AzTrials
AzTrials

Multiple MyelomaPhase 3NCT02312258

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

A Phase 3 study testing Ixazomib in people with Multiple Myeloma, run by Takeda at 275 sites in 35 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Ixazomib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
706 participants
Where
275 sitesin 35 countries
Study dates
9 Apr 2015to 26 Aug 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult male or female participants 18 years or older with a confirmed diagnosis of symptomatic newly diagnosed multiple myeloma (NDMM) according to standard criteria.
  • Completed 6 to 12 months (± 2 weeks) of initial therapy, during which the participant was treated to best response, defined as the best response maintained for 2 cycles after the M-protein nadir is reached.
  • Documented major response (PR, VGPR, CR) according to the International Myeloma Working Group (IMWG) uniform response criteria, version 2011, after this initial therapy.
  • Female participants who:
  • Are postmenopausal for at least 1 year before the screening visit, OR
  • Are surgically sterile, OR
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  • If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 90 days after the last dose of study drug, OR
  • Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.)
  • Male participants, even if surgically sterilized (that is, status postvasectomy), who:
  • Agree to practice effective barrier contraception during the entire study Treatment period and through 90 days after the last dose of study drug, OR
  • Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)
  • Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
  • Complete documentation of the details of the initial therapy before randomization including cytogenetics and International Staging System (ISS) is available.
  • Eastern Cooperative Oncology Group Performance Status of 0 to 2.
  • Suitable venous access for the study-required blood sampling and consent for the specific amounts that will be taken.
  • Is willing and able to adhere to the study visit schedule and other protocol requirements including blood sampling and bone marrow aspiration.
  • 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).

Who cannot join

  • Multiple myeloma that has relapsed after, or was not responsive to, initial therapy.
  • Prior SCT.
  • Radiotherapy within 14 days before randomization.
  • Diagnosed or treated for another malignancy within 5 years before randomization or previous diagnosis with another malignancy. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
  • Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period.
  • Major surgery within 14 days before randomization.
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  • Central nervous system involvement.
  • Infection requiring intravenous (IV) antibiotic therapy or other serious infection within 14 days before randomization.
  • Diagnosis of Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes syndrome (POEMS), plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome.
  • Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, uncontrolled congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.
  • Systemic treatment with strong cytochrome P450 3A (CYP3A) inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital) or St. John's wort within 14 days before randomization.
  • Ongoing or active infection, known human immunodeficiency virus (HIV) positive, active hepatitis B or C infection.
  • Comorbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens (example, PN that is Grade 1 with pain or Grade 2 or higher of any cause).
  • Psychiatric illness or social situation that would limit compliance with study requirements.
  • Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
  • 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.
  • Treatment with any investigational products within 30 days before randomization.

Trial locations and contacts

275 sites in 35 countries.

275 sites in 35 countries

Brazil28 sites

  • Fundacao PIO XII

    Barretos, São Paulo, 14784-400

  • Hospital Das Clinicas Da UFMG

    Belo Horizonte, Minas Gerais, 30130-100

  • Universidade Estadual de Campinas

    Campinas, São Paulo, 13083-878

  • Universidade de Caxias do Sul

    Caxias do Sul, Rio Grande do Sul, 95070-560

  • Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner

    Curitiba, Paraná, 81520-060

  • Hospital Das Clinicas Da Universidade Federal de Goias

    Goiânia, Goiás, 74605-020

  • Associacao Hospital de Caridade Ijui

    Ijuí, Rio Grande do Sul, 98700-000

  • Hospital Amaral Carvalho

    Jaú, São Paulo, 17210-120

  • Instituto Joinvilense de Hematologia E Oncologia

    Joinville, Santa Catarina, 89201260

  • Liga Norte Riograndense Contra O Cancer

    Natal, Rio Grande do Norte, 59040-150

  • American Oncology Partners of Maryland, PA

    Passo Fundo, Rio Grande do Sul, 99010-260

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Mae de Deus Center Hospital Giovanni Battista

    Porto Alegre, Rio Grande do Sul, 90470-340

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

    Porto Alegre, Rio Grande do Sul, 90610-000

  • HEMORIO - Unidade de Pesquisa Clinica

    Rio de Janeiro, 20211-030

  • Instituto Nacional de Cancer

    Rio de Janeiro, 20231-050

  • Fundação Antônio Prudente - AC Camargo Câncer Center

    Rio de Janeiro, 21941-913

  • Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet

    Salvador, Estado de Bahia, 41253-196

  • Faculdade de Medicina Do ABC

    Santo André, São Paulo, 09060-650

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

    São José do Rio Preto, 15090-000

  • Instituto de Ensino E Pesquisa Sao Lucas

    São Paulo, 01236-030

  • Hospital Sirio Libanes

    São Paulo, 01308-050

  • Ealing Hospital

    São Paulo, 01509-900

  • Clinica Sao Germano

    São Paulo, 04537-080

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

    São Paulo, 05403-000

  • Hospital Israelita Albert Einstein

    São Paulo, 05652-900

  • Hospital Santa Marcelina

    São Paulo, 08270-070

Other trials in Brazil

United Kingdom26 sites

  • Royal United Hospital

    Bath, BA1 3NG

  • Belfast City Hospital

    Belfast, Antrim, BT9 7AB

  • Ulster Hospital

    Belfast, BT16 1RH

  • Royal Bournemouth Hospital

    Bournemouth, Dorset, BH7 7DW

  • Bristol Haematology and Oncology Centre

    Bristol, Bristol, City of, BS2 8ED

  • Southmead Hospital

    Bristol, BS10 5NB

  • Kent and Canterbury Hospital

    Canterbury, Kent, CT1 3NG

  • University Clinical Center Nis

    Cardiff, CF14 4XW

  • West Middlesex University Hospital

    Isleworth, TW7 6AF

  • Leicester Royal Infirmary

    Leicester, LE1 5WW

  • Barts Health NHS Trust

    London, London, City of, EC1A 7BE

  • University College London

    London, London, City of, NW1 2BU

  • Kings College Hospital

    London, London, City of, SE5 9RS

  • Hammersmith Hospital

    London, London, City of, W12 0HS

  • Chelsea and Westminster NHS Trust

    London

  • Manchester Royal Infirmary - PPDS

    Manchester, M13 9WL

  • Northwick Park Hospital

    Middlesex, HA1 3UJ

  • The Royal Oldham Hospital - PPDS

    Oldham, OL1 2JH

  • Churchill Hospital

    Oxford, Oxfordshire, OX3 7LJ

  • Queen Alexandra Hospital

    Portsmouth, Hampshire, PO6 3LY

  • University Clinical Center of Serbia - PPDS

    Southall, UB1 3HW

  • Royal Marsden Hospital - Surrey

    Sutton, Surrey, SM2 5PT

  • Singleton Hospital - PPDS

    Swansea

  • Hillingdon Hospital

    Uxbridge, London, City of, UB8 3NN

  • Birmingham Heartlands Hospital

    West Malling, Birmingham, B9 5SS

  • New Cross Hospital

    Wolverhampton, Staffordshire, WV10 0QP

Other trials in United Kingdom

United States23 sites

  • Cancer Care of WNC PA

    Asheville, North Carolina, 28801

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322

  • Saint Agnes Hospital - Baltimore - Hunt - PPDS

    Baltimore, Maryland, 21229

  • University Hospital of Wales -

    Bethesda, Maryland, 20817

  • Tufts Medical Center - PPDS

    Boston, Massachusetts, 02111

  • John H. Stroger Jr. Hospital of Cook County

    Chicago, Illinois, 60612

  • Robert A Moss MD FACP Inc

    Fountain Valley, California, 92708

  • Appalachian Regional Healthcare

    Hazard, Kentucky, 41701

  • Herbert-Herman Cancer Center

    Lansing, Michigan, 48912

  • UCLA Medical Hematology and Oncology

    Los Angeles, California, 90095

  • W VA University Mary Babb Randolph Cancer Center

    Morgantown, West Virginia, 26506

  • Clinical Research Alliance Inc

    New York, New York, 10021

  • New York Presbyterian Hospital - Weill-Cornell

    New York, New York, 10021

  • North County Oncology Medical Clinic Inc

    Oceanside, California, 92056

  • Ventura County Hematology Oncology Specialists

    Oxnard, California, 93030

  • UPMC Cancer Pavillion

    Pittsburgh, Pennsylvania, 15232

  • Emad Ibrahim, MD, Inc

    Redlands, California, 92373

  • Global Cancer Research Institute (GCRI), Inc.

    San Jose, California, 95124

  • Central Coast Medical Oncology Corporation

    Santa Maria, California, 93454

  • New England Cancer Specialists

    Scarborough, Maine, 04074

  • Swedish Cancer Institute

    Seattle, Washington, 98109

  • Siouxland Hematology - Oncology Associates LLP

    Sioux City, Iowa, 51101

  • HOPE Cancer Center of East Texas

    Tyler, Texas, 75701

Other trials in United States

Japan20 sites

  • Juntendo University Hospital

    Bunkyo, Tokyo, 113-8431

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810-8563

  • Fukushima Medical University Hospital

    Fukushima, 960-1295

  • Hitachi General Hospital

    Hitachi, Ibaraki, 317-0077

  • National Hospital Organization Mito Medical Center

    Ibaraki, 311-3193

  • Nara Hospital Kinki University Faculty of Medicine

    Ikoma, Nara, 630-0293

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • Kurume University Hospital

    Kurume, 830-0011

  • Shizuoka Cancer Center

    Nagaizumi-chō, 4118777

  • Japanese Red Cross Nagoya Daiichi Hospital

    Nagoya, 453-8511

  • Nagoya City University Hospital

    Nagoya, 467-8602

  • Japanese Red Cross Narita Hospital

    Narita-shi, 286-8523

  • Niigata Cancer Center Hospital

    Niigata

  • Ogaki Municipal Hospital

    Ōgaki, Gihu, 503-8502

  • National Hospital Organization Okayama Medical Center

    Okayama, Okayama-ken, 701-1192

  • Osaka Saiseikai Nakatsu Hospital

    Osaka, 530-0012

  • Japanese Red Cross Medical Center

    Shibuya-ku, Tokyo, 150-8935

  • National Hospital Organization Disaster Medical Center

    Tachikawa, 1900014

  • Toyohashi Municipal Hospital

    Toyohashi

  • Yamanashi Prefectural Central Hospital

    Yamanashi, 400-8506

Other trials in Japan

Germany17 sites

  • Onkologie Aschaffenburg

    Aschaffenburg, 63739

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

    Augsburg, Bavaria, 86150

  • Charite - Universitatsmedizin Berlin

    Berlin, 12200

  • Medizinisches Versorgungszentrum Onkologischer Schwerpunkt

    Berlin, 14195

  • Universitatsklinikum Essen

    Essen, North Rhine-Westphalia, 45122

  • Internistisch Hamatologische und Internistische Praxis

    Herrsching am Ammersee, Bavaria, 82211

  • Universitat Des Saarlandes

    Homburg, Saarland, 66421

  • Klinikum Landshut

    Landshut, 84034

  • Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

    Mainz, Rhineland-Palatinate, 55131

  • LMU Klinikum der Universitat Munchen

    München, Bavaria, 81377

  • Klinikum rechts der Isar der Technischen Universitat Munchen

    München, 81675

  • Gemeinschaftspraxis fur Hamatologie und Onkologie

    Münster, North Rhine-Westphalia, 48149

  • Pius Hospital Oldenburg

    Oldenburg, Lower Saxony, 26121

  • Praxis Pihusch Medizinisches Versorgungszentrum GbR

    Rosenheim, 83022

  • Universitatsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

  • Schwarzwald Baar Klinkum Villingen-Schwenningen GmbH

    Villingen-Schwenningen, Baden-Wurttemberg, 78050

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

    Würzburg, 97080

Other trials in Germany

Italy15 sites

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

    Ancona, 60126

  • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

    Bologna, Emilia-Romagna, 40138

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

    Brescia, Lombardy, 25123

  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

    Catania, Sicily, 95124

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50139

  • IRCCS Az. Osp. Universitaria San Martino- IST

    Genoa, Liguria, 16132

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

    Milan, Lombardy, 20162

  • AORN A Cardarelli

    Naples, Campania, 80131

  • Azienda Ospedaliero Universitaria di Parma

    Parma, 43126

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Tuscany, 56216

  • Ospedale Santa Maria Delle Croci

    Ravenna, 48100

  • Ospedale Infermi di Rimini

    Rimini, Emilia-Romagna, 47900

  • Ospedale Casa Sollievo Della Sofferenza IRCCS

    San Giovanni Rotondo, Apulia, 71013

  • Azienda Ospedaliera S Maria Di Terni

    Terni, Umbria, 05100

  • Azienda Ospedaliera Citta della Salute e della Scienza di Torino

    Torino, 10126

Other trials in Italy

Spain13 sites

  • Hospital Universitario Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Universitario de La Princesa

    Madrid, 28006

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28009

  • Hospital Universitario Infanta Leonor

    Madrid, 28031

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario HM Sanchinarro CIOCC

    Madrid, 28050

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008

  • Clinica Universidad Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, Madrid, Communidad Delaware, 28223

  • Complejo Asistencial Universitario de Salamanca H. Clinico

    Salamanca, 37007

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

Other trials in Spain

China12 sites

  • Beijing Chaoyang Hospital Capital Medical University

    Beijing, 100020

  • Peking University Third Hospital

    Beijing, 100191

  • Peking Union Medical College Hospital

    Beijing

  • The First Affiliated Hospital, College of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310003

  • The First Affiliated Hospital, College of Medicine, Zhejiang University

    Hangzhou, 310003

  • Hospital de Clinicas de Passo Fundo

    Nanjing, Jiangsu, 210029

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

  • Renji Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, 200001

  • Shanghai Chang Zheng Hospital

    Shanghai, 200003

  • Hospital São Rafael

    Shenyang, 110004

  • Second Hospital of Shanxi Medical University

    Taiyuan, 030001

  • James Lind Centro de Investigación del Cáncer

    Wuhan, 430030

Other trials in China

France11 sites

  • Hopital Antoine Beclere

    Clamart, Hauts-de-Seine, 92140

  • CHRU Dijon Complexe Du Bocage

    Dijon, 21079

  • Hopital Saint Vincent de Paul GHICL

    Lille, 59020

  • CHRU Lille

    Lille, 59037

  • Hotel Dieu

    Nantes, Loire-Atlantique, 44093

  • Hopital de la Pitie Salpetriere

    Paris, 75013

  • Groupe Hospitalier Necker Enfants Malades

    Paris, 75015

  • Hopital Haut Leveque

    Pessac, 33604

  • Hopital Jean Bernard

    Poitiers, 86021

  • CHRU Rennes

    Rennes

  • CHRU Nancy

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511

Other trials in France

Israel10 sites

  • Rigshospitalet

    Beer Yaakov, 70300

  • Shamir Medical Center Assaf Harofeh

    Beersheba, 84101

  • Bnai Zion Medical Center

    Haifa, 33394

  • Hadassah Medical Center - PPDS

    Jerusalem, 91120

  • Meir Medical Center

    Kfar Saba, 44281

  • Rabin Medical Center - PPDS

    Petah Tikva, 49100

  • Chaim Sheba Medical Center

    Ramat Gan, 52621

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

  • Assuta Medical Centers

    Tel Aviv, 69710

  • Baruch Padeh Poriya Medical Center

    Tiberias, 15208

Other trials in Israel

Portugal7 sites

  • Hospital Garcia de Orta

    Almada, 2801-951

  • Hospital de Braga

    Braga, 4710-243

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

    Lisbon, Lisbon District, 1099-023

  • Champalimaud Cancer Center

    Lisbon, 1400-038

  • Centro Hospitalar do Porto - Hospital de Santo Antonio

    Porto, 4099-001

  • Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

    Porto, 4200-072

  • Centro Hospitalar de Sao Joao EPE

    Porto, 4200-319

Other trials in Portugal

Czechia6 sites

  • Fakultni nemocnice Brno

    Brno, 625 00

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, Kralovehradeck Kraj, 500 05

  • Fakultni nemocnice Olomouc

    Olomouc, 775 20

  • Fakultni nemocnice Ostrava

    Ostrava, 708 52

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, Praha, Hlavni Mesto, 100 34

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

Other trials in Czechia

Greece6 sites

  • University of Athens Medical School - Regional General Hospital Alexandra

    Athens, Attica, 115 28

  • Evangelismos General Hospital of Athens

    Athens, 10676

  • University General Hospital of Ioannina

    Ioannina, 45500

  • University General Hospital of Larissa

    Larissa, 41110

  • Theageneio Anticancer Oncology Hospital of Thessaloniki

    Thessaloniki, 54007

  • Georgios Papanikolaou General Hospital of Thessaloniki

    Thessaloniki, 57010

Other trials in Greece

South Korea6 sites

  • National Cancer Center

    Goyang-si, Gyeonggido, 10408

  • Gachon University Gil Medical Center

    Incheon, 405-760

  • Seoul National University Hospital

    Seoul, 110-744

  • Severance Hospital Yonsei University Health System - PPDS

    Seoul, 120-752

  • Samsung Medical Center - PPDS

    Seoul, 135-710

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

    Seoul, 137-701

Other trials in South Korea

Argentina5 sites

  • Hospital Universitario Austral

    Buenos Aires, Ciudad Autonoma de BuenosAires, B1629AHJ

  • Hospital Italiano de Buenos Aires

    Buenos Aires, Ciudad Autonoma de BuenosAires, C1181ACH

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

    Buenos Aires, Ciudad Autonoma de BuenosAires, C1431FWO

  • Sanatorio Allende S.A.

    Córdoba, X5000JHQ

  • Hospital Iturraspe

    Santa Fe, S3000ADL

Other trials in Argentina

Mexico5 sites

  • Centro de Investigacion Farmaceutica Especializada de Occidente, SC - PPDS

    Guadalajara, Jalisco, 44160

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, 14000

  • Hospital Y Clinica OCA Sociedad Anonima de Capital Variable

    Monterrey, Nuevo León, 64000

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, Nuevo León, 64460

  • Oaxaca Site management Organization (OSMO) - PPDS

    Oaxaca City, 68000

Other trials in Mexico

Russia5 sites

  • State Medical and Preventive Treatment Institution Kirov Regional Clinical Oncology Dispensary

    Kirov, 610027

  • Stavropol Regional Clinical Oncology Centre Pyatigorsk Affiliate

    Pyatigorsk, 357500

  • Ryazan Regional Clinical Hospital

    Ryazan, 390039

  • Russian Research Institute of Hematology and Blood Transfusion

    Saint Petersburg, 193024

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

    Saint Petersburg, 197110

Other trials in Russia

Austria4 sites

  • Universitatsklinikum Innsbruck

    Innsbruck, Tyrol, 6020

  • Paracelsus Medizinische Privatuniversitat

    Salzburg, 5020

  • Medizinische Universitat Wien (Medical University of Vienna)

    Vienna, A-1090

  • Klinikum Wels-Grieskirchen GmbH

    Wels, 4600

Other trials in Austria

Canada4 sites

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2

  • William Osler Health Centre

    Brampton, Ontario, L6W 3J7

  • McGill University Health Center

    Montreal, Quebec, H4A 3J1

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Chile4 sites

  • Instituto Nacional Del Cancer

    Santiago, 8380455

  • Centro Internacional de Estudios Clinicos

    Santiago

  • Hospital Amaral Carvalho

    Temuco, Araucania, 4800827

  • Centro de Investigaciones Clinicas Vina del Mar

    Viña del Mar, 2570017

Other trials in Chile

Denmark4 sites

  • Aarhus Universitetshospital Århus Sygehus

    Aarhus N, DK-8200

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

    Copenhagen, Capital, 2100

  • Regionshospitalet Holstebro

    Holstebro, 7500

  • Odense Universitetshospital

    Odense, 5000

Other trials in Denmark

Hungary4 sites

  • Semmelweis Egyetem

    Budapest, 1083

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

    Budapest, 1097

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, 6725

Other trials in Hungary

Poland4 sites

  • Shengjing Hospital of China Medical University

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

    Chorzów

  • MTZ Clinical Research Sp z o o - PRATIA - PPDS

    Warsaw, Masovian Voivodeship, 02-106

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

    Wroclaw, 50-367

Other trials in Poland

Serbia4 sites

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Belgrade, 11000

  • Clinical Hospital Center ''Bezanijska Kosa''

    Belgrade, 11080

  • University Clinical Center Kragujevac

    Kragujevac, 34000

  • Soroka University Medical Centre

    Niš, 18000

Other trials in Serbia

Sweden4 sites

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, Västra Götaland County

  • Skanes Universitetssjukhus Lund

    Lund, SE-22185

  • Karolinska Universitetssjukhuset Huddinge

    Stockholm, Södermanland County

  • Karolinska Universitetssjukhuset Solna

    Stockholm, Södermanland County

Other trials in Sweden

Turkey (Türkiye)4 sites

  • Hacettepe Universitesi Tip Fakultesi Hastanesi

    Ankara, 06100

  • Ankara University Medical Faculty PPDS

    Ankara, 06590

  • Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

    Istanbul, 34093

  • Dokuz Eylul University Medical Faculty

    Izmir, 35340

Other trials in Turkey (Türkiye)

Australia3 sites

  • St Vincents Hospital Melbourne - PPDS

    Fitzroy, Victoria, 3065

  • Frankston Hospital

    Frankston, Victoria, 3199

  • The Alfred Hospital

    Melbourne, Victoria, 3004

Other trials in Australia

Belgium3 sites

  • Universitair Ziekenhuis Brussel - PIN

    Brussels, Brussels Capital, 1090

  • UZ Brussel

    Brussels, Brussels Capital, 1090

  • Cliniques Universitaires Saint-Luc

    Brussels, Brussels Capital, 1200

Other trials in Belgium

Colombia3 sites

  • Instituto Nacional de Cancerologia Colombia

    Bogota, Cundinamarca

  • Hospital Universitario San Ignacio

    Bogotá, Bogota D.C., 110311

  • Hospital Pablo Tobon Uribe

    Medellín, Antioquia, 050034

Other trials in Colombia

Croatia3 sites

  • Clinical Hospital Center Rijeka

    Rijeka, 51000

  • Clinical Hospital Dubrava

    Zagreb, City of Zagreb, 10000

  • Clinical Hospital Center Zagreb - PPDS

    Zagreb, 10 000

Other trials in Croatia

South Africa3 sites

  • Medical Oncology Centre of Rosebank

    Johannesburg, Gauteng, 2196

  • Albert Alberts Stem Cell Transplant Centre

    Pretoria, Gauteng, 0044

  • Mary Potter Oncology Centre

    Pretoria, Gauteng, 0181

Other trials in South Africa

Taiwan3 sites

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 807

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Taiwan University Hospital

    Taipei, 100

Other trials in Taiwan

Thailand3 sites

  • Ramathibodi Hospital

    Bangkok, Bangkok, 10400

  • Chulalongkorn University

    Bangkok, 10330

  • Maharaj Nakorn Chiang Mai Chiang Mai University

    Chiang Mai, 50200

Other trials in Thailand

Singapore2 sites

  • National University Hospital

    Singapore, 119074

  • Singapore General Hospital (SGH)

    Singapore, 169608

Other trials in Singapore

Switzerland1 site

  • Spital STS AG

    Thun, CH-3600

Other trials in Switzerland

About this study

Official title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation

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.

Read the 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.

Being tested
Placebo, Ixazomib
Keywords
Drug Therapy
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Ixazomib placebo-matching capsules.

  • IxazomibDrug

    Ixazomib capsules.

Study groups in NCT02312258
Study groupRoleWhat they receive
PlaceboPlacebo comparatorIxazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.
Receives: Drug: Placebo
IxazomibExperimentalIxazomib 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.
Receives: Drug: Ixazomib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    PFS is defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause, as evaluated by an independent review committee (IRC) according to International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first. Per IMWG criteria, PD is defined as, increase of 25% of lowest response value in one or more of following criteria: serum M-component (absolute increase ≥0.5 g/ deciliter (dL)); or urine M-component (absolute increase ≥200 mg/24-hour); difference between involved and uninvolved free light chains (FLC) levels (absolute increase >10 mg/dL); or bone marrow plasma cell percentage (absolute plasma cell percentage ≥10%); development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma; or development of hypercalcemia (corrected serum calcium >11.5mg/dL).

    Measured: From randomization until PD or death (up to 52 months)

Secondary outcomes (19)

  1. Overall Survival (OS)

    OS was measured as the time from the date of randomization to the date of death.

    Measured: From the date of randomization and every 12 weeks after PD on next-line therapy until death (up to 88 months)

  2. Percentage of Participants Who Achieve or Maintain Any Best Response Category During the Treatment Period

    Response was assessed according to IMWG criteria based on IRC assessment. Best response included PR, VGPR and CR. PR= >=50% reduction of serum M protein and >=90% or <200 mg reduction urinary M protein in 24-hour, or >50% decrease in difference between involved and uninvolved FLC levels, or >50% reduction in bone marrow plasma cells, if bone marrow plasma cells >30% and >50% reduction in size of soft tissue plasmacytomas at baseline. VGPR= >90% reduction (<100 mg/24-hour) in serum M-protein + urine M-protein detectable by immunofixation but not on electrophoresis. Complete response= >5% plasma cells in myelogram with absence of paraprotein in serum and urine according to immunofixation.

    Measured: Up to 27 months

  3. 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.

    Measured: From randomization until PD or death (up to 52 months)

  4. Progression Free Survival 2 (PFS2)

    PFS2 is defined as the time from the date of randomization to objective PD on next-line treatment using IMWG criteria, or death due to any cause, whichever occurred first.

    Measured: From the date of randomization to every 12 weeks until second PD or death (up to 88 months)

  5. Time to Next Line Therapy (TTNT)

    TTNT is defined as the time from the date of randomization to the date of the first dose of next-line antineoplastic therapy.

    Measured: From randomization until PD or death (up to 52 months)

  6. Time to End of the Next-line of Therapy After Study Treatment

    Time to end of the next line of therapy is 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.

    Measured: From randomization until PD or death (up to 52 months)

  7. Duration of Next-line Therapy

    Duration of next-line therapy is defined as the time from the date of the first dose of the next line of antineoplastic therapy coming after study treatment to the date of the last dose.

    Measured: From randomization until PD or death (up to 52 months)

  8. Percentage of Participants Who Develop a New Primary Malignancy

    Measured: From randomization until PD or death (up to 52 months)

  9. Percentage of Participants With Conversion From Minimal Residual Disease (MRD) Positive to MRD Negative

    Bone marrow aspirates and blood samples were sent to a central laboratory and were assessed for MRD using flow cytometry. MRD negativity was defined as absence of MRD and MRD positivity was defined as presence of MRD. MRD was assessed by 8-color flow cytometry with the IMWG recommended sensitivity of 10^-5.

    Measured: Up to 52 months

  10. Correlation of MRD Status With PFS and OS

    PFS is defined as the time from the date of randomization to the date of first documentation of PD or death from any cause, as evaluated by an IRC according to IMWG criteria, or death due to any cause, whichever occurred first, assessed for up to 52 months in this outcome measure. OS was measured as the time from the date of randomization to the date of death, assessed for up to 52 months in this outcome measure. Participants with various types of known MRD status were pooled together for analysis of overall survival in this outcome measure.

    Measured: From randomization up to 52 months

  11. OS in a High-risk Population

    High-risk population included but not be limited to participants carrying cytogenetic deletion (del)17, translocation [t](4;14), t(14;16). OS was measured as the time from the date of randomization to the date of death.

    Measured: From the date of randomization and every 12 weeks after PD on next-line therapy until death (up to 88 months)

  12. PFS in a High-risk Population

    High-risk population included but not be limited to participants carrying del17, t(4;14), t(14;16). PFS was defined as the time from the date of randomization to the date of first documentation of PD or death from any cause.

    Measured: From randomization until PD or death (up to 52 months)

  13. Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status

    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 grades indicate improvement.

    Measured: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26, progression free survival follow-up (PFSFU)- Visit 37 and progressive disease follow-up (PDFU)- Visit 26 (cycle length=28 days)

  14. Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAEs were defined as events that occurred after administration of the first dose of ixazomib or placebo through 30 days after the last dose of ixazomib or placebo. A SAE means any untoward medical occurrence that resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was considered medically significant.

    Measured: First dose of study drug through 30 days after last dose of study drug (up to 88 months)

  15. Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) as Measured by the Global Health Status (GHS)

    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The change from baseline in GHS (EORTC QLQ-C30) score is presented. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1=very poor to 7=excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall GHS.

    Measured: Baseline, Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26 (cycle length=28 days)

  16. Correlation Between Frailty Status and PFS and OS

    Participant's frailty status is classified as fit, unfit or frail on the bases of 4 components: age, the Charlson comorbidity scoring system without age weighting, the Katz index of independence in activities of daily living, and the Lawton instrumental activities of daily living scale. The sum of the 4 frailty scores equals the total frailty score. A total frailty score of 0 corresponds to a frailty status of fit; a total score of 1, to unfit; and a total score of 2 or more, to frail. PFS is defined as the time from the date of randomization to the date of first documentation of PD or death from any cause, as evaluated by an IRC according to IMWG criteria, or death due to any cause, whichever occurs first, assessed for up to 52 months in this outcome measure. OS will be measured as the time from the date of randomization to the date of death, assessed for up to 52 months in this outcome measure.

    Measured: From randomization up to 52 months

  17. Pharmacokinetic Parameter: 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.

    Measured: Cycle 1 (1 and 4 hours post-dose Day 1, Days 8 and 15 pre-dose); Cycle 2 and 5 (Days 1 and 8 pre-dose) and Cycles 3, 4, 6 to 10 (Day 1 pre-dose) (cycle length=28 days)

  18. Time to Resolution of Peripheral Neuropathy (PN) Events

    PN is defined as the 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 was considered as resolved if its final outcome was resolved with no subsequent PN event of the same preferred term occurring on the resolution date or the day before and after. Time to resolution was defined as the time from the initial onset date (inclusive) to the resolution date for resolved events.

    Measured: Up to 52 months

  19. Time to Improvement of PN Events

    PN is defined as the event in the high-level term of peripheral neuropathies NEC according to the MedDRA. A PN event was considered as resolved if its final outcome was resolved with no subsequent PN event of the same preferred term occurring on the improvement date or the day before and after. Time to improvement was defined as the time from the initial onset date (inclusive) to the improvement of event.

    Measured: Up to 52 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2014 (estimated)
  2. Study start9 Apr 2015
  3. Primary completion12 Aug 2019
  4. Study completion26 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
706 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02312258
Sponsor's protocol ID
C16021
Other IDs
U1111-1160-1702, 2014-001394-13, REec-2015-1414, JapicCTI-152873, 153300410A0048, 1046003327, SNCTP000001745, 15/NE/0167
Status last verified
Aug 2023
First submitted
5 Dec 2014
Last updated
21 Sep 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 36130300

  • 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.

    PubMed 33021870

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ixazomib in people with Multiple Myeloma, run by Takeda at 275 sites in 35 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 275 sites in Brazil, United Kingdom, United States, Japan, Germany and 30 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: From randomization until PD or death (up to 52 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02312258, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.

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