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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004742-28 | EudraCT Number | ||
| U1111-1188-2677 | Other Identifier | WHO | |
| 2017/1235 | Registry Identifier | Norwegian Medicines Agency | |
| N-20170083 | Registry Identifier | Danish Medicines Agency | |
| 17/NW/0546 | Registry Identifier | NRES |
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The main aim of this study is to learn if ixazomib, given with dexamethasone, stops the cancer from getting worse in people with relapsed or refractory multiple myeloma. It will be compared to another medicine called pomalidomide, given with dexamethasone with people with the same condition. Relapsed means the previous cancer treatment stopped working, over time. Refractory means they did not respond to previous cancer treatment. Another aim is to check for side effects from the study medicines.
At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 treatments by chance.
All participants will take their study medicine on specific days during a 28-day cycle.
The 1st dose of study medicines in each 28-day cycle will take place in the clinic, The other doses of the study medicines will be taken at home. This will happen for 6 cycles. After this, all study medicines will be taken at home.
After treatment, participants will visit the clinic every 12 weeks for a check-up.
If participants cannot attend their clinic for an important reason (for example, due to the COVID-19 pandemic), the clinic will make alternative arrangements using their local procedures.
The drug being tested in this study is called Ixazomib. Ixazomib is being tested to treat people who have relapsed and/or refractory multiple myeloma (RRMM). This study will compare the efficacy and safety in participants who take ixazomib and dexamethasone to pomalidomide and dexamethasone. It is an open-label, Phase 2 study.
The study will enroll approximately 120 participants. Participants will receive:
All participants will be asked to take either ixazomib plus dexamethasone (in cases where only 4 mg tablets for dexamethasone are available, the following dexamethasone schedule is recommended for participants aged >=75 years: 12 mg dexamethasone will be given on Days 1, 8, 15, and 22 of every 28-day cycle; and 8 mg dexamethasone will be given on Days 2, 9, 16, and 23 of every 28-day cycle) or pomalidomide 4 mg + dexamethasone 40 mg at recommended doses.
This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 28 months after the first participant enters the study.
Participants will make multiple visits to the clinic, and will be contacted for progression free-survival (PFS) follow-up, in case of study drug discontinuation for up to 4 years from first dose administration. After disease progression, participants will be followed-up for overall survival (OS) every 12 weeks until death or up to 4 years.
Alternative methods for administering study procedures/assessments may be considered when it is not possible for the participants to come to the study site due to extenuating circumstances (e.g., due to the COVID-19 pandemic).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pomalidomide 4 mg + Dexamethasone 40 mg | Active Comparator | Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged >=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years. |
|
| Ixazomib 4 mg + Dexamethasone 20 mg | Experimental | Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged >=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ixazomib | Drug | Ixazomib capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS: Time from randomization to first occurrence of confirmed progressive disease (PD) as assessed by investigator by International Myeloma Working Group(IMWG) response criteria/death from any cause, whichever occurs first. PD requires following: Increase of >=25 % from nadir in: Serum M component (increase must be >=0.5 gram per deciliter [g/dl]); Urine M-component (increase must be >=200 milligram [mg]/24-hour); In participants without measurable serum and urine M-protein levels difference between involved and uninvolved free light chain (FLC) increase of >10 mg/dl; In participants without measurable serum and urine M protein levels and without measurable disease by FLC level: bone marrow plasma cell percentage must be >=10%; Development of new/increase in size of existing bone lesions/soft tissue plasmacytomas; development of hypercalcemia (>11.5mg/dL corrected serum calcium) attributed solely to plasma cell proliferative disease. | From date of randomization until first occurrence of confirmed disease progression or death due to any cause, whichever occurs first (Up to approximately 3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time from randomization to death from any cause, up to 3 years are reported. | From date of randomization to death due to any cause (Up to approximately 3 years) |
| Percentage of Participants With Overall Response |
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Inclusion Criteria:
Must have a confirmed diagnosis of multiple myeloma (MM) requiring therapy according to International Myeloma Working Group (IMWG) criteria.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Must have had a relapse or progressive disease (PD) after having received 2 or more prior lines of systemic therapy. Note: A line of therapy is defined as 1 or more cycles of a planned treatment program; this may consist of 1 or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner. For example, a planned treatment approach of induction therapy followed by autologous stem cell transplantation (SCT), followed by maintenance is considered 1 line of therapy. Typically each line of therapy is separated by PD. Discussion with the medical monitor may help clarify the number of lines of therapy that a prospective study participant had.
Must be refractory to lenalidomide, defined as having received at least 2 consecutive cycles of lenalidomide as a single agent or within a lenalidomide-containing regimen and having had PD during treatment with or within 60 days after the last dose of lenalidomide. The starting dose of lenalidomide should have been 25 mg (or as low as 10 mg in the case of renal function impairment or other safety concern), and the final dose should have been a minimum of 10 mg.
Must have received at least 2 consecutive cycles of a bortezomib- or carfilzomib-containing regimen, and either:
Must have measurable disease defined by:
Suitable venous access for the study-required blood sampling, including pharmacokinetic (PK) sampling.
Recovered (that is, less than or equal to [<=] Grade 1 nonhematologic toxicity) from the reversible effects of prior anticancer therapy.
Must be willing and able to adhere to pomalidomide-related risk mitigation activities if randomized to the pom+dex arm (example, Risk Evaluation and Mitigation Strategies [REMS], pregnancy prevention programs).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | United States | ||
| St Joseph Heritage Healthcare |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35075109 | Derived | Dimopoulos MA, Schjesvold F, Doronin V, Vinogradova O, Quach H, Leleu X, Montes YG, Ramasamy K, Pompa A, Levin MD, Lee C, Mellqvist UH, Fenk R, Demarquette H, Sati H, Vorog A, Labotka R, Du J, Darif M, Kumar S. Oral ixazomib-dexamethasone vs oral pomalidomide-dexamethasone for lenalidomide-refractory, proteasome inhibitor-exposed multiple myeloma: a randomized Phase 2 trial. Blood Cancer J. 2022 Jan 24;12(1):9. doi: 10.1038/s41408-021-00593-2. |
| Label | URL |
|---|---|
| Related Info | View source |
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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 a diagnosis of relapsed and/or refractory multiple myeloma (RRMM) who received at least 2 prior lines of therapy were enrolled in 2:3 ratio to receive pomalidomide + dexamethasone or ixazomib + dexamethasone in this study.
Participants took part in the study at 54 investigative sites in Australia, Turkey, Czech Republic, France, Germany, Italy, Netherlands, Norway, Spain, Israel, United Kingdom, Sweden, Greece, and Russian Federation from 01 August 2017 up to 26 November 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pomalidomide 4 mg + Dexamethasone 40 mg | Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged >=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years. |
| 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 | Aug 31, 2020 | Jul 30, 2021 |
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| Pomalidomide | Drug | Pomalidomide capsules |
|
| Dexamethasone | Drug | Dexamethasone tablets |
|
Overall Response Rate (ORR) was defined as the percentage of participants who achieved partial response (PR), very good partial response (VGPR), or complete response (CR) based on laboratory results and IRC assessment using modified IMWG criteria. PR: >=50% reduction of serum M protein + reduction in 24-hour urinary M protein by >=90% or to <200 mg/24-hour; if M protein is not measurable, >=50% decrease in difference between involved and uninvolved FLC levels is required; if not measurable by FLC, >=50% reduction in bone marrow plasma cells, when baseline value >=30% and; if present at baseline, >=50% reduction in size of soft tissue plasmacytomas is required. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein + urine M-protein level <100 mg/24-hour. CR: negative immunofixation on serum + urine; disappearance of soft tissue plasmacytomas; <5 % plasma cells in bone marrow. |
| From date of randomization until first documentation of CR, VGPR or PR (Up to approximately 3 years) |
| Duration of Response (DOR) | DOR: Time from first documentation of CR/PR/VGPR to first documentation of PD. Per IMWG criteria, PR:>=50% reduction of serum M protein+reduction in 24-hour urinary M protein by >=90% to <200 mg/24-hour or >=50% decrease in difference between involved and uninvolved FLC levels/ >=50% reduction in bone marrow plasma cells, if >=30% at Baseline/ >=50% reduction in size of soft tissue plasmacytomas. VGPR: serum+urine M-protein detectable by immunofixation but not on electrophoresis/ >=90% reduction in serum M-protein + urine M-protein level <100 mg/24-hour. CR:negative immunofixation on serum + urine+disappearance of soft tissue plasmacytomas+<5% plasma cells in bone marrow. PD:serum M-component increase >=0.5 g/dl or urine M-component increase >=200 mg/24-hour/ difference between involved and uninvolved FLC levels increase >10 mg/dl or bone marrow plasma cell >=10%/development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia. | From date of first documentation of CR, VGPR or PR until first occurrence of confirmed disease progression or death due to any cause, whichever occurs first (Up to approximately 3 years) |
| Time to Response | Time to response was defined as the time from randomization to the first documentation of PR/VGPR/CR. Per IMWG criteria, PR: >=50% reduction of serum M protein + reduction in 24-hour urinary M protein by >=90% or to <200 mg/24-hour; if M-protein is not measurable, >=50% decrease in difference between involved and uninvolved FLC levels is required; if not measurable by FLC, >=50% reduction in bone marrow plasma cells, when Baseline value >=30% and; if present at Baseline, >=50% reduction in size of soft tissue plasmacytomas is required. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein + urine M-protein level <100 mg/24-hour. CR: negative immunofixation on serum + urine; disappearance of soft tissue plasmacytomas; <5% plasma cells in bone marrow. | From date of randomization until first documentation of CR, VGPR or PR (Up to approximately 3 years) |
| Time to Progression (TTP) | TTP was defined as the time from the date of randomization to first documentation of PD. Per IMWG criteria, PD required 1 of the following: Increase of >=25% from nadir in: Serum M-component (increase must be >=0.5 g/dl; Urine M-component (increase must be >=200 mg/24-hour); In participants without measurable serum and urine M-protein levels difference between involved and uninvolved FLC levels increase of >10 mg/dl; In participants without measurable serum and urine M protein levels and without measurable disease by FLC level: Bone marrow plasma cell percentage must be >=10%; Development of new or increase in size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (>11.5 mg/dL corrected serum calcium) attributed solely to plasma cell proliferative disease. | From date of randomization until first occurrence of confirmed disease progression or death due to any cause, whichever occurs first (Up to approximately 3 years) |
| Health-Related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 (EORTC QLQ-C30) Physical Domain Score | The EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/quality of life (QOL) scale. The physical domain consisted of 5 items covering participant's daily physical activities on a scale from 1 (not at all) to 4 (very much). Raw scores were linearly transformed to a total score between 0-100, with a high score indicating better physical functioning. | Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days) |
| HRQOL Based on EORTC QLQ-C30 SubScale Score | The EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a QOL scale. Most of the 30 items had 4 response levels (not at all, a little, quite a bit, and very much), with 2 questions relying on a 7-point numeric rating scale. Each subscale raw score were linearly transformed to a total score between 0 to 100. For the functional scales and the global health status/QOL scale, higher scores represent better QOL; for the symptom scales, lower scores represent better QOL. The Physical domain of the functional subscale is reported in the secondary outcome measure 7. | Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days) |
| HRQOL Based on EORTC Multiple Myeloma Module 20 (EORTC QLQ-MY20) Score | The EORTC QLQ-MY20 has 20 items across 4 independent subscales, 2 symptoms scales (disease symptoms, side effects of treatment), and 2 functional subscales (body image, future perspective). Scores were averaged and transformed to 0-100 scale. Higher scores for the future perspective scale indicate better perspective of the future, for the body image scale indicate better body image and for the disease symptoms scale indicate higher level of symptomatology. | Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days) |
| Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score | EQ-5D-5L comprises of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, 5= extremely severe problems. Higher scores indicated greater levels of problems across the five dimensions. | End of Treatment (Up to 28 cycles, each cycle was of 28 days) |
| HRQOL Based on EuroQol Visual Analogue Scale (EQ VAS) Score | The EQ VAS records the respondent's self-rated health on a 20 centimeter (cm), vertical, visual analogue scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores from all dimensions were combined into a single index score that was reported, where higher score was better quality of life. | Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days) |
| Health Care Utilization (HU): Number of Participants With at Least One Medical Encounter | Healthcare resources used during medical encounters included hospitalizations, emergency room stays, or outpatient visits. A hospitalization was defined as at least 1 overnight stay in an Intensive Care Unit and/or non-Intensive Care Unit (acute care unit, palliative care unit, and hospice). | Up to approximately 3 years |
| HU: Duration of Medical Encounters | Duration of healthcare resources used during medical encounters including hospitalizations, emergency room stays, or outpatient visits was reported in days. A hospitalization was defined as at least 1 overnight stay in an Intensive Care Unit and/or non-Intensive Care Unit (acute care unit, palliative care unit, and hospice). | Up to approximately 3 years |
| Santa Rosa |
| California |
| 95403 |
| United States |
| Lynn Cancer Institute | Boca Raton | Florida | 33486 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Michigan State University | Lansing | Michigan | 48910 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| San Juan Oncology Associates | Farmington | New Mexico | 87401 | United States |
| University of Toledo Medical Center | Toledo | Ohio | 43614 | United States |
| Icon Cancer Care South Brisbane | South Brisbane | Queensland | 4101 | Australia |
| The Queen Elizabeth Hospital | Woodville South | South Australia | 5011 | Australia |
| Box Hill Hospital | Box Hill | Victoria | 3128 | Australia |
| St Vincents Hospital Melbourne | Fitzroy | Victoria | 3065 | Australia |
| Royal Adelaide Hospital | Adelaide | Australia |
| GasthuisZusters Antwerpen | Wilrijk | Antwerpen | 2610 | Belgium |
| AZ St Jan Brugge Oostende AV | Bruges | 8000 | Belgium |
| Royal Victoria Regional Health Centre | Barrie | Ontario | L4M 6M2 | Canada |
| Lakeridge Health Center | Ottawa | Ontario | L1G 2B9 | Canada |
| Fakultni nemocnice Hradec Kralove | Hradec Králové | Kralovehradeck Kraj | 500 05 | Czechia |
| University Hospital Olomouc | Olomouc | Olomouck Kraj | 775 20 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady | Prague | Praha, Hlavni Mesto | 100 34 | Czechia |
| Vseobecna fakultni nemocnice v Praze | Prague | Praha, Hlavni Mesto | 128 08 | Czechia |
| Fakultni nemocnice Brno | Brno | 625 00 | Czechia |
| Fakultni nemocnice Ostrava | Ostrava | Czechia |
| Fakultni nemocnice Plzen | Plzen Lochotin | 304 60 | Czechia |
| Aalborg Universitetshospital | Aalborg | North Denmark | 9100 | Denmark |
| Regionshospitalet Holstebro | Holstebro | 7500 | Denmark |
| Centre Antoine Lacassagne Centre Regional de Lutte Contre Le Cancer | Nice | Alpes-Maritimes | 06189 | France |
| CHRU Dijon Complexe Du Bocage | Dijon | Cote-d'Or | 21034 | France |
| CHRU de Brest - Hopital Morvan | Brest | Finistere | 29609 | France |
| CHRU Nancy | Vandœuvre-lès-Nancy | Meurthe-et-Moselle | 54511 | France |
| Centre Hospitalier Bretagne Atlantique Vannes | Vannes | Morbihan | 56017 | France |
| Centre Hospitalier Le Mans | Le Mans | Sarthe | 72037 | France |
| Groupe Hospitalier du Havre | Montivilliers | Seine-Maritime | 76290 | France |
| CHU Amiens Hopital Sud | Amiens | 80054 | France |
| Centre Hospitalier Fleyriat | Bourg-en-Bresse | 01012 | France |
| Centre Hospitalier (CH) William Morey | Chalon-sur-Saône | 71100 | France |
| Hospital d Instructions des Armees Percy | Clamart | 92140 | France |
| Centre Hospitalier de Dunkerque | Dunkirk | 59240 | France |
| Centre Jean Bernard Clinique Victor Hugo | Le Mans | 72015 | France |
| Centre Hospitalier Regional d'Orleans | Orléans | 45100 | France |
| Centre Hospitalier de Perigueux | Périgueux | 24000 | France |
| CHRU de Poitiers La Miletrie | Poitiers | 86021 | France |
| CHRU Rennes | Rennes | 35033 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Uberortliche Gemeinschaftspraxis Pasing und Furstenfeldbruck | München | Bavaria | 81241 | Germany |
| Universitatsklinikum Dusseldorf | Düsseldorf | 40225 | Germany |
| Asklepios Klinik Altona | Hamburg | 22763 | Germany |
| Universitatsklinikum Tubingen | Tübingen | 72076 | Germany |
| University General Hospital of Patras | Pátrai | Achaia | 26500 | Greece |
| University Hospital of Alexandroupolis | Alexandroupoli | 68100 | Greece |
| Evangelismos General Hospital of Athens | Athens | 10676 | Greece |
| Alexandra Hospital | Athens | 11528 | Greece |
| University General Hospital of Ioannina | Ioannina | 45500 | Greece |
| Theageneio Anticancer Oncology Hospital of Thessaloniki | Thessaloniki | 54007 | Greece |
| Soroka University Medical Centre | Beersheba | 84001 | Israel |
| Bnai Zion Medical Center | Haifa | 31048 | Israel |
| Rambam Health Corporation | Haifa | 31096 | Israel |
| Lady Davis Carmel Medical Center | Haifa | 34362 | Israel |
| Hadassah Medical Center | Jerusalem | 91120 | Israel |
| Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi | Bologna | Emilia-Romagna | 40138 | Italy |
| Ospedale Santa Maria Delle Croci | Ravenna | Emilia-Romagna | 48100 | Italy |
| Arcispedale Santa Maria Nuova | Reggio Emilia | Emilia-Romagna | 42123 | Italy |
| Ospedale Infermi di Rimini | Rimini | Emilia-Romagna | 47900 | Italy |
| Fondazione del Piemonte per lOncologia (IRCCS) | Candiolo | Piedmont | 10060 | Italy |
| Azienda Sanitaria Ospedaliera S Luigi Gonzaga | Orbassano | Piedmont | 10043 | Italy |
| Azienda Ospedaliera Citta della Salute e della Scienza di Torino | Turin | Piedmont | 10126 | Italy |
| Centro Di Riferimento Oncologico Della Basilicata | Rionero in Vulture | PZ | Italy |
| Azienda Ospedaliera Ospedali Riuniti Marche Nord | Pesaro | The Marches | 61122 | Italy |
| Centro Di Riferimento Oncologico | Aviano | 33081 | Italy |
| ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia | Brescia | 25123 | Italy |
| Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST | Meldola | 47014 | Italy |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| Azienda Ospedaliero Universitaria Di Modena Policlinico | Modena | 41100 | Italy |
| Azienda Ospedaliero Universitaria di Parma | Parma | 43100 | Italy |
| Ospedale Santa Maria Della Misericordia | Udine | 33100 | Italy |
| Azienda ULSS 6 Vicenza | Vicenza | 36100 | Italy |
| Albert Schweitzer Ziekenhuis | Dordrecht | South Holland | 3318 AT | Netherlands |
| Zuyderland Medisch Centrum | Sittard | 6162 BG | Netherlands |
| Oslo Universitetssykehus HF Rikshospitalet | Oslo | Oppland | N-1346 | Norway |
| Haukeland Universitetssykehus | Bergen | N-5021 | Norway |
| Forde Sentralsjukehus | Førde | 6812 | Norway |
| Stavanger Universitetssykehus | Stavanger | N-4011 | Norway |
| St Olavs Hospital | Trondheim | N-7006 | Norway |
| Kirov Research Institute of Haematology and Blood Transfusion | Kirov | 610027 | Russia |
| Moscow Clinical Scientific Center | Moscow | 111123 | Russia |
| City Clinical Hospital n a S P Botkin | Moscow | 125284 | Russia |
| City Clinical Hospital # 40 | Moscow | 129301 | Russia |
| Samara State Medical University | Samara | 433021 | Russia |
| Hospital Universitario Infanta Leonor | Madrid | Madrid, Communidad Delaware | 28031 | Spain |
| Hospital Universitari de Girona Dr Josep Trueta | Girona | 17007 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Helsingborg Lasarett | Helsingborg | Skåne County | SE-25187 | Sweden |
| Sodra Alvsborgs Sjukhus Boras | Borås | SE-50182 | Sweden |
| Norrlands Universitetssjukhus | Umeå | 901 85 | Sweden |
| Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi | Ankara | 06200 | Turkey (Türkiye) |
| Gazi University Medical Faculty Gazi Hospital | Ankara | 06500 | Turkey (Türkiye) |
| Ankara University Medical Faculty Cebeci Hospital | Ankara | 06590 | Turkey (Türkiye) |
| Dokuz Eylul University Medical Faculty | Izmir | 35340 | Turkey (Türkiye) |
| Ege Universitesi Tip Fakultesi Hastanesi | Izmir | Turkey (Türkiye) |
| Erciyes Universitesi Tip Fakultesi Hastanesi | Kayseri | 38039 | Turkey (Türkiye) |
| Royal Cornwall Hospital | Truro | Cornwall | TR1 3LJ | United Kingdom |
| Betsi Cadwaladr University Health Board | Bodelwyddan | Denbighshire-SirDdinbych | LL18 5UJ | United Kingdom |
| Royal Bournemouth Hospital | Bournemouth | Dorset | BH7 7DW | United Kingdom |
| Kent and Canterbury Hospital | Canterbury | Kent | CT1 3NG | United Kingdom |
| GenesisCare Oxford | Oxford | Oxfordshire | OX4 6LB | United Kingdom |
| Royal Stoke University Hospital | Stoke-on-Trent | Staffordshire | ST4 6QG | United Kingdom |
| Leicester Royal Infirmary | Leicester | LE1 5WW | United Kingdom |
| Singleton Hospital | Swansea | SA2 8QA | United Kingdom |
| New Cross Hospital | Wolverhampton | WV10 0QP | United Kingdom |
| FG001 | Ixazomib 4 mg + Dexamethasone 20 mg | Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged >=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years. |
| Treated: Safety Population | Safety Population included all participants who received at least 1 dose of any study drug. |
|
| ITT PRO Population | Intent-to-Treat Patient Reported Outcomes (ITT PRO) Population included participants with a measurement at study entry and at least one post study entry measurement for at least 1 subscale on all 3 questionnaires (EORTC QLQ-C30, EORTC QLQ-MY20 and EQ-5D-5L). |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-Treat (ITT) Population included all participants who were randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pomalidomide 4 mg + Dexamethasone 40 mg | Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged >=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years. |
| BG001 | Ixazomib 4 mg + Dexamethasone 20 mg | Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged >=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years. |
| 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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| Baseline Height | Mean | Standard Deviation | cm |
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| Baseline Weight | Mean | Standard Deviation | kg |
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| Baseline Body Surface Area | 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: Time from randomization to first occurrence of confirmed progressive disease (PD) as assessed by investigator by International Myeloma Working Group(IMWG) response criteria/death from any cause, whichever occurs first. PD requires following: Increase of >=25 % from nadir in: Serum M component (increase must be >=0.5 gram per deciliter [g/dl]); Urine M-component (increase must be >=200 milligram [mg]/24-hour); In participants without measurable serum and urine M-protein levels difference between involved and uninvolved free light chain (FLC) increase of >10 mg/dl; In participants without measurable serum and urine M protein levels and without measurable disease by FLC level: bone marrow plasma cell percentage must be >=10%; Development of new/increase in size of existing bone lesions/soft tissue plasmacytomas; development of hypercalcemia (>11.5mg/dL corrected serum calcium) attributed solely to plasma cell proliferative disease. | ITT Population included all participants who were randomized. Participants without documentation of PD were censored at the date of last response assessment that is stable disease (SD) or better. | Posted | Median | 95% Confidence Interval | months | From date of randomization until first occurrence of confirmed disease progression or death due to any cause, whichever occurs first (Up to approximately 3 years) |
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| Secondary | Overall Survival (OS) | OS was defined as the time from randomization to death from any cause, up to 3 years are reported. | ITT Population included all participants who were randomized. Participants without documented death at the time of analysis were censored at the date last known to be alive. | Posted | Median | 95% Confidence Interval | months | From date of randomization to death due to any cause (Up to approximately 3 years) |
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| Secondary | Percentage of Participants With Overall Response | Overall Response Rate (ORR) was defined as the percentage of participants who achieved partial response (PR), very good partial response (VGPR), or complete response (CR) based on laboratory results and IRC assessment using modified IMWG criteria. PR: >=50% reduction of serum M protein + reduction in 24-hour urinary M protein by >=90% or to <200 mg/24-hour; if M protein is not measurable, >=50% decrease in difference between involved and uninvolved FLC levels is required; if not measurable by FLC, >=50% reduction in bone marrow plasma cells, when baseline value >=30% and; if present at baseline, >=50% reduction in size of soft tissue plasmacytomas is required. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein + urine M-protein level <100 mg/24-hour. CR: negative immunofixation on serum + urine; disappearance of soft tissue plasmacytomas; <5 % plasma cells in bone marrow. | ITT Population included all participants who were randomized. | Posted | Number | 95% Confidence Interval | percentage of participants | From date of randomization until first documentation of CR, VGPR or PR (Up to approximately 3 years) |
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| Secondary | Duration of Response (DOR) | DOR: Time from first documentation of CR/PR/VGPR to first documentation of PD. Per IMWG criteria, PR:>=50% reduction of serum M protein+reduction in 24-hour urinary M protein by >=90% to <200 mg/24-hour or >=50% decrease in difference between involved and uninvolved FLC levels/ >=50% reduction in bone marrow plasma cells, if >=30% at Baseline/ >=50% reduction in size of soft tissue plasmacytomas. VGPR: serum+urine M-protein detectable by immunofixation but not on electrophoresis/ >=90% reduction in serum M-protein + urine M-protein level <100 mg/24-hour. CR:negative immunofixation on serum + urine+disappearance of soft tissue plasmacytomas+<5% plasma cells in bone marrow. PD:serum M-component increase >=0.5 g/dl or urine M-component increase >=200 mg/24-hour/ difference between involved and uninvolved FLC levels increase >10 mg/dl or bone marrow plasma cell >=10%/development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia. | Response Evaluable Population included all participants with multiple myeloma who had documentation of a confirmed PR, or PR/VGPR/CR. Only responders were reported for this outcome measure. | Posted | Median | 95% Confidence Interval | months | From date of first documentation of CR, VGPR or PR until first occurrence of confirmed disease progression or death due to any cause, whichever occurs first (Up to approximately 3 years) |
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| Secondary | Time to Response | Time to response was defined as the time from randomization to the first documentation of PR/VGPR/CR. Per IMWG criteria, PR: >=50% reduction of serum M protein + reduction in 24-hour urinary M protein by >=90% or to <200 mg/24-hour; if M-protein is not measurable, >=50% decrease in difference between involved and uninvolved FLC levels is required; if not measurable by FLC, >=50% reduction in bone marrow plasma cells, when Baseline value >=30% and; if present at Baseline, >=50% reduction in size of soft tissue plasmacytomas is required. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein + urine M-protein level <100 mg/24-hour. CR: negative immunofixation on serum + urine; disappearance of soft tissue plasmacytomas; <5% plasma cells in bone marrow. | Response Evaluable Population included all participants with multiple myeloma who had documentation of a confirmed PR, or PR/VGPR/CR. | Posted | Median | 95% Confidence Interval | months | From date of randomization until first documentation of CR, VGPR or PR (Up to approximately 3 years) |
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| Secondary | Time to Progression (TTP) | TTP was defined as the time from the date of randomization to first documentation of PD. Per IMWG criteria, PD required 1 of the following: Increase of >=25% from nadir in: Serum M-component (increase must be >=0.5 g/dl; Urine M-component (increase must be >=200 mg/24-hour); In participants without measurable serum and urine M-protein levels difference between involved and uninvolved FLC levels increase of >10 mg/dl; In participants without measurable serum and urine M protein levels and without measurable disease by FLC level: Bone marrow plasma cell percentage must be >=10%; Development of new or increase in size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (>11.5 mg/dL corrected serum calcium) attributed solely to plasma cell proliferative disease. | ITT Population included all participants who were randomized. Participants without documentation of PD at the time of analysis are censored at the date of last response assessment that is SD or better. | Posted | Median | 95% Confidence Interval | months | From date of randomization until first occurrence of confirmed disease progression or death due to any cause, whichever occurs first (Up to approximately 3 years) |
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| Secondary | Health-Related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 (EORTC QLQ-C30) Physical Domain Score | The EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/quality of life (QOL) scale. The physical domain consisted of 5 items covering participant's daily physical activities on a scale from 1 (not at all) to 4 (very much). Raw scores were linearly transformed to a total score between 0-100, with a high score indicating better physical functioning. | ITT PRO Population included participants with a measurement at study entry and at least one post study entry measurement for at least 1 subscale on all 3 questionnaires (EORTC QLQ-C30, EORTC Multiple Myeloma Module 20 [QLQ-MY20] and EuroQol 5-Dimensional Health Questionnaire [EQ-5D-5L]). Number analyzed are the number of participants with data available for analyses at the given timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days) |
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| Secondary | HRQOL Based on EORTC QLQ-C30 SubScale Score | The EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a QOL scale. Most of the 30 items had 4 response levels (not at all, a little, quite a bit, and very much), with 2 questions relying on a 7-point numeric rating scale. Each subscale raw score were linearly transformed to a total score between 0 to 100. For the functional scales and the global health status/QOL scale, higher scores represent better QOL; for the symptom scales, lower scores represent better QOL. The Physical domain of the functional subscale is reported in the secondary outcome measure 7. | ITT PRO Population included participants with a measurement at study entry and at least one post study entry measurement for at least 1 subscale on all 3 questionnaires (EORTC QLQ-C30, EORTC QLQ-MY20 and EQ-5D-5L). Number analyzed are the number of participants with data available for analyses at the given timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days) |
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| Secondary | HRQOL Based on EORTC Multiple Myeloma Module 20 (EORTC QLQ-MY20) Score | The EORTC QLQ-MY20 has 20 items across 4 independent subscales, 2 symptoms scales (disease symptoms, side effects of treatment), and 2 functional subscales (body image, future perspective). Scores were averaged and transformed to 0-100 scale. Higher scores for the future perspective scale indicate better perspective of the future, for the body image scale indicate better body image and for the disease symptoms scale indicate higher level of symptomatology. | ITT PRO Population included participants with a measurement at study entry and at least one post study entry measurement for at least 1 subscale on all 3 questionnaires (EORTC QLQ-C30, EORTC QLQ-MY20 and EQ-5D-5L). Number analyzed are the number of participants with data available for analyses at the given timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days) |
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| Secondary | Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score | EQ-5D-5L comprises of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, 5= extremely severe problems. Higher scores indicated greater levels of problems across the five dimensions. | ITT PRO Population included participants with a measurement at study entry and at least one post study entry measurement for at least 1 subscale on all 3 questionnaires (EORTC QLQ-C30, EORTC QLQ-MY20 and EQ-5D-5L). Overall number of participants analyzed are the number of participants with data available for analyses. | Posted | Count of Participants | Participants | End of Treatment (Up to 28 cycles, each cycle was of 28 days) |
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| Secondary | HRQOL Based on EuroQol Visual Analogue Scale (EQ VAS) Score | The EQ VAS records the respondent's self-rated health on a 20 centimeter (cm), vertical, visual analogue scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores from all dimensions were combined into a single index score that was reported, where higher score was better quality of life. | ITT PRO Population included participants with a measurement at study entry and at least one post study entry measurement for at least 1 subscale on all 3 questionnaires (EORTC QLQ-C30, EORTC QLQ-MY20 and EQ-5D-5L). Number analyzed are the number of participants with data available for analyses at the given timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days) |
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| Secondary | Health Care Utilization (HU): Number of Participants With at Least One Medical Encounter | Healthcare resources used during medical encounters included hospitalizations, emergency room stays, or outpatient visits. A hospitalization was defined as at least 1 overnight stay in an Intensive Care Unit and/or non-Intensive Care Unit (acute care unit, palliative care unit, and hospice). | ITT Population included all participants who were randomized. | Posted | Count of Participants | Participants | Up to approximately 3 years |
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| Secondary | HU: Duration of Medical Encounters | Duration of healthcare resources used during medical encounters including hospitalizations, emergency room stays, or outpatient visits was reported in days. A hospitalization was defined as at least 1 overnight stay in an Intensive Care Unit and/or non-Intensive Care Unit (acute care unit, palliative care unit, and hospice). | ITT Population included all participants who were randomized. | Posted | Median | Full Range | days | Up to approximately 3 years |
|
From signing of the informed consent up to 30 days after last dose of the study drug (Up to approximately 4 years 3 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All cause-mortality was collected for all randomized participants. Serious and other (non-serious) adverse events were collected for participants from Safety Population who received at least 1 dose of any study drug.
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 | Pomalidomide 4 mg + Dexamethasone 40 mg | Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged >=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years. | 17 | 49 | 26 | 47 | 45 | 47 |
| EG001 | Ixazomib 4 mg + Dexamethasone 20 mg | Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged >=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years. | 29 | 73 | 40 | 72 | 62 | 72 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| H1N1 influenza | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Respiratory syncytial virus bronchitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Neutropenic infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Enterobacter sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Lower respiratory tract infection fungal | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Hepatitis E | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Cervix carcinoma stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Metastatic squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gastrointestinal toxicity | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Erosive oesophagitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Peripheral sensorimotor neuropathy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Lung consolidation | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute left ventricular failure | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiomegaly | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Crystal arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Enterobacter test positive | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Scrotal haematoma | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA24 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA24 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA24 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA24 | Systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA24 | Systematic Assessment |
| |
| Sialodenitis | Infections and infestations | MedDRA24 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA24 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA24 | Systematic Assessment |
| |
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA24 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 11, 2019 | Jul 30, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C548400 | ixazomib |
| C467566 | pomalidomide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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 |
|
| Norway |
|
| Italy |
|
| France |
|
| Ireland |
|
| Germany |
|
| Turkey |
|
| Spain |
|
| Israel |
|
| Czechia |
|
| Netherlands |
|
| Greece |
|
| Sweden |
|
| Australia |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| OG001 | Ixazomib 4 mg + Dexamethasone 20 mg | Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged >=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years. |
|
|
|
| OG001 | Ixazomib 4 mg + Dexamethasone 20 mg | Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged >=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years. |
|
|
| Ixazomib 4 mg + Dexamethasone 20 mg |
Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged >=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years. |
|
|
|
| OG001 | Ixazomib 4 mg + Dexamethasone 20 mg | Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged >=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years. |
|
|
|
| OG001 | Ixazomib 4 mg + Dexamethasone 20 mg | Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged >=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years. |
|
|
| OG001 | Ixazomib 4 mg + Dexamethasone 20 mg | Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged >=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years. |
|
|
|
|
|
|
|
|
|
|
|
|