A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participants With Multiple Myeloma Following Autologous Stem Cell Transplant

NCT ID: NCT02181413

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 656 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-16
• Study Completion Date: 2023-09-08

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).

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.

Conditions

Multiple Myeloma; Autologous Stem Cell Transplant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Ixazomib citrate placebo-matching capsules

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.

Group Type: EXPERIMENTAL

Ixazomib Citrate

Intervention Type: DRUG

Ixazomib citrate capsules

Interventions

Ixazomib Citrate

Ixazomib citrate capsules

Intervention Type: DRUG

Placebo

Ixazomib citrate placebo-matching capsules

Intervention Type: DRUG

Other Intervention Names

MLN9708

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Mayo Clinic - PPDS

Rochester, Minnesota, United States

Montefiore Medical Center

The Bronx, New York, United States

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Baylor University Medical Center

Dallas, Texas, United States

West Virginia University Hospital

Morgantown, West Virginia, United States

Hospital Italiano de La Plata

La Plata, Buenos Aires, Argentina

Instituto de Hematologia Y Medicina Clinica Dr Ruben Davoli

Rosario, Santa Fe Province, Argentina

Sanatorio Britanico de Rosario

Rosario, Santa Fe Province, Argentina

Sanatorio Parque de Rosario

Rosario, Santa Fe Province, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, , Argentina

Hospital Iturraspe

Santa Fe, , Argentina

St George Hospital

Kogarah, New South Wales, Australia

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Icon Cancer Care South Brisbane

South Brisbane, Queensland, Australia

Gold Coast University Hospital

Southport, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

The Queen Elizabeth Hospital

Woodville South, South Australia, Australia

Austin Health

Heidelberg, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Elisabethinen Hospital Linz

Linz, , Austria

Salzburger Landeskliniken

Salzburg, , Austria

Allgemeines Krankenhaus der Stadt Wien

Vienna, , Austria

Klinik Ottakring (fruher: Wilhelminenspital)

Vienna, , Austria

Centre Hospitalier Jolimont-Lobbes

La Louvière, Hainaut, Belgium

Centre Hospitalier Universitaire Ambroise Pare

Mons, Hainaut, Belgium

UZ Gent

Ghent, Oost-Vlaanderen, Belgium

AZ Sint-Jan AV

Bruges, West-Vlaanderen, Belgium

ZNA Middelheim

Antwerp, , Belgium

ZNA Stuivenberg

Antwerp, , Belgium

Hospital Das Clinicas Da Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Instituto de Oncologia Do Parana

Curitiba, Paraná, Brazil

Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner

Curitiba, Paraná, Brazil

Hospital de Clinicas de Passo Fundo

Passo Fundo, Rio Grande do Sul, Brazil

Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

Porto Alegre, Rio Grande do Sul, Brazil

Mae de Deus Center Hospital Giovanni Battista

Porto Alegre, Rio Grande do Sul, Brazil

Centro de Pesquisas Oncologicas

Florianópolis, Santa Catarina, Brazil

Instituto Joinvilense de Hematologia E Oncologia

Joinville, Santa Catarina, Brazil

Hospital Amaral Carvalho

Jaú, São Paulo, Brazil

Hospital de Base Da FAMERP

São José do Rio Preto, São Paulo, Brazil

Instituto Nacional de Cancer

Rio de Janeiro, , Brazil

Universidade Federal do Rio de Janeiro - UFRJ

Rio de Janeiro, , Brazil

Irmandade Da Santa Casa de Misericordia de Sao Paulo

São Paulo, , Brazil

Hospital Israelita Albert Einstein

São Paulo, , Brazil

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, , Brazil

University Health Network

Toronto, Ontario, Canada

MUHC-Glen Site

Montreal, Quebec, 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, Czechia

Fakultni nemocnice Brno

Brno, , Czechia

Fakultni nemocnice Olomouc

Olomouc, , Czechia

Fakultni nemocnice Ostrava

Ostrava, , Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, , Czechia

Vseobecna Fakultni Nemocnice V Praze

Prague, , Czechia

Herlev Hospital

Herlev, Capital, Denmark

Aalborg Universitetshospital

Aalborg, North Denmark, Denmark

Aarhus Universitetshospital Arhus Sygehus

Aarhus N, , Denmark

Rigshospitalet

Copenhagen, , Denmark

Odense Universitetshospital

Odense, , Denmark

Sjallands Universitetshospital, Roskilde

Roskilde, , Denmark

Vejle Sygehus

Vejle, , Denmark

Hopital Antoine Beclere

Clamart, Hauts-de-Seine, France

Hotel Dieu - Nantes

Nantes, Loire-Atlantique, France

CHRU Lille

Lille, Nord, France

Hopital Universitaire Dupuytren

Limoges, , France

Groupe Hospitalier Necker Enfants Malades

Paris, , France

University Clinic Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Klinikum Mannheim Universitatsklinikum gGmbH

Mannheim, Baden-Wurttemberg, Germany

Universitatsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

LMU Klinikum der Universitat Munchen

München, Bavaria, Germany

Universitatsklinikum Wurzburg

Würzburg, Bavaria, Germany

Klinikum Darmstadt GmbH

Darmstadt, Hesse, Germany

Klinikum Frankfurt Hochst GmbH

Frankfurt am Main, Hesse, Germany

Pius Hospital Oldenburg

Oldenburg, Lower Saxony, Germany

Universitatsklinikum Bonn

Bonn, North Rhine-Westphalia, Germany

Uniklinik Koln

Cologne, North Rhine-Westphalia, Germany

Universitatsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Evangelisches Krankenhaus Essen Werden gGmbH

Essen, North Rhine-Westphalia, Germany

Katholisches Krankenhaus Hagen gGmbH

Hagen, North Rhine-Westphalia, Germany

Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

Mainz, Rhineland-Palatinate, Germany

Universitatsklinikum Carl Gustav Carus an der TU Dresden

Dresden, Saxony, Germany

Helios Klinikum Berlin-Buch

Berlin, , Germany

Charite - Universitatsmedizin Berlin

Berlin, , Germany

Asklepios Klinik St. Georg

Hamburg, , Germany

Universitatsklinikum Hamburg Eppendorf

Hamburg, , Germany

Asklepios Klinik Altona

Hamburg, , Germany

KRH Klinikum Siloah-Oststadt-Heidehaus

Hanover, , Germany

Klinikum der Stadt Ludwigshafen gGmbH

Ludwigshafen, , Germany

Universitatsklinikum Tubingen

Tübingen, , Germany

Evangelismos General Hospital of Athens

Athens, Attica, Greece

Laiko General Hospital of Athens

Athens, Attica, Greece

Alexandra Hospital

Athens, , Greece

Georgios Papanikolaou General Hospital of Thessaloniki

Thessaloniki, , Greece

Semmelweis Egyetem

Budapest, , Hungary

Del-pesti Centrumkorhaz- Orszagos Hematologiai es Infektologiai Intezet

Budapest, , Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

Somogy Megyei Kaposi Mor Oktato Korhaz

Kaposvár, , Hungary

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, , Hungary

Barzilai Medical Center

Ashkelon, , Israel

Soroka University Medical Centre

Beersheba, , Israel

Bnai Zion Medical Center

Haifa, , Israel

Rambam Medical Center - PPDS

Haifa, , Israel

Lady Davis Carmel Medical Center

Haifa, , Israel

Shaare Zedek Medical Center

Jerusalem, , Israel

Hadassah Medical Center PPDS -

Jerusalem, , Israel

Galilee Medical Center

Nahariya, , Israel

Rabin Medical Center - PPDS

Petah Tikva, , Israel

Sheba Medical Center - PPDS

Ramat Gan, , Israel

Kaplan Medical Center

Rehovot, , Israel

ZIV Medical Center

Safed, , Israel

Tel Aviv Sourasky Medical Center PPDS

Tel Aviv, , Israel

Shamir Medical Center Assaf Harofeh

Tzrifin, , Israel

Presidio Ospedaliero di Pescara

Pescara, Abruzzo, Italy

Azienda Ospedaliera San Camillo Forlanini

Rome, Lazio, Italy

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Lombardy, Italy

Azienda Ospedaliera Citta della Salute e della Scienza di Torino

Turin, Piedmont, Italy

IRCCS Centro Di Riferimento Oncologico Della Basilicata

Rionero in Vulture, Potenza, Italy

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi

Ancona, The Marches, Italy

Azienda Ospedaliera S Maria Di Terni

Terni, Umbria, Italy

Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

Bologna, , Italy

ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN

Brescia, , Italy

Azienda Ospedaliera Universitaria Careggi

Florence, , Italy

IRCCS Az. Osp. Universitaria San Martino- IST

Genova, , Italy

Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l - PPDS

Meldola, , Italy

ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda

Milan, , Italy

Ospedale Infermi di Rimini

Rimini, , Italy

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Iwate Medical University Hospital

Morioka, Iwate, Japan

National Hospital Organization Sendai Medical Center

Sendai, Miyagi, Japan

Niigata Cancer Center Hospital

Niigata, Niigata, Japan

National Hospital Organization Okayama Medical Center

Okayama, Okayama-ken, Japan

Saitama Medical Center

Kawagoe, Saitama, Japan

Juntendo University Hospital

Bunkyo, Tokyo, Japan

Chiba University Hospital

Chiba, Tokyo, Japan

Japanese Red Cross Medical Center

Shibuya-ku, Tokyo, Japan

Center Hospital of the National Center for Global Health and Medicine

Shinjuku, Tokyo, Japan

Keio University Hospital

Shinjuku-ku, Tokyo, Japan

Kyushu University Hospital

Fukuoka, , Japan

National Hospital Organization Nagoya Medical Center

Nagoya, , Japan

Nagoya City University Hospital

Nagoya, , Japan

National Hospital Organaization Shibukawa Medical Center

Shibukawa, , Japan

National Hospital Organization Disaster Medical Center

Tachikawa, , Japan

Toyohashi Municipal Hospital

Toyohashi, , Japan

Centro de Investigacion Farmaceutica Especializada de Occidente, SC - PPDS

Guadalajara, Jalisco, Mexico

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Monterrey, Nuevo León, Mexico

VU Medisch Centrum

Amsterdam, North Holland, Netherlands

Albert Schweitzer Ziekenhuis

Dordrecht, South Holland, Netherlands

Universitair Medisch Centrum Groningen

Groningen, , Netherlands

Erasmus MC

Rotterdam, , Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, , Netherlands

Vestre Viken HF Sykehuset Asker Og Barum

Gjelta, Oppland, Norway

St. Olav's University Hospital

Trondheim, Sor-Trondelag, Norway

Oslo Universitetssykehus HF, Ulleval

Oslo, , Norway

Stavanger Universitetssykehus

Stavanger, , Norway

Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

Wroclaw, Lower Silesian Voivodeship, Poland

Wojskowy Instytut Medyczny

Warsaw, Masovian Voivodeship, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Pomeranian Voivodeship, Poland

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

Chorzów, Silesian Voivodeship, Poland

Szpital Specjalistyczny w Brzozowie

Brzozów, , Poland

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

Lodz, , Poland

Hospital de Braga

Braga, , Portugal

Centro Hospitalar E Universitario de Coimbra EPE

Coimbra, , Portugal

Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

Porto, , Portugal

Centro Hospitalar de Sao Joao, E.P.E.

Porto, , Portugal

National University Hospital

Singapore, , Singapore

Singapore General Hospital (SGH)

Singapore, , Singapore

Medical Oncology Centre of Rosebank

Johannesburg, Gauteng, South Africa

Mary Potter Oncology Centre

Pretoria, Gauteng, South Africa

Albert Alberts Stem Cell Transplant Centre

Pretoria, Gauteng, South Africa

National Cancer Center

Goyang, Gyeonggido, South Korea

Chungnam National University Hospital

Daejeon, , South Korea

Gachon University Gil Medical Center Pharmacy

Incheon, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital Yonsei University Health System - PPDS

Seoul, , South Korea

Samsung Medical Center - PPDS

Seoul, , South Korea

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, , South Korea

Asan Medical Center - PPDS

Seoul, , South Korea

Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital General Universitario Gregorio Maranon

Madrid, Madrid, Communidad Delaware, Spain

Clinica Universidad Navarra

Pamplona, Navarre, Spain

Hospital Clinic de Barcelona

Barcelona, , Spain

C.H. Regional Reina Sofia - PPDS

Córdoba, , Spain

Institut Catala d'Oncologia Girona

Girona, , Spain

Hospital Universitario de La Princesa

Madrid, , Spain

Hospital Universitario La Paz - PPDS

Madrid, , Spain

Hospital Universitario HM Sanchinarro CIOCC

Madrid, , Spain

Hospital Universitario Puerta de Hierro - Majadahonda

Madrid, , Spain

Hospital General Universitario Morales Meseguer

Murcia, , Spain

Complejo Asistencial Universitario de Salamanca H. Clinico

Salamanca, , Spain

Hospital Universitario Virgen del Rocio - PPDS

Seville, , 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, , Sweden

Akademiska Sjukhuset I Uppsala

Uppsala, , Sweden

Universitatsspital Basel

Basel, Basel-Stadt (de), Switzerland

Universitatsspital Zurich

Zurich, Zurich (de), Switzerland

Kaohsiung Medical University Hospital

Kaohsiung City, , Taiwan

Chang Gung Medical Foundation-Kaoshiung Branch

Kaohsiung City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Chang Gung Medical Foundation Chiayi Chang Gung Memorial Hospital

Taipei, , Taiwan

Chang Gung Memorial Hospital, Linkou

Taoyuan, , Taiwan

Chulalongkorn University

Bangkok, Krung Thep Maha Nakhon-Bangkok, Thailand

Phramongkutklao Hospital

Bangkok, Krung Thep Maha Nakhon-Bangkok, Thailand

Hacettepe Universitesi Tip Fakultesi Hastanesi

Ankara, , Turkey (Türkiye)

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

Ankara, , Turkey (Türkiye)

Ankara University Medical Faculty PPDS

Ankara, , Turkey (Türkiye)

Pamukkale Universitesi Tip Fakultesi Hastanesi

Denizli, , Turkey (Türkiye)

Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

Istanbul, , Turkey (Türkiye)

Erciyes Universitesi Tip Fakultesi Hastanesi

Kayseri, , Turkey (Türkiye)

Karadeniz Technical University Faculty of Medicine

Trabzon, , Turkey (Türkiye)

MNPE Kyiv Center of Bone Marrow Transplantation of executive body of Kyiv council

Kyiv, , Ukraine

Southampton General Hospital

Southampton, Hampshire, United Kingdom

Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre

London, London, City of, United Kingdom

Kings College Hospital

London, London, City of, United Kingdom

Imperial College Healthcare NHS Trust

London, London, City of, United Kingdom

Churchill Hospital

Oxford, Oxfordshire, United Kingdom

Royal Marsden Hospital - Surrey

Sutton, Surrey, United Kingdom

St James University Hospital

Leeds, Yorkshire, United Kingdom

Royal Hallamshire Hospital

Sheffield, Yorkshire, United Kingdom

University Hospitals Leicester

Leicester, , United Kingdom

University College London Hospitals (UCLH)

London, , United Kingdom

Singleton Hospital - PPDS

Swansea, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Belgium; Brazil; Canada; Colombia; Czechia; Denmark; France; Germany; Greece; Hungary; Israel; Italy; Japan; Mexico; Netherlands; Norway; Poland; Portugal; Singapore; South Africa; South Korea; Spain; Sweden; Switzerland; Taiwan; Thailand; Turkey (Türkiye); Ukraine; United Kingdom

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Reference Type: DERIVED

PMID: 31880006 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30545780 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

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Other Identifiers

U1111-1155-8695

Identifier Type: OTHER

Identifier Source: secondary_id

2013-002076-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C16019CTIL

Identifier Type: REGISTRY

Identifier Source: secondary_id

NL.47795.029.14

Identifier Type: REGISTRY

Identifier Source: secondary_id

173116

Identifier Type: REGISTRY

Identifier Source: secondary_id

1036024001

Identifier Type: REGISTRY

Identifier Source: secondary_id

SNCTP000001745

Identifier Type: REGISTRY

Identifier Source: secondary_id

C16019

Identifier Type: -

Identifier Source: org_study_id