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| ID | Type | Description | Link |
|---|---|---|---|
| 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 |
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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.
The drug being tested in this study is called ixazomib citrate. Ixazomib citrate is being tested to slow progressive disease (PD) and improve overall survival in people who have NDMM who have had a major positive response to initial therapy and have not undergone SCT. This study will look at the effect of ixazomib citrate has on the length of time that participants are free of PD and their overall survival.
The study will enrol approximately 700 participants. Participants will be randomly assigned (by chance, like flipping a coin) in 3:2 ratio to Ixazomib or matching placebo groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
All participants will be asked to take one capsule on Days 1, 8 and 15 of each 28-day cycle. The treatment period will be approximately 24 months (equivalent to 26 cycles) or until patients experience PD or unacceptable toxicities, whichever occurs first.
This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 78 to 106 months. Participants will make 28 visits to the clinic during the treatment period and will continue to make follow-up visits every 4 weeks until the next line of therapy begins. Participants will also be contacted by telephone every 12 weeks after last treatment visit for a follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Ixazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26. |
|
| Ixazomib | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Ixazomib placebo-matching capsules. |
| |
| Ixazomib |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | 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). | From randomization until PD or death (up to 52 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was measured as the time from the date of randomization to the date of death. | From the date of randomization and every 12 weeks after PD on next-line therapy until death (up to 88 months) |
| Percentage of Participants Who Achieve or Maintain Any Best Response Category During the Treatment Period |
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Inclusion Criteria:
Adult male or female participants 18 years or older with a confirmed diagnosis of symptomatic newly diagnosed multiple myeloma (NDMM) according to standard criteria.
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.
Documented major response (PR, VGPR, CR) according to the International Myeloma Working Group (IMWG) uniform response criteria, version 2011, after this initial therapy.
Female participants who:
Male participants, even if surgically sterilized (that is, status postvasectomy), who:
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.
Complete documentation of the details of the initial therapy before randomization including cytogenetics and International Staging System (ISS) is available.
Eastern Cooperative Oncology Group Performance Status of 0 to 2.
Suitable venous access for the study-required blood sampling and consent for the specific amounts that will be taken.
Is willing and able to adhere to the study visit schedule and other protocol requirements including blood sampling and bone marrow aspiration.
Must meet the following clinical laboratory criteria at study entry:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert A Moss MD FACP Inc | Fountain Valley | California | 92708 | United States | ||
| UCLA Medical Hematology and Oncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36130300 | Derived | Paiva B, Manrique I, Dimopoulos MA, Gay F, Min CK, Zweegman S, Spicka I, Teipel R, Mateos MV, Giuliani N, Cavo M, Hopkins CR, Fu W, Suryanarayan K, Vorog A, Li C, Wang B, Estevam J, Labotka R, Dash AB. MRD dynamics during maintenance for improved prognostication of 1280 patients with myeloma in the TOURMALINE-MM3 and -MM4 trials. Blood. 2023 Feb 9;141(6):579-591. doi: 10.1182/blood.2022016782. | |
| 33021870 |
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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.
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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
Participants with newly diagnosed multiple myeloma not treated with stem cell transplantation (SCT) were enrolled and randomized in a 3:2 ratio to receive ixazomib or placebo respectively.
Participants took part in the study from 09 April 2015 to 26 August 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Ixazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 18, 2021 | Aug 23, 2023 |
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| Drug |
Ixazomib capsules. |
|
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. |
| Up to 27 months |
| 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. | From randomization until PD or death (up to 52 months) |
| 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 occurred first. | From the date of randomization to every 12 weeks until second PD or death (up to 88 months) |
| 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. | From randomization until PD or death (up to 52 months) |
| 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. | From randomization until PD or death (up to 52 months) |
| Duration of Next-line Therapy | 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. | From randomization until PD or death (up to 52 months) |
| Percentage of Participants Who Develop a New Primary Malignancy | From randomization until PD or death (up to 52 months) |
| Percentage of Participants With Conversion From Minimal Residual Disease (MRD) Positive to MRD Negative | 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. | Up to 52 months |
| 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 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. | From randomization up to 52 months |
| OS in a High-risk Population | 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. | From the date of randomization and every 12 weeks after PD on next-line therapy until death (up to 88 months) |
| PFS in a High-risk Population | 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. | From randomization until PD or death (up to 52 months) |
| Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | 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. | 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) |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 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. | First dose of study drug through 30 days after last dose of study drug (up to 88 months) |
| 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) | 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. | 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) |
| 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, 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. | From randomization up to 52 months |
| Pharmacokinetic Parameter: Plasma Concentration of Ixazomib | 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. | 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) |
| Time to Resolution of Peripheral Neuropathy (PN) Events | 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. | Up to 52 months |
| Time to Improvement of PN Events | 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. | Up to 52 months |
| Los Angeles |
| California |
| 90095 |
| United States |
| North County Oncology Medical Clinic Inc | Oceanside | California | 92056 | United States |
| Ventura County Hematology Oncology Specialists | Oxnard | California | 93030 | United States |
| Emad Ibrahim, MD, Inc | Redlands | California | 92373 | United States |
| Global Cancer Research Institute (GCRI), Inc. | San Jose | California | 95124 | United States |
| Central Coast Medical Oncology Corporation | Santa Maria | California | 93454 | United States |
| Winship Cancer Institute, Emory University | Atlanta | Georgia | 30322 | United States |
| John H. Stroger Jr. Hospital of Cook County | Chicago | Illinois | 60612 | United States |
| Siouxland Hematology - Oncology Associates LLP | Sioux City | Iowa | 51101 | United States |
| Appalachian Regional Healthcare | Hazard | Kentucky | 41701 | United States |
| New England Cancer Specialists | Scarborough | Maine | 04074 | United States |
| Saint Agnes Hospital - Baltimore - Hunt - PPDS | Baltimore | Maryland | 21229 | United States |
| University Hospital of Wales - | Bethesda | Maryland | 20817 | United States |
| Tufts Medical Center - PPDS | Boston | Massachusetts | 02111 | United States |
| Herbert-Herman Cancer Center | Lansing | Michigan | 48912 | United States |
| Clinical Research Alliance Inc | New York | New York | 10021 | United States |
| New York Presbyterian Hospital - Weill-Cornell | New York | New York | 10021 | United States |
| Cancer Care of WNC PA | Asheville | North Carolina | 28801 | United States |
| UPMC Cancer Pavillion | Pittsburgh | Pennsylvania | 15232 | United States |
| HOPE Cancer Center of East Texas | Tyler | Texas | 75701 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98109 | United States |
| W VA University Mary Babb Randolph Cancer Center | Morgantown | West Virginia | 26506 | United States |
| Hospital Universitario Austral | Buenos Aires | Ciudad Autonoma de BuenosAires | B1629AHJ | Argentina |
| Hospital Italiano de Buenos Aires | Buenos Aires | Ciudad Autonoma de BuenosAires | C1181ACH | Argentina |
| Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC) | Buenos Aires | Ciudad Autonoma de BuenosAires | C1431FWO | Argentina |
| Sanatorio Allende S.A. | Córdoba | X5000JHQ | Argentina |
| Hospital Iturraspe | Santa Fe | S3000ADL | Argentina |
| St Vincents Hospital Melbourne - PPDS | Fitzroy | Victoria | 3065 | Australia |
| Frankston Hospital | Frankston | Victoria | 3199 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Universitatsklinikum Innsbruck | Innsbruck | Tyrol | 6020 | Austria |
| Paracelsus Medizinische Privatuniversitat | Salzburg | 5020 | Austria |
| Medizinische Universitat Wien (Medical University of Vienna) | Vienna | A-1090 | Austria |
| Klinikum Wels-Grieskirchen GmbH | Wels | 4600 | Austria |
| Universitair Ziekenhuis Brussel - PIN | Brussels | Brussels Capital | 1090 | Belgium |
| UZ Brussel | Brussels | Brussels Capital | 1090 | Belgium |
| Cliniques Universitaires Saint-Luc | Brussels | Brussels Capital | 1200 | Belgium |
| Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet | Salvador | Estado de Bahia | 41253-196 | Brazil |
| Hospital Das Clinicas Da Universidade Federal de Goias | Goiânia | Goiás | 74605-020 | Brazil |
| Hospital Das Clinicas Da UFMG | Belo Horizonte | Minas Gerais | 30130-100 | Brazil |
| Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner | Curitiba | Paraná | 81520-060 | Brazil |
| Liga Norte Riograndense Contra O Cancer | Natal | Rio Grande do Norte | 59040-150 | Brazil |
| Universidade de Caxias do Sul | Caxias do Sul | Rio Grande do Sul | 95070-560 | Brazil |
| Associacao Hospital de Caridade Ijui | Ijuí | Rio Grande do Sul | 98700-000 | Brazil |
| American Oncology Partners of Maryland, PA | Passo Fundo | Rio Grande do Sul | 99010-260 | Brazil |
| Hospital Moinhos de Vento | Porto Alegre | Rio Grande do Sul | 90035-001 | Brazil |
| Hospital de Clinicas de Porto Alegre (HCPA) - PPDS | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Mae de Deus Center Hospital Giovanni Battista | Porto Alegre | Rio Grande do Sul | 90470-340 | Brazil |
| Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS) | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Instituto Joinvilense de Hematologia E Oncologia | Joinville | Santa Catarina | 89201260 | Brazil |
| Fundacao PIO XII | Barretos | São Paulo | 14784-400 | Brazil |
| Universidade Estadual de Campinas | Campinas | São Paulo | 13083-878 | Brazil |
| Hospital Amaral Carvalho | Jaú | São Paulo | 17210-120 | Brazil |
| Faculdade de Medicina Do ABC | Santo André | São Paulo | 09060-650 | Brazil |
| HEMORIO - Unidade de Pesquisa Clinica | Rio de Janeiro | 20211-030 | Brazil |
| Instituto Nacional de Cancer | Rio de Janeiro | 20231-050 | Brazil |
| Fundação Antônio Prudente - AC Camargo Câncer Center | Rio de Janeiro | 21941-913 | Brazil |
| Hospital de Base Da Faculdade de Medicina de Sao Jose Do Rio Preto | São José do Rio Preto | 15090-000 | Brazil |
| Instituto de Ensino E Pesquisa Sao Lucas | São Paulo | 01236-030 | Brazil |
| Hospital Sirio Libanes | São Paulo | 01308-050 | Brazil |
| Ealing Hospital | São Paulo | 01509-900 | Brazil |
| Clinica Sao Germano | São Paulo | 04537-080 | Brazil |
| Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo | São Paulo | 05403-000 | Brazil |
| Hospital Israelita Albert Einstein | São Paulo | 05652-900 | Brazil |
| Hospital Santa Marcelina | São Paulo | 08270-070 | Brazil |
| Royal Victoria Regional Health Centre | Barrie | Ontario | L4M 6M2 | Canada |
| William Osler Health Centre | Brampton | Ontario | L6W 3J7 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| McGill University Health Center | Montreal | Quebec | H4A 3J1 | Canada |
| Hospital Amaral Carvalho | Temuco | Araucania | 4800827 | Chile |
| Instituto Nacional Del Cancer | Santiago | 8380455 | Chile |
| Centro Internacional de Estudios Clinicos | Santiago | Chile |
| Centro de Investigaciones Clinicas Vina del Mar | Viña del Mar | 2570017 | Chile |
| Hospital de Clinicas de Passo Fundo | Nanjing | Jiangsu | 210029 | China |
| Ruijin Hospital Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
| The First Affiliated Hospital, College of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
| Beijing Chaoyang Hospital Capital Medical University | Beijing | 100020 | China |
| Peking University Third Hospital | Beijing | 100191 | China |
| Peking Union Medical College Hospital | Beijing | China |
| The First Affiliated Hospital, College of Medicine, Zhejiang University | Hangzhou | 310003 | China |
| Renji Hospital Shanghai Jiaotong University School of Medicine | Shanghai | 200001 | China |
| Shanghai Chang Zheng Hospital | Shanghai | 200003 | China |
| Hospital São Rafael | Shenyang | 110004 | China |
| Second Hospital of Shanxi Medical University | Taiyuan | 030001 | China |
| James Lind Centro de Investigación del Cáncer | Wuhan | 430030 | China |
| Hospital Pablo Tobon Uribe | Medellín | Antioquia | 050034 | Colombia |
| Hospital Universitario San Ignacio | Bogotá | Bogota D.C. | 110311 | Colombia |
| Instituto Nacional de Cancerologia Colombia | Bogota | Cundinamarca | Colombia |
| Clinical Hospital Dubrava | Zagreb | City of Zagreb | 10000 | Croatia |
| Clinical Hospital Center Rijeka | Rijeka | 51000 | Croatia |
| Clinical Hospital Center Zagreb - PPDS | Zagreb | 10 000 | Croatia |
| Fakultni nemocnice Hradec Kralove | Hradec Králové | Kralovehradeck Kraj | 500 05 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady | Prague | Praha, Hlavni Mesto | 100 34 | Czechia |
| Fakultni nemocnice Brno | Brno | 625 00 | Czechia |
| Fakultni nemocnice Olomouc | Olomouc | 775 20 | Czechia |
| Fakultni nemocnice Ostrava | Ostrava | 708 52 | Czechia |
| Vseobecna fakultni nemocnice v Praze | Prague | 128 08 | Czechia |
| Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University) | Copenhagen | Capital | 2100 | Denmark |
| Aarhus Universitetshospital Århus Sygehus | Aarhus N | DK-8200 | Denmark |
| Regionshospitalet Holstebro | Holstebro | 7500 | Denmark |
| Odense Universitetshospital | Odense | 5000 | Denmark |
| Hopital Antoine Beclere | Clamart | Hauts-de-Seine | 92140 | France |
| Hotel Dieu | Nantes | Loire-Atlantique | 44093 | France |
| CHRU Nancy | Vandœuvre-lès-Nancy | Meurthe-et-Moselle | 54511 | France |
| CHRU Dijon Complexe Du Bocage | Dijon | 21079 | France |
| Hopital Saint Vincent de Paul GHICL | Lille | 59020 | France |
| CHRU Lille | Lille | 59037 | France |
| Hopital de la Pitie Salpetriere | Paris | 75013 | France |
| Groupe Hospitalier Necker Enfants Malades | Paris | 75015 | France |
| Hopital Haut Leveque | Pessac | 33604 | France |
| Hopital Jean Bernard | Poitiers | 86021 | France |
| CHRU Rennes | Rennes | France |
| Universitatsklinikum Ulm | Ulm | Baden-Wurttemberg | 89081 | Germany |
| Schwarzwald Baar Klinkum Villingen-Schwenningen GmbH | Villingen-Schwenningen | Baden-Wurttemberg | 78050 | Germany |
| Hamatologische Onkologische Gemeinschaftspraxis Dr. Brudler, Dr. Heinrich, Dr. Bangerter | Augsburg | Bavaria | 86150 | Germany |
| Internistisch Hamatologische und Internistische Praxis | Herrsching am Ammersee | Bavaria | 82211 | Germany |
| LMU Klinikum der Universitat Munchen | München | Bavaria | 81377 | Germany |
| Pius Hospital Oldenburg | Oldenburg | Lower Saxony | 26121 | Germany |
| Universitatsklinikum Essen | Essen | North Rhine-Westphalia | 45122 | Germany |
| Gemeinschaftspraxis fur Hamatologie und Onkologie | Münster | North Rhine-Westphalia | 48149 | Germany |
| Universitatsmedizin der Johannes Gutenberg-Universitat Mainz | Mainz | Rhineland-Palatinate | 55131 | Germany |
| Universitat Des Saarlandes | Homburg | Saarland | 66421 | Germany |
| Onkologie Aschaffenburg | Aschaffenburg | 63739 | Germany |
| Charite - Universitatsmedizin Berlin | Berlin | 12200 | Germany |
| Medizinisches Versorgungszentrum Onkologischer Schwerpunkt | Berlin | 14195 | Germany |
| Klinikum Landshut | Landshut | 84034 | Germany |
| Klinikum rechts der Isar der Technischen Universitat Munchen | München | 81675 | Germany |
| Praxis Pihusch Medizinisches Versorgungszentrum GbR | Rosenheim | 83022 | Germany |
| Gemeinschaftspraxis Dr. med. R. Schlag & Dr. med. B. Schottker & Dr. med. J. Haas | Würzburg | 97080 | Germany |
| University of Athens Medical School - Regional General Hospital Alexandra | Athens | Attica | 115 28 | Greece |
| Evangelismos General Hospital of Athens | Athens | 10676 | Greece |
| University General Hospital of Ioannina | Ioannina | 45500 | Greece |
| University General Hospital of Larissa | Larissa | 41110 | Greece |
| Theageneio Anticancer Oncology Hospital of Thessaloniki | Thessaloniki | 54007 | Greece |
| Georgios Papanikolaou General Hospital of Thessaloniki | Thessaloniki | 57010 | Greece |
| Semmelweis Egyetem | Budapest | 1083 | Hungary |
| Klinika Hematologii, Szpital Uniwersytecki Nr 2 im. Jana Biziela w Bydgoszczy | Budapest | 1097 | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | 4032 | Hungary |
| Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont | Szeged | 6725 | Hungary |
| Rigshospitalet | Beer Yaakov | 70300 | Israel |
| Shamir Medical Center Assaf Harofeh | Beersheba | 84101 | Israel |
| Bnai Zion Medical Center | Haifa | 33394 | Israel |
| Hadassah Medical Center - PPDS | Jerusalem | 91120 | Israel |
| Meir Medical Center | Kfar Saba | 44281 | Israel |
| Rabin Medical Center - PPDS | Petah Tikva | 49100 | Israel |
| Chaim Sheba Medical Center | Ramat Gan | 52621 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Assuta Medical Centers | Tel Aviv | 69710 | Israel |
| Baruch Padeh Poriya Medical Center | Tiberias | 15208 | Israel |
| Ospedale Casa Sollievo Della Sofferenza IRCCS | San Giovanni Rotondo | Apulia | 71013 | Italy |
| AORN A Cardarelli | Naples | Campania | 80131 | Italy |
| Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi | Bologna | Emilia-Romagna | 40138 | Italy |
| Ospedale Infermi di Rimini | Rimini | Emilia-Romagna | 47900 | Italy |
| IRCCS Az. Osp. Universitaria San Martino- IST | Genoa | Liguria | 16132 | Italy |
| ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN | Brescia | Lombardy | 25123 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda | Milan | Lombardy | 20162 | Italy |
| Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele | Catania | Sicily | 95124 | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | Tuscany | 56216 | Italy |
| Azienda Ospedaliera S Maria Di Terni | Terni | Umbria | 05100 | Italy |
| Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi | Ancona | 60126 | Italy |
| Azienda Ospedaliera Universitaria Careggi | Florence | 50139 | Italy |
| Azienda Ospedaliero Universitaria di Parma | Parma | 43126 | Italy |
| Ospedale Santa Maria Delle Croci | Ravenna | 48100 | Italy |
| Azienda Ospedaliera Citta della Salute e della Scienza di Torino | Torino | 10126 | Italy |
| Ogaki Municipal Hospital | Ōgaki | Gihu | 503-8502 | Japan |
| Kobe City Medical Center General Hospital | Kobe | Hyōgo | 650-0047 | Japan |
| Hitachi General Hospital | Hitachi | Ibaraki | 317-0077 | Japan |
| Nara Hospital Kinki University Faculty of Medicine | Ikoma | Nara | 630-0293 | Japan |
| National Hospital Organization Okayama Medical Center | Okayama | Okayama-ken | 701-1192 | Japan |
| Juntendo University Hospital | Bunkyo | Tokyo | 113-8431 | Japan |
| Japanese Red Cross Medical Center | Shibuya-ku | Tokyo | 150-8935 | Japan |
| National Hospital Organization Kyushu Medical Center | Fukuoka | 810-8563 | Japan |
| Fukushima Medical University Hospital | Fukushima | 960-1295 | Japan |
| National Hospital Organization Mito Medical Center | Ibaraki | 311-3193 | Japan |
| Kurume University Hospital | Kurume | 830-0011 | Japan |
| Shizuoka Cancer Center | Nagaizumi-chō | 4118777 | Japan |
| Japanese Red Cross Nagoya Daiichi Hospital | Nagoya | 453-8511 | Japan |
| Nagoya City University Hospital | Nagoya | 467-8602 | Japan |
| Japanese Red Cross Narita Hospital | Narita-shi | 286-8523 | Japan |
| Niigata Cancer Center Hospital | Niigata | Japan |
| Osaka Saiseikai Nakatsu Hospital | Osaka | 530-0012 | Japan |
| National Hospital Organization Disaster Medical Center | Tachikawa | 1900014 | Japan |
| Toyohashi Municipal Hospital | Toyohashi | Japan |
| Yamanashi Prefectural Central Hospital | Yamanashi | 400-8506 | Japan |
| Centro de Investigacion Farmaceutica Especializada de Occidente, SC - PPDS | Guadalajara | Jalisco | 44160 | Mexico |
| Hospital Y Clinica OCA Sociedad Anonima de Capital Variable | Monterrey | Nuevo León | 64000 | Mexico |
| Hospital Universitario Dr. Jose Eleuterio Gonzalez | Monterrey | Nuevo León | 64460 | Mexico |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Mexico City | 14000 | Mexico |
| Oaxaca Site management Organization (OSMO) - PPDS | Oaxaca City | 68000 | Mexico |
| Shengjing Hospital of China Medical University | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-168 | Poland |
| MTZ Clinical Research Sp z o o - PRATIA - PPDS | Warsaw | Masovian Voivodeship | 02-106 | Poland |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich | Chorzów | Poland |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu | Wroclaw | 50-367 | Poland |
| Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. | Lisbon | Lisbon District | 1099-023 | Portugal |
| Hospital Garcia de Orta | Almada | 2801-951 | Portugal |
| Hospital de Braga | Braga | 4710-243 | Portugal |
| Champalimaud Cancer Center | Lisbon | 1400-038 | Portugal |
| Centro Hospitalar do Porto - Hospital de Santo Antonio | Porto | 4099-001 | Portugal |
| Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS | Porto | 4200-072 | Portugal |
| Centro Hospitalar de Sao Joao EPE | Porto | 4200-319 | Portugal |
| State Medical and Preventive Treatment Institution Kirov Regional Clinical Oncology Dispensary | Kirov | 610027 | Russia |
| Stavropol Regional Clinical Oncology Centre Pyatigorsk Affiliate | Pyatigorsk | 357500 | Russia |
| Ryazan Regional Clinical Hospital | Ryazan | 390039 | Russia |
| Russian Research Institute of Hematology and Blood Transfusion | Saint Petersburg | 193024 | Russia |
| City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31 | Saint Petersburg | 197110 | Russia |
| Tongji Hospital Tongji Medical College Huazhong University of Science and Technology | Belgrade | 11000 | Serbia |
| Clinical Hospital Center ''Bezanijska Kosa'' | Belgrade | 11080 | Serbia |
| University Clinical Center Kragujevac | Kragujevac | 34000 | Serbia |
| Soroka University Medical Centre | Niš | 18000 | Serbia |
| National University Hospital | Singapore | 119074 | Singapore |
| Singapore General Hospital (SGH) | Singapore | 169608 | Singapore |
| Medical Oncology Centre of Rosebank | Johannesburg | Gauteng | 2196 | South Africa |
| Albert Alberts Stem Cell Transplant Centre | Pretoria | Gauteng | 0044 | South Africa |
| Mary Potter Oncology Centre | Pretoria | Gauteng | 0181 | South Africa |
| National Cancer Center | Goyang-si | Gyeonggido | 10408 | South Korea |
| Gachon University Gil Medical Center | Incheon | 405-760 | South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| Severance Hospital Yonsei University Health System - PPDS | Seoul | 120-752 | South Korea |
| Samsung Medical Center - PPDS | Seoul | 135-710 | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | 137-701 | South Korea |
| Hospital Universitario Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Hospital Universitario Quironsalud Madrid | Pozuelo de Alarcón | Madrid, Communidad Delaware | 28223 | Spain |
| Clinica Universidad Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital de La Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| Hospital Universitario de La Princesa | Madrid | 28006 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28009 | Spain |
| Hospital Universitario Infanta Leonor | Madrid | 28031 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitario HM Sanchinarro CIOCC | Madrid | 28050 | Spain |
| Hospital General Universitario Morales Meseguer | Murcia | 30008 | Spain |
| Complejo Asistencial Universitario de Salamanca H. Clinico | Salamanca | 37007 | Spain |
| Hospital Universitari i Politecnic La Fe de Valencia | Valencia | 46026 | Spain |
| Karolinska Universitetssjukhuset Huddinge | Stockholm | Södermanland County | Sweden |
| Karolinska Universitetssjukhuset Solna | Stockholm | Södermanland County | Sweden |
| Sahlgrenska Universitetssjukhuset | Gothenburg | Västra Götaland County | Sweden |
| Skanes Universitetssjukhus Lund | Lund | SE-22185 | Sweden |
| Spital STS AG | Thun | CH-3600 | Switzerland |
| Kaohsiung Medical University Hospital | Kaohsiung City | 807 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Ramathibodi Hospital | Bangkok | Bangkok | 10400 | Thailand |
| Chulalongkorn University | Bangkok | 10330 | Thailand |
| Maharaj Nakorn Chiang Mai Chiang Mai University | Chiang Mai | 50200 | Thailand |
| Hacettepe Universitesi Tip Fakultesi Hastanesi | Ankara | 06100 | Turkey (Türkiye) |
| Ankara University Medical Faculty PPDS | Ankara | 06590 | Turkey (Türkiye) |
| Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi | Istanbul | 34093 | Turkey (Türkiye) |
| Dokuz Eylul University Medical Faculty | Izmir | 35340 | Turkey (Türkiye) |
| Belfast City Hospital | Belfast | Antrim | BT9 7AB | United Kingdom |
| Birmingham Heartlands Hospital | West Malling | Birmingham | B9 5SS | United Kingdom |
| Bristol Haematology and Oncology Centre | Bristol | Bristol, City of | BS2 8ED | United Kingdom |
| Royal Bournemouth Hospital | Bournemouth | Dorset | BH7 7DW | United Kingdom |
| Queen Alexandra Hospital | Portsmouth | Hampshire | PO6 3LY | United Kingdom |
| Kent and Canterbury Hospital | Canterbury | Kent | CT1 3NG | United Kingdom |
| Barts Health NHS Trust | London | London, City of | EC1A 7BE | United Kingdom |
| University College London | London | London, City of | NW1 2BU | United Kingdom |
| Kings College Hospital | London | London, City of | SE5 9RS | United Kingdom |
| Hammersmith Hospital | London | London, City of | W12 0HS | United Kingdom |
| Hillingdon Hospital | Uxbridge | London, City of | UB8 3NN | United Kingdom |
| Churchill Hospital | Oxford | Oxfordshire | OX3 7LJ | United Kingdom |
| New Cross Hospital | Wolverhampton | Staffordshire | WV10 0QP | United Kingdom |
| Royal Marsden Hospital - Surrey | Sutton | Surrey | SM2 5PT | United Kingdom |
| Royal United Hospital | Bath | BA1 3NG | United Kingdom |
| Ulster Hospital | Belfast | BT16 1RH | United Kingdom |
| Southmead Hospital | Bristol | BS10 5NB | United Kingdom |
| University Clinical Center Nis | Cardiff | CF14 4XW | United Kingdom |
| West Middlesex University Hospital | Isleworth | TW7 6AF | United Kingdom |
| Leicester Royal Infirmary | Leicester | LE1 5WW | United Kingdom |
| Chelsea and Westminster NHS Trust | London | United Kingdom |
| Manchester Royal Infirmary - PPDS | Manchester | M13 9WL | United Kingdom |
| Northwick Park Hospital | Middlesex | HA1 3UJ | United Kingdom |
| The Royal Oldham Hospital - PPDS | Oldham | OL1 2JH | United Kingdom |
| University Clinical Center of Serbia - PPDS | Southall | UB1 3HW | United Kingdom |
| Singleton Hospital - PPDS | Swansea | United Kingdom |
| Derived |
| 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. |
| Safety Population | The safety population was defined as all participants who received at least 1 dose of ixazomib or placebo. Three placebo participants who erroneously received a single dose of ixazomib were included in the ixazomib arm of the safety population. |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Intent-to-treat (ITT) Population included all participants who were randomized and had post-randomization data.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Ixazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) | 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). | ITT Population included all participants who were randomized and had post-randomization data. | Posted | Median | 95% Confidence Interval | months | From randomization until PD or death (up to 52 months) |
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| Secondary | Overall Survival (OS) | OS was measured as the time from the date of randomization to the date of death. | ITT Population included all participants who were randomized and had post-randomization data. | Posted | Median | 95% Confidence Interval | months | 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 | Percentage of Participants Who Achieve or Maintain Any Best Response Category During the Treatment Period | 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. | ITT Population included all participants who were randomized and had post-randomization data. The percentages are rounded off to the single nearest decimal point. | Posted | Number | percentage of participants | Up to 27 months |
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| Secondary | 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. | ITT Population included all participants who were randomized and had post-randomization data. | Posted | Median | 95% Confidence Interval | months | From randomization until PD or death (up to 52 months) |
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| Secondary | 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 occurred first. | ITT Population included all participants who were randomized and had post-randomization data. | Posted | Median | 95% Confidence Interval | months | From the date of randomization to every 12 weeks until second PD or death (up to 88 months) |
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| Secondary | 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. | ITT Population included all participants who were randomized and had post-randomization data. | Posted | Median | 95% Confidence Interval | months | From randomization until PD or death (up to 52 months) |
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| Secondary | 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. | ITT Population included all participants who were randomized and had post-randomization data. Overall number analyzed is the number of participants with data available for analyses. | Posted | Median | 95% Confidence Interval | months | From randomization until PD or death (up to 52 months) |
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| Secondary | Duration of Next-line Therapy | 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. | ITT Population included all participants who were randomized and had post-randomization data. Overall number analyzed is the number of participants with data available for analyses. | Posted | Median | 95% Confidence Interval | months | From randomization until PD or death (up to 52 months) |
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| Secondary | Percentage of Participants Who Develop a New Primary Malignancy | Safety Population included all participants who received at least 1 dose of ixazomib or placebo. Three placebo participants who erroneously received a single dose of ixazomib were included in the ixazomib arm of the safety population. The percentages are rounded off to the single nearest decimal point. | Posted | Number | percentage of participants | From randomization until PD or death (up to 52 months) |
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| Secondary | Percentage of Participants With Conversion From Minimal Residual Disease (MRD) Positive to MRD Negative | 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. | ITT Population included all participants who were randomized and had post-randomization data. Overall number analyzed is the number of participants with data available for analyses. The percentages are rounded off to the nearest single decimal point. | Posted | Number | percentage of participants | Up to 52 months |
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| Secondary | 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 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. | ITT Population included all participants who were randomized and had post-randomization data. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses for the specified category. | Posted | Median | 95% Confidence Interval | months | From randomization up to 52 months |
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| Secondary | OS in a High-risk Population | 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. | ITT Population included all participants who were randomized and had post-randomization data. Overall number of participants analyzed is the number of participants present in the high-risk group. | Posted | Median | 95% Confidence Interval | months | 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 | PFS in a High-risk Population | 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. | ITT Population included all participants who were randomized and had post-randomization data. Overall number of participants analyzed is the number of participants present in the high-risk group. | Posted | Median | 95% Confidence Interval | months | From randomization until PD or death (up to 52 months) |
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| Secondary | Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | 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. | Safety Population included all participants who received at least 1 dose of ixazomib or placebo. Three placebo participants who erroneously received a single dose of ixazomib were included in the ixazomib arm of the safety population. Overall number of participants analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses for the specified category. | Posted | Mean | Standard Deviation | score on a scale | 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 | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 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. | Safety Population included all participants who received at least 1 dose of ixazomib or placebo. Three placebo participants who erroneously received a single dose of ixazomib were included in the ixazomib arm of the safety population. The percentages were rounded off to the nearest single decimal point. | Posted | Number | percentage of participants | First dose of study drug through 30 days after last dose of study drug (up to 88 months) |
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| Secondary | 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) | 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. | ITT Population included all participants who were randomized and had post-randomization data. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses for the specified time point. | Posted | Mean | Standard Deviation | score on a scale | 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 | 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, 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. | ITT Population included all participants who were randomized and had post-randomization data. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis for the specified category. | Posted | Median | 95% Confidence Interval | months | From randomization up to 52 months |
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| Secondary | Pharmacokinetic Parameter: Plasma Concentration of Ixazomib | 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. | Pharmacokinetic Analysis Population included all participants with at least one pharmacokinetic (PK) sample that was collected and analyzed. Number analyzed is the number of participants with data available for analysis at the specified time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | 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 | Time to Resolution of Peripheral Neuropathy (PN) Events | 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. | Safety Population included all participants who received at least 1 dose of ixazomib or placebo. Overall number of participants analyzed are the number of participants with events. | Posted | Median | 95% Confidence Interval | days | Up to 52 months |
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| Secondary | Time to Improvement of PN Events | 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. | Safety Population included all participants who received at least 1 dose of ixazomib or placebo. Overall number of participants analyzed are the number of participants with events. | Posted | Median | 95% Confidence Interval | days | Up to 52 months |
|
|
First dose of study drug through 30 days after last dose of study drug (up to 88 months)
All-cause mortality= ITT Population included all participants who were randomized and had post-randomization data. Serious and Other Adverse Events: Safety population included all participants who received at least 1 dose of ixazomib or placebo. Three participants assigned to placebo arm each received a single 3 mg dose of ixazomib. These participants were excluded from the placebo arm and included in the ixazomib arm in the safety population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Ixazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26. | 115 | 281 | 48 | 276 | 188 | 276 |
| EG001 | 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. | 184 | 425 | 101 | 426 | 340 | 426 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA 25 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 25 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 25 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 25 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 25 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 25 | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA 25 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 25 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 25 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 25 | Systematic Assessment |
| |
| Carcinoma in situ of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 25 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 25 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 25 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 25 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 25 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 25 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 25 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 25 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 25 | Systematic Assessment |
| |
| Chilaiditi's syndrome | Gastrointestinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 25 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 25 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 25 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 25 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 25 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 25 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA 25 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 25 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 25 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 25 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 25 | Systematic Assessment |
| |
| Gastric disorder | Gastrointestinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 25 | Systematic Assessment |
| |
| Gastroenteritis radiation | Injury, poisoning and procedural complications | MedDRA 25 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Gastrointestinal motility disorder | Gastrointestinal disorders | MedDRA 25 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 25 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 25 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 25 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 25 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 25 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 25 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA 25 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 25 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 25 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Intestinal haemorrhage | Gastrointestinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 25 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 25 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 25 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 25 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 25 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25 | Systematic Assessment |
| |
| Monoparesis | Nervous system disorders | MedDRA 25 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 25 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 25 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 25 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 25 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 25 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25 | Systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 25 | Systematic Assessment |
| |
| Osteolysis | Musculoskeletal and connective tissue disorders | MedDRA 25 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 25 | Systematic Assessment |
| |
| Paraneoplastic pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA 25 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 25 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 25 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 25 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25 | Systematic Assessment |
| |
| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 25 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA 25 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 25 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 25 | Systematic Assessment |
| |
| Rectal prolapse | Gastrointestinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 25 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 25 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 25 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 25 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 25 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 25 | Systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 25 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 25 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25 | Systematic Assessment |
| |
| Subcapsular renal haematoma | Renal and urinary disorders | MedDRA 25 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 25 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 25 | Systematic Assessment |
| |
| Tendon injury | Injury, poisoning and procedural complications | MedDRA 25 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 25 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 25 | Systematic Assessment |
| |
| Transitional cell cancer of the renal pelvis and ureter | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25 | Systematic Assessment |
| |
| Trismus | Musculoskeletal and connective tissue disorders | MedDRA 25 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 25 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25 | Systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA 25 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA 25 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 25 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 25 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 25 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 25 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 20, 2019 | Aug 6, 2020 | SAP_000.pdf |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C548400 | ixazomib |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| China |
|
| Japan |
|
| Singapore |
|
| Korea, Republic Of |
|
| Taiwan, Province Of China |
|
| Thailand |
|
| Austria |
|
| Belgium |
|
| Czech Republic |
|
| Denmark |
|
| France |
|
| Germany |
|
| Greece |
|
| Hungary |
|
| Israel |
|
| Italy |
|
| Poland |
|
| Portugal |
|
| Russia |
|
| Serbia |
|
| South Africa |
|
| Spain |
|
| Sweden |
|
| Switzerland |
|
| Turkey |
|
| United Kingdom |
|
| Argentina |
|
| Brazil |
|
| Chile |
|
| Colombia |
|
| Canada |
|
| Mexico |
|
| United States |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| 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. |
|
|
| OG001 |
| 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. |
|
|
|
|
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.
|
|
|
|
| Participants |
|
|
|