Clinical trial NCT02312258: A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-12-09
Enrollment: 706
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From randomization until PD or death (up to 52 months)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From the date of randomization and every 12 weeks after PD on next-line therapy until death (up to 88 months)
measure: Percentage of Participants Who Achieve or Maintain Any Best Response Category During the Treatment Period
timeFrame: Up to 27 months
measure: Time to Progression (TTP)
timeFrame: From randomization until PD or death (up to 52 months)
measure: Progression Free Survival 2 (PFS2)
timeFrame: From the date of randomization to every 12 weeks until second PD or death (up to 88 months)
measure: Time to Next Line Therapy (TTNT)
timeFrame: From randomization until PD or death (up to 52 months)
measure: Time to End of the Next-line of Therapy After Study Treatment
timeFrame: From randomization until PD or death (up to 52 months)
measure: Duration of Next-line Therapy
timeFrame: From randomization until PD or death (up to 52 months)
measure: Percentage of Participants Who Develop a New Primary Malignancy
timeFrame: From randomization until PD or death (up to 52 months)
measure: Percentage of Participants With Conversion From Minimal Residual Disease (MRD) Positive to MRD Negative
timeFrame: Up to 52 months
measure: Correlation of MRD Status With PFS and OS
timeFrame: From randomization up to 52 months
measure: OS in a High-risk Population
timeFrame: From the date of randomization and every 12 weeks after PD on next-line therapy until death (up to 88 months)
measure: PFS in a High-risk Population
timeFrame: From randomization until PD or death (up to 52 months)
measure: Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
timeFrame: 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)
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: First dose of study drug through 30 days after last dose of study drug (up to 88 months)
measure: 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)
timeFrame: 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)
measure: Correlation Between Frailty Status and PFS and OS
timeFrame: From randomization up to 52 months
measure: Pharmacokinetic Parameter: Plasma Concentration of Ixazomib
timeFrame: 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)
measure: Time to Resolution of Peripheral Neuropathy (PN) Events
timeFrame: Up to 52 months
measure: Time to Improvement of PN Events
timeFrame: Up to 52 months
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Robert A Moss MD FACP Inc
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Hematology and Oncology
state: California
city: Oceanside
country: United States
facility: North County Oncology Medical Clinic Inc
state: California
city: Oxnard
country: United States
facility: Ventura County Hematology Oncology Specialists
state: California
city: Redlands
country: United States
facility: Emad Ibrahim, MD, Inc
state: California
city: San Jose
country: United States
facility: Global Cancer Research Institute (GCRI), Inc.
state: California
city: Santa Maria
country: United States
facility: Central Coast Medical Oncology Corporation
state: California
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University
state: Georgia
city: Chicago
country: United States
facility: John H. Stroger Jr. Hospital of Cook County
state: Illinois
city: Sioux City
country: United States
facility: Siouxland Hematology - Oncology Associates LLP
state: Iowa
city: Hazard
country: United States
facility: Appalachian Regional Healthcare
state: Kentucky
city: Scarborough
country: United States
facility: New England Cancer Specialists
state: Maine
city: Baltimore
country: United States
facility: Saint Agnes Hospital - Baltimore - Hunt - PPDS
state: Maryland
city: Bethesda
country: United States
facility: University Hospital of Wales -
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center - PPDS
state: Massachusetts
city: Lansing
country: United States
facility: Herbert-Herman Cancer Center
state: Michigan
city: New York
country: United States
facility: Clinical Research Alliance Inc
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital - Weill-Cornell
state: New York
city: Asheville
country: United States
facility: Cancer Care of WNC PA
state: North Carolina
city: Pittsburgh
country: United States
facility: UPMC Cancer Pavillion
state: Pennsylvania
city: Tyler
country: United States
facility: HOPE Cancer Center of East Texas
state: Texas
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Morgantown
country: United States
facility: W VA University Mary Babb Randolph Cancer Center
state: West Virginia
city: Buenos Aires
country: Argentina
facility: Hospital Universitario Austral
state: Ciudad Autonoma De BuenosAires
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: Ciudad Autonoma De BuenosAires
city: Buenos Aires
country: Argentina
facility: Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)
state: Ciudad Autonoma De BuenosAires
city: Cordoba
country: Argentina
facility: Sanatorio Allende S.A.
city: Santa Fe
country: Argentina
facility: Hospital Iturraspe
city: Fitzroy
country: Australia
facility: St Vincents Hospital Melbourne - PPDS
state: Victoria
city: Frankston
country: Australia
facility: Frankston Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Innsbruck
country: Austria
facility: Universitatsklinikum Innsbruck
state: Tirol
city: Salzburg
country: Austria
facility: Paracelsus Medizinische Privatuniversitat
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH
city: Wien
country: Austria
facility: Medizinische Universitat Wien (Medical University of Vienna)
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel - PIN
state: Brussels
city: Brussel
country: Belgium
facility: UZ Brussel
state: Brussels
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
state: Brussels
city: Salvador
country: Brazil
facility: Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet
state: Bahia
city: Goiania
country: Brazil
facility: Hospital Das Clinicas Da Universidade Federal de Goias
state: Goias
city: Belo Horizonte
country: Brazil
facility: Hospital Das Clinicas Da UFMG
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner
state: Parana
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra O Cancer
state: Rio Grande Do Norte
city: Caxias Do Sul
country: Brazil
facility: Universidade de Caxias do Sul
state: Rio Grande Do Sul
city: Ijui
country: Brazil
facility: Associacao Hospital de Caridade Ijui
state: Rio Grande Do Sul
city: Passo Fundo
country: Brazil
facility: American Oncology Partners of Maryland, PA
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Mae de Deus Center Hospital Giovanni Battista
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
state: Rio Grande Do Sul
city: Joinville
country: Brazil
facility: Instituto Joinvilense de Hematologia E Oncologia
state: Santa Catarina
city: Barretos
country: Brazil
facility: Fundacao PIO XII
state: Sao Paulo
city: Campinas
country: Brazil
facility: Universidade Estadual de Campinas
state: Sao Paulo
city: Jau
country: Brazil
facility: Hospital Amaral Carvalho
state: Sao Paulo
city: Santo Andre
country: Brazil
facility: Faculdade de Medicina Do ABC
state: Sao Paulo
city: Rio De Janeiro
country: Brazil
facility: HEMORIO - Unidade de Pesquisa Clinica
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cancer
city: Rio De Janeiro
country: Brazil
facility: Fundação Antônio Prudente - AC Camargo Câncer Center
city: Sao Jose Do Rio Preto
country: Brazil
facility: Hospital de Base Da Faculdade de Medicina de Sao Jose Do Rio Preto
city: Sao Paulo
country: Brazil
facility: Instituto de Ensino E Pesquisa Sao Lucas
city: Sao Paulo
country: Brazil
facility: Hospital Sirio Libanes
city: Sao Paulo
country: Brazil
facility: Ealing Hospital
city: Sao Paulo
country: Brazil
facility: Clinica Sao Germano
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
city: Sao Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
city: Sao Paulo
country: Brazil
facility: Hospital Santa Marcelina
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre
state: Ontario
city: Brampton
country: Canada
facility: William Osler Health Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
city: Temuco
country: Chile
facility: Hospital Amaral Carvalho
state: Araucanía
city: Santiago
country: Chile
facility: Instituto Nacional Del Cancer
city: Santiago
country: Chile
facility: Centro Internacional de Estudios Clinicos
city: Vina Del Mar
country: Chile
facility: Centro de Investigaciones Clinicas Vina del Mar
city: Nanjing
country: China
facility: Hospital de Clinicas de Passo Fundo
state: Jiangsu
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Hangzhou
country: China
facility: The First Affiliated Hospital, College of Medicine, Zhejiang University
state: Zhejiang
city: Beijing
country: China
facility: Beijing Chaoyang Hospital Capital Medical University
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Hangzhou
country: China
facility: The First Affiliated Hospital, College of Medicine, Zhejiang University
city: Shanghai
country: China
facility: Renji Hospital Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Shanghai Chang Zheng Hospital
city: Shenyang
country: China
facility: Hospital São Rafael
city: Taiyuan
country: China
facility: Second Hospital of Shanxi Medical University
city: Wuhan
country: China
facility: James Lind Centro de Investigación del Cáncer
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
state: Antioquia
city: Bogota
country: Colombia
facility: Instituto Nacional de Cancerologia Colombia
state: Cundinamarca
city: Bogota
country: Colombia
facility: Hospital Universitario San Ignacio
state: Distrito Capital De Bogota
city: Zagreb
country: Croatia
facility: Clinical Hospital Dubrava
state: Grad Zagreb
city: Rijeka
country: Croatia
facility: Clinical Hospital Center Rijeka
city: Zagreb
country: Croatia
facility: Clinical Hospital Center Zagreb - PPDS
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
state: Kralovehradeck Kraj
city: Prague
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
state: Praha, Hlavni Mesto
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: København
country: Denmark
facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
state: Capital
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital Århus Sygehus
city: Holstebro
country: Denmark
facility: Regionshospitalet Holstebro
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Clamart
country: France
facility: Hopital Antoine Beclere
state: Hauts-de-Seine
city: Nantes
country: France
facility: Hotel Dieu
state: Loire-Atlantique
city: Vandoeuvre-les-nancy
country: France
facility: CHRU Nancy
state: Meurthe-et-Moselle
city: Dijon
country: France
facility: CHRU Dijon Complexe Du Bocage
city: Lille
country: France
facility: Hopital Saint Vincent de Paul GHICL
city: Lille
country: France
facility: CHRU Lille
city: Paris
country: France
facility: Hopital de la Pitie Salpetriere
city: Paris
country: France
facility: Groupe Hospitalier Necker Enfants Malades
city: Pessac
country: France
facility: Hopital Haut Leveque
city: Poitiers
country: France
facility: Hopital Jean Bernard
city: Rennes
country: France
facility: CHRU Rennes
city: Ulm
country: Germany
facility: Universitatsklinikum Ulm
state: Baden-Wurttemberg
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald Baar Klinkum Villingen-Schwenningen GmbH
state: Baden-Wurttemberg
city: Augsburg
country: Germany
facility: Hamatologische Onkologische Gemeinschaftspraxis Dr. Brudler, Dr. Heinrich, Dr. Bangerter
state: Bayern
city: Herrsching am Ammersee
country: Germany
facility: Internistisch Hamatologische und Internistische Praxis
state: Bayern
city: Munchen
country: Germany
facility: LMU Klinikum der Universitat Munchen
state: Bayern
city: Oldenburg
country: Germany
facility: Pius Hospital Oldenburg
state: Niedersachsen
city: Essen
country: Germany
facility: Universitatsklinikum Essen
state: Nordrhein-Westfalen
city: Munster
country: Germany
facility: Gemeinschaftspraxis fur Hamatologie und Onkologie
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
state: Rheinland-Pfalz
city: Homburg
country: Germany
facility: Universitat Des Saarlandes
state: Saarland
city: Aschaffenburg
country: Germany
facility: Onkologie Aschaffenburg
city: Berlin
country: Germany
facility: Charite - Universitatsmedizin Berlin
city: Berlin
country: Germany
facility: Medizinisches Versorgungszentrum Onkologischer Schwerpunkt
city: Landshut
country: Germany
facility: Klinikum Landshut
city: Munchen
country: Germany
facility: Klinikum rechts der Isar der Technischen Universitat Munchen
city: Rosenheim
country: Germany
facility: Praxis Pihusch Medizinisches Versorgungszentrum GbR
city: Wurzburg
country: Germany
facility: Gemeinschaftspraxis Dr. med. R. Schlag & Dr. med. B. Schottker & Dr. med. J. Haas
city: Athens
country: Greece
facility: University of Athens Medical School - Regional General Hospital Alexandra
state: Attiki
city: Athens
country: Greece
facility: Evangelismos General Hospital of Athens
city: Ioannina
country: Greece
facility: University General Hospital of Ioannina
city: Larissa
country: Greece
facility: University General Hospital of Larissa
city: Thessaloniki
country: Greece
facility: Theageneio Anticancer Oncology Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: Georgios Papanikolaou General Hospital of Thessaloniki
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Klinika Hematologii, Szpital Uniwersytecki Nr 2 im. Jana Biziela w Bydgoszczy
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
city: Be'er Sheva
country: Israel
facility: Shamir Medical Center Assaf Harofeh
city: Beer Yaakov
country: Israel
facility: Rigshospitalet
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center - PPDS
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center - PPDS
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Tel Aviv
country: Israel
facility: Assuta Medical Centers
city: Tiberias
country: Israel
facility: Baruch Padeh Poriya Medical Center
city: Napoli
country: Italy
facility: AORN A Cardarelli
state: Campania
city: Bologna
country: Italy
facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
state: Emilia-Romagna
city: Rimini
country: Italy
facility: Ospedale Infermi di Rimini
state: Emilia-Romagna
city: Genova
country: Italy
facility: IRCCS Az. Osp. Universitaria San Martino- IST
state: Liguria
city: Brescia
country: Italy
facility: ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN
state: Lombardia
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
state: Lombardia
city: San Giovanni Rotondo
country: Italy
facility: Ospedale Casa Sollievo Della Sofferenza IRCCS
state: Puglia
city: Catania
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
state: Sicilia
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
state: Toscana
city: Terni
country: Italy
facility: Azienda Ospedaliera S Maria Di Terni
state: Umbria
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma
city: Ravenna
country: Italy
facility: Ospedale Santa Maria Delle Croci
city: Torino
country: Italy
facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino
city: Ogaki
country: Japan
facility: Ogaki Municipal Hospital
state: Gihu
city: Kobe-City
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Hitachi
country: Japan
facility: Hitachi General Hospital
state: Ibaraki
city: Ikoma-City
country: Japan
facility: Nara Hospital Kinki University Faculty of Medicine
state: Nara
city: Okayama-city
country: Japan
facility: National Hospital Organization Okayama Medical Center
state: Okayama
city: Bunkyo
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Japanese Red Cross Medical Center
state: Tokyo
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Fukushima-City
country: Japan
facility: Fukushima Medical University Hospital
city: Ibaraki
country: Japan
facility: National Hospital Organization Mito Medical Center
city: Kurume
country: Japan
facility: Kurume University Hospital
city: Nagaizumi-chō
country: Japan
facility: Shizuoka Cancer Center
city: Nagoya
country: Japan
facility: Japanese Red Cross Nagoya Daiichi Hospital
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
city: Narita-shi
country: Japan
facility: Japanese Red Cross Narita Hospital
city: Niigata-city
country: Japan
facility: Niigata Cancer Center Hospital
city: Osaka
country: Japan
facility: Osaka Saiseikai Nakatsu Hospital
city: Tachikawa
country: Japan
facility: National Hospital Organization Disaster Medical Center
city: Toyohashi
country: Japan
facility: Toyohashi Municipal Hospital
city: Yamanashi
country: Japan
facility: Yamanashi Prefectural Central Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggido
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System - PPDS
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center - PPDS
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Guadalajara
country: Mexico
facility: Centro de Investigacion Farmaceutica Especializada de Occidente, SC - PPDS
state: Jalisco
city: Monterrey
country: Mexico
facility: Hospital Y Clinica OCA Sociedad Anonima de Capital Variable
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez
state: Nuevo Leon
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
city: Oaxaca
country: Mexico
facility: Oaxaca Site management Organization (OSMO) - PPDS
city: Bydgoszcz
country: Poland
facility: Shengjing Hospital of China Medical University
state: Kujawsko-pomorskie
city: Warszawa
country: Poland
facility: MTZ Clinical Research Sp z o o - PRATIA - PPDS
state: Mazowieckie
city: Chorzow
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
city: Wroclaw
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
city: Lisbon
country: Portugal
facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.
state: Lisboa
city: Almada
country: Portugal
facility: Hospital Garcia de Orta
city: Braga
country: Portugal
facility: Hospital de Braga
city: Lisboa
country: Portugal
facility: Champalimaud Cancer Center
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto - Hospital de Santo Antonio
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
city: Porto
country: Portugal
facility: Centro Hospitalar de Sao Joao EPE
city: Kirov
country: Russian Federation
facility: State Medical and Preventive Treatment Institution Kirov Regional Clinical Oncology Dispensary
city: Pyatigorsk
country: Russian Federation
facility: Stavropol Regional Clinical Oncology Centre Pyatigorsk Affiliate
city: Ryazan
country: Russian Federation
facility: Ryazan Regional Clinical Hospital
city: St. Petersburg
country: Russian Federation
facility: Russian Research Institute of Hematology and Blood Transfusion
city: St. Petersburg
country: Russian Federation
facility: City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31
city: Belgrade
country: Serbia
facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
city: Belgrade
country: Serbia
facility: Clinical Hospital Center ''Bezanijska Kosa''
city: Kragujevac
country: Serbia
facility: University Clinical Center Kragujevac
city: Nis
country: Serbia
facility: Soroka University Medical Centre
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital (SGH)
city: Johannesburg
country: South Africa
facility: Medical Oncology Centre of Rosebank
state: Gauteng
city: Pretoria
country: South Africa
facility: Albert Alberts Stem Cell Transplant Centre
state: Gauteng
city: Pretoria
country: South Africa
facility: Mary Potter Oncology Centre
state: Gauteng
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
state: Barcelona
city: Pozuelo De Alarcon
country: Spain
facility: Hospital Universitario Quironsalud Madrid
state: Madrid, Communidad Delaware
city: Pamplona
country: Spain
facility: Clinica Universidad Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro CIOCC
city: Murcia
country: Spain
facility: Hospital General Universitario Morales Meseguer
city: Salamanca
country: Spain
facility: Complejo Asistencial Universitario de Salamanca H. Clinico
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Huddinge
state: Sodermanlands Lan
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Solna
state: Sodermanlands Lan
city: Goteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
state: Vastra Gotalands Lan
city: Lund
country: Sweden
facility: Skanes Universitetssjukhus Lund
city: Thun
country: Switzerland
facility: Spital STS AG
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
state: Krung Thep Maha Nakhon
city: Bangkok
country: Thailand
facility: Chulalongkorn University
city: Chiangmai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Chiang Mai University
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi Hastanesi
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty PPDS
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
city: Izmir
country: Turkey
facility: Dokuz Eylul University Medical Faculty
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
state: Antrim
city: West Malling
country: United Kingdom
facility: Birmingham Heartlands Hospital
state: Birmingham
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
state: Bristol, City Of
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
state: Dorset
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
state: Hampshire
city: Canterbury
country: United Kingdom
facility: Kent and Canterbury Hospital
state: Kent
city: London
country: United Kingdom
facility: Barts Health NHS Trust
state: London, City Of
city: London
country: United Kingdom
facility: University College London
state: London, City Of
city: London
country: United Kingdom
facility: Kings College Hospital
state: London, City Of
city: London
country: United Kingdom
facility: Hammersmith Hospital
state: London, City Of
city: Uxbridge
country: United Kingdom
facility: Hillingdon Hospital
state: London, City Of
city: Oxford
country: United Kingdom
facility: Churchill Hospital
state: Oxfordshire
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
state: Staffordshire
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital - Surrey
state: Surrey
city: Bath
country: United Kingdom
facility: Royal United Hospital
city: Belfast
country: United Kingdom
facility: Ulster Hospital
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: Cardiff
country: United Kingdom
facility: University Clinical Center Nis
city: Isleworth
country: United Kingdom
facility: West Middlesex University Hospital
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: London
country: United Kingdom
facility: Chelsea and Westminster NHS Trust
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary - PPDS
city: Middlesex
country: United Kingdom
facility: Northwick Park Hospital
city: Oldham
country: United Kingdom
facility: The Royal Oldham Hospital - PPDS
city: Southall
country: United Kingdom
facility: University Clinical Center of Serbia - PPDS
city: Swansea
country: United Kingdom
facility: Singleton Hospital - PPDS
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.