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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-183860 | Registry Identifier | JapicCTI |
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The purpose of this study is to investigate the real world effectiveness and safety of ixazomib in combination with lenalidomide and dexamethasone (IRd) in patients with relapsed and/or refractory multiple myeloma (RRMM), under conditions of standard medical care. In addition, an exploratory study of biomarkers will be conducted.
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) under the conditions of standard medical care. This study is a non-interventional (observational), domestic, multicenter, prospective study in patients with RRMM. This study will look at the effectiveness and safety of ixazomib in combination with lenalidomide and dexamethasone in Japanese patients with RRMM as standard medical care. In addition, an exploratory study of biomarkers will be conducted in this study.
The study will enroll approximately 300 patients. All participants will receive Ixazomib + Lenalidomide + Dexamethasone (IRd) therapy as standard medical care.
This multi-center trial will be conducted in Japan. The overall time of observational period in this study will be 36 months. For each participant, the observation period will be from the start of IRd therapy until either 24 months after the enrollment date of the final patient to enroll, or until death or withdrawal of consent, whichever is earlier.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ixazomib + Lenalidomide + Dexamethasone | Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ixazomib | Drug | Ixazomib capsules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS was defined as the period from the start of ixazomib, lenalidomide, dexamethasone (IRd) therapy in standard medical care to the time of confirmed progressive disease (PD) or confirmed death (regardless of the cause of death), whichever was earlier. PFS was assessed by International Myeloma Working Group (IMWG) Criteria (2014 version). Per IMWG criteria, PD: serum M-component increase ≥ 0.5 g/dl or urine M-component increase ≥ 200 mg/24-hour/ difference between involved and uninvolved free light chain (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. | Up to 36 Months as a maximum |
| Measure | Description | Time Frame |
|---|---|---|
| PFS Rate at 12 Months and 24 Months After the Start of Treatment | PFS rate was defined as the percentage of participants who were alive and have not had disease progression at 12 months and 24 months after the date of start of study treatment. PFS was assessed by IMWG Criteria (2014 version). Per IMWG criteria, PD: serum M-component increase ≥ 0.5 g/dl or urine M-component increase ≥ 200 mg/24-hour/ difference between involved and uninvolved FLC levels increase >10 mg/dl or bone marrow plasma cell ≥ 10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of adult men and women who have a confirmed diagnosis of multiple myeloma, who is scheduled to begin treatment with IRd due to relapsed and/or refractory disease, and who meet other eligibility criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takeda Selected Site | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38427753 | Derived | Kogure Y, Handa H, Ito Y, Ri M, Horigome Y, Iino M, Harazaki Y, Kobayashi T, Abe M, Ishida T, Ito S, Iwasaki H, Kuroda J, Shibayama H, Sunami K, Takamatsu H, Tamura H, Hayashi T, Akagi K, Shinozaki T, Yoshida T, Mori I, Iida S, Maeda T, Kataoka K. ctDNA improves prognostic prediction for patients with relapsed/refractory MM receiving ixazomib, lenalidomide, and dexamethasone. Blood. 2024 Jun 6;143(23):2401-2413. doi: 10.1182/blood.2023022540. | |
| 37695378 |
| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | 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.
A total of 295 participants were enrolled and received the study treatment in this study.
Participant s took part in the survey at 101 investigative sites in Japan, from 2 April 2018 to 11 June 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ixazomib + Lenalidomide + Dexamethasone | Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ixazomib + Lenalidomide + Dexamethasone | Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | PFS was defined as the period from the start of ixazomib, lenalidomide, dexamethasone (IRd) therapy in standard medical care to the time of confirmed progressive disease (PD) or confirmed death (regardless of the cause of death), whichever was earlier. PFS was assessed by International Myeloma Working Group (IMWG) Criteria (2014 version). Per IMWG criteria, PD: serum M-component increase ≥ 0.5 g/dl or urine M-component increase ≥ 200 mg/24-hour/ difference between involved and uninvolved free light chain (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. | Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib. | Posted | Median | Standard Deviation | Months | Up to 36 Months as a maximum |
|
Up to 36 months as a maximum
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ixazomib + Lenalidomide + Dexamethasone | Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA/J v24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA/J v24.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 24, 2021 | May 20, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 1, 2021 | May 22, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C548400 | ixazomib |
| D000077269 | Lenalidomide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| Lenalidomide |
| Drug |
Lenalidomide capsules |
|
| Dexamethasone | Drug | Dexamethasone tablets |
|
| 12 months and 24 months |
| Overall Survival (OS) | OS is defined as the period from the start of IRd therapy in standard medical care to the time when death (regardless of the cause of death) is confirmed. | Up to 36 months as a maximum |
| Percentage of Participants Who Achieve or Maintain Any Best Response | Best response is defined as the cumulative numbers of participants who achieve each level of best response including partial response (PR), very good PR (VGPR) and complete response (CR) assessed with IMWG Criteria after each cycle of treatment. 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 free light chain (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. | Up to 36 months as a maximum |
| Time to Next Treatment (TTNT) | TTNT will be measured as the period from the start of IRd therapy in standard medical care to the start of next treatment or time when death is confirmed (regardless of the cause of death), whichever is earlier. | Up to 36 months as a maximum |
| Duration of Therapy (DOT) | DOT is defined as the treatment duration of IRd therapy. | Up to 36 months as a maximum |
| Percentage of Participants Who Continue to Receive Treatment at 12 Months and 24 Months After Start of Treatment | 12 months and 24 months |
| Overall Response Rate (ORR) | ORR is defined as the percentage of participants who achieve a best response of PR or better including stringent complete response (sCR), VGPR and PR assessed with IMWG Criteria, after the start of the study treatment. | Up to 36 months as a maximum |
| Percentage of Participants Who Achieve VGPR or Better (CR+VGPR) | The percentage of participants of CR + VGPR is defined as the rate of participants who achieve a best response of VGPR or better (sCR, CR, or VGPR) according to the IMWG Criteria after the start of the IRd therapy. | Up to 36 months as a maximum |
| Patient-Reported Outcome Health-Related Quality of Life (HRQoL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Global Health Status Score | 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/QOL scale. EORTC QLQ-C30 contains 28 questions (4-point scale where 1=Not at all [best] to 4=Very Much [worst]) and 2 questions (7-point scale where 1=Very poor [worst] to 7= Excellent [best]). Raw scores of Global Health Status in EORTC QLQ-C30 were linearly transformed to a total score between 0-100 and reported, with a high score indicating better QOL. | Baseline and End of Treatment (Up to 37 cycles, each cycle was of 28 days) |
| Patient-Reported Outcome HRQoL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Score | EORTC QLQ-MY20 has 20 items across 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms, and side effects of treatment). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future. For the body image scale, higher scores = better body image. Higher score for the disease symptoms scale = higher level of symptomatology. | Baseline and End of Treatment (Up to 37 cycles, each cycle was of 28 days) |
| Rate of Minimal Residual Disease (MRD) Negativity in Bone Marrow in Participants Who Achieved CR | Rate of MRD will be calculated by the percentage of participants who are MRD-negative. | Up to 36 months as a maximum |
| Relative Dose Intensity (RDI) | RDI is defined as 100*(Total amount of dose taken)/(Total prescribed dose of treated cycles), where total prescribed dose equals [dose prescribed at enrollment* number of prescribed doses per cycle* the number of treated cycles]. | Up to 36 months as a maximum |
| Percentage of Participants With Bone Lesions (Bone Evaluation) | Up to 36 months as a maximum |
| Number of Participants Reporting One or More Treatment-Emergent AEs (TEAEs) | An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. | Up to 36 months as a maximum |
| Derived |
| Horigome Y, Iino M, Harazaki Y, Kobayashi T, Handa H, Hiramatsu Y, Kuroi T, Tanimoto K, Matsue K, Abe M, Ishida T, Ito S, Iwasaki H, Kuroda J, Shibayama H, Sunami K, Takamatsu H, Tamura H, Hayashi T, Akagi K, Maeda T, Yoshida T, Mori I, Shinozaki T, Iida S. A prospective, multicenter, observational study of ixazomib plus lenalidomide-dexamethasone in patients with relapsed/refractory multiple myeloma in Japan. Ann Hematol. 2024 Feb;103(2):475-488. doi: 10.1007/s00277-023-05428-7. Epub 2023 Sep 11. |
| Death |
|
| Lost to Follow-up |
|
| Other |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | All participants were enrolled in Japan. | Count of Participants | Participants |
|
| Hight | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Centimeters (cm) |
|
| Weight | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Kilograms (kg) |
|
| BMI | Body Mass Index = weight (kg)/[height (m)^2] | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Kilogram (kg)/meter (m)^2] |
|
| Body Surface Area | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | m^2 |
|
| International Staging System (at Initial Diagnosis) | International Staging System is a staging system for cancer progression. Stages are classified by Stage I to Stage III. Stage I: Serum beta2-microglobulin <3.5 mg/L and albumin ≥3.5 g/dL; Stage II: Neither Stage I or III, meaning that either: beta2-microglobulin level ≥3.5 and <5.5 mg/L (with any albumin level), OR albumin <3.5 g/dL with beta2-microglobulin <3.5 mg/L; Stage III: Serum beta2-microglobulin ≥5.5 mg/L. Normal serum beta2-microglobulin: <3.0 mg/L; normal albumin: 3.5-5.0 g/dL. | Count of Participants | Participants |
|
| International Staging System (at First Treatment) | Count of Participants | Participants |
|
| Eastern Cooperative Oncology Group performance status (ECOG P.S.) | ECOG P.S. assess participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory ( greater than [>] 50 percent [%] of waking hours), capable of all self-care, unable to carry out any work activities; 3=capable of only limited self-care, confined to bed/chair >50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=dead. | Count of Participants | Participants |
|
Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug. |
|
|
| Secondary | PFS Rate at 12 Months and 24 Months After the Start of Treatment | PFS rate was defined as the percentage of participants who were alive and have not had disease progression at 12 months and 24 months after the date of start of study treatment. PFS was assessed by IMWG Criteria (2014 version). Per IMWG criteria, PD: serum M-component increase ≥ 0.5 g/dl or urine M-component increase ≥ 200 mg/24-hour/ difference between involved and uninvolved FLC levels increase >10 mg/dl or bone marrow plasma cell ≥ 10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia. | Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 12 months and 24 months |
|
|
|
| Secondary | Overall Survival (OS) | OS is defined as the period from the start of IRd therapy in standard medical care to the time when death (regardless of the cause of death) is confirmed. | Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib. | Posted | Median | Standard Deviation | Months | Up to 36 months as a maximum |
|
|
|
| Secondary | Percentage of Participants Who Achieve or Maintain Any Best Response | Best response is defined as the cumulative numbers of participants who achieve each level of best response including partial response (PR), very good PR (VGPR) and complete response (CR) assessed with IMWG Criteria after each cycle of treatment. 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 free light chain (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. | Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib. | Posted | Number | Percentage of Participants | Up to 36 months as a maximum |
|
|
|
| Secondary | Time to Next Treatment (TTNT) | TTNT will be measured as the period from the start of IRd therapy in standard medical care to the start of next treatment or time when death is confirmed (regardless of the cause of death), whichever is earlier. | Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib. | Posted | Median | Standard Deviation | Months | Up to 36 months as a maximum |
|
|
|
| Secondary | Duration of Therapy (DOT) | DOT is defined as the treatment duration of IRd therapy. | Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib. | Posted | Mean | Standard Deviation | Days | Up to 36 months as a maximum |
|
|
|
| Secondary | Percentage of Participants Who Continue to Receive Treatment at 12 Months and 24 Months After Start of Treatment | Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 12 months and 24 months |
|
|
|
| Secondary | Overall Response Rate (ORR) | ORR is defined as the percentage of participants who achieve a best response of PR or better including stringent complete response (sCR), VGPR and PR assessed with IMWG Criteria, after the start of the study treatment. | Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 36 months as a maximum |
|
|
|
| Secondary | Percentage of Participants Who Achieve VGPR or Better (CR+VGPR) | The percentage of participants of CR + VGPR is defined as the rate of participants who achieve a best response of VGPR or better (sCR, CR, or VGPR) according to the IMWG Criteria after the start of the IRd therapy. | Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 36 months as a maximum |
|
|
|
| Secondary | Patient-Reported Outcome Health-Related Quality of Life (HRQoL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Global Health Status Score | 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/QOL scale. EORTC QLQ-C30 contains 28 questions (4-point scale where 1=Not at all [best] to 4=Very Much [worst]) and 2 questions (7-point scale where 1=Very poor [worst] to 7= Excellent [best]). Raw scores of Global Health Status in EORTC QLQ-C30 were linearly transformed to a total score between 0-100 and reported, with a high score indicating better QOL. | Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline and End of Treatment (Up to 37 cycles, each cycle was of 28 days) |
|
|
|
| Secondary | Patient-Reported Outcome HRQoL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Score | EORTC QLQ-MY20 has 20 items across 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms, and side effects of treatment). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future. For the body image scale, higher scores = better body image. Higher score for the disease symptoms scale = higher level of symptomatology. | Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline and End of Treatment (Up to 37 cycles, each cycle was of 28 days) |
|
|
|
| Secondary | Rate of Minimal Residual Disease (MRD) Negativity in Bone Marrow in Participants Who Achieved CR | Rate of MRD will be calculated by the percentage of participants who are MRD-negative. | Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib. | Posted | Number | Percentage of Participants | Up to 36 months as a maximum |
|
|
|
| Secondary | Relative Dose Intensity (RDI) | RDI is defined as 100*(Total amount of dose taken)/(Total prescribed dose of treated cycles), where total prescribed dose equals [dose prescribed at enrollment* number of prescribed doses per cycle* the number of treated cycles]. | Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib. | Posted | Mean | Standard Deviation | Percent | Up to 36 months as a maximum |
|
|
|
| Secondary | Percentage of Participants With Bone Lesions (Bone Evaluation) | Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 36 months as a maximum |
|
|
|
| Secondary | Number of Participants Reporting One or More Treatment-Emergent AEs (TEAEs) | An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. | Safety Analysis Set: all participants who were enrolled into the study and who receive at least one dose of any drug used in IRd therapy (i.e. ixazomib, lenalidomide, or dexamethasone) | Posted | Count of Participants | Participants | Up to 36 months as a maximum |
|
|
|
| 24 |
| 295 |
| 96 |
| 295 |
| 225 |
| 295 |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Cardiac death | General disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA/J v24.0 | Systematic Assessment | The reasons of events are not determined because assessment findings were insufficient to specify the reason. |
|
| Fatigue | General disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA/J v24.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA/J v24.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA/J v24.0 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA/J v24.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA/J v24.0 | Systematic Assessment |
|
| Pneumonia influenzal | Infections and infestations | MedDRA/J v24.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA/J v24.0 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA/J v24.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA/J v24.0 | Systematic Assessment |
|
| Bronchitis viral | Infections and infestations | MedDRA/J v24.0 | Systematic Assessment |
|
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA/J v24.0 | Systematic Assessment |
|
| Cytomegalovirus enterocolitis | Infections and infestations | MedDRA/J v24.0 | Systematic Assessment |
|
| Enteritis infectious | Infections and infestations | MedDRA/J v24.0 | Systematic Assessment |
|
| Enterocolitis bacterial | Infections and infestations | MedDRA/J v24.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA/J v24.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA/J v24.0 | Systematic Assessment |
|
| Periodontitis | Infections and infestations | MedDRA/J v24.0 | Systematic Assessment |
|
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA/J v24.0 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA/J v24.0 | Systematic Assessment |
|
| Pneumonia cryptococcal | Infections and infestations | MedDRA/J v24.0 | Systematic Assessment |
|
| Pneumonia pneumococcal | Infections and infestations | MedDRA/J v24.0 | Systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA/J v24.0 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA/J v24.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA/J v24.0 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA/J v24.0 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA/J v24.0 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA/J v24.0 | Systematic Assessment |
|
| Bone contusion | Injury, poisoning and procedural complications | MedDRA/J v24.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA/J v24.0 | Systematic Assessment |
|
| Heat illness | Injury, poisoning and procedural complications | MedDRA/J v24.0 | Systematic Assessment |
|
| Radiation oesophagitis | Injury, poisoning and procedural complications | MedDRA/J v24.0 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA/J v24.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA/J v24.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA/J v24.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA/J v24.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v24.0 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v24.0 | Systematic Assessment |
|
| Cerebellar haemorrhage | Nervous system disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Nephropathy toxic | Renal and urinary disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Urinary tract obstruction | Renal and urinary disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Pulmonary amyloidosis | Respiratory, thoracic and mediastinal disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Aortic aneurysm rupture | Vascular disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Shock | Vascular disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA/J v24.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA/J v24.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA/J v24.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA/J v24.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA/J v24.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA/J v24.0 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| Title | Measurements |
|---|
|
|
|
| Side-Effects of Treatment: Baseline |
|
|
| Side-Effects of Treatment: End of Treatment |
|
|
| Body Image: Baseline |
|
|
| Body Image: End of Treatment |
|
|
| Future Perspective: Baseline |
|
|
| Future Perspective: End of Treatment |
|
|
| Title | Measurements |
|---|---|
|
| Negative |
|
| Title | Measurements |
|---|---|
|