Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-173592 | Registry Identifier | Japic-CTI |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety of NINLARO in participants with relapsed/refractory multiple myeloma in daily clinical practice.
The drug being tested in this study is called Ixazomib (NINLARO). Ixazomib is being tested to treat people who have relapsed/refractory multiple myeloma. This study will look at the safety of NINLARO in participants with relapsed/refractory multiple myeloma in daily clinical practice.
The study will enroll approximately 480 patients.
• Ixazomib 4 mg
This multi-center trial will be conducted in Japan.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ixazomib 4 mg | The usual adult dosage for oral administration is 4 mg as ixazomib, in the fasting state, once a day, once a week for 3 weeks (Days 1, 8, and 15), with a 13-day washout period (Days 16 through 28). This 4-week cycle will be repeated for 6 cycles. The dose may be reduced appropriately according to the patient's condition. Participants will receive interventions as part of routine medical care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ixazomib | Drug | Ixazomib capsules |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting One or More Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | Up to 24 Week (From start of administration to the end of 6 cycles) |
| Number of Participants Who Had One or More Adverse Drug Reactions (ADRs) | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction (ADR) refers to AE related to administered drug. | Up to 24 Week (From start of administration to the end of 6 cycles) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
The study population will consist of all participants with a diagnosis of multiple myeloma and received their first dose of NINLARO/lenalidomide, and dexamethasone.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takeda Selected Site | Tokyo | Japan |
Not provided
| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
Not provided
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.
Not provided
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 historical diagnosis of relapsed/refractory multiple myeloma were enrolled. Participants received ixazomib as part of a routine medical care.
Participants took part in the survey at 316 investigative sites in Japan, from 24 May 2017 to 8 March 2022.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ixazomib 4 mg | The usual adult dosage for oral administration was 4 mg as ixazomib, in the fasting state, once a day, once a week for 3 weeks (Days 1, 8, and 15), with a 13-day washout period (Days 16 through 28). This 4-week cycle was repeated for 6 cycles. The dose might be reduced appropriately according to the patient's condition. Participants received interventions as part of routine medical care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ixazomib 4 mg | The usual adult dosage for oral administration was 4 mg as ixazomib, in the fasting state, once a day, once a week for 3 weeks (Days 1, 8, and 15), with a 13-day washout period (Days 16 through 28). This 4-week cycle was repeated for 6 cycles. The dose might be reduced appropriately according to the patient's condition. Participants received interventions as part of routine medical care. |
| 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 | Number of Participants Reporting One or More Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | No | Up to 24 Week (From start of administration to the end of 6 cycles) |
|
Up to 24 Week (From start of administration to the end of 6 cycles)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded. The data reported are only serious and the other (not including serious) ADRs by events because only serious and the other ADRs were planned to be collected and assessed in this study. Seriousness of AEs by events was out of the scope for the data collection plan.
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 | Ixazomib 4 mg | The usual adult dosage for oral administration was 4 mg as ixazomib, in the fasting state, once a day, once a week for 3 weeks (Days 1, 8, and 15), with a 13-day washout period (Days 16 through 28). This 4-week cycle was repeated for 6 cycles. The dose might be reduced appropriately according to the patient's condition. Participants received interventions as part of routine medical care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacteraemia | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v22.0 | 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 | Jun 23, 2020 | Mar 5, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 25, 2019 | Mar 5, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C548400 | ixazomib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
| Duration of Diagnosis of Relapsed/Refractory Multiple Myeloma | Mean duration between the first diagnosis of relapsed/refractory multiple myeloma and the start of the study was reported. | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Years |
|
| Number of Participants with Relapsed/Refractory Multiple Myeloma | Count of Participants | Participants |
|
| International Staging System | 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. | The number analyzed is the number of participants with data available for analysis. | Count of Participants | Participants |
|
| Eastern Cooperative Oncology Group Performance Status | Eastern Cooperative Oncology Group performance status 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 |
|
| Healthcare Category | Count of Participants | Participants |
|
| Hepatic Impairment | Count of Participants | Participants |
|
| Renal Impairment | Count of Participants | Participants |
|
| Medical Complications | Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above. | The number analyzed is the number of participants with data available for analysis. | Count of Participants | Participants |
|
| Medical History | Medical history defined as a disease or a health condition for each participant before start of the study. Medical history was classified as congenital anomalies, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, GI disorders, hepatic and biliary disorders, renal disease and other medical history. Other medical history included all medical history except for those mentioned above. Unknown: Data could not be collected. | The number analyzed is the number of participants with data available for analysis. | Count of Participants | Participants |
|
| Height | 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) |
|
| Body Surface Area | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Square Meter |
|
|
|
| Primary | Number of Participants Who Had One or More Adverse Drug Reactions (ADRs) | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction (ADR) refers to AE related to administered drug. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | No | Up to 24 Week (From start of administration to the end of 6 cycles) |
|
|
|
| 11 |
| 742 |
| 193 |
| 742 |
| 515 |
| 742 |
| Bronchitis | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
|
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
|
| Escherichia sepsis | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
|
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
|
| Pneumonia haemophilus | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
|
| Pneumonia influenzal | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
|
| Pneumonia staphylococcal | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
|
| Pseudomembranous colitis | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
|
| Candida sepsis | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
|
| Enteritis infectious | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
|
| Intervertebral discitis | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
|
| Herpes zoster disseminated | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
|
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.0 | Systematic Assessment |
|
| Bronchioloalveolar carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA v22.0 | Systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA v22.0 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v22.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA v22.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA v22.0 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA v22.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v22.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA v22.0 | Systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA v22.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v22.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v22.0 | Systematic Assessment |
|
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA v22.0 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA v22.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v22.0 | Systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA v22.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v22.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA v22.0 | Systematic Assessment |
|
| Thalamus haemorrhage | Nervous system disorders | MedDRA v22.0 | Systematic Assessment |
|
| Autonomic neuropathy | Nervous system disorders | MedDRA v22.0 | Systematic Assessment |
|
| Taste disorder | Nervous system disorders | MedDRA v22.0 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA v22.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA v22.0 | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA v22.0 | Systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | MedDRA v22.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA v22.0 | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA v22.0 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA v22.0 | Systematic Assessment |
|
| Stress cardiomyopathy | Cardiac disorders | MedDRA v22.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA v22.0 | Systematic Assessment |
|
| Hypovolaemic shock | Vascular disorders | MedDRA v22.0 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA v22.0 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Systematic Assessment |
|
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
|
| Gastrointestinal necrosis | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
|
| Volvulus | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
|
| Tongue haemorrhage | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
|
| Mechanical ileus | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA v22.0 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA v22.0 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA v22.0 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Systematic Assessment |
|
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA v22.0 | Systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA v22.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA v22.0 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA v22.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA v22.0 | Systematic Assessment |
|
| Prerenal failure | Renal and urinary disorders | MedDRA v22.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA v22.0 | Systematic Assessment | The reasons of events are not determined because assessment findings were insufficient to specify the reason. |
|
| Malaise | General disorders | MedDRA v22.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA v22.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v22.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA v22.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA v22.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA v22.0 | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA v22.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA v22.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA v22.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA v22.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA v22.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA v22.0 | 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.
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |