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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1155-8695 | Other Identifier | WHO | |
| 2013-002076-41 | EudraCT Number | ||
| C16019CTIL | Registry Identifier | Israel MOH | |
| NL.47795.029.14 | Registry Identifier | CCMO | |
| 173116 | Registry Identifier | HC-CTD | |
| 1036024001 | Registry Identifier | TCTIN | |
| SNCTP000001745 | Registry Identifier | SNCTP |
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The purpose of this study is to determine the effect of ixazomib citrate maintenance therapy on progression-free survival (PFS), compared to placebo, in participants with newly diagnosed multiple myeloma (NDMM) who have had a response (complete response [CR], very good partial response [VGPR], or partial response [PR]) to induction therapy followed by high-dose therapy (HDT) and autologous stem cell transplant (ASCT).
The investigational drug being tested in this study is called ixazomib citrate. Ixazomib citrate is being tested to slow disease progression and improve overall survival in people who have NDMM and who have had any type of positive response to induction therapy followed by HDT and ASCT. This study will look at the effect ixazomib citrate has on the length of time that participants are free of progressive disease (PD) and their overall survival (OS).
The study enrolled 656 participants. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need, or if the disease has progressed and the information is required for planning the next treatment):
All participants will be asked to take one capsule on Days 1, 8 and 15 of each 28-day cycle, for up to 26 cycles (approximately 24 months).
This multi-center trial will be conducted globally. The overall time to participate in this study is up to 107 months. Participants will make 28 visits to the clinic during the treatment period and will continue to make visits after treatment has ended. During this initial follow up period, participants will be assessed for disease status with follow up every 12 weeks. After the next line of therapy begins, follow-up will occur every 12 weeks until death or termination of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. |
|
| Ixazomib Citrate | Experimental | Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who have had any dose reductions due to adverse events (AEs) would not be dose escalated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ixazomib Citrate | Drug | Ixazomib citrate capsules |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS was defined as the time from the date of randomization to the date of first documentation of PD, as evaluated by an independent review committee (IRC) according to International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurred first. PD was defined as ≥25% increase from lowest value in: serum/urine M component; participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved free light chain (FLC) levels must be >10 milligrams per deciliter (mg/dL); participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must have been ≥10%; new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size increase; hypercalcemia development. | Randomization up to End of treatment (EOT) (24 months); thereafter followed up every 4 weeks (up to 45 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was measured as the time from the date of randomization to the date of death. | Randomization up to end of follow up period (up to 107 months) |
| Percentage of Participants With Any Best Response Category Before PD or Subsequent Therapy |
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Inclusion Criteria:
Adult male or female participants 18 years or older with a confirmed diagnosis of symptomatic multiple myeloma according to standard criteria.
Documented results of cytogenetics/ fluorescence in situ hybridization (FISH) obtained at any time before transplant, and International Staging System (ISS) staging at the time of diagnosis available.
Underwent standard of care (SOC) induction therapy (induction therapy must include proteasome inhibitor (PI) and/or immunomodulating drugs (IMiD)-based regimens as primary therapy for multiple myeloma), followed by a single autologous stem cell transplant (ASCT) with a high-dose melphalan (200 mg/m^2) conditioning regimen, within 12 months of diagnosis. Vincristine, Adriamycin [doxorubicin], and dexamethasone (VAD) is not an acceptable induction therapy for this trial.
Started screening no earlier than 75 days after transplant, completed screening within 15 days, and randomized no later than 115 days after transplant.
Must have not received post-ASCT consolidation therapy.
Documented response to ASCT (PR, VGPR, CR/stringent complete response [sCR]) according to IMWG criteria.
ECOG performance status of 0 to 2.
Female participants 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.
Suitable venous access for the study-required blood sampling.
Is willing and able to adhere to the study visit schedule and other protocol requirements.
Must meet the following clinical laboratory criteria at study entry:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States | ||
| Mayo Clinic - PPDS |
| 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. | |
| 32613281 |
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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 (NDMM) who underwent induction therapy according to regional standard of care (SoC), followed by high-dose melphalan (200 milligrams per meter square [mg/m^2]) and Autologous Stem Cell Transplant (ASCT) were enrolled in a 3:2 ratio to receive ixazomib citrate or placebo.
Participants enrolled at 167 sites globally to take part in this study from 16 July 2014 to 8 September 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until progressive disease (PD), unacceptable toxicity, or discontinuation for alternate reasons. |
| FG001 | Ixazomib Citrate |
| 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 22, 2021 | Sep 6, 2024 |
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| Placebo | Drug | Ixazomib citrate placebo-matching capsules |
|
Response was assessed according to IMWG criteria. Best response includes partial response (PR), very good partial response (VGPR) and complete response (CR). PR as per IMWG criteria is 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to less than (<)200 milligrams (mg) per 24 hours. VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours. CR is negative immunofixation of serum and urine and disappearance of soft tissue plasmacytomas and <5% plasma cells in bone marrow. Stringent CR (sCR) is CR and normal FLC ratio and absence of clonal plasma cells (PCs) by immunohistochemistry or 2- to 4-color flow cytometry. The decimal values of percentages were subjected to rounding off. |
| Randomization up to EOT (up to 24 months) and thereafter every 4 weeks until initiation of the next line of therapy (up to 107 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. PD is defined as ≥25% increase from lowest value in: serum/urine M-component; participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved FLC levels must be >10mg/dL; participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must be ≥10%;new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development. Participants without documentation of PD at the time of analysis were censored at the date of last response assessment that is stable disease or better. | Randomization up to PD (up to 107 months) |
| Second Progression Free Survival (PFS2) | PFS2 is defined as the time from the date of randomization to the date of objective disease progression on next line treatment or death from any cause (whichever occurs first). PD is defined as ≥25% increase from lowest value in: serum/urine M-component; participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved FLC levels must be >10 mg/dL; participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must be ≥10%; new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development. | Randomization up to EOT (24 months); thereafter followed up every 4 weeks until initiation of next-line therapy and then every 12 weeks until second progressive disease (PD2) or death (up to 107 months) |
| Time to Start of the Next Line of Therapy | Time to start of the next line of therapy was defined as the time from the date of randomization to the date of initiation dose of the next line of antineoplastic therapy following study treatment or death due to any cause, whichever occurred first. Participants who never took antineoplastic therapy were censored at the date of last contact or death. | Randomization up to 107 months |
| Time to End of the Next Line of Therapy | Time to end of the next line of therapy was 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 or death due to any cause, whichever occurred first or date of last contact for participants who never took antineoplastic therapy. | Randomization up to 107 months |
| Duration of the Next Line of Therapy | Duration of the next line of therapy was defined as the time from the date of the first dose of the next line of therapy to the date of the last dose of the next antineoplastic therapy following study treatment or death due to any cause, whichever occurred first. Duration of the next line of therapy was analyzed on those participants who received the next line of therapy following the study treatment and duration was summarized using Kaplan-Meier method. | Up to 107 months |
| Percentage of Participants Who Develop a New Primary Malignancy | The decimal values of percentages were subjected to rounding off. | Up to 107 months |
| Number of Participants With Conversion to Minimal Residual Disease (MRD) Negative | MRD negativity (MRD-) is defined as absence of MRD and MRD positivity (MRD+) is defined as presence of MRD. The conversion rate from MRD positive to MRD negative was assessed and reported. Bone marrow aspirates and blood samples were sent to a central laboratory and were assessed for MRD using flow cytometry and a sequencing methodology. | Baseline up to EOT (up to 24 months) |
| Number of Participants With Maintenance of MRD Negativity | MRD negativity is defined as absence of MRD and MRD positivity is defined as presence of MRD. The maintenance of MRD negativity up to the end of treatment was assessed and reported in participants converting from MRD+ at Baseline to MRD negative. Bone marrow aspirates and blood samples were sent to a central laboratory and were assessed for MRD using flow cytometry and a sequencing methodology. | Up to EOT (up to 24 months) |
| Correlation Between MRD Status and Progression Free Survival (PFS) | PFS is defined as the time from the date of randomization to the date of first documentation of PD as evaluated by an IRC according to IMWG criteria, or death due to any cause, whichever occurred first, assessed for up to 107 months in this outcome measure. | From randomization up to 107 months |
| Correlation Between MRD Status and Overall Survival (OS) | OS was measured as the time from the date of randomization to the date of death, assessed for up to 107 months in this outcome measure. | From randomization up to 107 months |
| OS Benefits in a High-Risk Population | High-risk population included but was not limited to participants carrying deletion (del)17, t(4:14), t(14:16), amplification (ampl) 1q, del13, or del1p. OS was measured as the time from the date of randomization to the date of death. | Randomization up to 107 months |
| PFS Benefits in a High-Risk Population | High-risk population included but not be limited to participants carrying deletion (del)17, t(4:14), t(14:16), amplification (ampl) 1q, del13, or del1p. PFS was defined as the time from the date of randomization to the date of first documentation of PD, as evaluated by an independent review committee according to IMWG criteria, or death due to any cause (whichever occurs first). PD is defined as ≥25% increase from lowest value in: serum/urine M-component; participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved FLC levels must be >10mg/dL; participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must be ≥10%;new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development. | Randomization up to 107 months |
| Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status Score | 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 scores indicate improvement. | Baseline up to EOT (up to Month 24) |
| Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) or Serious Adverse Events (SAEs) | An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation subject administered a drug. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. A TEAE was defined as an AE that started or worsened after first study drug administration and within 30 days of last dose of study drug. An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, was a congenital abnormality or birth defect, an important medical event. | Up to 107 months |
| Number of Participants With Markedly Abnormal Clinical Laboratory Values Reported as TEAEs | Laboratory tests included chemistry, hematology and urinalysis. Abnormal laboratory value was assessed as an AE if the value led to discontinuation or delay in treatment, dose modification, therapeutic intervention, or was considered by the investigator to be a clinically significant change from baseline. A TEAE was defined as an AE that started or worsened after first study drug administration and within 30 days of last dose of study drug. | Up to 107 months |
| Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Domain Score | The EORTC QLQ-C30 is a 30-item questionnaire used to assess the health-related quality of life of cancer patients. GHS/QoL domain is based on questions 29 ("How would you rate your overall health during the past week?") and 30 ("How would you rate your overall quality of life during the past week?") of the EORTC QLQ-C30 where the study participants' self-reported responses to the questions on a 7-point scale (1=very poor to 7=excellent). The raw GHS/QoL domain scores were linearly transformed to a scale ranging 0 (worse outcome) to 100 (best outcome), with higher scores indicating better quality of life. The change from baseline in EORTC QLQ-C30 GHS/QoL domain was evaluated by treatment group. | Baseline up to EOT (up to Month 24) |
| 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. | Day 1 of Cycle 1: 1 hour and 4 hours post-dose; Predose on Days 8 and 15 of Cycle 1, Days 1 and 8 of Cycle 2, Day 1 of Cycles 3 through 10 (each cycle length= 28 days) |
| Time to Resolution of Peripheral Neuropathy (PN) Events | Peripheral neuropathy is defined as the TEAE in the high-level term of peripheral neuropathies not elsewhere classified (NEC) according to Medical Dictionary for Regulatory Activities (MedDRA). A PN event is considered as improved if the event improves from the maximum grade. That is, all the grades recorded after the maximum grade is less than the maximum grade. Time to improvement is defined as the time from the initial onset date (inclusive) of the maximum grade to the first onset date that the toxicity grade is below the maximum grade with no higher grade thereafter, or the resolution date, whichever occurs first. | Up to 107 months |
| Time to Improvement of PN Events | PN is defined as the treatment-emergent adverse event in the high-level term of peripheral neuropathies not elsewhere classified (NEC) according to the Medical Dictionary for Regulatory Activities (MedDRA). A PN event is considered as resolved if its final outcome is resolved with no subsequent PN event of the same preferred term occurring on the resolution date or the day before and after. A PN event is considered as improved if the event improves from the maximum grade. That is, all the grades recorded after the maximum grade is less than the maximum grade. Time to improvement is defined as the time from the initial onset date (inclusive) of the maximum grade to the first onset date that the toxicity grade is below the maximum grade with no higher grade thereafter, or the resolution date, whichever occurs first. | Up to 107 months |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| West Virginia University Hospital | Morgantown | West Virginia | 26506 | United States |
| Hospital Italiano de La Plata | La Plata | Buenos Aires | B1900AX | Argentina |
| Instituto de Hematologia Y Medicina Clinica Dr Ruben Davoli | Rosario | Santa Fe Province | 2000 | Argentina |
| Sanatorio Britanico de Rosario | Rosario | Santa Fe Province | S2000CVB | Argentina |
| Sanatorio Parque de Rosario | Rosario | Santa Fe Province | S2000DSV | Argentina |
| Hospital Italiano de Buenos Aires | Buenos Aires | C1181ACH | Argentina |
| Hospital Iturraspe | Santa Fe | S3006FTP | Argentina |
| St George Hospital | Kogarah | New South Wales | 2217 | Australia |
| Calvary Mater Newcastle | Waratah | New South Wales | 2298 | Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Icon Cancer Care South Brisbane | South Brisbane | Queensland | 4101 | Australia |
| Gold Coast University Hospital | Southport | Queensland | 4215 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| The Queen Elizabeth Hospital | Woodville South | South Australia | 5011 | Australia |
| Austin Health | Heidelberg | Victoria | 3084 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Elisabethinen Hospital Linz | Linz | 4020 | Austria |
| Salzburger Landeskliniken | Salzburg | 5020 | Austria |
| Allgemeines Krankenhaus der Stadt Wien | Vienna | 1090 | Austria |
| Klinik Ottakring (fruher: Wilhelminenspital) | Vienna | 1160 | Austria |
| Centre Hospitalier Jolimont-Lobbes | La Louvière | Hainaut | 7100 | Belgium |
| Centre Hospitalier Universitaire Ambroise Pare | Mons | Hainaut | 7000 | Belgium |
| UZ Gent | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| AZ Sint-Jan AV | Bruges | West-Vlaanderen | 8000 | Belgium |
| ZNA Middelheim | Antwerp | 2020 | Belgium |
| ZNA Stuivenberg | Antwerp | 2060 | Belgium |
| Hospital Das Clinicas Da Universidade Federal de Minas Gerais | Belo Horizonte | Minas Gerais | 30130-100 | Brazil |
| Instituto de Oncologia Do Parana | Curitiba | Paraná | 80530-010 | Brazil |
| Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner | Curitiba | Paraná | 81520-060 | Brazil |
| Hospital de Clinicas de Passo Fundo | Passo Fundo | Rio Grande do Sul | 99010-260 | 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 |
| Centro de Pesquisas Oncologicas | Florianópolis | Santa Catarina | 88034000 | Brazil |
| Instituto Joinvilense de Hematologia E Oncologia | Joinville | Santa Catarina | 89201-260 | Brazil |
| Hospital Amaral Carvalho | Jaú | São Paulo | 17210-080 | Brazil |
| Hospital de Base Da FAMERP | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Instituto Nacional de Cancer | Rio de Janeiro | 20231-050 | Brazil |
| Universidade Federal do Rio de Janeiro - UFRJ | Rio de Janeiro | 21941-913 | Brazil |
| Irmandade Da Santa Casa de Misericordia de Sao Paulo | São Paulo | 01223-001 | Brazil |
| Hospital Israelita Albert Einstein | São Paulo | 05651-901 | Brazil |
| Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo | São Paulo | 5403000 | Brazil |
| University Health Network | Toronto | Ontario | M5G 2N2 | Canada |
| MUHC-Glen Site | Montreal | Quebec | H4A 3J1 | Canada |
| Instituto Nacional de Cancerologia Colombia | Bogota | Cundinamarca | Colombia |
| Fundacion Valle Del Lili | Cali | Valle del Cauca Department | Colombia |
| Hospital Pablo Tobon Uribe | Medellín | Colombia |
| Fakultni nemocnice Hradec Kralove | Hradec Králové | Kralovehradeck Kraj | 500 05 | Czechia |
| Fakultni nemocnice Brno | Brno | 625 00 | Czechia |
| Fakultni nemocnice Olomouc | Olomouc | 779 00 | Czechia |
| Fakultni nemocnice Ostrava | Ostrava | 708 52 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady | Prague | 100 34 | Czechia |
| Vseobecna Fakultni Nemocnice V Praze | Prague | 128 08 | Czechia |
| Herlev Hospital | Herlev | Capital | 2730 | Denmark |
| Aalborg Universitetshospital | Aalborg | North Denmark | DK-9000 | Denmark |
| Aarhus Universitetshospital Arhus Sygehus | Aarhus N | DK-8200 | Denmark |
| Rigshospitalet | Copenhagen | 2100 | Denmark |
| Odense Universitetshospital | Odense | 5000 | Denmark |
| Sjallands Universitetshospital, Roskilde | Roskilde | DK-4000 | Denmark |
| Vejle Sygehus | Vejle | DK-7100 | Denmark |
| Hopital Antoine Beclere | Clamart | Hauts-de-Seine | 92140 | France |
| Hotel Dieu - Nantes | Nantes | Loire-Atlantique | 44093 | France |
| CHRU Lille | Lille | Nord | 59037 | France |
| Hopital Universitaire Dupuytren | Limoges | 87042 | France |
| Groupe Hospitalier Necker Enfants Malades | Paris | 75015 | France |
| University Clinic Heidelberg | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| Klinikum Mannheim Universitatsklinikum gGmbH | Mannheim | Baden-Wurttemberg | 68167 | Germany |
| Universitatsklinikum Ulm | Ulm | Baden-Wurttemberg | 89081 | Germany |
| LMU Klinikum der Universitat Munchen | München | Bavaria | 81377 | Germany |
| Universitatsklinikum Wurzburg | Würzburg | Bavaria | 97080 | Germany |
| Klinikum Darmstadt GmbH | Darmstadt | Hesse | 64283 | Germany |
| Klinikum Frankfurt Hochst GmbH | Frankfurt am Main | Hesse | 65929 | Germany |
| Pius Hospital Oldenburg | Oldenburg | Lower Saxony | 26121 | Germany |
| Universitatsklinikum Bonn | Bonn | North Rhine-Westphalia | 53105 | Germany |
| Uniklinik Koln | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Universitatsklinikum Essen | Essen | North Rhine-Westphalia | 45122 | Germany |
| Evangelisches Krankenhaus Essen Werden gGmbH | Essen | North Rhine-Westphalia | 45239 | Germany |
| Katholisches Krankenhaus Hagen gGmbH | Hagen | North Rhine-Westphalia | 58095 | Germany |
| Universitatsmedizin der Johannes Gutenberg-Universitat Mainz | Mainz | Rhineland-Palatinate | 55131 | Germany |
| Universitatsklinikum Carl Gustav Carus an der TU Dresden | Dresden | Saxony | 1307 | Germany |
| Helios Klinikum Berlin-Buch | Berlin | 13125 | Germany |
| Charite - Universitatsmedizin Berlin | Berlin | 13353 | Germany |
| Asklepios Klinik St. Georg | Hamburg | 20099 | Germany |
| Universitatsklinikum Hamburg Eppendorf | Hamburg | 20246 | Germany |
| Asklepios Klinik Altona | Hamburg | 22763 | Germany |
| KRH Klinikum Siloah-Oststadt-Heidehaus | Hanover | 30459 | Germany |
| Klinikum der Stadt Ludwigshafen gGmbH | Ludwigshafen | 67063 | Germany |
| Universitatsklinikum Tubingen | Tübingen | 72076 | Germany |
| Evangelismos General Hospital of Athens | Athens | Attica | 10676 | Greece |
| Laiko General Hospital of Athens | Athens | Attica | 11527 | Greece |
| Alexandra Hospital | Athens | 11528 | Greece |
| Georgios Papanikolaou General Hospital of Thessaloniki | Thessaloniki | 57010 | Greece |
| Semmelweis Egyetem | Budapest | 1083 | Hungary |
| Del-pesti Centrumkorhaz- Orszagos Hematologiai es Infektologiai Intezet | Budapest | 1097 | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | 4032 | Hungary |
| Somogy Megyei Kaposi Mor Oktato Korhaz | Kaposvár | 7400 | Hungary |
| Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont | Szeged | 6725 | Hungary |
| Barzilai Medical Center | Ashkelon | 78278 | Israel |
| Soroka University Medical Centre | Beersheba | 84101 | Israel |
| Bnai Zion Medical Center | Haifa | 31048 | Israel |
| Rambam Medical Center - PPDS | Haifa | 31096 | Israel |
| Lady Davis Carmel Medical Center | Haifa | 34362 | Israel |
| Shaare Zedek Medical Center | Jerusalem | 91031 | Israel |
| Hadassah Medical Center PPDS - | Jerusalem | 91120 | Israel |
| Galilee Medical Center | Nahariya | 22100 | Israel |
| Rabin Medical Center - PPDS | Petah Tikva | 49100 | Israel |
| Sheba Medical Center - PPDS | Ramat Gan | 52621 | Israel |
| Kaplan Medical Center | Rehovot | 76100 | Israel |
| ZIV Medical Center | Safed | 13100 | Israel |
| Tel Aviv Sourasky Medical Center PPDS | Tel Aviv | 64239 | Israel |
| Shamir Medical Center Assaf Harofeh | Tzrifin | 70300 | Israel |
| Presidio Ospedaliero di Pescara | Pescara | Abruzzo | 65100 | Italy |
| Azienda Ospedaliera San Camillo Forlanini | Rome | Lazio | 152 | Italy |
| Fondazione IRCCS Policlinico San Matteo di Pavia | Pavia | Lombardy | 27100 | Italy |
| Azienda Ospedaliera Citta della Salute e della Scienza di Torino | Turin | Piedmont | 10126 | Italy |
| IRCCS Centro Di Riferimento Oncologico Della Basilicata | Rionero in Vulture | Potenza | 85028 | Italy |
| Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi | Ancona | The Marches | 60020 | Italy |
| Azienda Ospedaliera S Maria Di Terni | Terni | Umbria | 5100 | Italy |
| Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi | Bologna | 40138 | Italy |
| ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN | Brescia | 25123 | Italy |
| Azienda Ospedaliera Universitaria Careggi | Florence | 50134 | Italy |
| IRCCS Az. Osp. Universitaria San Martino- IST | Genova | 16132 | Italy |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l - PPDS | Meldola | 47014 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda | Milan | 20162 | Italy |
| Ospedale Infermi di Rimini | Rimini | 47900 | Italy |
| Kobe City Medical Center General Hospital | Kobe | Hyōgo | 650-0047 | Japan |
| Iwate Medical University Hospital | Morioka | Iwate | 020-8505 | Japan |
| National Hospital Organization Sendai Medical Center | Sendai | Miyagi | 9838520 | Japan |
| Niigata Cancer Center Hospital | Niigata | Niigata | 951-8566 | Japan |
| National Hospital Organization Okayama Medical Center | Okayama | Okayama-ken | 701-1192 | Japan |
| Saitama Medical Center | Kawagoe | Saitama | 350-8550 | Japan |
| Juntendo University Hospital | Bunkyo | Tokyo | 113-8431 | Japan |
| Chiba University Hospital | Chiba | Tokyo | 2608677 | Japan |
| Japanese Red Cross Medical Center | Shibuya-ku | Tokyo | 150-8935 | Japan |
| Center Hospital of the National Center for Global Health and Medicine | Shinjuku | Tokyo | 162-8655 | Japan |
| Keio University Hospital | Shinjuku-ku | Tokyo | 160-8582 | Japan |
| Kyushu University Hospital | Fukuoka | 812-8582 | Japan |
| National Hospital Organization Nagoya Medical Center | Nagoya | 460-0001 | Japan |
| Nagoya City University Hospital | Nagoya | 467-8602 | Japan |
| National Hospital Organaization Shibukawa Medical Center | Shibukawa | 377-0280 | Japan |
| National Hospital Organization Disaster Medical Center | Tachikawa | 1900014 | Japan |
| Toyohashi Municipal Hospital | Toyohashi | 441-8570 | Japan |
| Centro de Investigacion Farmaceutica Especializada de Occidente, SC - PPDS | Guadalajara | Jalisco | 44160 | Mexico |
| Hospital Universitario Dr. Jose Eleuterio Gonzalez | Monterrey | Nuevo León | 64460 | Mexico |
| VU Medisch Centrum | Amsterdam | North Holland | 1081 HV | Netherlands |
| Albert Schweitzer Ziekenhuis | Dordrecht | South Holland | 3318 AT | Netherlands |
| Universitair Medisch Centrum Groningen | Groningen | 9713 GZ | Netherlands |
| Erasmus MC | Rotterdam | 3015 CE | Netherlands |
| Universitair Medisch Centrum Utrecht | Utrecht | 3584 CX | Netherlands |
| Vestre Viken HF Sykehuset Asker Og Barum | Gjelta | Oppland | N-1346 | Norway |
| St. Olav's University Hospital | Trondheim | Sor-Trondelag | N-7030 | Norway |
| Oslo Universitetssykehus HF, Ulleval | Oslo | 450 | Norway |
| Stavanger Universitetssykehus | Stavanger | 4011 | Norway |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu | Wroclaw | Lower Silesian Voivodeship | 50-367 | Poland |
| Wojskowy Instytut Medyczny | Warsaw | Masovian Voivodeship | 04-141 | Poland |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Pomeranian Voivodeship | 80-952 | Poland |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich | Chorzów | Silesian Voivodeship | 41-500 | Poland |
| Szpital Specjalistyczny w Brzozowie | Brzozów | 36-200 | Poland |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi | Lodz | 93-510 | Poland |
| Hospital de Braga | Braga | 4710-243 | Portugal |
| Centro Hospitalar E Universitario de Coimbra EPE | Coimbra | 3000-075 | Portugal |
| Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS | Porto | 4200-072 | Portugal |
| Centro Hospitalar de Sao Joao, E.P.E. | Porto | 4200-319 | Portugal |
| National University Hospital | Singapore | 119074 | Singapore |
| Singapore General Hospital (SGH) | Singapore | 169608 | Singapore |
| Medical Oncology Centre of Rosebank | Johannesburg | Gauteng | 2196 | South Africa |
| Mary Potter Oncology Centre | Pretoria | Gauteng | 181 | South Africa |
| Albert Alberts Stem Cell Transplant Centre | Pretoria | Gauteng | 44 | South Africa |
| National Cancer Center | Goyang | Gyeonggido | 410769 | South Korea |
| Chungnam National University Hospital | Daejeon | 301-721 | South Korea |
| Gachon University Gil Medical Center Pharmacy | Incheon | 405-760 | South Korea |
| Seoul National University Hospital | Seoul | 110744 | 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 |
| Asan Medical Center - PPDS | Seoul | 138-736 | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | 158710 | South Korea |
| Hospital Universitario Germans Trias i Pujol | Badalona | Barcelona | 8916 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | Madrid, Communidad Delaware | 28009 | Spain |
| Clinica Universidad Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 8036 | Spain |
| C.H. Regional Reina Sofia - PPDS | Córdoba | 14004 | Spain |
| Institut Catala d'Oncologia Girona | Girona | 17007 | Spain |
| Hospital Universitario de La Princesa | Madrid | 28006 | Spain |
| Hospital Universitario La Paz - PPDS | Madrid | 28046 | Spain |
| Hospital Universitario HM Sanchinarro CIOCC | Madrid | 28050 | Spain |
| Hospital Universitario Puerta de Hierro - Majadahonda | Madrid | 28222 | Spain |
| Hospital General Universitario Morales Meseguer | Murcia | 30008 | Spain |
| Complejo Asistencial Universitario de Salamanca H. Clinico | Salamanca | 37007 | Spain |
| Hospital Universitario Virgen del Rocio - PPDS | Seville | 41013 | Spain |
| Helsingborg Lasarett | Helsingborg | Skåne County | Sweden |
| Skanes Universitetssjukhus Lund | Lund | Skåne County | Sweden |
| Sahlgrenska Universitetssjukhuset | Gothenburg | Västra Götaland County | Sweden |
| Karolinska Universitetssjukhuset Huddinge | Stockholm | 14186 | Sweden |
| Akademiska Sjukhuset I Uppsala | Uppsala | SE-751 85 | Sweden |
| Universitatsspital Basel | Basel | Basel-Stadt (de) | 4031 | Switzerland |
| Universitatsspital Zurich | Zurich | Zurich (de) | 8091 | Switzerland |
| Kaohsiung Medical University Hospital | Kaohsiung City | 807 | Taiwan |
| Chang Gung Medical Foundation-Kaoshiung Branch | Kaohsiung City | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Chang Gung Medical Foundation Chiayi Chang Gung Memorial Hospital | Taipei | 613 | Taiwan |
| Chang Gung Memorial Hospital, Linkou | Taoyuan City | 333 | Taiwan |
| Chulalongkorn University | Bangkok | Krung Thep Maha Nakhon-Bangkok | 10330 | Thailand |
| Phramongkutklao Hospital | Bangkok | Krung Thep Maha Nakhon-Bangkok | 10400 | Thailand |
| Hacettepe Universitesi Tip Fakultesi Hastanesi | Ankara | 6100 | Turkey (Türkiye) |
| Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi | Ankara | 6200 | Turkey (Türkiye) |
| Ankara University Medical Faculty PPDS | Ankara | Turkey (Türkiye) |
| Pamukkale Universitesi Tip Fakultesi Hastanesi | Denizli | 20070 | Turkey (Türkiye) |
| Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi | Istanbul | 34093 | Turkey (Türkiye) |
| Erciyes Universitesi Tip Fakultesi Hastanesi | Kayseri | 38039 | Turkey (Türkiye) |
| Karadeniz Technical University Faculty of Medicine | Trabzon | 61080 | Turkey (Türkiye) |
| MNPE Kyiv Center of Bone Marrow Transplantation of executive body of Kyiv council | Kyiv | 3115 | Ukraine |
| Southampton General Hospital | Southampton | Hampshire | SO16 6YD | United Kingdom |
| Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre | London | London, City of | EC1A 7BE | United Kingdom |
| Kings College Hospital | London | London, City of | SE5 9RS | United Kingdom |
| Imperial College Healthcare NHS Trust | London | London, City of | W12 0HS | United Kingdom |
| Churchill Hospital | Oxford | Oxfordshire | OX3 7LJ | United Kingdom |
| Royal Marsden Hospital - Surrey | Sutton | Surrey | SM2 5PT | United Kingdom |
| St James University Hospital | Leeds | Yorkshire | LS9 7TF | United Kingdom |
| Royal Hallamshire Hospital | Sheffield | Yorkshire | S10 2JF | United Kingdom |
| University Hospitals Leicester | Leicester | LE1 5WW | United Kingdom |
| University College London Hospitals (UCLH) | London | WC1E 6AG | United Kingdom |
| Singleton Hospital - PPDS | Swansea | United Kingdom |
| Derived |
| Kaiser M, Beksac M, Gulbrandsen N, Schjesvold F, Hajek R, Moreau P, de Arriba de la Fuente F, Mateos MV, West S, Spencer A, Rajkumar SV, Suryanarayan K, Czorniak M, Li C, Teng Z, Labotka R, Dimopoulos MA. Adverse event management in the TOURMALINE-MM3 study of post-transplant ixazomib maintenance in multiple myeloma. Ann Hematol. 2020 Aug;99(8):1793-1804. doi: 10.1007/s00277-020-04149-5. Epub 2020 Jul 1. |
| 31880006 | Derived | Schjesvold F, Goldschmidt H, Maisnar V, Spicka I, Abildgaard N, Rowlings P, Cain L, Romanus D, Suryanarayan K, Rajkumar V, Odom D, Gnanasakthy A, Dimopoulos M. Quality of life is maintained with ixazomib maintenance in post-transplant newly diagnosed multiple myeloma: The TOURMALINE-MM3 trial. Eur J Haematol. 2020 May;104(5):443-458. doi: 10.1111/ejh.13379. Epub 2020 Feb 22. |
| 30545780 | Derived | Dimopoulos MA, Gay F, Schjesvold F, Beksac M, Hajek R, Weisel KC, Goldschmidt H, Maisnar V, Moreau P, Min CK, Pluta A, Chng WJ, Kaiser M, Zweegman S, Mateos MV, Spencer A, Iida S, Morgan G, Suryanarayan K, Teng Z, Skacel T, Palumbo A, Dash AB, Gupta N, Labotka R, Rajkumar SV; TOURMALINE-MM3 study group. Oral ixazomib maintenance following autologous stem cell transplantation (TOURMALINE-MM3): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2019 Jan 19;393(10168):253-264. doi: 10.1016/S0140-6736(18)33003-4. Epub 2018 Dec 10. |
Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to adverse events (AEs) were not dose escalated. |
| Intent-to-Treat (ITT) Population |
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| Safety Population |
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| Per Protocol (PP) Population |
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| COMPLETED |
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| NOT COMPLETED |
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Intent-to-Treat (ITT) population was defined as all participants who were randomized and had post randomization data.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. |
| BG001 | Ixazomib Citrate | Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to AEs were not dose escalated. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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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| Age, Customized | Count of Participants | Participants |
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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/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Height | Number analyzed is the number of participants with available height data. | Mean | Standard Deviation | cm |
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| Weight | Number analyzed is the number of participants with available weight data. | Mean | Standard Deviation | kg |
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| Body Surface Area (BSA) | Number analyzed is the number of participants with available BSA data. | Mean | Standard Deviation | m^2 |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Progression Free Survival (PFS) | PFS was defined as the time from the date of randomization to the date of first documentation of PD, as evaluated by an independent review committee (IRC) according to International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurred first. PD was defined as ≥25% increase from lowest value in: serum/urine M component; participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved free light chain (FLC) levels must be >10 milligrams per deciliter (mg/dL); participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must have been ≥10%; new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size increase; hypercalcemia development. | Intent-to-Treat (ITT) population was defined as all participants who were randomized and had post randomization data. | Posted | Median | 95% Confidence Interval | months | Randomization up to End of treatment (EOT) (24 months); thereafter followed up every 4 weeks (up to 45 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 was defined as all participants who were randomized and had post randomization data. | Posted | Median | 95% Confidence Interval | months | Randomization up to end of follow up period (up to 107 months) |
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| Secondary | Percentage of Participants With Any Best Response Category Before PD or Subsequent Therapy | Response was assessed according to IMWG criteria. Best response includes partial response (PR), very good partial response (VGPR) and complete response (CR). PR as per IMWG criteria is 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to less than (<)200 milligrams (mg) per 24 hours. VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours. CR is negative immunofixation of serum and urine and disappearance of soft tissue plasmacytomas and <5% plasma cells in bone marrow. Stringent CR (sCR) is CR and normal FLC ratio and absence of clonal plasma cells (PCs) by immunohistochemistry or 2- to 4-color flow cytometry. The decimal values of percentages were subjected to rounding off. | ITT population was defined as all participants who were randomized and had post randomization data. | Posted | Number | percentage of participants | Randomization up to EOT (up to 24 months) and thereafter every 4 weeks until initiation of the next line of therapy (up to 107 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. PD is defined as ≥25% increase from lowest value in: serum/urine M-component; participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved FLC levels must be >10mg/dL; participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must be ≥10%;new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development. Participants without documentation of PD at the time of analysis were censored at the date of last response assessment that is stable disease or better. | ITT Population was defined as all participants who were randomized and had post randomization data. | Posted | Median | 95% Confidence Interval | months | Randomization up to PD (up to 107 months) |
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| Secondary | Second Progression Free Survival (PFS2) | PFS2 is defined as the time from the date of randomization to the date of objective disease progression on next line treatment or death from any cause (whichever occurs first). PD is defined as ≥25% increase from lowest value in: serum/urine M-component; participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved FLC levels must be >10 mg/dL; participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must be ≥10%; new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development. | ITT population was defined as all participants who were randomized and had post randomization data. | Posted | Median | 95% Confidence Interval | months | Randomization up to EOT (24 months); thereafter followed up every 4 weeks until initiation of next-line therapy and then every 12 weeks until second progressive disease (PD2) or death (up to 107 months) |
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| Secondary | Time to Start of the Next Line of Therapy | Time to start of the next line of therapy was defined as the time from the date of randomization to the date of initiation dose of the next line of antineoplastic therapy following study treatment or death due to any cause, whichever occurred first. Participants who never took antineoplastic therapy were censored at the date of last contact or death. | ITT population was defined as all participants who were randomized and had post randomization data. | Posted | Median | 95% Confidence Interval | months | Randomization up to 107 months |
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| Secondary | Time to End of the Next Line of Therapy | Time to end of the next line of therapy was 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 or death due to any cause, whichever occurred first or date of last contact for participants who never took antineoplastic therapy. | ITT Population was defined as all participants who were randomized and had post randomization data. | Posted | Median | 95% Confidence Interval | months | Randomization up to 107 months |
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| Secondary | Duration of the Next Line of Therapy | Duration of the next line of therapy was defined as the time from the date of the first dose of the next line of therapy to the date of the last dose of the next antineoplastic therapy following study treatment or death due to any cause, whichever occurred first. Duration of the next line of therapy was analyzed on those participants who received the next line of therapy following the study treatment and duration was summarized using Kaplan-Meier method. | ITT Population was defined as all participants who were randomized and had post randomization data. Overall number of participants analyzed indicates the number of participants who started next line of therapy. | Posted | Median | 95% Confidence Interval | months | Up to 107 months |
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| Secondary | Percentage of Participants Who Develop a New Primary Malignancy | The decimal values of percentages were subjected to rounding off. | Safety Population was defined as participants who received at least 1 dose of ixzaomib citrate or placebo. | Posted | Number | percentage of participants | Up to 107 months |
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| Secondary | Number of Participants With Conversion to Minimal Residual Disease (MRD) Negative | MRD negativity (MRD-) is defined as absence of MRD and MRD positivity (MRD+) is defined as presence of MRD. The conversion rate from MRD positive to MRD negative was assessed and reported. Bone marrow aspirates and blood samples were sent to a central laboratory and were assessed for MRD using flow cytometry and a sequencing methodology. | ITT population was defined as all participants who were randomized and had post randomization data. Overall number of participants analyzed indicates the number of participants with MRD+ at Baseline. | Posted | Count of Participants | Participants | Baseline up to EOT (up to 24 months) |
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| Secondary | Number of Participants With Maintenance of MRD Negativity | MRD negativity is defined as absence of MRD and MRD positivity is defined as presence of MRD. The maintenance of MRD negativity up to the end of treatment was assessed and reported in participants converting from MRD+ at Baseline to MRD negative. Bone marrow aspirates and blood samples were sent to a central laboratory and were assessed for MRD using flow cytometry and a sequencing methodology. | ITT population was defined as all participants who were randomized and had post randomization data. Overall number analyzed is the number of participants who converted from MRD+ at Baseline to MRD negative. | Posted | Count of Participants | Participants | Up to EOT (up to 24 months) |
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| Secondary | Correlation Between MRD Status and Progression Free Survival (PFS) | PFS is defined as the time from the date of randomization to the date of first documentation of PD as evaluated by an IRC according to IMWG criteria, or death due to any cause, whichever occurred first, assessed for up to 107 months in this outcome measure. | ITT population was defined as 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 indicates the number of participants available for analysis in the specified category. | Posted | Median | 95% Confidence Interval | months | From randomization up to 107 months |
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| Secondary | Correlation Between MRD Status and Overall Survival (OS) | OS was measured as the time from the date of randomization to the date of death, assessed for up to 107 months in this outcome measure. | ITT population was defined as 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 indicates the number of participants available for analysis in the specified category. | Posted | Median | 95% Confidence Interval | months | From randomization up to 107 months |
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| Secondary | OS Benefits in a High-Risk Population | High-risk population included but was not limited to participants carrying deletion (del)17, t(4:14), t(14:16), amplification (ampl) 1q, del13, or del1p. OS was measured as the time from the date of randomization to the date of death. | ITT population was defined as all participants who were randomized and had post randomization data. Overall number analyzed is the number of participants present in the high-risk group. | Posted | Median | 95% Confidence Interval | months | Randomization up to 107 months |
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| Secondary | PFS Benefits in a High-Risk Population | High-risk population included but not be limited to participants carrying deletion (del)17, t(4:14), t(14:16), amplification (ampl) 1q, del13, or del1p. PFS was defined as the time from the date of randomization to the date of first documentation of PD, as evaluated by an independent review committee according to IMWG criteria, or death due to any cause (whichever occurs first). PD is defined as ≥25% increase from lowest value in: serum/urine M-component; participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved FLC levels must be >10mg/dL; participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must be ≥10%;new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development. | ITT population was defined as 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 | Randomization up to 107 months |
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| Secondary | Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status Score | 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 scores indicate improvement. | Safety population was defined as participants who received at least 1 dose of ixazomib citrate or placebo. Overall number of participants analyzed indicates the number of participants with data available for analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to EOT (up to Month 24) |
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| Secondary | Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) or Serious Adverse Events (SAEs) | An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation subject administered a drug. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. A TEAE was defined as an AE that started or worsened after first study drug administration and within 30 days of last dose of study drug. An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, was a congenital abnormality or birth defect, an important medical event. | Safety Population was defined as participants who received at least 1 dose of ixazomib citrate or placebo. | Posted | Count of Participants | Participants | Up to 107 months |
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| Secondary | Number of Participants With Markedly Abnormal Clinical Laboratory Values Reported as TEAEs | Laboratory tests included chemistry, hematology and urinalysis. Abnormal laboratory value was assessed as an AE if the value led to discontinuation or delay in treatment, dose modification, therapeutic intervention, or was considered by the investigator to be a clinically significant change from baseline. A TEAE was defined as an AE that started or worsened after first study drug administration and within 30 days of last dose of study drug. | Safety Population was defined as participants who received at least 1 dose of ixazomib citrate or placebo. | Posted | Count of Participants | Participants | Up to 107 months |
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| Secondary | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Domain Score | The EORTC QLQ-C30 is a 30-item questionnaire used to assess the health-related quality of life of cancer patients. GHS/QoL domain is based on questions 29 ("How would you rate your overall health during the past week?") and 30 ("How would you rate your overall quality of life during the past week?") of the EORTC QLQ-C30 where the study participants' self-reported responses to the questions on a 7-point scale (1=very poor to 7=excellent). The raw GHS/QoL domain scores were linearly transformed to a scale ranging 0 (worse outcome) to 100 (best outcome), with higher scores indicating better quality of life. The change from baseline in EORTC QLQ-C30 GHS/QoL domain was evaluated by treatment group. | ITT Population was defined as all participants who were randomized and had post randomization data. Overall number of participants analyzed indicates the number of participants with data available for analysis. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline up to EOT (up to Month 24) |
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| Secondary | 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. | The Pharmacokinetic (PK) Analysis Population was defined as participants with at least one PK sample that was collected and analyzed. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Day 1 of Cycle 1: 1 hour and 4 hours post-dose; Predose on Days 8 and 15 of Cycle 1, Days 1 and 8 of Cycle 2, Day 1 of Cycles 3 through 10 (each cycle length= 28 days) |
|
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| Secondary | Time to Resolution of Peripheral Neuropathy (PN) Events | Peripheral neuropathy is defined as the TEAE in the high-level term of peripheral neuropathies not elsewhere classified (NEC) according to Medical Dictionary for Regulatory Activities (MedDRA). A PN event is considered as improved if the event improves from the maximum grade. That is, all the grades recorded after the maximum grade is less than the maximum grade. Time to improvement is defined as the time from the initial onset date (inclusive) of the maximum grade to the first onset date that the toxicity grade is below the maximum grade with no higher grade thereafter, or the resolution date, whichever occurs first. | Safety population was defined as participants who received at least 1 dose of ixazomib citrate or placebo. Overall number of participants analyzed indicates the number of participants with peripheral neuropathy events. | Posted | Median | 95% Confidence Interval | days | Up to 107 months |
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| Secondary | Time to Improvement of PN Events | PN is defined as the treatment-emergent adverse event in the high-level term of peripheral neuropathies not elsewhere classified (NEC) according to the Medical Dictionary for Regulatory Activities (MedDRA). A PN event is considered as resolved if its final outcome is resolved with no subsequent PN event of the same preferred term occurring on the resolution date or the day before and after. A PN event is considered as improved if the event improves from the maximum grade. That is, all the grades recorded after the maximum grade is less than the maximum grade. Time to improvement is defined as the time from the initial onset date (inclusive) of the maximum grade to the first onset date that the toxicity grade is below the maximum grade with no higher grade thereafter, or the resolution date, whichever occurs first. | Safety population was defined as participants who received at least 1 dose of ixazomib citrate or placebo. Overall number of participants analyzed indicates number of participants with peripheral neuropathy events. | Posted | Median | 95% Confidence Interval | days | Up to 107 months |
|
Randomization up to end of follow up period (107 months)
All cause-mortality: ITT Population was defined as all participants who were randomized and had post randomization data. Serious and Other Adverse Events: Safety Population was defined as participants who received at least 1 dose of ixazomib citrate or placebo.
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 citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. | 93 | 261 | 51 | 259 | 229 | 259 |
| EG001 | Ixazomib Citrate | Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to AEs were not dose escalated. | 144 | 395 | 108 | 394 | 371 | 394 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Ankylosing spondylitis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Bone contusion | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA 26.0 | Systematic Assessment |
| |
| Diaphragmatic hernia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Herpes zoster disseminated | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Influenza B virus test positive | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Kyphosis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Light chain analysis increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Metapneumovirus infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Periodontal disease | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Picornavirus infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Plasma cell leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumococcal sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia parainfluenzae viral | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia streptococcal | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Radicular pain | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Ulnar nerve injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 31, 2018 | Apr 15, 2019 | 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
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| Korea, Republic Of |
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| Taiwan, Province Of China |
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Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to AEs were not dose escalated.
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Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to AEs were not dose escalated.
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| Units | Counts |
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| Participants |
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Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to AEs were not dose escalated.
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