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

Last updated: August 23, 2023
Sponsor: Takeda
Overall Status: Completed

Phase

3

Condition

Red Blood Cell Disorders

Cancer/tumors

Leukemia

Treatment

Placebo

Ixazomib

Clinical Study ID

NCT02312258
C16021
JapicCTI-152873
REec-2015-1414
MOH_2017-06-15_000529
153300410A0048
15/NE/0167
SNCTP000001745
182602
2014-001394-13
U1111-1160-1702
1046003327
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult male or female participants 18 years or older with a confirmed diagnosis ofsymptomatic newly diagnosed multiple myeloma (NDMM) according to standard criteria.
  2. Completed 6 to 12 months (± 2 weeks) of initial therapy, during which the participantwas treated to best response, defined as the best response maintained for 2 cyclesafter the M-protein nadir is reached.
  3. Documented major response (PR, VGPR, CR) according to the International MyelomaWorking Group (IMWG) uniform response criteria, version 2011, after this initialtherapy.
  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 ofcontraception, at the same time, from the time of signing the informed consentthrough 90 days after the last dose of study drug, OR
  • Agree to practice true abstinence, when this is in line with the preferred andusual lifestyle of the participant. (Periodic abstinence [eg, calendar,ovulation, symptothermal, postovulation methods] and withdrawal are notacceptable methods of contraception.) Male participants, even if surgically sterilized (that is, status postvasectomy), who:
  • Agree to practice effective barrier contraception during the entire studyTreatment 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 andusual lifestyle of the participant. (Periodic abstinence [example, calendar,ovulation, symptothermal, postovulation methods for the female partner] andwithdrawal are not acceptable methods of contraception.)
  1. Voluntary written consent must be given before performance of any study-relatedprocedure not part of standard medical care, with the understanding that consent maybe withdrawn by the participant at any time without prejudice to future medical care.
  2. Complete documentation of the details of the initial therapy before randomizationincluding cytogenetics and International Staging System (ISS) is available.
  3. Eastern Cooperative Oncology Group Performance Status of 0 to 2.
  4. Suitable venous access for the study-required blood sampling and consent for thespecific amounts that will be taken.
  5. Is willing and able to adhere to the study visit schedule and other protocolrequirements including blood sampling and bone marrow aspiration.
  6. Must meet the following clinical laboratory criteria at study entry:
  • Absolute neutrophil count (ANC) greater than or equal to (≥) 1,000 per cubicmillimeter (/mm^3) without growth factor support and platelet count ≥75,000/mm^3.Platelet transfusions to help participants meet eligibility criteria are notallowed 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 theCockcroft-Gault equation).

Exclusion

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 orprevious diagnosis with another malignancy. Participants with nonmelanoma skin canceror carcinoma in situ of any type are not excluded if they have undergone completeresection.
  5. Female participants who are lactating and breastfeeding or have a positive serumpregnancy 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 infectionwithin 14 days before randomization.
  9. Diagnosis of Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly,endocrinopathy, monoclonal gammopathy, and skin changes syndrome (POEMS), plasma cellleukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferativesyndrome.
  10. Evidence of current uncontrolled cardiovascular conditions, including uncontrolledhypertension, 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 wortwithin 14 days before randomization.
  12. Ongoing or active infection, known human immunodeficiency virus (HIV) positive, activehepatitis B or C infection.
  13. Comorbid systemic illnesses or other severe concurrent disease that, in the judgmentof the investigator, would make the participant inappropriate for entry into thisstudy or interfere significantly with the proper assessment of safety and toxicity ofthe prescribed regimens (example, PN that is Grade 1 with pain or Grade 2 or higher ofany cause).
  14. Psychiatric illness or social situation that would limit compliance with studyrequirements.
  15. Known allergy to any of the study medications, their analogues, or excipients in thevarious formulations of any agent.
  16. Inability to swallow oral medication, inability or unwillingness to comply with thedrug administration requirements, or gastrointestinal (GI) procedure that couldinterfere with the oral absorption or tolerance of treatment.
  17. Treatment with any investigational products within 30 days before randomization.

Study Design

Total Participants: 706
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
April 09, 2015
Estimated Completion Date:
August 26, 2022

Study 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.

Connect with a study center

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

    Buenos Aires, Ciudad Autonoma De BuenosAires C1431FWO
    Argentina

    Site Not Available

  • Hospital Italiano de Buenos Aires

    Buenos Aires, Ciudad Autonoma De BuenosAires C1181ACH
    Argentina

    Site Not Available

  • Hospital Universitario Austral

    Buenos Aires, Ciudad Autonoma De BuenosAires B1629AHJ
    Argentina

    Site Not Available

  • empty

    Ciudad Autonoma de Buenos Aires,
    Argentina

    Site Not Available

  • Sanatorio Allende S.A.

    Cordoba, X5000JHQ
    Argentina

    Site Not Available

  • Hospital Iturraspe

    Santa Fe, S3000ADL
    Argentina

    Site Not Available

  • St Vincents Hospital Melbourne - PPDS

    Fitzroy, Victoria 3065
    Australia

    Site Not Available

  • Frankston Hospital

    Frankston, Victoria 3199
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Universitatsklinikum Innsbruck

    Innsbruck, Tirol 6020
    Austria

    Site Not Available

  • Paracelsus Medizinische Privatuniversitat

    Salzburg, 5020
    Austria

    Site Not Available

  • Klinikum Wels-Grieskirchen GmbH

    Wels, 4600
    Austria

    Site Not Available

  • Medizinische Universitat Wien (Medical University of Vienna)

    Wien, A-1090
    Austria

    Site Not Available

  • UZ Brussel

    Brussel, Brussels 1090
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Brussel - PIN

    Brussel, Brussels 1090
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Bruxelles, Brussels 1200
    Belgium

    Site Not Available

  • Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet

    Salvador, Bahia 41253-196
    Brazil

    Site Not Available

  • Hospital Das Clinicas Da Universidade Federal de Goias

    Goiania, Goias 74605-020
    Brazil

    Site Not Available

  • Hospital Das Clinicas Da UFMG

    Belo Horizonte, Minas Gerais 30130-100
    Brazil

    Site Not Available

  • Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner

    Curitiba, Parana 81520-060
    Brazil

    Site Not Available

  • Liga Norte Riograndense Contra O Cancer

    Natal, Rio Grande Do Norte 59040-150
    Brazil

    Site Not Available

  • Universidade de Caxias do Sul

    Caxias Do Sul, Rio Grande Do Sul 95070-560
    Brazil

    Site Not Available

  • Associacao Hospital de Caridade Ijui

    Ijui, Rio Grande Do Sul 98700-000
    Brazil

    Site Not Available

  • American Oncology Partners of Maryland, PA

    Passo Fundo, Rio Grande Do Sul 99010-260
    Brazil

    Site Not Available

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande Do Sul 90035-001
    Brazil

    Site Not Available

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

    Porto Alegre, Rio Grande Do Sul 90610-000
    Brazil

    Site Not Available

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

    Porto Alegre, Rio Grande Do Sul 90035-903
    Brazil

    Site Not Available

  • Mae de Deus Center Hospital Giovanni Battista

    Porto Alegre, Rio Grande Do Sul 90470-340
    Brazil

    Site Not Available

  • Instituto Joinvilense de Hematologia E Oncologia

    Joinville, Santa Catarina 89201260
    Brazil

    Site Not Available

  • Fundacao PIO XII

    Barretos, Sao Paulo 14784-400
    Brazil

    Site Not Available

  • Universidade Estadual de Campinas

    Campinas, Sao Paulo 13083-878
    Brazil

    Site Not Available

  • Hospital Amaral Carvalho

    Jau, Sao Paulo 17210-120
    Brazil

    Site Not Available

  • Faculdade de Medicina Do ABC

    Santo Andre, Sao Paulo 09060-650
    Brazil

    Site Not Available

  • Fundação Antônio Prudente - AC Camargo Câncer Center

    Rio De Janeiro, 21941-913
    Brazil

    Site Not Available

  • HEMORIO - Unidade de Pesquisa Clinica

    Rio De Janeiro, 20211-030
    Brazil

    Site Not Available

  • Instituto Nacional de Cancer

    Rio de Janeiro, 20231-050
    Brazil

    Site Not Available

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

    Sao Jose Do Rio Preto, 15090-000
    Brazil

    Site Not Available

  • Clinica Sao Germano

    Sao Paulo, 04537-080
    Brazil

    Site Not Available

  • Ealing Hospital

    Sao Paulo, 01509-900
    Brazil

    Site Not Available

  • Hospital Israelita Albert Einstein

    Sao Paulo, 05652-900
    Brazil

    Site Not Available

  • Hospital Santa Marcelina

    Sao Paulo, 08270-070
    Brazil

    Site Not Available

  • Hospital Sirio Libanes

    Sao Paulo, 01308-050
    Brazil

    Site Not Available

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

    Sao Paulo, 05403-000
    Brazil

    Site Not Available

  • Instituto de Ensino E Pesquisa Sao Lucas

    Sao Paulo, 01236-030
    Brazil

    Site Not Available

  • Royal Victoria Regional Health Centre

    Barrie, Ontario L4M 6M2
    Canada

    Site Not Available

  • William Osler Health Centre

    Brampton, Ontario L6W 3J7
    Canada

    Site Not Available

  • Princess Margaret Hospital

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • McGill University Health Center

    Montreal, Quebec H4A 3J1
    Canada

    Site Not Available

  • Hospital Amaral Carvalho

    Temuco, Araucanía 4800827
    Chile

    Site Not Available

  • Centro Internacional de Estudios Clinicos

    Santiago,
    Chile

    Site Not Available

  • Instituto Nacional Del Cancer

    Santiago, 8380455
    Chile

    Site Not Available

  • Centro de Investigaciones Clinicas Vina del Mar

    Vina Del Mar, 2570017
    Chile

    Site Not Available

  • Hospital de Clinicas de Passo Fundo

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai 200025
    China

    Site Not Available

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

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • Beijing Chaoyang Hospital Capital Medical University

    Beijing, 100020
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing,
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, 100191
    China

    Site Not Available

  • West China Hospital Sichuan University

    Chengdu, 610041
    China

    Site Not Available

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, 510080
    China

    Site Not Available

  • Renji Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, 200001
    China

    Site Not Available

  • Shanghai Chang Zheng Hospital

    Shanghai, 200003
    China

    Site Not Available

  • Hospital São Rafael

    Shenyang, 110004
    China

    Site Not Available

  • Second Hospital of Shanxi Medical University

    Taiyuan, 030001
    China

    Site Not Available

  • Shanxi Medical University - Second Hospital

    Taiyuan Shi, 030001
    China

    Site Not Available

  • James Lind Centro de Investigación del Cáncer

    Wuhan, 430030
    China

    Site Not Available

  • Hospital Pablo Tobon Uribe

    Medellin, Antioquia 050034
    Colombia

    Site Not Available

  • Instituto Nacional de Cancerologia Colombia

    Bogota, Cundinamarca
    Colombia

    Site Not Available

  • Hospital Universitario San Ignacio

    Bogota, Distrito Capital De Bogota 110311
    Colombia

    Site Not Available

  • Clinical Hospital Dubrava

    Zagreb, Grad Zagreb 10000
    Croatia

    Site Not Available

  • Clinical Hospital Center Rijeka

    Rijeka, 51000
    Croatia

    Site Not Available

  • Clinical Hospital Center Zagreb - PPDS

    Zagreb, 10 000
    Croatia

    Site Not Available

  • empty

    Praha,
    Czech Republic

    Site Not Available

  • Fakultni nemocnice Hradec Kralove

    Hradec Kralove, Kralovehradeck Kraj 500 05
    Czechia

    Site Not Available

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, Praha, Hlavni Mesto 100 34
    Czechia

    Site Not Available

  • Fakultni nemocnice Brno

    Brno, 625 00
    Czechia

    Site Not Available

  • Fakultni nemocnice Olomouc

    Olomouc, 775 20
    Czechia

    Site Not Available

  • Fakultni nemocnice Ostrava

    Ostrava, 708 52
    Czechia

    Site Not Available

  • Vseobecna fakultni nemocnice v Praze

    Praha 2, 128 08
    Czechia

    Site Not Available

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

    København, Capital 2100
    Denmark

    Site Not Available

  • Arhus Universitetshospital Arhus Sygehus

    Aarhus, 8000
    Denmark

    Site Not Available

  • Aarhus Universitetshospital Århus Sygehus

    Aarhus N, DK-8200
    Denmark

    Site Not Available

  • empty

    Arhus,
    Denmark

    Site Not Available

  • Herlev Hospital

    Herlev, DK-2730
    Denmark

    Site Not Available

  • Regionshospitalet Holstebro

    Holstebro, 7500
    Denmark

    Site Not Available

  • Odense Universitetshospital

    Odense, 5000
    Denmark

    Site Not Available

  • Hopital Antoine Beclere

    Clamart, Hauts-de-Seine 92140
    France

    Site Not Available

  • Hotel Dieu

    Nantes, Loire-Atlantique 44093
    France

    Site Not Available

  • CHRU Nancy

    Vandoeuvre-les-nancy, Meurthe-et-Moselle 54511
    France

    Site Not Available

  • CHRU Dijon Complexe Du Bocage

    Dijon, 21079
    France

    Site Not Available

  • CHRU Lille

    Lille, 59037
    France

    Site Not Available

  • Hopital Saint Vincent de Paul GHICL

    Lille, 59020
    France

    Site Not Available

  • Groupe Hospitalier Necker Enfants Malades

    Paris, 75015
    France

    Site Not Available

  • Hopital de la Pitie Salpetriere

    Paris, 75013
    France

    Site Not Available

  • Hopital Haut Leveque

    Pessac, 33604
    France

    Site Not Available

  • Hopital Jean Bernard

    Poitiers, 86021
    France

    Site Not Available

  • CHRU Rennes

    Rennes,
    France

    Site Not Available

  • Universitatsklinikum Ulm

    Ulm, Baden-Wurttemberg 89081
    Germany

    Site Not Available

  • Schwarzwald Baar Klinkum Villingen-Schwenningen GmbH

    Villingen-Schwenningen, Baden-Wurttemberg 78050
    Germany

    Site Not Available

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

    Augsburg, Bayern 86150
    Germany

    Site Not Available

  • Internistisch Hamatologische und Internistische Praxis

    Herrsching am Ammersee, Bayern 82211
    Germany

    Site Not Available

  • LMU Klinikum der Universitat Munchen

    Munchen, Bayern 81377
    Germany

    Site Not Available

  • Pius Hospital Oldenburg

    Oldenburg, Niedersachsen 26121
    Germany

    Site Not Available

  • Universitatsklinikum Essen

    Essen, Nordrhein-Westfalen 45122
    Germany

    Site Not Available

  • Gemeinschaftspraxis fur Hamatologie und Onkologie

    Munster, Nordrhein-Westfalen 48149
    Germany

    Site Not Available

  • Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

    Mainz, Rheinland-Pfalz 55131
    Germany

    Site Not Available

  • Universitat Des Saarlandes

    Homburg, Saarland 66421
    Germany

    Site Not Available

  • Onkologie Aschaffenburg

    Aschaffenburg, 63739
    Germany

    Site Not Available

  • Charite - Universitatsmedizin Berlin

    Berlin, 12200
    Germany

    Site Not Available

  • Medizinisches Versorgungszentrum Onkologischer Schwerpunkt

    Berlin, 14195
    Germany

    Site Not Available

  • Klinikum Landshut

    Landshut, 84034
    Germany

    Site Not Available

  • Klinikum rechts der Isar der Technischen Universitat Munchen

    Munchen, 81675
    Germany

    Site Not Available

  • Praxis Pihusch Medizinisches Versorgungszentrum GbR

    Rosenheim, 83022
    Germany

    Site Not Available

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

    Wurzburg, 97080
    Germany

    Site Not Available

  • University of Athens Medical School - Regional General Hospital Alexandra

    Athens, Attiki 115 28
    Greece

    Site Not Available

  • Evangelismos General Hospital of Athens

    Athens, 10676
    Greece

    Site Not Available

  • University General Hospital of Ioannina

    Ioannina, 45500
    Greece

    Site Not Available

  • University General Hospital of Larissa

    Larissa, 41110
    Greece

    Site Not Available

  • Georgios Papanikolaou General Hospital of Thessaloniki

    Thessaloniki, 57010
    Greece

    Site Not Available

  • Theageneio Anticancer Oncology Hospital of Thessaloniki

    Thessaloniki, 54007
    Greece

    Site Not Available

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

    Budapest, 1097
    Hungary

    Site Not Available

  • Semmelweis Egyetem

    Budapest, 1083
    Hungary

    Site Not Available

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032
    Hungary

    Site Not Available

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, 6725
    Hungary

    Site Not Available

  • Shamir Medical Center Assaf Harofeh

    Be'er Sheva, 84101
    Israel

    Site Not Available

  • Soroka University Medical Centre

    Beer Sheva, 84101
    Israel

    Site Not Available

  • Rigshospitalet

    Beer Yaakov, 70300
    Israel

    Site Not Available

  • Bnai Zion Medical Center

    Haifa, 33394
    Israel

    Site Not Available

  • Hadassah Medical Center - PPDS

    Jerusalem, 91120
    Israel

    Site Not Available

  • Meir Medical Center

    Kfar Saba, 44281
    Israel

    Site Not Available

  • empty

    Petach Tikva,
    Israel

    Site Not Available

  • Rabin Medical Center - PPDS

    Petah Tikva, 49100
    Israel

    Site Not Available

  • Chaim Sheba Medical Center

    Ramat Gan, 52621
    Israel

    Site Not Available

  • empty

    Ramat-Gan,
    Israel

    Site Not Available

  • Assuta Medical Centers

    Tel Aviv, 69710
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239
    Israel

    Site Not Available

  • Baruch Padeh Poriya Medical Center

    Tiberias, 15208
    Israel

    Site Not Available

  • Assaf Harofe Medical Center

    Zerfin, 70300
    Israel

    Site Not Available

  • AORN A Cardarelli

    Napoli, Campania 80131
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

    Bologna, Emilia-Romagna 40138
    Italy

    Site Not Available

  • Ospedale Infermi di Rimini

    Rimini, Emilia-Romagna 47900
    Italy

    Site Not Available

  • IRCCS Az. Osp. Universitaria San Martino- IST

    Genova, Liguria 16132
    Italy

    Site Not Available

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

    Brescia, Lombardia 25123
    Italy

    Site Not Available

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

    Milano, Lombardia 20162
    Italy

    Site Not Available

  • AO Ospedale Policlinico Consorziale Di Bari

    Bari, Puglia 70120
    Italy

    Site Not Available

  • Ospedale Casa Sollievo Della Sofferenza IRCCS

    San Giovanni Rotondo, Puglia 71013
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

    Catania, Sicilia 95124
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Toscana 56216
    Italy

    Site Not Available

  • Azienda Ospedaliera S Maria Di Terni

    Terni, Umbria 05100
    Italy

    Site Not Available

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

    Ancona, 60126
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Careggi

    Firenze, 50139
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria di Parma

    Parma, 43126
    Italy

    Site Not Available

  • Ospedale Santa Maria Delle Croci

    Ravenna, 48100
    Italy

    Site Not Available

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    San Giovanni Rotondo (FG),
    Italy

    Site Not Available

  • Azienda Ospedaliera Citta della Salute e della Scienza di Torino

    Torino, 10126
    Italy

    Site Not Available

  • Ogaki Municipal Hospital

    Ogaki, Gihu 503-8502
    Japan

    Site Not Available

  • Kobe City Medical Center General Hospital

    Kobe-City, Hyogo 650-0047
    Japan

    Site Not Available

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    Higashi Ibaraki-gun, Ibaraki
    Japan

    Site Not Available

  • Hitachi General Hospital

    Hitachi, Ibaraki 317-0077
    Japan

    Site Not Available

  • Nara Hospital Kinki University Faculty of Medicine

    Ikoma-City, Nara 630-0293
    Japan

    Site Not Available

  • National Hospital Organization Okayama Medical Center

    Okayama-city, Okayama 701-1192
    Japan

    Site Not Available

  • empty

    Sunto-gun, Sizuoka
    Japan

    Site Not Available

  • Juntendo University Hospital

    Bunkyo, Tokyo 113-8431
    Japan

    Site Not Available

  • Japanese Red Cross Medical Center

    Shibuya-ku, Tokyo 150-8935
    Japan

    Site Not Available

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810-8563
    Japan

    Site Not Available

  • Fukushima Medical University Hospital

    Fukushima-City, 960-1295
    Japan

    Site Not Available

  • National Hospital Organization Mito Medical Center

    Higashiibaraki-gun, 311-3193
    Japan

    Site Not Available

  • National Hospital Organization Mito Medical Center

    Ibaraki, 311-3193
    Japan

    Site Not Available

  • empty

    Kobe,
    Japan

    Site Not Available

  • Kurume University Hospital

    Kurume, 830-0011
    Japan

    Site Not Available

  • Shizuoka Cancer Center

    Nagaizumi-chō, 4118777
    Japan

    Site Not Available

  • Japanese Red Cross Nagoya Daiichi Hospital

    Nagoya, 453-8511
    Japan

    Site Not Available

  • Nagoya City University Hospital

    Nagoya, 467-8602
    Japan

    Site Not Available

  • empty

    Nagoya-City,
    Japan

    Site Not Available

  • Japanese Red Cross Narita Hospital

    Narita-shi, 286-8523
    Japan

    Site Not Available

  • Niigata Cancer Center Hospital

    Niigata-city,
    Japan

    Site Not Available

  • Osaka Saiseikai Nakatsu Hospital

    Osaka, 530-0012
    Japan

    Site Not Available

  • Shizuoka Cancer Center

    Suntou-gun, 4118777
    Japan

    Site Not Available

  • National Hospital Organization Disaster Medical Center

    Tachikawa, 1900014
    Japan

    Site Not Available

  • empty

    Tokyo,
    Japan

    Site Not Available

  • Toyohashi Municipal Hospital

    Toyohashi,
    Japan

    Site Not Available

  • Toyohashi Municipal Hospital

    Toyohashi, Aichi,
    Japan

    Site Not Available

  • empty

    Toyohashi-city,
    Japan

    Site Not Available

  • Yamanashi Prefectural Central Hospital

    Yamanashi, 400-8506
    Japan

    Site Not Available

  • National Cancer Center

    Goyang-si, Gyeonggido 10408
    Korea, Republic of

    Site Not Available

  • Gachon University Gil Medical Center

    Incheon, 405-760
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center - PPDS

    Seoul, 135-710
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 110-744
    Korea, Republic of

    Site Not Available

  • Severance Hospital Yonsei University Health System - PPDS

    Seoul, 120-752
    Korea, Republic of

    Site Not Available

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

    Seoul, 137-701
    Korea, Republic of

    Site Not Available

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

    Guadalajara, Jalisco 44160
    Mexico

    Site Not Available

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, Nuevo Leon 64460
    Mexico

    Site Not Available

  • Hospital Y Clinica OCA Sociedad Anonima de Capital Variable

    Monterrey, Nuevo Leon 64000
    Mexico

    Site Not Available

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, 14000
    Mexico

    Site Not Available

  • Oaxaca Site management Organization (OSMO) - PPDS

    Oaxaca, 68000
    Mexico

    Site Not Available

  • Shengjing Hospital of China Medical University

    Bydgoszcz, Kujawsko-pomorskie 85-168
    Poland

    Site Not Available

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

    Warszawa, Mazowieckie 02-106
    Poland

    Site Not Available

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

    Chorzow,
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

    Wroclaw, 50-367
    Poland

    Site Not Available

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

    Lisbon, Lisboa 1099-023
    Portugal

    Site Not Available

  • Hospital Garcia de Orta

    Almada, 2801-951
    Portugal

    Site Not Available

  • Hospital de Braga

    Braga, 4710-243
    Portugal

    Site Not Available

  • Champalimaud Cancer Center

    Lisboa, 1400-038
    Portugal

    Site Not Available

  • Centro Hospitalar de Sao Joao EPE

    Porto, 4200-319
    Portugal

    Site Not Available

  • Centro Hospitalar do Porto - Hospital de Santo Antonio

    Porto, 4099-001
    Portugal

    Site Not Available

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

    Porto, 4200-072
    Portugal

    Site Not Available

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

    Kirov, 610027
    Russian Federation

    Site Not Available

  • Stavropol Regional Clinical Oncology Centre Pyatigorsk Affiliate

    Pyatigorsk, 357500
    Russian Federation

    Site Not Available

  • Ryazan Regional Clinical Hospital

    Ryazan, 390039
    Russian Federation

    Site Not Available

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

    St. Petersburg, 197110
    Russian Federation

    Site Not Available

  • Russian Research Institute of Hematology and Blood Transfusion

    St. Petersburg, 193024
    Russian Federation

    Site Not Available

  • Clinical Hospital Center ''Bezanijska Kosa''

    Belgrade, 11080
    Serbia

    Site Not Available

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

    Belgrade, 11000
    Serbia

    Site Not Available

  • University Clinical Center Kragujevac

    Kragujevac, 34000
    Serbia

    Site Not Available

  • Soroka University Medical Centre

    Nis, 18000
    Serbia

    Site Not Available

  • National University Hospital

    Singapore, 119074
    Singapore

    Site Not Available

  • Singapore General Hospital (SGH)

    Singapore, 169608
    Singapore

    Site Not Available

  • Medical Oncology Centre of Rosebank

    Johannesburg, Gauteng 2196
    South Africa

    Site Not Available

  • Albert Alberts Stem Cell Transplant Centre

    Pretoria, Gauteng 0044
    South Africa

    Site Not Available

  • Mary Potter Oncology Centre

    Pretoria, Gauteng 0181
    South Africa

    Site Not Available

  • Hospital Universitario Germans Trias i Pujol

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • Hospital Universitario Quironsalud Madrid

    Pozuelo De Alarcon, Madrid, Communidad Delaware 28223
    Spain

    Site Not Available

  • Clinica Universidad Navarra

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, 08041
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28009
    Spain

    Site Not Available

  • Hospital Universitario HM Sanchinarro CIOCC

    Madrid, 28050
    Spain

    Site Not Available

  • Hospital Universitario Infanta Leonor

    Madrid, 28031
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario de La Princesa

    Madrid, 28006
    Spain

    Site Not Available

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008
    Spain

    Site Not Available

  • Complejo Asistencial Universitario de Salamanca H. Clinico

    Salamanca, 37007
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026
    Spain

    Site Not Available

  • Karolinska Universitetssjukhuset Huddinge

    Stockholm, Sodermanlands Lan
    Sweden

    Site Not Available

  • Karolinska Universitetssjukhuset Solna

    Stockholm, Sodermanlands Lan
    Sweden

    Site Not Available

  • Sahlgrenska Universitetssjukhuset

    Goteborg, Vastra Gotalands Lan
    Sweden

    Site Not Available

  • Skanes Universitetssjukhus Lund

    Lund, SE-22185
    Sweden

    Site Not Available

  • Spital STS AG

    Thun, CH-3600
    Switzerland

    Site Not Available

  • Kaohsiung Medical University Hospital

    Kaohsiung, 807
    Taiwan

    Site Not Available

  • empty

    Kaohsiung City,
    Taiwan

    Site Not Available

  • Taichung Veterans General Hospital

    Taichung, 40705
    Taiwan

    Site Not Available

  • empty

    Taichung City,
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Site Not Available

  • empty

    Taipei City,
    Taiwan

    Site Not Available

  • Ramathibodi Hospital

    Bangkok, Krung Thep Maha Nakhon 10400
    Thailand

    Site Not Available

  • Chulalongkorn University

    Bangkok, 10330
    Thailand

    Site Not Available

  • Maharaj Nakorn Chiang Mai Chiang Mai University

    Chiangmai, 50200
    Thailand

    Site Not Available

  • Ankara University Medical Faculty PPDS

    Ankara, 06590
    Turkey

    Site Not Available

  • Hacettepe Universitesi Tip Fakultesi Hastanesi

    Ankara, 06100
    Turkey

    Site Not Available

  • Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

    Istanbul, 34093
    Turkey

    Site Not Available

  • Dokuz Eylul University Medical Faculty

    Izmir, 35340
    Turkey

    Site Not Available

  • Belfast City Hospital

    Belfast, Antrim BT9 7AB
    United Kingdom

    Site Not Available

  • Birmingham Heartlands Hospital

    West Malling, Birmingham B9 5SS
    United Kingdom

    Site Not Available

  • Birmingham Heartlands Hospital

    West Midlands, Birmingham B9 5SS
    United Kingdom

    Site Not Available

  • Bristol Haematology and Oncology Centre

    Bristol, Bristol, City Of BS2 8ED
    United Kingdom

    Site Not Available

  • Royal Bournemouth Hospital

    Bournemouth, Dorset BH7 7DW
    United Kingdom

    Site Not Available

  • Queen Alexandra Hospital

    Portsmouth, Hampshire PO6 3LY
    United Kingdom

    Site Not Available

  • Kent and Canterbury Hospital

    Canterbury, Kent CT1 3NG
    United Kingdom

    Site Not Available

  • Barts Health NHS Trust

    London, London, City Of EC1A 7BE
    United Kingdom

    Site Not Available

  • Hammersmith Hospital

    London, London, City Of W12 0HS
    United Kingdom

    Site Not Available

  • Kings College Hospital

    London, London, City Of SE5 9RS
    United Kingdom

    Site Not Available

  • University College London

    London, London, City Of NW1 2BU
    United Kingdom

    Site Not Available

  • Hillingdon Hospital

    Uxbridge, London, City Of UB8 3NN
    United Kingdom

    Site Not Available

  • James Paget University Hospitals NHS Foundation Trust

    Great Yarmouth, Norfolk NR31 6LA
    United Kingdom

    Site Not Available

  • Churchill Hospital

    Oxford, Oxfordshire OX3 7LJ
    United Kingdom

    Site Not Available

  • New Cross Hospital

    Wolverhampton, Staffordshire WV10 0QP
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital - Surrey

    Sutton, Surrey SM2 5PT
    United Kingdom

    Site Not Available

  • Royal United Hospital

    Bath, BA1 3NG
    United Kingdom

    Site Not Available

  • Ulster Hospital

    Belfast, BT16 1RH
    United Kingdom

    Site Not Available

  • Southmead Hospital

    Bristol, BS10 5NB
    United Kingdom

    Site Not Available

  • Broomfield Hospital

    Broomfield, CM1 7ET
    United Kingdom

    Site Not Available

  • University Clinical Center Nis

    Cardiff, CF14 4XW
    United Kingdom

    Site Not Available

  • empty

    Harrow,
    United Kingdom

    Site Not Available

  • West Middlesex University Hospital

    Isleworth, TW7 6AF
    United Kingdom

    Site Not Available

  • Leicester Royal Infirmary

    Leicester, LE1 5WW
    United Kingdom

    Site Not Available

  • Chelsea and Westminster NHS Trust

    London,
    United Kingdom

    Site Not Available

  • Manchester Royal Infirmary - PPDS

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • Northwick Park Hospital

    Middlesex, HA1 3UJ
    United Kingdom

    Site Not Available

  • The Royal Oldham Hospital - PPDS

    Oldham, OL1 2JH
    United Kingdom

    Site Not Available

  • University Clinical Center of Serbia - PPDS

    Southall, UB1 3HW
    United Kingdom

    Site Not Available

  • Singleton Hospital - PPDS

    Swansea,
    United Kingdom

    Site Not Available

  • Robert A Moss MD FACP Inc

    Fountain Valley, California 92708
    United States

    Site Not Available

  • empty

    Gilroy, California
    United States

    Site Not Available

  • empty

    Highland, California
    United States

    Site Not Available

  • UCLA Medical Hematology and Oncology

    Los Angeles, California 90095
    United States

    Site Not Available

  • North County Oncology Medical Clinic Inc

    Oceanside, California 92056
    United States

    Site Not Available

  • Ventura County Hematology Oncology Specialists

    Oxnard, California 93030
    United States

    Site Not Available

  • Emad Ibrahim, MD, Inc

    Redlands, California 92373
    United States

    Site Not Available

  • Global Cancer Research Institute (GCRI), Inc.

    San Jose, California 95124
    United States

    Site Not Available

  • Central Coast Medical Oncology Corporation

    Santa Maria, California 93454
    United States

    Site Not Available

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • John H. Stroger Jr. Hospital of Cook County

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Siouxland Hematology - Oncology Associates LLP

    Sioux City, Iowa 51101
    United States

    Site Not Available

  • Appalachian Regional Healthcare

    Hazard, Kentucky 41701
    United States

    Site Not Available

  • New England Cancer Specialists

    Scarborough, Maine 04074
    United States

    Site Not Available

  • Saint Agnes Hospital - Baltimore - Hunt - PPDS

    Baltimore, Maryland 21229
    United States

    Site Not Available

  • University Hospital of Wales -

    Bethesda, Maryland 20817
    United States

    Site Not Available

  • Tufts Medical Center - PPDS

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Herbert-Herman Cancer Center

    Lansing, Michigan 48912
    United States

    Site Not Available

  • Clinical Research Alliance Inc

    New York, New York 10021
    United States

    Site Not Available

  • New York Presbyterian Hospital - Weill-Cornell

    New York, New York 10021
    United States

    Site Not Available

  • Cancer Care of WNC PA

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • UPMC Cancer Pavillion

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • HOPE Cancer Center of East Texas

    Tyler, Texas 75701
    United States

    Site Not Available

  • Swedish Cancer Institute

    Seattle, Washington 98109
    United States

    Site Not Available

  • W VA University Mary Babb Randolph Cancer Center

    Morgantown, West Virginia 26506
    United States

    Site Not Available

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