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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02312258




Registration number
NCT02312258
Ethics application status
Date submitted
5/12/2014
Date registered
9/12/2014
Date last updated
10/11/2020

Titles & IDs
Public title
A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT)
Scientific 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
Secondary ID [1] 0 0
U1111-1160-1702
Secondary ID [2] 0 0
C16021
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Ixazomib

Experimental: Placebo - Ixazomib placebo-matching capsule, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 (Up to data cut-off 12 August 2019).

Placebo Comparator: Ixazomib - Ixazomib 3 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 (Up to data cut-off 12 August 2019).


Treatment: Drugs: Placebo
Ixazomib placebo-matching capsules.

Treatment: Drugs: Ixazomib
Ixazomib capsules.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) - 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. Per IMWG criteria, PD: serum M-component increase =0.5 g/dl or urine M-component increase =200 mg/24-hour/ difference between involved and uninvolved FLC levels increase >10 mg/dl or bone marrow plasma cell =10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.
Timepoint [1] 0 0
From the randomization until progressive disease (PD) or death or data cut-off date (12 Aug 2019) (Up to approximately 42 months)
Secondary outcome [1] 0 0
Overall Survival (OS) - OS will be measured as the time from the date of randomization to the date of death.
Timepoint [1] 0 0
From the date of randomization every 12 weeks after PD on next-line therapy until death (Up to approximately 76 to 104 months)
Secondary outcome [2] 0 0
Percentage of Participants Who Achieve or Maintain Any Best Response Category During the Treatment Period - Response will be assessed according to IMWG criteria. Best response includes PR, VGPR and CR.
Timepoint [2] 0 0
Up to 24 months
Secondary outcome [3] 0 0
Time to Progression (TTP) - TTP is defined as the time from the date of randomization to the date of first documentation of PD, using IMWG criteria.
Timepoint [3] 0 0
From the date of randomization to the date of first documented PD (Up to approximately 76 to 104 months)
Secondary outcome [4] 0 0
Progression Free Survival 2 (PFS2) - PFS2 is defined as the time from the date of randomization to objective PD on next-line treatment using IMWG criteria, or death due to any cause, whichever occurs first.
Timepoint [4] 0 0
From the date of randomization to every 12 weeks until 2nd PD or death (Up to approximately 76 to 104 months)
Secondary outcome [5] 0 0
Time to Next Line Therapy (TTNT) - TTNT is defined as the time from the date of randomization to the date of the first dose of next-line antineoplastic therapy.
Timepoint [5] 0 0
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)
Secondary outcome [6] 0 0
Time to End of the Next-line of Therapy After Study Treatment - Time to end of the next line of therapy is defined as the time from the date of randomization to the date of last dose of the next line of antineoplastic therapy following study treatment.
Timepoint [6] 0 0
From the date of randomization to the date of last dose of the next-line of therapy (Up to approximately 76 to 104 months)
Secondary outcome [7] 0 0
Duration of Next-line Therapy - 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.
Timepoint [7] 0 0
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)
Secondary outcome [8] 0 0
Percentage of Participants Who Develop A New Primary Malignancy
Timepoint [8] 0 0
From the randomization date till death or termination of the study (Up to approximately 76 to 104 months)
Secondary outcome [9] 0 0
Percentage of Participants With Conversion From Minimal Residual Disease (MRD) Positive to MRD Negative, or the Maintenance of MRD Negativity - 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.
Timepoint [9] 0 0
Screening, Cycle 13, and Cycle 26 (Cycle length is equal to [=] 28 days)
Secondary outcome [10] 0 0
Correlation of MRD Status With PFS and OS - PFS is defined as the time from the date of randomization to the date of first documentation of PD or death from any cause, as evaluated by an IRC according to IMWG criteria, or death due to any cause, whichever occurs first. OS will be measured as the time from the date of randomization to the date of death.
Timepoint [10] 0 0
Screening, Cycle 13, and Cycle 26 (Cycle length=28 days)
Secondary outcome [11] 0 0
OS in a High-risk Population - 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.
Timepoint [11] 0 0
From the date of randomization to every 12 weeks after PD on next-line therapy until death (Up to approximately 76 to 104 months)
Secondary outcome [12] 0 0
PFS in a High-risk Population - 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.
Timepoint [12] 0 0
From the date of randomization to every 4 weeks during follow-up until PD or death (Up to approximately 76 to 104 months)
Secondary outcome [13] 0 0
Eastern Cooperative Oncology Group (ECOG) Performance Status - 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.
Timepoint [13] 0 0
Cycle 2 and every 28 days ( Up to 24 months) (Cycle length =28 days)
Secondary outcome [14] 0 0
Percentage of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) - 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.
Timepoint [14] 0 0
First dose of study drug through 30 days after last dose of study drug (Up to 25 months)
Secondary outcome [15] 0 0
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) - 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).
Timepoint [15] 0 0
Baseline and every 28 days (Up to 24 months)
Secondary outcome [16] 0 0
Number of Participants With Any Markedly Abnormal Standard Safety Laboratory Values - 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.
Timepoint [16] 0 0
From First dose date of study drug through 30 days after the last dose of study drug (Up to 25 months)
Secondary outcome [17] 0 0
Correlation Between Frailty Status and PFS and OS - Participant's frailty status is classified as fit, unfit or frail on the bases of 4 components: age, the Charlson comorbidity scoring system without age weighting, the Katz index of independence in activities of daily living, and the Lawton instrumental activities of daily living scale. The sum of the 4 frailty scores equals the total frailty score. A total frailty score of 0 corresponds to a frailty status of fit; a total score of 1, to unfit; and a total score of 2 or more, to frail. PFS is defined as the time from the date of randomization to the date of first documentation of PD or death from any cause, as evaluated by an IRC according to IMWG criteria, or death due to any cause, whichever occurs first. OS will be measured as the time from the date of randomization to the date of death.
Timepoint [17] 0 0
Up to approximately 76 to 104 months
Secondary outcome [18] 0 0
Pharmacokinetic Parameter: Plasma Concentration of Ixazomib - 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.
Timepoint [18] 0 0
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)
Secondary outcome [19] 0 0
Time to Resolution of Peripheral Neuropathy (PN) Events - 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.
Timepoint [19] 0 0
From the initial onset date of PN up to the resolution date for resolved events (Up to 25 Months)
Secondary outcome [20] 0 0
Time to Improvement of PN Events - 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.
Timepoint [20] 0 0
From the initial onset date of PN up to the improvement of event (Up to 25 Months)

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Multiple myeloma that has relapsed after, or was not responsive to, initial therapy.

2. Prior stem cell transplant (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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [2] 0 0
Frankston Hospital - Frankston
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Iowa
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Maine
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
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United States of America
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North Carolina
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United States of America
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Pennsylvania
Country [13] 0 0
United States of America
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Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
United States of America
State/province [15] 0 0
West Virginia
Country [16] 0 0
Argentina
State/province [16] 0 0
Ciudad Autonoma De BuenosAires
Country [17] 0 0
Argentina
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Cordoba
Country [18] 0 0
Argentina
State/province [18] 0 0
Santa Fe
Country [19] 0 0
Austria
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Tirol
Country [20] 0 0
Austria
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Salzburg
Country [21] 0 0
Austria
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Wels
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Austria
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Wien
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Belgium
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Brussels
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Brazil
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Bahia
Country [25] 0 0
Brazil
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Goias
Country [26] 0 0
Brazil
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Minas Gerais
Country [27] 0 0
Brazil
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Parana
Country [28] 0 0
Brazil
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Rio Grande Do Norte
Country [29] 0 0
Brazil
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Rio Grande Do Sul
Country [30] 0 0
Brazil
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Santa Catarina
Country [31] 0 0
Brazil
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Sao Paulo
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Brazil
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Rio De Janeiro
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Brazil
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Rio de Janeiro
Country [34] 0 0
Brazil
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Sao Jose Do Rio Preto
Country [35] 0 0
Canada
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Ontario
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Canada
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Quebec
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Chile
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Santiago
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Chile
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Temuco
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Chile
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Vina Del Mar
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China
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Shanghai
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China
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Zhejiang
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China
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Beijing
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China
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Chengdu
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China
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Guangzhou
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China
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Taiyuan Shi
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Colombia
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Antioquia
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Colombia
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Cundinamarca
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Colombia
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Distrito Capital De Bogota
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Croatia
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Grad Zagreb
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Croatia
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Rijeka
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Croatia
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Zagreb
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Czechia
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Kralovehradeck Kraj
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Czechia
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Praha, Hlavni Mesto
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Czechia
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Brno
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Czechia
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Olomouc
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Czechia
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Ostrava
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Czechia
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Praha 2
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Denmark
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Aarhus
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Denmark
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Herlev
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Denmark
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Holstebro
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Denmark
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Odense
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France
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Hauts-de-Seine
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France
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Loire-Atlantique
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France
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Meurthe-et-Moselle
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France
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Dijon
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France
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Lille
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France
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Paris
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France
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Pessac
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France
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Poitiers
Country [70] 0 0
France
State/province [70] 0 0
Rennes
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Germany
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Baden-Wurttemberg
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Germany
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Bayern
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
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Rheinland-Pfalz
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Germany
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Saarland
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Germany
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Aschaffenburg
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Germany
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Berlin
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Germany
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Landshut
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Germany
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Munchen
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Germany
State/province [81] 0 0
Rosenheim
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Germany
State/province [82] 0 0
Wurzburg
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Greece
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Attiki
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Greece
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Athens
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Greece
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Ioannina
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Greece
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Larissa
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Greece
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Thessaloniki
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Hungary
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Budapest
Country [89] 0 0
Hungary
State/province [89] 0 0
Debrecen
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Hungary
State/province [90] 0 0
Szeged
Country [91] 0 0
Israel
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Beer Sheva
Country [92] 0 0
Israel
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Haifa
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Israel
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Jerusalem
Country [94] 0 0
Israel
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Kfar Saba
Country [95] 0 0
Israel
State/province [95] 0 0
Petah Tikva
Country [96] 0 0
Israel
State/province [96] 0 0
Ramat Gan
Country [97] 0 0
Israel
State/province [97] 0 0
Tel Aviv
Country [98] 0 0
Israel
State/province [98] 0 0
Tiberias
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Israel
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Zerfin
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Italy
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Campania
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Italy
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Emilia-Romagna
Country [102] 0 0
Italy
State/province [102] 0 0
Liguria
Country [103] 0 0
Italy
State/province [103] 0 0
Lombardia
Country [104] 0 0
Italy
State/province [104] 0 0
Puglia
Country [105] 0 0
Italy
State/province [105] 0 0
Sicilia
Country [106] 0 0
Italy
State/province [106] 0 0
Toscana
Country [107] 0 0
Italy
State/province [107] 0 0
Umbria
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Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Millennium Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02312258
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director Clinical Science
Address 0 0
Millennium Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications