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

NCT ID: NCT02312258

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 706 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-09
• Study Completion Date: 2022-08-26

Brief Summary

The purpose of this study is to determine the effect of ixazomib maintenance therapy on progression free survival (PFS) compared with placebo, in participants with NDMM who have had a major response (complete response [CR], very good partial response [VGPR], or partial response [PR]) to initial therapy and who have not undergone SCT.

Detailed Description

The drug being tested in this study is called ixazomib citrate. Ixazomib citrate is being tested to slow progressive disease (PD) and improve overall survival in people who have NDMM who have had a major positive response to initial therapy and have not undergone SCT. This study will look at the effect of ixazomib citrate has on the length of time that participants are free of PD and their overall survival.

The study will enrol approximately 700 participants. Participants will be randomly assigned (by chance, like flipping a coin) in 3:2 ratio to Ixazomib or matching placebo groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

• Ixazomib citrate initiates at 3 mg which will be escalated to 4 mg with cycle 5 day 1
• Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has no active ingredient

All participants will be asked to take one capsule on Days 1, 8 and 15 of each 28-day cycle. The treatment period will be approximately 24 months (equivalent to 26 cycles) or until patients experience PD or unacceptable toxicities, whichever occurs first.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 78 to 106 months. Participants will make 28 visits to the clinic during the treatment period and will continue to make follow-up visits every 4 weeks until the next line of therapy begins. Participants will also be contacted by telephone every 12 weeks after last treatment visit for a follow-up assessment.

Conditions

Multiple Myeloma

Study Design

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

Study Groups

Placebo

Ixazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Ixazomib placebo-matching capsules.

Ixazomib

Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.

Group Type: EXPERIMENTAL

Ixazomib

Intervention Type: DRUG

Ixazomib capsules.

Interventions

Placebo

Ixazomib placebo-matching capsules.

Intervention Type: DRUG

Ixazomib

Ixazomib capsules.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Adult male or female participants 18 years or older with a confirmed diagnosis of symptomatic newly diagnosed multiple myeloma (NDMM) according to standard criteria.

2. Completed 6 to 12 months (± 2 weeks) of initial therapy, during which the participant was treated to best response, defined as the best response maintained for 2 cycles after the M-protein nadir is reached.

3. Documented major response (PR, VGPR, CR) according to the International Myeloma Working Group (IMWG) uniform response criteria, version 2011, after this initial therapy.

4. Female participants who:

• Are postmenopausal for at least 1 year before the screening visit, OR
• Are surgically sterile, OR
• If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 90 days after the last dose of study drug, OR
• Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.)

Male participants, even if surgically sterilized (that is, status postvasectomy), who:

• Agree to practice effective barrier contraception during the entire study Treatment period and through 90 days after the last dose of study drug, OR
• Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)

5. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.

6. Complete documentation of the details of the initial therapy before randomization including cytogenetics and International Staging System (ISS) is available.

7. Eastern Cooperative Oncology Group Performance Status of 0 to 2.

8. Suitable venous access for the study-required blood sampling and consent for the specific amounts that will be taken.

9. Is willing and able to adhere to the study visit schedule and other protocol requirements including blood sampling and bone marrow aspiration.

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

• Absolute neutrophil count (ANC) greater than or equal to (≥) 1,000 per cubic millimeter (/mm^3) without growth factor support and platelet count ≥75,000/mm^3. Platelet transfusions to help participants meet eligibility criteria are not allowed within 3 days before randomization.
• Total bilirubin less than or equal to (≤) 1.5*the upper limit of the normal range (ULN).
• Alanine aminotransferase and aspartate aminotransferase ≤ 3*ULN.
• Calculated creatinine clearance ≥ 30 milliliter per minute (mL/min) (using the Cockcroft-Gault equation).

Exclusion Criteria

1. Multiple myeloma that has relapsed after, or was not responsive to, initial therapy.

2. Prior SCT.

3. Radiotherapy within 14 days before randomization.

4. Diagnosed or treated for another malignancy within 5 years before randomization or previous diagnosis with another malignancy. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.

5. Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period.

6. Major surgery within 14 days before randomization.

7. Central nervous system involvement.

8. Infection requiring intravenous (IV) antibiotic therapy or other serious infection within 14 days before randomization.

9. Diagnosis of Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes syndrome (POEMS), plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome.

10. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, uncontrolled congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.

11. Systemic treatment with strong cytochrome P450 3A (CYP3A) inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital) or St. John's wort within 14 days before randomization.

12. Ongoing or active infection, known human immunodeficiency virus (HIV) positive, active hepatitis B or C infection.

13. Comorbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens (example, PN that is Grade 1 with pain or Grade 2 or higher of any cause).

14. Psychiatric illness or social situation that would limit compliance with study requirements.

15. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.

16. Inability to swallow oral medication, inability or unwillingness to comply with the drug administration requirements, or gastrointestinal (GI) procedure that could interfere with the oral absorption or tolerance of treatment.

17. Treatment with any investigational products within 30 days before randomization.

• 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

Medical Director

Role: STUDY_DIRECTOR

Takeda

Locations

Robert A Moss MD FACP Inc

Fountain Valley, California, United States

UCLA Medical Hematology and Oncology

Los Angeles, California, United States

North County Oncology Medical Clinic Inc

Oceanside, California, United States

Ventura County Hematology Oncology Specialists

Oxnard, California, United States

Emad Ibrahim, MD, Inc

Redlands, California, United States

Global Cancer Research Institute (GCRI), Inc.

San Jose, California, United States

Central Coast Medical Oncology Corporation

Santa Maria, California, United States

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

John H. Stroger Jr. Hospital of Cook County

Chicago, Illinois, United States

Siouxland Hematology - Oncology Associates LLP

Sioux City, Iowa, United States

Appalachian Regional Healthcare

Hazard, Kentucky, United States

New England Cancer Specialists

Scarborough, Maine, United States

Saint Agnes Hospital - Baltimore - Hunt - PPDS

Baltimore, Maryland, United States

University Hospital of Wales -

Bethesda, Maryland, United States

Tufts Medical Center - PPDS

Boston, Massachusetts, United States

Herbert-Herman Cancer Center

Lansing, Michigan, United States

Clinical Research Alliance Inc

New York, New York, United States

New York Presbyterian Hospital - Weill-Cornell

New York, New York, United States

Cancer Care of WNC PA

Asheville, North Carolina, United States

UPMC Cancer Pavillion

Pittsburgh, Pennsylvania, United States

HOPE Cancer Center of East Texas

Tyler, Texas, United States

Swedish Cancer Institute

Seattle, Washington, United States

W VA University Mary Babb Randolph Cancer Center

Morgantown, West Virginia, United States

Hospital Universitario Austral

Buenos Aires, Ciudad Autonoma de BuenosAires, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Ciudad Autonoma de BuenosAires, Argentina

Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)

Buenos Aires, Ciudad Autonoma de BuenosAires, Argentina

Sanatorio Allende S.A.

Córdoba, , Argentina

Hospital Iturraspe

Santa Fe, , Argentina

St Vincents Hospital Melbourne - PPDS

Fitzroy, Victoria, Australia

Frankston Hospital

Frankston, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Universitatsklinikum Innsbruck

Innsbruck, Tyrol, Austria

Paracelsus Medizinische Privatuniversitat

Salzburg, , Austria

Medizinische Universitat Wien (Medical University of Vienna)

Vienna, , Austria

Klinikum Wels-Grieskirchen GmbH

Wels, , Austria

Universitair Ziekenhuis Brussel - PIN

Brussels, Brussels Capital, Belgium

UZ Brussel

Brussels, Brussels Capital, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Brussels Capital, Belgium

Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet

Salvador, Estado de Bahia, Brazil

Hospital Das Clinicas Da Universidade Federal de Goias

Goiânia, Goiás, Brazil

Hospital Das Clinicas Da UFMG

Belo Horizonte, Minas Gerais, Brazil

Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner

Curitiba, Paraná, Brazil

Liga Norte Riograndense Contra O Cancer

Natal, Rio Grande do Norte, Brazil

Universidade de Caxias do Sul

Caxias do Sul, Rio Grande do Sul, Brazil

Associacao Hospital de Caridade Ijui

Ijuí, Rio Grande do Sul, Brazil

American Oncology Partners of Maryland, PA

Passo Fundo, Rio Grande do Sul, Brazil

Hospital Moinhos de Vento

Porto Alegre, 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

Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)

Porto Alegre, Rio Grande do Sul, Brazil

Instituto Joinvilense de Hematologia E Oncologia

Joinville, Santa Catarina, Brazil

Fundacao PIO XII

Barretos, São Paulo, Brazil

Universidade Estadual de Campinas

Campinas, São Paulo, Brazil

Hospital Amaral Carvalho

Jaú, São Paulo, Brazil

Faculdade de Medicina Do ABC

Santo André, São Paulo, Brazil

HEMORIO - Unidade de Pesquisa Clinica

Rio de Janeiro, , Brazil

Instituto Nacional de Cancer

Rio de Janeiro, , Brazil

Fundação Antônio Prudente - AC Camargo Câncer Center

Rio de Janeiro, , Brazil

Hospital de Base Da Faculdade de Medicina de Sao Jose Do Rio Preto

São José do Rio Preto, , Brazil

Instituto de Ensino E Pesquisa Sao Lucas

São Paulo, , Brazil

Hospital Sirio Libanes

São Paulo, , Brazil

Ealing Hospital

São Paulo, , Brazil

Clinica Sao Germano

São Paulo, , Brazil

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

São Paulo, , Brazil

Hospital Israelita Albert Einstein

São Paulo, , Brazil

Hospital Santa Marcelina

São Paulo, , Brazil

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

William Osler Health Centre

Brampton, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

McGill University Health Center

Montreal, Quebec, Canada

Hospital Amaral Carvalho

Temuco, Región de la Araucanía, Chile

Instituto Nacional Del Cancer

Santiago, , Chile

Centro Internacional de Estudios Clinicos

Santiago, , Chile

Centro de Investigaciones Clinicas Vina del Mar

Viña del Mar, , Chile

Hospital de Clinicas de Passo Fundo

Nanjing, Jiangsu, China

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Beijing Chaoyang Hospital Capital Medical University

Beijing, , China

Peking University Third Hospital

Beijing, , China

Peking Union Medical College Hospital

Beijing, , China

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, , China

Renji Hospital Shanghai Jiaotong University School of Medicine

Shanghai, , China

Shanghai Chang Zheng Hospital

Shanghai, , China

Hospital São Rafael

Shenyang, , China

Second Hospital of Shanxi Medical University

Taiyuan, , China

James Lind Centro de Investigación del Cáncer

Wuhan, , China

Hospital Pablo Tobon Uribe

Medellín, Antioquia, Colombia

Hospital Universitario San Ignacio

Bogotá, Bogota D.C., Colombia

Instituto Nacional de Cancerologia Colombia

Bogota, Cundinamarca, Colombia

Clinical Hospital Dubrava

Zagreb, City of Zagreb, Croatia

Clinical Hospital Center Rijeka

Rijeka, , Croatia

Clinical Hospital Center Zagreb - PPDS

Zagreb, , Croatia

Fakultni nemocnice Hradec Kralove

Hradec Králové, Kralovehradeck Kraj, Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, Praha, Hlavni Mesto, Czechia

Fakultni nemocnice Brno

Brno, , Czechia

Fakultni nemocnice Olomouc

Olomouc, , Czechia

Fakultni nemocnice Ostrava

Ostrava, , Czechia

Vseobecna fakultni nemocnice v Praze

Prague, , Czechia

Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

Copenhagen, Capital, Denmark

Aarhus Universitetshospital Århus Sygehus

Aarhus N, , Denmark

Regionshospitalet Holstebro

Holstebro, , Denmark

Odense Universitetshospital

Odense, , Denmark

Hopital Antoine Beclere

Clamart, Hauts-de-Seine, France

Hotel Dieu

Nantes, Loire-Atlantique, France

CHRU Nancy

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France

CHRU Dijon Complexe Du Bocage

Dijon, , France

Hopital Saint Vincent de Paul GHICL

Lille, , France

CHRU Lille

Lille, , France

Hopital de la Pitie Salpetriere

Paris, , France

Groupe Hospitalier Necker Enfants Malades

Paris, , France

Hopital Haut Leveque

Pessac, , France

Hopital Jean Bernard

Poitiers, , France

CHRU Rennes

Rennes, , France

Universitatsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Schwarzwald Baar Klinkum Villingen-Schwenningen GmbH

Villingen-Schwenningen, Baden-Wurttemberg, Germany

Hamatologische Onkologische Gemeinschaftspraxis Dr. Brudler, Dr. Heinrich, Dr. Bangerter

Augsburg, Bavaria, Germany

Internistisch Hamatologische und Internistische Praxis

Herrsching am Ammersee, Bavaria, Germany

LMU Klinikum der Universitat Munchen

München, Bavaria, Germany

Pius Hospital Oldenburg

Oldenburg, Lower Saxony, Germany

Universitatsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Gemeinschaftspraxis fur Hamatologie und Onkologie

Münster, North Rhine-Westphalia, Germany

Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

Mainz, Rhineland-Palatinate, Germany

Universitat Des Saarlandes

Homburg, Saarland, Germany

Onkologie Aschaffenburg

Aschaffenburg, , Germany

Charite - Universitatsmedizin Berlin

Berlin, , Germany

Medizinisches Versorgungszentrum Onkologischer Schwerpunkt

Berlin, , Germany

Klinikum Landshut

Landshut, , Germany

Klinikum rechts der Isar der Technischen Universitat Munchen

München, , Germany

Praxis Pihusch Medizinisches Versorgungszentrum GbR

Rosenheim, , Germany

Gemeinschaftspraxis Dr. med. R. Schlag & Dr. med. B. Schottker & Dr. med. J. Haas

Würzburg, , Germany

University of Athens Medical School - Regional General Hospital Alexandra

Athens, Attica, Greece

Evangelismos General Hospital of Athens

Athens, , Greece

University General Hospital of Ioannina

Ioannina, , Greece

University General Hospital of Larissa

Larissa, , Greece

Theageneio Anticancer Oncology Hospital of Thessaloniki

Thessaloniki, , Greece

Georgios Papanikolaou General Hospital of Thessaloniki

Thessaloniki, , Greece

Semmelweis Egyetem

Budapest, , Hungary

Klinika Hematologii, Szpital Uniwersytecki Nr 2 im. Jana Biziela w Bydgoszczy

Budapest, , Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, , Hungary

Rigshospitalet

Beer Yaakov, , Israel

Shamir Medical Center Assaf Harofeh

Beersheba, , Israel

Bnai Zion Medical Center

Haifa, , Israel

Hadassah Medical Center - PPDS

Jerusalem, , Israel

Meir Medical Center

Kfar Saba, , Israel

Rabin Medical Center - PPDS

Petah Tikva, , Israel

Chaim Sheba Medical Center

Ramat Gan, , Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Assuta Medical Centers

Tel Aviv, , Israel

Baruch Padeh Poriya Medical Center

Tiberias, , Israel

Ospedale Casa Sollievo Della Sofferenza IRCCS

San Giovanni Rotondo, Apulia, Italy

AORN A Cardarelli

Napoli, Campania, Italy

Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

Bologna, Emilia-Romagna, Italy

Ospedale Infermi di Rimini

Rimini, Emilia-Romagna, Italy

IRCCS Az. Osp. Universitaria San Martino- IST

Genoa, Liguria, Italy

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

Brescia, Lombardy, Italy

ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda

Milan, Lombardy, Italy

Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

Catania, Sicily, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, Italy

Azienda Ospedaliera S Maria Di Terni

Terni, Umbria, Italy

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

Ancona, , Italy

Azienda Ospedaliera Universitaria Careggi

Florence, , Italy

Azienda Ospedaliero Universitaria di Parma

Parma, , Italy

Ospedale Santa Maria Delle Croci

Ravenna, , Italy

Azienda Ospedaliera Citta della Salute e della Scienza di Torino

Torino, , Italy

Ogaki Municipal Hospital

Ōgaki, Gihu, Japan

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Hitachi General Hospital

Hitachi, Ibaraki, Japan

Nara Hospital Kinki University Faculty of Medicine

Ikoma, Nara, Japan

National Hospital Organization Okayama Medical Center

Okayama, Okayama-ken, Japan

Juntendo University Hospital

Bunkyo, Tokyo, Japan

Japanese Red Cross Medical Center

Shibuya-ku, Tokyo, Japan

National Hospital Organization Kyushu Medical Center

Fukuoka, , Japan

Fukushima Medical University Hospital

Fukushima, , Japan

National Hospital Organization Mito Medical Center

Ibaraki, , Japan

Kurume University Hospital

Kurume, , Japan

Shizuoka Cancer Center

Nagaizumi-chō, , Japan

Japanese Red Cross Nagoya Daiichi Hospital

Nagoya, , Japan

Nagoya City University Hospital

Nagoya, , Japan

Japanese Red Cross Narita Hospital

Narita-shi, , Japan

Niigata Cancer Center Hospital

Niigata, , Japan

Osaka Saiseikai Nakatsu Hospital

Osaka, , Japan

National Hospital Organization Disaster Medical Center

Tachikawa, , Japan

Toyohashi Municipal Hospital

Toyohashi, , Japan

Yamanashi Prefectural Central Hospital

Yamanashi, , Japan

Centro de Investigacion Farmaceutica Especializada de Occidente, SC - PPDS

Guadalajara, Jalisco, Mexico

Hospital Y Clinica OCA Sociedad Anonima de Capital Variable

Monterrey, Nuevo León, Mexico

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Monterrey, Nuevo León, Mexico

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, , Mexico

Oaxaca Site management Organization (OSMO) - PPDS

Oaxaca City, , Mexico

Shengjing Hospital of China Medical University

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

MTZ Clinical Research Sp z o o - PRATIA - PPDS

Warsaw, Masovian Voivodeship, Poland

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

Chorzów, , Poland

Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

Wroclaw, , Poland

Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.

Lisbon, Lisbon District, Portugal

Hospital Garcia de Orta

Almada, , Portugal

Hospital de Braga

Braga, , Portugal

Champalimaud Cancer Center

Lisbon, , Portugal

Centro Hospitalar do Porto - Hospital de Santo Antonio

Porto, , Portugal

Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

Porto, , Portugal

Centro Hospitalar de Sao Joao EPE

Porto, , Portugal

State Medical and Preventive Treatment Institution Kirov Regional Clinical Oncology Dispensary

Kirov, , Russia

Stavropol Regional Clinical Oncology Centre Pyatigorsk Affiliate

Pyatigorsk, , Russia

Ryazan Regional Clinical Hospital

Ryazan, , Russia

Russian Research Institute of Hematology and Blood Transfusion

Saint Petersburg, , Russia

City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31

Saint Petersburg, , Russia

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Belgrade, , Serbia

Clinical Hospital Center ''Bezanijska Kosa''

Belgrade, , Serbia

University Clinical Center Kragujevac

Kragujevac, , Serbia

Soroka University Medical Centre

Niš, , Serbia

National University Hospital

Singapore, , Singapore

Singapore General Hospital (SGH)

Singapore, , Singapore

Medical Oncology Centre of Rosebank

Johannesburg, Gauteng, South Africa

Albert Alberts Stem Cell Transplant Centre

Pretoria, Gauteng, South Africa

Mary Potter Oncology Centre

Pretoria, Gauteng, South Africa

National Cancer Center

Goyang-si, Gyeonggido, South Korea

Gachon University Gil Medical Center

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

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, Communidad Delaware, Spain

Clinica Universidad Navarra

Pamplona, Navarre, Spain

Hospital Clinic de Barcelona

Barcelona, , Spain

Hospital de La Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Universitario de La Princesa

Madrid, , Spain

Hospital General Universitario Gregorio Maranon

Madrid, , Spain

Hospital Universitario Infanta Leonor

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Hospital Universitario HM Sanchinarro CIOCC

Madrid, , Spain

Hospital General Universitario Morales Meseguer

Murcia, , Spain

Complejo Asistencial Universitario de Salamanca H. Clinico

Salamanca, , Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, , Spain

Karolinska Universitetssjukhuset Huddinge

Stockholm, Södermanland County, Sweden

Karolinska Universitetssjukhuset Solna

Stockholm, Södermanland County, Sweden

Sahlgrenska Universitetssjukhuset

Gothenburg, Västra Götaland County, Sweden

Skanes Universitetssjukhus Lund

Lund, , Sweden

Spital STS AG

Thun, , Switzerland

Kaohsiung Medical University Hospital

Kaohsiung City, , Taiwan

Taichung Veterans General Hospital

Taichung, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Ramathibodi Hospital

Bangkok, Bangkok, Thailand

Chulalongkorn University

Bangkok, , Thailand

Maharaj Nakorn Chiang Mai Chiang Mai University

Chiang Mai, , Thailand

Hacettepe Universitesi Tip Fakultesi Hastanesi

Ankara, , Turkey (Türkiye)

Ankara University Medical Faculty PPDS

Ankara, , Turkey (Türkiye)

Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

Istanbul, , Turkey (Türkiye)

Dokuz Eylul University Medical Faculty

Izmir, , Turkey (Türkiye)

Belfast City Hospital

Belfast, Antrim, United Kingdom

Birmingham Heartlands Hospital

West Malling, Birmingham, United Kingdom

Bristol Haematology and Oncology Centre

Bristol, Bristol, City of, United Kingdom

Royal Bournemouth Hospital

Bournemouth, Dorset, United Kingdom

Queen Alexandra Hospital

Portsmouth, Hampshire, United Kingdom

Kent and Canterbury Hospital

Canterbury, Kent, United Kingdom

Barts Health NHS Trust

London, London, City of, United Kingdom

University College London

London, London, City of, United Kingdom

Kings College Hospital

London, London, City of, United Kingdom

Hammersmith Hospital

London, London, City of, United Kingdom

Hillingdon Hospital

Uxbridge, London, City of, United Kingdom

Churchill Hospital

Oxford, Oxfordshire, United Kingdom

New Cross Hospital

Wolverhampton, Staffordshire, United Kingdom

Royal Marsden Hospital - Surrey

Sutton, Surrey, United Kingdom

Royal United Hospital

Bath, , United Kingdom

Ulster Hospital

Belfast, , United Kingdom

Southmead Hospital

Bristol, , United Kingdom

University Clinical Center Nis

Cardiff, , United Kingdom

West Middlesex University Hospital

Isleworth, , United Kingdom

Leicester Royal Infirmary

Leicester, , United Kingdom

Chelsea and Westminster NHS Trust

London, , United Kingdom

Manchester Royal Infirmary - PPDS

Manchester, , United Kingdom

Northwick Park Hospital

Middlesex, , United Kingdom

The Royal Oldham Hospital - PPDS

Oldham, , United Kingdom

University Clinical Center of Serbia - PPDS

Southall, , United Kingdom

Singleton Hospital - PPDS

Swansea, , United Kingdom

Countries

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

References

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.

Reference Type: DERIVED

PMID: 36130300 (View on PubMed)

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

Reference Type: DERIVED

PMID: 33021870 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1160-1702

Identifier Type: REGISTRY

Identifier Source: secondary_id

2014-001394-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

REec-2015-1414

Identifier Type: REGISTRY

Identifier Source: secondary_id

JapicCTI-152873

Identifier Type: REGISTRY

Identifier Source: secondary_id

153300410A0048

Identifier Type: REGISTRY

Identifier Source: secondary_id

1046003327

Identifier Type: REGISTRY

Identifier Source: secondary_id

SNCTP000001745

Identifier Type: REGISTRY

Identifier Source: secondary_id

15/NE/0167

Identifier Type: REGISTRY

Identifier Source: secondary_id

182602

Identifier Type: REGISTRY

Identifier Source: secondary_id

C16021

Identifier Type: -

Identifier Source: org_study_id