 16132, Italy
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l - PPDS
Meldola, 47014, Italy
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda
Milan, 20162, Italy
Ospedale Infermi di Rimini
Rimini, 47900, Italy
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047, Japan
Iwate Medical University Hospital
Morioka, Iwate, 020-8505, Japan
National Hospital Organization Sendai Medical Center
Sendai, Miyagi, 9838520, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566, Japan
National Hospital Organization Okayama Medical Center
Okayama, Okayama-ken, 701-1192, Japan
Saitama Medical Center
Kawagoe, Saitama, 350-8550, Japan
Juntendo University Hospital
Bunkyo, Tokyo, 113-8431, Japan
Chiba University Hospital
Chiba, Tokyo, 2608677, Japan
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo, 150-8935, Japan
Center Hospital of the National Center for Global Health and Medicine
Shinjuku, Tokyo, 162-8655, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
National Hospital Organization Nagoya Medical Center
Nagoya, 460-0001, Japan
Nagoya City University Hospital
Nagoya, 467-8602, Japan
National Hospital Organaization Shibukawa Medical Center
Shibukawa, 377-0280, Japan
National Hospital Organization Disaster Medical Center
Tachikawa, 1900014, Japan
Toyohashi Municipal Hospital
Toyohashi, 441-8570, Japan
Centro de Investigacion Farmaceutica Especializada de Occidente, SC - PPDS
Guadalajara, Jalisco, 44160, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, 64460, Mexico
VU Medisch Centrum
Amsterdam, North Holland, 1081 HV, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, South Holland, 3318 AT, Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ, Netherlands
Erasmus MC
Rotterdam, 3015 CE, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX, Netherlands
Vestre Viken HF Sykehuset Asker Og Barum
Gjelta, Oppland, N-1346, Norway
St. Olav's University Hospital
Trondheim, Sor-Trondelag, N-7030, Norway
Oslo Universitetssykehus HF, Ulleval
Oslo, 450, Norway
Stavanger Universitetssykehus
Stavanger, 4011, Norway
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
Wroclaw, Lower Silesian Voivodeship, 50-367, Poland
Wojskowy Instytut Medyczny
Warsaw, Masovian Voivodeship, 04-141, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, 80-952, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Chorzów, Silesian Voivodeship, 41-500, Poland
Szpital Specjalistyczny w Brzozowie
Brzozów, 36-200, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz, 93-510, Poland
Hospital de Braga
Braga, 4710-243, Portugal
Centro Hospitalar E Universitario de Coimbra EPE
Coimbra, 3000-075, Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
Porto, 4200-072, Portugal
Centro Hospitalar de Sao Joao, E.P.E.
Porto, 4200-319, Portugal
National University Hospital
Singapore, 119074, Singapore
Singapore General Hospital (SGH)
Singapore, 169608, Singapore
Medical Oncology Centre of Rosebank
Johannesburg, Gauteng, 2196, South Africa
Mary Potter Oncology Centre
Pretoria, Gauteng, 181, South Africa
Albert Alberts Stem Cell Transplant Centre
Pretoria, Gauteng, 44, South Africa
National Cancer Center
Goyang, Gyeonggido, 410769, South Korea
Chungnam National University Hospital
Daejeon, 301-721, South Korea
Gachon University Gil Medical Center Pharmacy
Incheon, 405-760, South Korea
Seoul National University Hospital
Seoul, 110744, 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
Asan Medical Center - PPDS
Seoul, 138-736, South Korea
Ewha Womans University Mokdong Hospital
Seoul, 158710, South Korea
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 8916, Spain
Hospital General Universitario Gregorio Maranon
Madrid, Madrid, Communidad Delaware, 28009, Spain
Clinica Universidad Navarra
Pamplona, Navarre, 31008, Spain
Hospital Clinic de Barcelona
Barcelona, 8036, Spain
C.H. Regional Reina Sofia - PPDS
Córdoba, 14004, Spain
Institut Catala d'Oncologia Girona
Girona, 17007, Spain
Hospital Universitario de La Princesa
Madrid, 28006, Spain
Hospital Universitario La Paz - PPDS
Madrid, 28046, Spain
Hospital Universitario HM Sanchinarro CIOCC
Madrid, 28050, Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Madrid, 28222, Spain
Hospital General Universitario Morales Meseguer
Murcia, 30008, Spain
Complejo Asistencial Universitario de Salamanca H. Clinico
Salamanca, 37007, Spain
Hospital Universitario Virgen del Rocio - PPDS
Seville, 41013, Spain
Helsingborg Lasarett
Helsingborg, Skåne County, Sweden
Skanes Universitetssjukhus Lund
Lund, Skåne County, Sweden
Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götaland County, Sweden
Karolinska Universitetssjukhuset Huddinge
Stockholm, 14186, Sweden
Akademiska Sjukhuset I Uppsala
Uppsala, SE-751 85, Sweden
Universitatsspital Basel
Basel, Basel-Stadt (de), 4031, Switzerland
Universitatsspital Zurich
Zurich, Zurich (de), 8091, Switzerland
Kaohsiung Medical University Hospital
Kaohsiung City, 807, Taiwan
Chang Gung Medical Foundation-Kaoshiung Branch
Kaohsiung City, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Chang Gung Medical Foundation Chiayi Chang Gung Memorial Hospital
Taipei, 613, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, 333, Taiwan
Chulalongkorn University
Bangkok, Krung Thep Maha Nakhon-Bangkok, 10330, Thailand
Phramongkutklao Hospital
Bangkok, Krung Thep Maha Nakhon-Bangkok, 10400, Thailand
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, 6100, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
Ankara, 6200, Turkey (Türkiye)
Ankara University Medical Faculty PPDS
Ankara, Turkey (Türkiye)
Pamukkale Universitesi Tip Fakultesi Hastanesi
Denizli, 20070, Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
Istanbul, 34093, Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi Hastanesi
Kayseri, 38039, Turkey (Türkiye)
Karadeniz Technical University Faculty of Medicine
Trabzon, 61080, Turkey (Türkiye)
MNPE Kyiv Center of Bone Marrow Transplantation of executive body of Kyiv council
Kyiv, 3115, Ukraine
Southampton General Hospital
Southampton, Hampshire, SO16 6YD, United Kingdom
Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre
London, London, City of, EC1A 7BE, United Kingdom
Kings College Hospital
London, London, City of, SE5 9RS, United Kingdom
Imperial College Healthcare NHS Trust
London, London, City of, W12 0HS, United Kingdom
Churchill Hospital
Oxford, Oxfordshire, OX3 7LJ, United Kingdom
Royal Marsden Hospital - Surrey
Sutton, Surrey, SM2 5PT, United Kingdom
St James University Hospital
Leeds, Yorkshire, LS9 7TF, United Kingdom
Royal Hallamshire Hospital
Sheffield, Yorkshire, S10 2JF, United Kingdom
University Hospitals Leicester
Leicester, LE1 5WW, United Kingdom
University College London Hospitals (UCLH)
London, WC1E 6AG, United Kingdom
Singleton Hospital - PPDS
Swansea, United Kingdom
Related Publications (4)
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: 36130300DERIVEDKaiser M, Beksac M, Gulbrandsen N, Schjesvold F, Hajek R, Moreau P, de Arriba de la Fuente F, Mateos MV, West S, Spencer A, Rajkumar SV, Suryanarayan K, Czorniak M, Li C, Teng Z, Labotka R, Dimopoulos MA. Adverse event management in the TOURMALINE-MM3 study of post-transplant ixazomib maintenance in multiple myeloma. Ann Hematol. 2020 Aug;99(8):1793-1804. doi: 10.1007/s00277-020-04149-5. Epub 2020 Jul 1.
PMID: 32613281DERIVEDSchjesvold F, Goldschmidt H, Maisnar V, Spicka I, Abildgaard N, Rowlings P, Cain L, Romanus D, Suryanarayan K, Rajkumar V, Odom D, Gnanasakthy A, Dimopoulos M. Quality of life is maintained with ixazomib maintenance in post-transplant newly diagnosed multiple myeloma: The TOURMALINE-MM3 trial. Eur J Haematol. 2020 May;104(5):443-458. doi: 10.1111/ejh.13379. Epub 2020 Feb 22.
PMID: 31880006DERIVEDDimopoulos MA, Gay F, Schjesvold F, Beksac M, Hajek R, Weisel KC, Goldschmidt H, Maisnar V, Moreau P, Min CK, Pluta A, Chng WJ, Kaiser M, Zweegman S, Mateos MV, Spencer A, Iida S, Morgan G, Suryanarayan K, Teng Z, Skacel T, Palumbo A, Dash AB, Gupta N, Labotka R, Rajkumar SV; TOURMALINE-MM3 study group. Oral ixazomib maintenance following autologous stem cell transplantation (TOURMALINE-MM3): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2019 Jan 19;393(10168):253-264. doi: 10.1016/S0140-6736(18)33003-4. Epub 2018 Dec 10.
PMID: 30545780DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- 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
June 27, 2014
First Posted
July 4, 2014
Study Start
July 16, 2014
Primary Completion
April 16, 2018
Study Completion
September 8, 2023
Last Updated
November 19, 2024
Results First Posted
May 7, 2019
Record last verified: 2024-10
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.