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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02312258
Registration number
NCT02312258
Ethics application status
Date submitted
5/12/2014
Date registered
9/12/2014
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)
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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
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Secondary ID [1]
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U1111-1160-1702
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Secondary ID [2]
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C16021
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
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Condition category
Condition code
Cancer
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0
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Ixazomib
Placebo comparator: Placebo - Ixazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.
Experimental: Ixazomib - Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.
Treatment: Drugs: Placebo
Ixazomib placebo-matching capsules.
Treatment: Drugs: Ixazomib
Ixazomib capsules.
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival (PFS)
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Assessment method [1]
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PFS is defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause, as evaluated by an independent review committee (IRC) according to International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first. Per IMWG criteria, PD is defined as, increase of 25% of lowest response value in one or more of following criteria: serum M-component (absolute increase =0.5 g/ deciliter (dL)); or urine M-component (absolute increase =200 mg/24-hour); difference between involved and uninvolved free light chains (FLC) levels (absolute increase \>10 mg/dL); or bone marrow plasma cell percentage (absolute plasma cell percentage =10%); development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma; or development of hypercalcemia (corrected serum calcium \>11.5mg/dL).
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Timepoint [1]
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From randomization until PD or death (up to 52 months)
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS was measured as the time from the date of randomization to the date of death.
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Timepoint [1]
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From the date of randomization and every 12 weeks after PD on next-line therapy until death (up to 88 months)
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Secondary outcome [2]
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Percentage of Participants Who Achieve or Maintain Any Best Response Category During the Treatment Period
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Assessment method [2]
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Response was assessed according to IMWG criteria based on IRC assessment. Best response included PR, VGPR and CR. PR= \>=50% reduction of serum M protein and \>=90% or \<200 mg reduction urinary M protein in 24-hour, or \>50% decrease in difference between involved and uninvolved FLC levels, or \>50% reduction in bone marrow plasma cells, if bone marrow plasma cells \>30% and \>50% reduction in size of soft tissue plasmacytomas at baseline. VGPR= \>90% reduction (\<100 mg/24-hour) in serum M-protein + urine M-protein detectable by immunofixation but not on electrophoresis. Complete response= \>5% plasma cells in myelogram with absence of paraprotein in serum and urine according to immunofixation.
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Timepoint [2]
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Up to 27 months
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Secondary outcome [3]
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Time to Progression (TTP)
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Assessment method [3]
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TTP is defined as the time from the date of randomization to the date of first documentation of PD, using IMWG criteria.
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Timepoint [3]
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From randomization until PD or death (up to 52 months)
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Secondary outcome [4]
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Progression Free Survival 2 (PFS2)
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Assessment method [4]
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PFS2 is defined as the time from the date of randomization to objective PD on next-line treatment using IMWG criteria, or death due to any cause, whichever occurred first.
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Timepoint [4]
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From the date of randomization to every 12 weeks until second PD or death (up to 88 months)
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Secondary outcome [5]
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Time to Next Line Therapy (TTNT)
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Assessment method [5]
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TTNT is defined as the time from the date of randomization to the date of the first dose of next-line antineoplastic therapy.
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Timepoint [5]
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From randomization until PD or death (up to 52 months)
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Secondary outcome [6]
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Time to End of the Next-line of Therapy After Study Treatment
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Assessment method [6]
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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.
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Timepoint [6]
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From randomization until PD or death (up to 52 months)
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Secondary outcome [7]
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Duration of Next-line Therapy
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Assessment method [7]
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Duration of next-line therapy is defined as the time from the date of the first dose of the next line of antineoplastic therapy coming after study treatment to the date of the last dose.
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Timepoint [7]
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From randomization until PD or death (up to 52 months)
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Secondary outcome [8]
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Percentage of Participants Who Develop a New Primary Malignancy
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Assessment method [8]
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Timepoint [8]
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From randomization until PD or death (up to 52 months)
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Secondary outcome [9]
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Percentage of Participants With Conversion From Minimal Residual Disease (MRD) Positive to MRD Negative
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Assessment method [9]
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Bone marrow aspirates and blood samples were sent to a central laboratory and were assessed for MRD using flow cytometry. MRD negativity was defined as absence of MRD and MRD positivity was defined as presence of MRD. MRD was assessed by 8-color flow cytometry with the IMWG recommended sensitivity of 10\^-5.
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Timepoint [9]
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Up to 52 months
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Secondary outcome [10]
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Correlation of MRD Status With PFS and OS
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Assessment method [10]
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PFS is defined as the time from the date of randomization to the date of first documentation of PD or death from any cause, as evaluated by an IRC according to IMWG criteria, or death due to any cause, whichever occurred first, assessed for up to 52 months in this outcome measure. OS was measured as the time from the date of randomization to the date of death, assessed for up to 52 months in this outcome measure. Participants with various types of known MRD status were pooled together for analysis of overall survival in this outcome measure.
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Timepoint [10]
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From randomization up to 52 months
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Secondary outcome [11]
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OS in a High-risk Population
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Assessment method [11]
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High-risk population included but not be limited to participants carrying cytogenetic deletion (del)17, translocation \[t\](4;14), t(14;16). OS was measured as the time from the date of randomization to the date of death.
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Timepoint [11]
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From the date of randomization and every 12 weeks after PD on next-line therapy until death (up to 88 months)
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Secondary outcome [12]
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PFS in a High-risk Population
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Assessment method [12]
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High-risk population included but not be limited to participants carrying del17, t(4;14), t(14;16). PFS was defined as the time from the date of randomization to the date of first documentation of PD or death from any cause.
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Timepoint [12]
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From randomization until PD or death (up to 52 months)
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Secondary outcome [13]
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Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
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Assessment method [13]
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ECOG performance status assesses a participant's performance status on a 6-point scale ranging from 0=fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (\>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=capable of only limited self-care, confined to bed/chair \>50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=dead. Lower grades indicate improvement.
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Timepoint [13]
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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)
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Secondary outcome [14]
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Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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Assessment method [14]
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An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAEs were defined as events that occurred after administration of the first dose of ixazomib or placebo through 30 days after the last dose of ixazomib or placebo. A SAE means any untoward medical occurrence that resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was considered medically significant.
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Timepoint [14]
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First dose of study drug through 30 days after last dose of study drug (up to 88 months)
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Secondary outcome [15]
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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)
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Assessment method [15]
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The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The change from baseline in GHS (EORTC QLQ-C30) score is presented. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1=very poor to 7=excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall GHS.
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Timepoint [15]
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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)
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Secondary outcome [16]
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Correlation Between Frailty Status and PFS and OS
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Assessment method [16]
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Participant's frailty status is classified as fit, unfit or frail on the bases of 4 components: age, the Charlson comorbidity scoring system without age weighting, the Katz index of independence in activities of daily living, and the Lawton instrumental activities of daily living scale. The sum of the 4 frailty scores equals the total frailty score. A total frailty score of 0 corresponds to a frailty status of fit; a total score of 1, to unfit; and a total score of 2 or more, to frail. PFS is defined as the time from the date of randomization to the date of first documentation of PD or death from any cause, as evaluated by an IRC according to IMWG criteria, or death due to any cause, whichever occurs first, assessed for up to 52 months in this outcome measure. OS will be measured as the time from the date of randomization to the date of death, assessed for up to 52 months in this outcome measure.
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Timepoint [16]
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From randomization up to 52 months
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Secondary outcome [17]
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Pharmacokinetic Parameter: Plasma Concentration of Ixazomib
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Assessment method [17]
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Plasma concentrations of the complete hydrolysis product of ixazomib citrate (ixazomib) were measured using a validated liquid chromatography-tandem mass spectrometry (LC/MS/MS) assay.
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Timepoint [17]
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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)
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Secondary outcome [18]
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Time to Resolution of Peripheral Neuropathy (PN) Events
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Assessment method [18]
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PN is defined as the event in the high-level term of peripheral neuropathies not elsewhere classified (NEC) according to the medical dictionary for regulatory activities (MedDRA). A PN event was considered as resolved if its final outcome was resolved with no subsequent PN event of the same preferred term occurring on the resolution date or the day before and after. Time to resolution was defined as the time from the initial onset date (inclusive) to the resolution date for resolved events.
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Timepoint [18]
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Up to 52 months
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Secondary outcome [19]
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Time to Improvement of PN Events
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Assessment method [19]
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PN is defined as the event in the high-level term of peripheral neuropathies NEC according to the MedDRA. A PN event was considered as resolved if its final outcome was resolved with no subsequent PN event of the same preferred term occurring on the improvement date or the day before and after. Time to improvement was defined as the time from the initial onset date (inclusive) to the improvement of event.
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Timepoint [19]
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Up to 52 months
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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).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/04/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/08/2022
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Sample size
Target
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Accrual to date
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Final
706
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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St Vincents Hospital Melbourne - PPDS - Fitzroy
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Recruitment hospital [2]
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Frankston Hospital - Frankston
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Recruitment hospital [3]
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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3065 - Fitzroy
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Recruitment postcode(s) [2]
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3199 - Frankston
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Recruitment postcode(s) [3]
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3004 - Melbourne
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Recruitment outside Australia
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0
United States of America
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State/province [1]
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California
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United States of America
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Georgia
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Illinois
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Iowa
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0
United States of America
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Kentucky
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United States of America
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Maine
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United States of America
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Maryland
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United States of America
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Massachusetts
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Michigan
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New York
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0
United States of America
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North Carolina
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Pennsylvania
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Texas
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Washington
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United States of America
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West Virginia
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Argentina
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Ciudad Autonoma De BuenosAires
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Argentina
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Cordoba
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Argentina
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Santa Fe
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Austria
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Tirol
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Austria
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Salzburg
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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
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Brazil
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Goias
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Brazil
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Minas Gerais
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Brazil
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Parana
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Brazil
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Rio Grande Do Norte
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Brazil
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Rio Grande Do Sul
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Brazil
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Santa Catarina
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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
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Brazil
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Sao Jose Do Rio Preto
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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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Araucanía
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Chile
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Santiago
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Chile
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Vina Del Mar
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China
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Jiangsu
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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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Hangzhou
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China
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Shenyang
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China
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Oldham
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Southall
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United Kingdom
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Swansea
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Takeda
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT02312258
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Trial related presentations / publications
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. Erratum In: J Clin Oncol. 2022 Mar 10;40(8):919. doi: 10.1200/JCO.22.00210.
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Public notes
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Contacts
Principal investigator
Name
0
0
Medical Director
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Address
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Takeda
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0
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Phone
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Fax
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Email
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0
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
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Available to whom?
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/58/NCT02312258/Prot_002.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/58/NCT02312258/SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02312258