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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02312258
Recruitment Status : Active, not recruiting
First Posted : December 9, 2014
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Ixazomib Drug: Placebo Phase 3

Detailed Description:

The drug being tested in this study is called ixazomib citrate. Ixazomib citrate is being tested to slow 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 enroll approximately 700 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

  • Ixazomib citrate 3 mg
  • Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has no active ingredient

All participants will be asked to take one capsule on Days 1, 8 and 15 of each 28-day cycle, for up to 26 cycles.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 76 to 104 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 706 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 9, 2015
Actual Primary Completion Date : August 12, 2019
Estimated Study Completion Date : October 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Ixazomib
Ixazomib 3 milligram (mg), capsule, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib 3 or 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26. Participants experiencing AEs attributed to study drug during any cycle may continue in the study but may have doses of study drug held or reduced by at least 1 dose level. Reduced doses are: 3 mg, 2.3 mg, 1.5 mg and discontinuation of study drug.
Drug: Ixazomib
Ixazomib Capsules.

Placebo Comparator: Placebo
Ixazomib placebo-matching 3 mg capsule, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib placebo-matching 3 or 4 mg capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26. Participants experiencing AEs attributed to study drug during any cycle may continue in the study, but may have doses of study drug held or reduced by at least 1 dose level. Reduced doses are: 3 mg, 2.3 mg, 1.5 mg and discontinuation of study drug.
Drug: Placebo
Ixazomib placebo-matching capsules.




Primary Outcome Measures :
  1. PFS [ Time Frame: From the date of randomization every 4 weeks during follow-up until progressive disease (PD) or death (Up to approximately 76 to 104 months) ]
    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 independent review committee (IRC) according to International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: From the date of randomization every 12 weeks after PD on next-line therapy until death (Up to approximately 76 to 104 months) ]
    OS will be measured as the time from the date of randomization to the date of death.

  2. Percentage of Participants who Achieve or Maintain any Best Response Category During the Treatment Period [ Time Frame: Up to 24 months ]
    Response will be assessed according to IMWG criteria. Best response includes PR, VGPR and CR.

  3. Time to Progression (TTP) [ Time Frame: From the date of randomization to the date of first documented PD (Up to approximately 76 to 104 months) ]
    TTP is defined as the time from the date of randomization to the date of first documentation of PD, using IMWG criteria.

  4. Progression Free Survival 2 (PFS2) [ Time Frame: From the date of randomization to every 12 weeks until 2nd PD or death (Up to approximately 76 to 104 months) ]
    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 occurs first.

  5. Time to Next Line Therapy (TTNT) [ Time Frame: From the date of randomization to the date of the first dose of the next-line of therapy (Up to approximately 76 to 104 months) ]
    TTNT is defined as the time from the date of randomization to the date of the first dose of next-line antineoplastic therapy.

  6. Time to end of the Next-line of Therapy After Study Treatment [ Time Frame: From the date of randomization to the date of last dose of the next-line of therapy (Up to approximately 76 to 104 months) ]
    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.

  7. Duration of Next-line Therapy [ Time Frame: From the date of the first dose of the line of antineoplastic therapy coming after study treatment to the date of the last dose (Up to approximately 76 to 104 months) ]
    Duration of next-line therapy is defined as the time from the date of the first dose of the line of antineoplastic therapy coming after study treatment to the date of the last dose.

  8. Percentage of Participants Who Develop A New Primary Malignancy [ Time Frame: From the randomization date till death or termination of the study (Up to approximately 76 to 104 months) ]
  9. Percentage of Participants with Conversion from Minimal Residual Disease (MRD) Positive to MRD Negative, or the Maintenance of MRD Negativity [ Time Frame: Screening, Cycle 13, and Cycle 26 (Cycle length is equal to [=] 28 days) ]
    Bone marrow aspirates and blood samples will be sent to a central laboratory and will be assessed for MRD using flow cytometry. MRD negativity is defined as absence of MRD and MRD positivity is defined as presence of MRD.

  10. Correlation of MRD Status With PFS and OS [ Time Frame: Screening, Cycle 13, and Cycle 26 (Cycle length=28 days) ]
    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. OS will be measured as the time from the date of randomization to the date of death.

  11. OS in a High-risk Population [ Time Frame: From the date of randomization to every 12 weeks after PD on next-line therapy until death (Up to approximately 76 to 104 months) ]
    High-risk population will include but not be limited to participants carrying deletion (del)17, t(4;14), t(14;16). OS will be measured as the time from the date of randomization to the date of death.

  12. PFS in a High-risk Population [ Time Frame: From the date of randomization to every 4 weeks during follow-up until PD or death (Up to approximately 76 to 104 months) ]
    High-risk population will include but not be limited to participants carrying del17, t(4;14), t(14;16). PFS is defined as the time from the date of randomization to the date of first documentation of PD or death from any cause.

  13. Eastern Cooperative Oncology Group (ECOG) Performance Status [ Time Frame: Cycle 2 and every 28 days ( Up to 24 months) (Cycle length =28 days) ]
    ECOG performance status assess participant's performance status on 5 point scale: 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 ( greater than [>] 50 percent [%] 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.

  14. Percentage of Participants with Serious Adverse Events (SAEs) and Adverse Events (AEs) [ Time Frame: First dose of study drug through 30 days after last dose of study drug (Up to 25 months) ]

    A SAE is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.

    AEs are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after the last dose of study drug.


  15. Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) [ Time Frame: Baseline and every 28 days (Up to 24 months) ]
    The EORTC QLQ-C30 is completed by the participant. The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 =Not at all (best) to 4 =Very Much (worst) and 2 questions answered on a 7-point scale where 1 =Very poor (worst) to 7 =Excellent (best).

  16. Number of Participants with any Markedly Abnormal Standard Safety Laboratory Values [ Time Frame: From First dose date of study drug through 30 days after the last dose of study drug (Up to 25 months) ]
    Clinical laboratory evaluations will be performed by a central laboratory. The number of participants with any markedly abnormal standard safety laboratory values collected throughout study.

  17. Correlation between Frailty Status and PFS and OS [ Time Frame: Up to approximately 76 to 104 months ]
    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. OS will be measured as the time from the date of randomization to the date of death.

  18. Pharmacokinetic Parameter: Plasma Concentration of Ixazomib [ Time Frame: 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, 6-10 (Day 1 pre-dose) (Cycle length =28 days) ]
    Plasma concentrations of the complete hydrolysis product of ixazomib citrate (ixazomib) will be measured using a validated Liquid Chromatography-tandem Mass Spectrometry (LC/MS/MS) assay.

  19. Time to Resolution of Peripheral Neuropathy (PN) Events [ Time Frame: From the initial onset date of PN up to the resolution date for resolved events (Up to 25 Months) ]
    PN is defined as the treatment-emergent adverse 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 is considered as resolved if its final outcome is 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 is defined as the time from the initial onset date (inclusive) to the resolution date for resolved events.

  20. Time to Improvement of PN Events [ Time Frame: From the initial onset date of PN up to the improvement of event (Up to 25 Months) ]
    PN is defined as the treatment-emergent adverse event in the high-level term of peripheral neuropathies NEC according to the MedDRA. A PN event is considered as resolved if its final outcome is 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 is defined as the time from the initial onset date (inclusive) to the improvement of event.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult male or female participants 18 years or older with a confirmed diagnosis of symptomatic 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 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 use of Ginkgo biloba 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02312258


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Locations
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United States, California
Robert A Moss MD FACP Inc
Fountain Valley, California, United States, 92708
UCLA Medical Hematology and Oncology
Los Angeles, California, United States, 90095-1678
North County Oncology Medical Clinic Inc
Oceanside, California, United States, 92056
Ventura County Hematology Oncology Specialists
Oxnard, California, United States, 93030
Emad Ibrahim, MD, Inc
Redlands, California, United States, 92373
Global Cancer Research Institute (GCRI), Inc.
San Jose, California, United States, 95124
Central Coast Medical Oncology Corporation
Santa Maria, California, United States, 93454
United States, Georgia
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois, United States, 60612
United States, Iowa
Siouxland Hematology - Oncology Associates LLP
Sioux City, Iowa, United States, 51101
United States, Kentucky
Appalachian Regional Healthcare
Hazard, Kentucky, United States, 41701
United States, Maine
New England Cancer Specialists
Scarborough, Maine, United States, 04074
United States, Maryland
Saint Agnes Hospital
Baltimore, Maryland, United States, 21229
Center For Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
Herbert-Herman Cancer Center
Lansing, Michigan, United States, 48912
United States, New York
Clinical Research Alliance Inc
New York, New York, United States, 10021
New York Presbyterian Hospital - Weill-Cornell
New York, New York, United States, 10021
United States, North Carolina
Cancer Care of WNC PA
Asheville, North Carolina, United States, 28801
United States, Pennsylvania
UPMC Cancer Pavillion
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
HOPE Cancer Center of East Texas
Tyler, Texas, United States, 75701
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98109
United States, West Virginia
W VA University Mary Babb Randolph Cancer Center
Morgantown, West Virginia, United States, 26506
Argentina
Hospital Universitario Austral
Buenos Aires, Ciudad Autonoma De BuenosAires, Argentina, B1629AHJ
Hospital Italiano de Buenos Aires
Buenos Aires, Ciudad Autonoma De BuenosAires, Argentina, C1181ACH
Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)
Buenos Aires, Ciudad Autonoma De BuenosAires, Argentina, C1431FWO
Sanatorio Allende
Cordoba, Argentina, X5000JHQ
Hospital Iturraspe
Santa Fe, Argentina, S3000ADL
Australia, Victoria
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
Frankston Hospital
Frankston, Victoria, Australia, 3199
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Austria
Universitatsklinikum Innsbruck
Innsbruck, Tirol, Austria, 6020
Paracelsus Medizinische Privatuniversitat
Salzburg, Austria, 5020
Klinikum Wels-Grieskirchen GmbH
Wels, Austria, 4600
Medizinische Universitat Wien
Wien, Austria, A-1090
Belgium
UZ Brussel
Brussel, Brussels, Belgium, 1090
Cliniques Universitaires Saint-Luc
Bruxelles, Brussels, Belgium, 1200
Brazil
CEHON - Centro de Hematologia e Oncologia da Bahia Ltda
Salvador, Bahia, Brazil, 40110-150
Hospital Das Clinicas Da Universidade Federal de Goias
Goiania, Goias, Brazil, 74605-020
Hospital Das Clinicas Da UFMG
Belo Horizonte, Minas Gerais, Brazil, 30130-100
Liga Paranaense de Combate Ao Cancer
Curitiba, Parana, Brazil, 81520-060
Liga Norte Riograndense Contra O Cancer
Natal, Rio Grande Do Norte, Brazil, 59040-150
Universidade de Caxias do Sul
Caxias Do Sul, Rio Grande Do Sul, Brazil, 95070-560
Associacao Hospital de Caridade Ijui
Ijui, Rio Grande Do Sul, Brazil, 98700-000
Hospital Da Cidade de Passo Fundo
Passo Fundo, Rio Grande Do Sul, Brazil, 99010-260
Hospital Moinhos de Vento
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-001
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Mae de Deus Center Hospital Giovanni Battista
Porto Alegre, Rio Grande Do Sul, Brazil, 90470-340
Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
Instituto Joinvilense de Hematologia E Oncologia
Joinville, Santa Catarina, Brazil, 89201260
Fundacao PIO XII
Barretos, Sao Paulo, Brazil, 14784-400
Universidade Estadual de Campinas
Campinas, Sao Paulo, Brazil, 13083-878
Hospital Amaral Carvalho
Jau, Sao Paulo, Brazil, 17210-120
Faculdade de Medicina Do ABC
Santo Andre, Sao Paulo, Brazil, 09060-650
HEMORIO - Unidade de Pesquisa Clinica
Rio De Janeiro, Brazil, 20211-030
Instituto Nacional de Cancer
Rio de Janeiro, Brazil, 20231-050
Universidade Federal do Rio de Janeiro - UFRJ
Rio De Janeiro, Brazil, 21941-913
Hospital de Base Da Faculdade de Medicina de Sao Jose Do Rio Preto
Sao Jose Do Rio Preto, Brazil, 15090-000
Instituto de Ensino E Pesquisa Sao Lucas
Sao Paulo, Brazil, 01236-030
Hospital Sirio Libanes
Sao Paulo, Brazil, 01308-050
Hospital Do Cancer A C Camargo
Sao Paulo, Brazil, 01509-900
Clinica Sao Germano
Sao Paulo, Brazil, 04537-080
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Sao Paulo, Brazil, 05403-000
Hospital Israelita Albert Einstein
Sao Paulo, Brazil, 05652-900
Hospital Santa Marcelina
Sao Paulo, Brazil, 08270-070
Canada, Ontario
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada, L4M 6M2
William Osler Health Centre
Brampton, Ontario, Canada, L6W 3J7
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
McGill University Health Center
Montreal, Quebec, Canada, H4A 3J1
Chile
Instituto Nacional Del Cancer
Santiago, Chile, 8380455
Centro Internacional de Estudios Clinicos
Santiago, Chile
Instituto Clinico Oncologico del Sur (ICOS)
Temuco, Chile, 4810469
Centro de Investigaciones Clinicas Vina del Mar
Vina Del Mar, Chile, 2570017
China, Shanghai
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai, China, 200025
China, Zhejiang
1st Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310003
China
Beijing Chaoyang Hospital Capital Medical University
Beijing, China, 100020
Peking University Third Hospital
Beijing, China, 100191
Jiangsu Province Hospital
Beijing, China, 610041
Peking Union Medical College Hospital
Beijing, China
West China Hospital Sichuan University
Chengdu, China, 610041
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, China, 510080
Renji Hospital Medical School of Shanghai Jiaotong University
Shanghai, China, 200001
Renji Hospital Medical School of Shanghai Jiaotong University
Shanghai, China, 200003
Shanghai Chang Zheng Hospital
Shanghai, China, 200003
Shanxi Medical University - Second Hospital
Taiyuan Shi, China, 030001
Colombia
Hospital Pablo Tobon Uribe
Medellin, Antioquia, Colombia, 050034
Instituto Nacional de Cancerologia Colombia
Bogota, Cundinamarca, Colombia
Hospital Universitario San Ignacio
Bogota, Distrito Capital De Bogota, Colombia, 110311
Croatia
Clinical Hospital Dubrava
Zagreb, Grad Zagreb, Croatia, 10000
Clinical Hospital Center Rijeka
Rijeka, Croatia, 51000
University Klinichki Bolnicki Centar Zagreb
Zagreb, Croatia, 10 000
Czechia
Fakultni nemocnice Hradec Kralove
Hradec Kralove, Kralovehradeck Kraj, Czechia, 500 05
Fakultni nemocnice Kralovske Vinohrady
Prague, Praha, Hlavni Mesto, Czechia, 100 34
Fakultni nemocnice Brno
Brno, Czechia, 625 00
Fakultni nemocnice Olomouc
Olomouc, Czechia, 775 20
Fakultni nemocnice Ostrava
Ostrava, Czechia, 708 52
Vseobecna fakultni nemocnice v Praze
Praha 2, Czechia, 128 08
Denmark
Arhus Universitetshospital Arhus Sygehus
Aarhus, Denmark, 8000
Herlev Hospital
Herlev, Denmark, DK-2730
Regionshospitalet Holstebro
Holstebro, Denmark, 7500
Odense Universitetshospital
Odense, Denmark, 5000
France
Hopital Antoine Beclere
Clamart, Hauts-de-Seine, France, 92140
Hotel Dieu
Nantes, Loire-Atlantique, France, 44093
CHRU Nancy
Vandoeuvre-les-nancy, Meurthe-et-Moselle, France, 54511
CHRU Dijon Complexe Du Bocage
Dijon, France, 21079
Hopital Saint Vincent de Paul GHICL
Lille, France, 59020
CHRU Lille
Lille, France, 59037
Hopital de la Pitie Salpetriere
Paris, France, 75013
Groupe Hospitalier Necker Enfants Malades
Paris, France, 75015
Hopital Haut Leveque
Pessac, France, 33604
Hopital Jean Bernard
Poitiers, France, 86021
CHRU Rennes
Rennes, France
Germany
Universitatsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany, 89081
Schwarzwald Baar Klinkum Villingen-Schwenningen GmbH
Villingen-Schwenningen, Baden-Wurttemberg, Germany, 78050
Hamatologische Onkologische Gemeinschaftspraxis Dr. Brudler, Dr. Heinrich, Dr. Bangerter
Augsburg, Bayern, Germany, 86150
Internistisch Hamatologische und Internistische Praxis
Herrsching am Ammersee, Bayern, Germany, 82211
LMU Klinikum der Universitat Munchen
Munchen, Bayern, Germany, 81377
Pius Hospital Oldenburg
Oldenburg, Niedersachsen, Germany, 26121
Universitatsklinikum Essen
Essen, Nordrhein-Westfalen, Germany, 45122
Gemeinschaftspraxis fur Hamatologie und Onkologie
Munster, Nordrhein-Westfalen, Germany, 48149
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
Mainz, Rheinland-Pfalz, Germany, 55131
Universitat Des Saarlandes
Homburg, Saarland, Germany, 66421
Onkologie Aschaffenburg
Aschaffenburg, Germany, 63739
Charite - Universitatsmedizin Berlin
Berlin, Germany, 12200
Medizinisches Versorgungszentrum Onkologischer Schwerpunkt
Berlin, Germany, 14195
Klinikum Landshut
Landshut, Germany, 84034
Klinikum rechts der Isar der Technischen Universitat Munchen
Munchen, Germany, 81675
Praxis Pihusch Medizinisches Versorgungszentrum GbR
Rosenheim, Germany, 83022
Gemeinschaftspraxis Dr. med. R. Schlag & Dr. med. B. Schottker & Dr. med. J. Haas
Wurzburg, Germany, 97080
Greece
University of Athens Medical School - Regional General Hospital Alexandra
Athens, Attiki, Greece, 115 28
Evangelismos General Hospital of Athens
Athens, Greece, 10676
University General Hospital of Ioannina
Ioannina, Greece, 45500
University General Hospital of Larissa
Larissa, Greece, 41110
Theageneio Anticancer Oncology Hospital of Thessaloniki
Thessaloniki, Greece, 54007
Georgios Papanikolaou General Hospital of Thessaloniki
Thessaloniki, Greece, 57010
Hungary
Semmelweis Egyetem
Budapest, Hungary, 1083
Egyesitett Szent Istvan es Szent Laszlo Korhaz - Rendelointezet
Budapest, Hungary, 1097
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary, 4032
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Hungary, 6725
Israel
Soroka University Medical Centre
Beer Sheva, Israel, 84101
Bnai Zion Medical Center
Haifa, Israel, 33394
Hadassah University Hospital Ein Kerem
Jerusalem, Israel, 91120
Meir Medical Center
Kfar Saba, Israel, 44281
Rabin Medical Center - PPDS
Petah Tikva, Israel, 49100
Chaim Sheba Medical Center
Ramat Gan, Israel, 52621
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Assuta Medical Centers
Tel Aviv, Israel, 69710
Baruch Padeh Poriya Medical Center
Tiberias, Israel, 15208
Assaf Harofe Medical Center
Zerfin, Israel, 70300
Italy
AORN A Cardarelli
Napoli, Campania, Italy, 80131
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
Bologna, Emilia-Romagna, Italy, 40138
Ospedale Infermi di Rimini
Rimini, Emilia-Romagna, Italy, 47900
IRCCS Azienda Ospedaliera Universitaria San Martino Istituto Nazionale Per La Ricerca Sul Cancro
Genova, Liguria, Italy, 16132
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
Brescia, Lombardia, Italy, 25123
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
Milano, Lombardia, Italy, 20162
AO Ospedale Policlinico Consorziale Di Bari
Bari, Puglia, Italy, 70120
Ospedale Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, Puglia, Italy, 71013
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Catania, Sicilia, Italy, 95124
Azienda Ospedaliero Universitaria Pisana
Pisa, Toscana, Italy, 56216
Azienda Ospedaliera S Maria Di Terni
Terni, Umbria, Italy, 05100
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
Ancona, Italy, 60126
Azienda Ospedaliera Universitaria Careggi
Firenze, Italy, 50139
Azienda Ospedaliero Universitaria di Parma
Parma, Italy, 43126
Ospedale Santa Maria Delle Croci
Ravenna, Italy, 48100
Azienda Ospedaliera Citta della Salute e della Scienza di Torino
Torino, Italy, 10126
Japan
Ogaki Municipal Hospital
Ogaki, Gihu, Japan, 503-8502
Kobe City Medical Center General Hospital
Kobe-City, Hyogo, Japan, 650-0047
Hitachi General Hospital
Hitachi, Ibaraki, Japan, 317-0077
Nara Hospital Kinki University Faculty of Medicine
Ikoma-City, Nara, Japan, 630-0293
National Hospital Organization Okayama Medical Center
Okayama-city, Okayama, Japan, 701-1192
Juntendo University Hospital
Bunkyo, Tokyo, Japan, 113-8431
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo, Japan, 150-8935
National Hospital Organization Kyushu Medical Center
Fukuoka, Japan, 810-8563
Fukushima Medical University Hospital
Fukushima-City, Japan, 960-1295
National Hospital Organization Mito Medical Center
Higashiibaraki-gun, Japan, 311-3193
Kurume University Hospital
Kurume, Japan, 830-0011
Japanese Red Cross Nagoya Daiichi Hospital
Nagoya, Japan, 453-8511
Nagoya City University Hospital
Nagoya, Japan, 467-8602
Japanese Red Cross Narita Hospital
Narita-shi, Japan, 286-8523
Niigata Cancer Center Hospital
Niigata-city, Japan
Osaka Saiseikai Nakatsu Hospital
Osaka, Japan, 530-0012
Shizuoka Cancer Center
Suntou-gun, Japan, 4118777
National Hospital Organization Disaster Medical Center
Tachikawa, Japan, 1900014
Toyohashi Municipal Hospital
Toyohashi, Aichi, Japan
Yamanashi Prefectural Central Hospital
Yamanashi, Japan, 400-8506
Korea, Republic of
National Cancer Center
Goyang-si, Gyeonggido, Korea, Republic of, 10408
Gachon University Gil Medical Center
Incheon, Korea, Republic of, 405-760
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Severance Hospital Yonsei University Health System - PPDS
Seoul, Korea, Republic of, 120-752
Samsung Medical Center - PPDS
Seoul, Korea, Republic of, 135-710
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 137-701
Mexico
Centro de Investigacion Farmaceutica Especializada de Occidente, SC
Guadalajara, Jalisco, Mexico, 44160
Hospital Y Clinica OCA Sociedad Anonima de Capital Variable
Monterrey, Nuevo Leon, Mexico, 64000
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo Leon, Mexico, 64460
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico, 14000
Oaxaca Site management Organization (OSMO)
Oaxaca, Mexico, 68000
Poland
MTZ Clinical Research Sp z o o
Warszawa, Mazowieckie, Poland, 02-106
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
Bydgoszcz, Poland, 85-168
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Chorzow, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
Wroclaw, Poland, 50-367
Portugal
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.
Lisbon, Lisboa, Portugal, 1099-023
Hospital Garcia de Orta
Almada, Portugal, 2801-951
Hospital de Braga
Braga, Portugal, 4710-243
Champalimaud Cancer Center
Lisboa, Portugal, 1400-038
Centro Hospitalar do Porto - Hospital de Santo Antonio
Porto, Portugal, 4099-001
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe
Porto, Portugal, 4200-072
Centro Hospitalar de Sao Joao EPE
Porto, Portugal, 4200-319
Russian Federation
State Medical and Preventive Treatment Institution Kirov Regional Clinical Oncology Dispensary
Kirov, Russian Federation, 610027
Stavropol Regional Clinical Oncology Centre Pyatigorsk Affiliate
Pyatigorsk, Russian Federation, 357500
Ryazan Regional Clinical Hospital
Ryazan, Russian Federation, 390039
Russian Research Institute of Hematology and Blood Transfusion
St. Petersburg, Russian Federation, 193024
City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31
St. Petersburg, Russian Federation, 197110
Serbia
Clinical Center of Serbia
Belgrade, Serbia, 11000
Clinical Hospital Center ''Bezanijska Kosa''
Belgrade, Serbia, 11080
Clinical Center Kragujevac
Kragujevac, Serbia, 34000
Clinical Center Nis
Nis, Serbia, 18000
Singapore
National University Hospital
Singapore, Singapore, 119074
Singapore General Hospital (SGH)
Singapore, Singapore, 169608
South Africa
Medical Oncology Centre of Rosebank
Johannesburg, Gauteng, South Africa, 2196
Albert Alberts Stem Cell Transplant Centre
Pretoria, Gauteng, South Africa, 0044
Mary Potter Oncology Centre
Pretoria, Gauteng, South Africa, 0181
Spain
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital Universitario Quironsalud Madrid
Pozuelo De Alarcon, Madrid, Communidad Delaware, Spain, 28223
Clinica Universidad Navarra
Pamplona, Navarra, Spain, 31008
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Hospital de La Santa Creu i Sant Pau
Barcelona, Spain, 08041
Hospital Universitario de La Princesa
Madrid, Spain, 28006
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28009
Hospital Universitario Infanta Leonor
Madrid, Spain, 28031
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Universitario HM Sanchinarro CIOCC
Madrid, Spain, 28050
Hospital General Universitario Morales Meseguer
Murcia, Spain, 30008
Complejo Asistencial Universitario de Salamanca H. Clinico
Salamanca, Spain, 37007
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain, 46026
Sweden
Karolinska Universitetssjukhuset Huddinge
Stockholm, Sodermanlands Lan, Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, Sodermanlands Lan, Sweden
Sahlgrenska Universitetssjukhuset
Goteborg, Vastra Gotalands Lan, Sweden
Skanes Universitetssjukhus Lund
Lund, Sweden, SE-22185
Switzerland
Spital STS AG
Thun, Switzerland, CH-3600
Taiwan
Kaohsiung Medical University Hospital
Kaohsiung, Taiwan, 807
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
National Taiwan University Hospital
Taipei, Taiwan, 100
Thailand
Ramathibodi Hospital
Bangkok, Krung Thep Maha Nakhon, Thailand, 10400
Chulalongkorn University
Bangkok, Thailand, 10330
Maharaj Nakorn Chiang Mai Chiang Mai University
Chiangmai, Thailand, 50200
Turkey
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, Turkey, 06100
Ankara University Medical Faculty Cebeci Hospital
Ankara, Turkey, 06590
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
Istanbul, Turkey, 34093
Dokuz Eylul University Medical Faculty
Izmir, Turkey, 35340
United Kingdom
Belfast City Hospital
Belfast, Antrim, United Kingdom, BT9 7AB
Birmingham Heartlands Hospital
West Midlands, Birmingham, United Kingdom, B9 5SS
Bristol Haematology and Oncology Centre
Bristol, Bristol, City Of, United Kingdom, BS2 8ED
Royal Bournemouth Hospital
Bournemouth, Dorset, United Kingdom, BH7 7DW
Queen Alexandra Hospital
Portsmouth, Hampshire, United Kingdom, PO6 3LY
Kent and Canterbury Hospital
Canterbury, Kent, United Kingdom, CT1 3NG
Barts Health NHS Trust
London, London, City Of, United Kingdom, EC1A 7BE
University College London
London, London, City Of, United Kingdom, NW1 2BU
Kings College Hospital
London, London, City Of, United Kingdom, SE5 9RS
Hammersmith Hospital
London, London, City Of, United Kingdom, W12 0HS
Hillingdon Hospital
Uxbridge, London, City Of, United Kingdom, UB8 3NN
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, Norfolk, United Kingdom, NR31 6LA
Churchill Hospital
Oxford, Oxfordshire, United Kingdom, OX3 7LJ
New Cross Hospital
Wolverhampton, Staffordshire, United Kingdom, WV10 0QP
Royal Marsden Hospital - Surrey
Sutton, Surrey, United Kingdom, SM2 5PT
Royal United Hospital
Bath, United Kingdom, BA1 3NG
Ulster Hospital
Belfast, United Kingdom, BT16 1RH
Southmead Hospital
Bristol, United Kingdom, BS10 5NB
Broomfield Hospital
Broomfield, United Kingdom, CM1 7ET
Cardiff University School of Medicine
Cardiff, United Kingdom, CF14 4XW
West Middlesex University Hospital
Isleworth, United Kingdom, TW7 6AF
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Chelsea and Westminster NHS Trust
London, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL
Northwick Park Hospital
Middlesex, United Kingdom, HA1 3UJ
Royal Oldham Hospital
Oldham, United Kingdom, OL1 2JH
Ealing Hospital
Southall, United Kingdom, UB1 3EU
Ealing Hospital
Southall, United Kingdom, UB1 3HW
Singleton Hospital
Swansea, United Kingdom
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
Layout table for investigator information
Study Director: Medical Director Clinical Science Millennium Pharmaceuticals, Inc.

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Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02312258     History of Changes
Other Study ID Numbers: C16021
U1111-1160-1702 ( Registry Identifier: WHO )
2014-001394-13 ( EudraCT Number )
REec-2015-1414 ( Registry Identifier: REec )
JapicCTI-152873 ( Registry Identifier: JapicCTI )
153300410A0048 ( Registry Identifier: RNEC )
1046003327 ( Registry Identifier: TCTIN )
SNCTP000001745 ( Registry Identifier: SNCTP )
15/NE/0167 ( Registry Identifier: NRES )
182602 ( Registry Identifier: HC-CTD )
MOH_2017-06-15_000529 ( Other Identifier: CRS )
First Posted: December 9, 2014    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda ( Millennium Pharmaceuticals, Inc. ):
Drug Therapy
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Ixazomib
Glycine
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Glycine Agents
Neurotransmitter Agents
Physiological Effects of Drugs