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

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).

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma; Autologous Stem Cell Transplant
• Intervention / Treatment: Drug: Ixazomib Citrate; Drug: Placebo

Detailed Description

The investigational drug being tested in this study is called ixazomib citrate. Ixazomib citrate is being tested to slow disease progression and improve overall survival in people who have NDMM and who have had any type of positive response to induction therapy followed by HDT and ASCT. This study will look at the effect ixazomib citrate has on the length of time that participants are free of progressive disease (PD) and their overall survival (OS).

The study enrolled 656 participants. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need, or if the disease has progressed and the information is required for planning the next treatment):

• Ixazomib citrate 3 mg for the first 4 cycles, then 4 mg for the remaining 22 cycles
• 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, for up to 26 cycles (approximately 24 months).

This multi-center trial will be conducted globally. The overall time to participate in this study is up to 107 months. Participants will make 28 visits to the clinic during the treatment period and will continue to make visits after treatment has ended. During this initial follow up period, participants will be assessed for disease status with follow up every 12 weeks. After the next line of therapy begins, follow-up will occur every 12 weeks until death or termination of the study.

• Study Type: Interventional
• Enrollment (Actual): 656
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autonoma de Buenos Aires, Argentina, C1181ACH
    • Hospital Italiano de Buenos Aires
  • Santa Fe, Argentina, S3006FTP
    • Hospital Iturraspe
  • Buenos Aires
    • La Plata, Buenos Aires, Argentina, B1900AX
      • Hospital Italiano de La Plata
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Instituto de Hematologia Y Medicina Clinica Dr Ruben Davoli
    • Rosario, Santa Fe, Argentina, S2000CVB
      • Sanatorio Británico de Rosario
    • Rosario, Santa Fe, Argentina, S2000DSV
      • Sanatorio Parque de Rosario
• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • St George Hospital
    • Waratah, New South Wales, Australia, 2298
      • Calvary Mater Newcastle
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Icon Cancer Care South Brisbane
    • Southport, Queensland, Australia, 4215
      • Gold Coast University Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
    • Woodville South, South Australia, Australia, 5011
      • The Queen Elizabeth Hospital
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
• Austria
  • Linz, Austria, 4020
    • Elisabethinen Hospital Linz
  • Salzburg, Austria, 5020
    • Salzburger Landeskliniken
  • Wien, Austria, 1090
    • Allgemeines Krankenhaus der Stadt Wien
  • Wien, Austria, 1160
    • Klinik Ottakring (fruher: Wilhelminenspital)
• Belgium
  • Antwerpen, Belgium, 2020
    • ZNA Middelheim
  • Antwerpen, Belgium, 2060
    • ZNA Stuivenberg
  • Hainaut
    • La Louviere, Hainaut, Belgium, 7100
      • Centre Hospitalier Jolimont-Lobbes
    • Mons, Hainaut, Belgium, 7000
      • Centre Hospitalier Universitaire Ambroise Pare
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • UZ Gent
  • West-Vlaanderen
    • Brugge, West-Vlaanderen, Belgium, 8000
      • AZ Sint-Jan AV
• Brazil
  • Rio De Janeiro, Brazil, 20231-050
    • Instituto Nacional de Cancer
  • Rio de Janeiro, Brazil, 21941-913
    • Universidade Federal do Rio de Janeiro - UFRJ
  • Sao Paulo, Brazil, 05651-901
    • Hospital Israelita Albert Einstein
  • Sao Paulo, Brazil, 01223-001
    • Irmandade Da Santa Casa De Misericordia De Sao Paulo
  • Sao Paulo, Brazil, 5403000
    • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30130-100
      • Hospital das Clinicas da Universidade Federal de Minas Gerais
  • Parana
    • Curitiba, Parana, Brazil, 81520-060
      • Liga Paranaense de Combate ao Câncer - Hospital Erasto Gaertner
    • Curitiba, Parana, Brazil, 80530-010
      • Instituto de Oncologia do Parana
  • Rio Grande Do Sul
    • Passo Fundo, Rio Grande Do Sul, Brazil, 99010-260
      • Hospital de Clínicas de Passo Fundo
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
      • Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90470-340
      • Mae de Deus Center Hospital Giovanni Battista
  • Santa Catarina
    • Florianopolis, Santa Catarina, Brazil, 88034000
      • Centro de Pesquisas Oncologicas
    • Joinville, Santa Catarina, Brazil, 89201-260
      • Instituto Joinvilense de Hematologia E Oncologia
  • Sao Paulo
    • Jau, Sao Paulo, Brazil, 17210-080
      • Hospital Amaral Carvalho
    • Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15090-000
      • Hospital de Base Da FAMERP
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2N2
      • University Health Network
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • MUHC-Glen Site
• Colombia
  • Medellin, Colombia
    • Hospital Pablo Tobón Uribe
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia
      • Instituto Nacional de Cancerologia Colombia
  • Valle Del Cauca
    • Cali, Valle Del Cauca, Colombia
      • Fundacion Valle del Lili
• Czechia
  • Brno, Czechia, 625 00
    • Fakultni Nemocnice Brno
  • Olomouc, Czechia, 779 00
    • Fakultni nemocnice Olomouc
  • Ostrava, Czechia, 708 52
    • Fakultni nemocnice Ostrava
  • Praha, Czechia, 100 34
    • Fakultni nemocnice Kralovske Vinohrady
  • Praha 2, Czechia, 128 08
    • Vseobecna fakultni nemocnice v Praze
  • Kralovehradeck Kraj
    • Hradec Kralove, Kralovehradeck Kraj, Czechia, 500 05
      • Fakultni nemocnice Hradec Kralove
• Denmark
  • Aarhus N, Denmark, DK-8200
    • Aarhus Universitetshospital Arhus Sygehus
  • Copenhagen, Denmark, 2100
    • Rigshospitalet
  • Odense, Denmark, 5000
    • Odense Universitetshospital
  • Roskilde, Denmark, DK-4000
    • Sjallands Universitetshospital, Roskilde
  • Vejle, Denmark, DK-7100
    • Vejle Sygehus
  • Capital
    • Herlev, Capital, Denmark, 2730
      • Herlev Hospital
  • Nordjylland
    • Aalborg, Nordjylland, Denmark, DK-9000
      • Aalborg Universitetshospital
• France
  • Limoges, France, 87042
    • Hopital Universitaire Dupuytren
  • Paris, France, 75015
    • Groupe Hospitalier Necker Enfants Malades
  • Hauts-de-Seine
    • Clamart, Hauts-de-Seine, France, 92140
      • Hôpital Antoine Béclère
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44093
      • Hotel Dieu - Nantes
  • Nord
    • Lille, Nord, France, 59037
      • CHRU Lille
• Germany
  • Berlin, Germany, 13125
    • HELIOS Klinikum Berlin-Buch
  • Berlin, Germany, 13353
    • Charité - Universitätsmedizin Berlin
  • Hamburg, Germany, 20099
    • Asklepios Klinik St. Georg
  • Hamburg, Germany, 22763
    • Asklepios Klinik Altona
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg Eppendorf
  • Hannover, Germany, 30459
    • KRH Klinikum Siloah-Oststadt-Heidehaus
  • Ludwigshafen, Germany, 67063
    • Klinikum der Stadt Ludwigshafen gGmbH
  • Tubingen, Germany, 72076
    • Universitätsklinikum Tübingen
  • Baden-Wurttemberg
    • Heidelberg, Baden-Wurttemberg, Germany, 69120
      • University Clinic Heidelberg
    • Mannheim, Baden-Wurttemberg, Germany, 68167
      • Klinikum Mannheim Universitätsklinikum gGmbH
    • Ulm, Baden-Wurttemberg, Germany, 89081
      • Universitätsklinikum Ulm
  • Bayern
    • Munchen, Bayern, Germany, 81377
      • LMU Klinikum der Universität München
    • Wurzburg, Bayern, Germany, 97080
      • Universitatsklinikum Wurzburg
  • Hessen
    • Darmstadt, Hessen, Germany, 64283
      • Klinikum Darmstadt GmbH
    • Frankfurt am Main, Hessen, Germany, 65929
      • Klinikum Frankfurt Höchst GmbH
  • Niedersachsen
    • Oldenburg, Niedersachsen, Germany, 26121
      • Pius Hospital Oldenburg
  • Nordrhein-Westfalen
    • Bonn, Nordrhein-Westfalen, Germany, 53105
      • Universitätsklinikum Bonn
    • Essen, Nordrhein-Westfalen, Germany, 45122
      • Universitätsklinikum Essen
    • Essen, Nordrhein-Westfalen, Germany, 45239
      • Evangelisches Krankenhaus Essen Werden gGmbH
    • Hagen, Nordrhein-Westfalen, Germany, 58095
      • Katholisches Krankenhaus Hagen gGmbH
    • Koln, Nordrhein-Westfalen, Germany, 50937
      • Uniklinik Köln
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Sachsen
    • Dresden, Sachsen, Germany, 1307
      • Universitätsklinikum Carl Gustav Carus an der TU Dresden
• Greece
  • Athens, Greece, 11528
    • Alexandra Hospital
  • Thessaloniki, Greece, 57010
    • Georgios Papanikolaou General Hospital of Thessaloniki
  • Attiki
    • Athens, Attiki, Greece, 10676
      • Evangelismos General Hospital of Athens
    • Athens, Attiki, Greece, 11527
      • Laiko General Hospital of Athens
• Hungary
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem
  • Budapest, Hungary, 1097
    • Del-pesti Centrumkorhaz- Orszagos Hematologiai es Infektologiai Intezet
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Kaposvar, Hungary, 7400
    • Somogy Megyei Kaposi Mor Oktato Korhaz
  • Szeged, Hungary, 6725
    • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
• Israel
  • Ashkelon, Israel, 78278
    • Barzilai Medical Center
  • Be'er Sheva, Israel, 84101
    • Soroka University Medical Centre
  • Haifa, Israel, 34362
    • Lady Davis Carmel Medical Center
  • Haifa, Israel, 31048
    • Bnai Zion Medical Center
  • Haifa, Israel, 31096
    • Rambam Medical Center - PPDS
  • Jerusalem, Israel, 91031
    • Shaare Zedek Medical Center
  • Jerusalem, Israel, 91120
    • Hadassah Medical Center PPDS -
  • Nahariya, Israel, 22100
    • Galilee Medical Center
  • Petach Tikva, Israel, 49100
    • Rabin Medical Center - PPDS
  • Ramat-Gan, Israel, 52621
    • Sheba Medical Center - PPDS
  • Rehovot, Israel, 76100
    • Kaplan Medical Center
  • Safed, Israel, 13100
    • Ziv Medical Center
  • Tel Aviv, Israel, 64239
    • Tel Aviv Sourasky Medical Center PPDS
  • Tzrifin, Israel, 70300
    • Shamir Medical Center Assaf Harofeh
• Italy
  • Bologna, Italy, 40138
    • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
  • Brescia, Italy, 25123
    • ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN
  • Firenze, Italy, 50134
    • Azienda Ospedaliera Universitaria Careggi
  • Genova, Italy, 16132
    • IRCCS Az. Osp. Universitaria San Martino- IST
  • Meldola, Italy, 47014
    • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l - PPDS
  • Milano, Italy, 20162
    • ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda
  • Rimini, Italy, 47900
    • Ospedale Infermi di Rimini
  • Abruzzo
    • Pescara, Abruzzo, Italy, 65100
      • Presidio Ospedaliero di Pescara
  • Lazio
    • Roma, Lazio, Italy, 152
      • Azienda Ospedaliera San Camillo Forlanini
  • Lombardia
    • Pavia, Lombardia, Italy, 27100
      • Fondazione IRCCS Policlinico San Matteo di Pavia
  • Marche
    • Ancona, Marche, Italy, 60020
      • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
  • Piemonte
    • Torino, Piemonte, Italy, 10126
      • Azienda Ospedaliera Città della Salute e della Scienza di Torino
  • Potenza
    • Rionero In Vulture, Potenza, Italy, 85028
      • IRCCS Centro Di Riferimento Oncologico Della Basilicata
  • Umbria
    • Terni, Umbria, Italy, 5100
      • Azienda Ospedaliera S Maria Di Terni
• Japan
  • Fukuoka-City, Japan, 812-8582
    • Kyushu University Hospital
  • Nagoya, Japan, 460-0001
    • National Hospital Organization Nagoya Medical Center
  • Nagoya-City, Japan, 467-8602
    • Nagoya City University Hospital
  • Shibukawa, Japan, 377-0280
    • National Hospital Organaization Shibukawa Medical Center
  • Tachikawa, Japan, 1900014
    • National Hospital Organization Disaster Medical Center
  • Toyohashi-City, Japan, 441-8570
    • Toyohashi Municipal Hospital
  • Hyogo
    • Kobe-City, Hyogo, Japan, 650-0047
      • Kobe City Medical Center General Hospital
  • Iwate
    • Morioka-shi, Iwate, Japan, 020-8505
      • Iwate Medical University Hospital
  • Miyagi
    • Sendai, Miyagi, Japan, 9838520
      • National Hospital Organization Sendai Medical Center
  • Niigata
    • Niigata-shi, Niigata, Japan, 951-8566
      • Niigata Cancer Center Hospital
  • Okayama
    • Okayama-City, Okayama, Japan, 701-1192
      • National Hospital Organization Okayama Medical Center
  • Saitama
    • Kawagoe-city, Saitama, Japan, 350-8550
      • Saitama Medical Center
  • Tokyo
    • Bunkyo, Tokyo, Japan, 113-8431
      • Juntendo University Hospital
    • Chiba, Tokyo, Japan, 2608677
      • Chiba University Hospital
    • Shibuya-ku, Tokyo, Japan, 150-8935
      • Japanese Red Cross Medical Center
    • Shinjuku, Tokyo, Japan, 162-8655
      • Center Hospital of the National Center for Global Health and Medicine
    • Shinjuku-ku, Tokyo, Japan, 160-8582
      • Keio University Hospital
• Korea, Republic of
  • Daejeon, Korea, Republic of, 301-721
    • Chungnam National University Hospital
  • Incheon, Korea, Republic of, 405-760
    • Gachon University Gil Medical Center Pharmacy
  • Seoul, Korea, Republic of, 110744
    • 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
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center - PPDS
  • Seoul, Korea, Republic of, 158710
    • Ewha Womans University Mokdong Hospital
  • Gyeonggido
    • Goyang, Gyeonggido, Korea, Republic of, 410769
      • National Cancer Center
• Mexico
  • 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
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • Universitair Medisch Centrum Groningen
  • Rotterdam, Netherlands, 3015 CE
    • Erasmus MC
  • Utrecht, Netherlands, 3584 CX
    • Universitair Medisch Centrum Utrecht
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1081 HV
      • VU Medisch Centrum
  • Zuid-Holland
    • Dordrecht, Zuid-Holland, Netherlands, 3318 AT
      • Albert Schweitzer Ziekenhuis
• Norway
  • Oslo, Norway, 450
    • Oslo Universitetssykehus HF, Ulleval
  • Stavanger, Norway, 4011
    • Stavanger Universitetssykehus
  • Oppland
    • Gjelta, Oppland, Norway, N-1346
      • Vestre Viken HF Sykehuset Asker Og Barum
  • Sor-Trondelag
    • Trondheim, Sor-Trondelag, Norway, N-7030
      • St. Olav's University Hospital
• Poland
  • Brzozow, Poland, 36-200
    • Szpital Specjalistyczny w Brzozowie
  • Lodz, Poland, 93-510
    • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
  • Dolnoslaskie
    • Wroclaw, Dolnoslaskie, Poland, 50-367
      • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 04-141
      • Wojskowy Instytut Medyczny
  • Pomorskie
    • Gdansk, Pomorskie, Poland, 80-952
      • Uniwersyteckie Centrum Kliniczne
  • Slaskie
    • Chorzow, Slaskie, Poland, 41-500
      • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
• Portugal
  • Braga, Portugal, 4710-243
    • Hospital de Braga
  • Coimbra, Portugal, 3000-075
    • Centro Hospitalar E Universitario de Coimbra EPE
  • Porto, Portugal, 4200-319
    • Centro Hospitalar de São João, E.P.E.
  • Porto, Portugal, 4200-072
    • Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
• 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, 181
      • Mary Potter Oncology Centre
    • Pretoria, Gauteng, South Africa, 44
      • Albert Alberts Stem Cell Transplant Centre
• Spain
  • Barcelona, Spain, 8036
    • Hospital Clinic De Barcelona
  • Cordoba, Spain, 14004
    • C.H. Regional Reina Sofia - PPDS
  • Girona, Spain, 17007
    • Institut Catala D'Oncologia Girona
  • Madrid, Spain, 28006
    • Hospital Universitario de la Princesa
  • Madrid, Spain, 28222
    • Hospital Universitario Puerta de Hierro - Majadahonda
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz - PPDS
  • 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
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio - PPDS
  • Barcelona
    • Badalona, Barcelona, Spain, 8916
      • Hospital Universitario Germans Trias i Pujol
  • Madrid, Communidad Delaware
    • Madrid, Madrid, Communidad Delaware, Spain, 28009
      • Hospital General Universitario Gregorio Marañón
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universidad Navarra
• Sweden
  • Stockholm, Sweden, 14186
    • Karolinska Universitetssjukhuset Huddinge
  • Uppsala, Sweden, SE-751 85
    • Akademiska Sjukhuset i Uppsala
  • Skane Lan
    • Helsingborg, Skane Lan, Sweden
      • Helsingborg lasarett
    • Lund, Skane Lan, Sweden
      • Skanes Universitetssjukhus Lund
  • Vastra Gotalands Lan
    • Goteborg, Vastra Gotalands Lan, Sweden
      • Sahlgrenska Universitetssjukhuset
• Switzerland
  • Basel-Stadt (de)
    • Basel, Basel-Stadt (de), Switzerland, 4031
      • Universitätsspital Basel
  • Zurich (de)
    • Zurich, Zurich (de), Switzerland, 8091
      • UniversitätsSpital Zürich
• Taiwan
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Hospital
  • Kaohsiung, Taiwan
    • Chang Gung Medical Foundation-Kaoshiung Branch
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 613
    • Chang Gung Medical Foundation Chiayi Chang Gung Memorial Hospital
  • Taoyuan City, Taiwan, 333
    • Chang Gung Memorial Hospital, Linkou
• Thailand
  • Krung Thep Maha Nakhon-Bangkok
    • Bangkok, Krung Thep Maha Nakhon-Bangkok, Thailand, 10330
      • Chulalongkorn University
    • Bangkok, Krung Thep Maha Nakhon-Bangkok, Thailand, 10400
      • Phramongkutklao Hospital
• Turkey
  • Ankara, Turkey, 6100
    • Hacettepe Universitesi Tip Fakultesi Hastanesi
  • Ankara, Turkey, 6200
    • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
  • Ankara, Turkey
    • Ankara University Medical Faculty PPDS
  • Denizli, Turkey, 20070
    • Pamukkale Universitesi Tip Fakultesi Hastanesi
  • Istanbul, Turkey, 34093
    • Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
  • Kayseri, Turkey, 38039
    • Erciyes Universitesi Tip Fakultesi Hastanesi
  • Trabzon, Turkey, 61080
    • Karadeniz Technical University Faculty of Medicine
• Ukraine
  • Kyiv, Ukraine, 3115
    • MNPE Kyiv Center of Bone Marrow Transplantation of executive body of Kyiv council
• United Kingdom
  • Leicester, United Kingdom, LE1 5WW
    • University Hospitals Leicester
  • London, United Kingdom, WC1E 6AG
    • University College London Hospitals (UCLH)
  • Swansea, United Kingdom
    • Singleton Hospital - PPDS
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 6YD
      • Southampton General Hospital
  • London, City Of
    • London, London, City Of, United Kingdom, W12 0HS
      • Imperial College Healthcare NHS Trust
    • London, London, City Of, United Kingdom, EC1A 7BE
      • Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre
    • London, London, City Of, United Kingdom, SE5 9RS
      • Kings College Hospital
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 7LJ
      • Churchill Hospital
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • Royal Marsden Hospital - Surrey
  • Yorkshire
    • Leeds, Yorkshire, United Kingdom, LS9 7TF
      • St James University Hospital
    • Sheffield, Yorkshire, United Kingdom, S10 2JF
      • Royal Hallamshire Hospital
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic - PPDS
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Health Milton S. Hershey Medical Center
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Hospital

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 multiple myeloma according to standard criteria.
2. 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.
3. 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.
4. Started screening no earlier than 75 days after transplant, completed screening within 15 days, and randomized no later than 115 days after transplant.
5. Must have not received post-ASCT consolidation therapy.
6. Documented response to ASCT (PR, VGPR, CR/stringent complete response [sCR]) according to IMWG criteria.
7. ECOG performance status of 0 to 2.

8. 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.)
9. 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.
10. Suitable venous access for the study-required blood sampling.
11. Is willing and able to adhere to the study visit schedule and other protocol requirements.

12. Must meet the following clinical laboratory criteria at study entry:

    • Absolute neutrophil count (ANC) ≥ 1,000 per cubic milliliter (/mm^3) 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 ≤ 1.5 * the upper limit of the normal range (ULN).
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 * ULN.
    • Calculated creatinine clearance ≥ 30 milliliter per minute (mL/min).

Exclusion Criteria:

1. 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.
2. Double (tandem) ASCT.
3. Radiotherapy within 14 days before the first dose of study drug.
4. 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.
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, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome.
10. 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.
11. 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.
12. Active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive.
13. 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).
14. Psychiatric illness/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 60 days before the first dose of the study drug regimen.

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 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.	Drug: Placebo; Ixazomib citrate placebo-matching capsules
Experimental: Ixazomib Citrate; Ixazomib 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.	Drug: Ixazomib Citrate; Ixazomib citrate capsules; Other Names: MLN9708

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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.	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	Response was assessed according to IMWG criteria. Best response includes partial response (PR), very good partial response (VGPR) and complete response (CR). PR as per IMWG criteria is 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to less than (<)200 milligrams (mg) per 24 hours. VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours. CR is negative immunofixation of serum and urine and disappearance of soft tissue plasmacytomas and <5% plasma cells in bone marrow. Stringent CR (sCR) is CR and normal FLC ratio and absence of clonal plasma cells (PCs) by immunohistochemistry or 2- to 4-color flow cytometry. The decimal values of percentages were subjected to rounding off.	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)	TTP is defined as the time from the date of randomization to the date of first documentation of PD, using IMWG criteria. PD is 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 FLC levels must be >10mg/dL; participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must be ≥10%;new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development. Participants without documentation of PD at the time of analysis were censored at the date of last response assessment that is stable disease or better.	Randomization up to PD (up to 107 months)
Second Progression Free Survival (PFS2)	PFS2 is defined as the time from the date of randomization to the date of objective disease progression on next line treatment or death from any cause (whichever occurs first). PD is 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 FLC levels must be >10 mg/dL; participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must be ≥10%; new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development.	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	Time to start of the next line of therapy was defined as the time from the date of randomization to the date of initiation dose of the next line of antineoplastic therapy following study treatment or death due to any cause, whichever occurred first. Participants who never took antineoplastic therapy were censored at the date of last contact or death.	Randomization up to 107 months
Time to End of the Next Line of Therapy	Time to end of the next line of therapy was 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 or death due to any cause, whichever occurred first or date of last contact for participants who never took antineoplastic therapy.	Randomization up to 107 months
Duration of the Next Line of Therapy	Duration of the next line of therapy was defined as the time from the date of the first dose of the next line of therapy to the date of the last dose of the next antineoplastic therapy following study treatment or death due to any cause, whichever occurred first. Duration of the next line of therapy was analyzed on those participants who received the next line of therapy following the study treatment and duration was summarized using Kaplan-Meier method.	Up to 107 months
Percentage of Participants Who Develop a New Primary Malignancy	The decimal values of percentages were subjected to rounding off.	Up to 107 months
Number of Participants With Conversion to Minimal Residual Disease (MRD) Negative	MRD negativity (MRD-) is defined as absence of MRD and MRD positivity (MRD+) is defined as presence of MRD. The conversion rate from MRD positive to MRD negative was assessed and reported. Bone marrow aspirates and blood samples were sent to a central laboratory and were assessed for MRD using flow cytometry and a sequencing methodology.	Baseline up to EOT (up to 24 months)
Number of Participants With Maintenance of MRD Negativity	MRD negativity is defined as absence of MRD and MRD positivity is defined as presence of MRD. The maintenance of MRD negativity up to the end of treatment was assessed and reported in participants converting from MRD+ at Baseline to MRD negative. Bone marrow aspirates and blood samples were sent to a central laboratory and were assessed for MRD using flow cytometry and a sequencing methodology.	Up to EOT (up to 24 months)
Correlation Between MRD Status and Progression Free Survival (PFS)	PFS is defined as the time from the date of randomization to the date of first documentation of PD as evaluated by an IRC according to IMWG criteria, or death due to any cause, whichever occurred first, assessed for up to 107 months in this outcome measure.	From randomization up to 107 months
Correlation Between MRD Status and Overall Survival (OS)	OS was measured as the time from the date of randomization to the date of death, assessed for up to 107 months in this outcome measure.	From randomization up to 107 months
OS Benefits in a High-Risk Population	High-risk population included but was not limited to participants carrying deletion (del)17, t(4:14), t(14:16), amplification (ampl) 1q, del13, or del1p. OS was measured as the time from the date of randomization to the date of death.	Randomization up to 107 months
PFS Benefits in a High-Risk Population	High-risk population included but not be limited to participants carrying deletion (del)17, t(4:14), t(14:16), amplification (ampl) 1q, del13, or del1p. 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 according to IMWG criteria, or death due to any cause (whichever occurs first). PD is 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 FLC levels must be >10mg/dL; participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must be ≥10%;new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development.	Randomization up to 107 months
Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status Score	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 scores indicate improvement.	Baseline up to EOT (up to Month 24)
Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) or Serious Adverse Events (SAEs)	An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation subject administered a drug. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. A TEAE was defined as an AE that started or worsened after first study drug administration and within 30 days of last dose of study drug. An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, was a congenital abnormality or birth defect, an important medical event.	Up to 107 months
Number of Participants With Markedly Abnormal Clinical Laboratory Values Reported as TEAEs	Laboratory tests included chemistry, hematology and urinalysis. Abnormal laboratory value was assessed as an AE if the value led to discontinuation or delay in treatment, dose modification, therapeutic intervention, or was considered by the investigator to be a clinically significant change from baseline. A TEAE was defined as an AE that started or worsened after first study drug administration and within 30 days of last dose of study drug.	Up to 107 months
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Domain Score	The EORTC QLQ-C30 is a 30-item questionnaire used to assess the health-related quality of life of cancer patients. GHS/QoL domain is based on questions 29 ("How would you rate your overall health during the past week?") and 30 ("How would you rate your overall quality of life during the past week?") of the EORTC QLQ-C30 where the study participants' self-reported responses to the questions on a 7-point scale (1=very poor to 7=excellent). The raw GHS/QoL domain scores were linearly transformed to a scale ranging 0 (worse outcome) to 100 (best outcome), with higher scores indicating better quality of life. The change from baseline in EORTC QLQ-C30 GHS/QoL domain was evaluated by treatment group.	Baseline up to EOT (up to Month 24)
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.	Day 1 of Cycle 1: 1 hour and 4 hours post-dose; Predose on Days 8 and 15 of Cycle 1, Days 1 and 8 of Cycle 2, Day 1 of Cycles 3 through 10 (each cycle length= 28 days)
Time to Resolution of Peripheral Neuropathy (PN) Events	Peripheral neuropathy is defined as the TEAE in the high-level term of peripheral neuropathies not elsewhere classified (NEC) according to Medical Dictionary for Regulatory Activities (MedDRA). A PN event is considered as improved if the event improves from the maximum grade. That is, all the grades recorded after the maximum grade is less than the maximum grade. Time to improvement is defined as the time from the initial onset date (inclusive) of the maximum grade to the first onset date that the toxicity grade is below the maximum grade with no higher grade thereafter, or the resolution date, whichever occurs first.	Up to 107 months
Time to Improvement of PN Events	PN is defined as the treatment-emergent adverse 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 is considered as resolved if its final outcome is resolved with no subsequent PN event of the same preferred term occurring on the resolution date or the day before and after. A PN event is considered as improved if the event improves from the maximum grade. That is, all the grades recorded after the maximum grade is less than the maximum grade. Time to improvement is defined as the time from the initial onset date (inclusive) of the maximum grade to the first onset date that the toxicity grade is below the maximum grade with no higher grade thereafter, or the resolution date, whichever occurs first.	Up to 107 months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Schjesvold 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.
• Dimopoulos 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.
• Kaiser 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. Erratum In: Ann Hematol. 2021 Jan;100(1):297-302. doi: 10.1007/s00277-020-04302-0.

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2014
• Primary Completion (Actual): April 16, 2018
• Study Completion (Actual): September 8, 2023

Study Registration Dates

• First Submitted: June 27, 2014
• First Submitted That Met QC Criteria: July 1, 2014
• First Posted (Estimated): July 4, 2014

Study Record Updates

• Last Update Posted (Actual): November 19, 2024
• Last Update Submitted That Met QC Criteria: October 28, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Drug therapy; Ixazomib citrate
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Ixazomib
• Other Study ID Numbers: C16019; U1111-1155-8695 (Other Identifier: WHO); 2013-002076-41 (EudraCT Number); C16019CTIL (Registry Identifier: Israel MOH); NL.47795.029.14 (Registry Identifier: CCMO); 173116 (Registry Identifier: HC-CTD); 1036024001 (Registry Identifier: TCTIN); SNCTP000001745 (Registry Identifier: SNCTP)

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