Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1155-5943 | Registry Identifier | WHO | |
| HKUCTR-1593 | Registry Identifier | HKUCTR |
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
Not provided
Not provided
The purpose of this Phase 1 study is to characterize the pharmacokinetic (PK) and tolerability of oral ixazomib (MLN9708) when administered in combination with lenalidomide and dexamethasone in adult Asian participants with relapsed and/or refractory multiple myeloma.
The drug being tested in this study was ixazomib. Ixazomib was tested to treat adult Asian people who had relapsed and/or refractory multiple myeloma.
The study enrolled 43 patients. Participants were enrolled to receive:
All participants were asked to take ixazomib capsules orally on Days 1, 8, and 15; lenalidomide capsules, orally, on Days 1 through 21; and dexamethasone tablets, orally, on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles).
This multi-center trial was conducted in Singapore, Hong Kong and South Korea. The overall time to participate in this study was up to 577 days. Participants made multiple visits to the clinic, and were contacted 30 days after last dose of study drug for a follow-up assessment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ixazomib+Lenalidomide+Dexamethasone | Experimental | Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ixazomib | Drug | Ixazomib capsules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Plasma Concentration for Ixazomib | Cycle 1, Day 1 pre-dose and multiple time-points (up to 168 hours) post-dose | |
| Cmax: Maximum Observed Plasma Concentration for Ixazomib | Cycle 1, Day 15 pre-dose and multiple time-points (up to 336 hours) post-dose | |
| Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib | Cycle 1, Day 1 pre-dose and multiple time-points (up to 168 hours) post-dose | |
| Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib | Cycle 1, Day 15 pre-dose and multiple time-points (up to 336 hours) post-dose | |
| AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for Ixazomib | Cycle 1, Day 1 pre-dose and multiple time-points (up to 168 hours) post-dose | |
| AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for Ixazomib | Cycle 1, Day 15 pre-dose and multiple time-points (up to 336 hours) post-dose | |
| Number of Participants With Dose Limiting Toxicities (DLTs) | DLT was defined as any of the following AEs that were considered by investigator to be possibly related to therapy: 1. Grade 4 neutropenia lasting at least 7 consecutive days; 2. Grade 3 neutropenia with fever and/or infection; 3. Grade 4 thrombocytopenia at least 7 consecutive days; 4. Grade 3 thrombocytopenia with clinically significant bleeding; 5. Platelet count <10,000/mm^3; 6. Grade 2 peripheral neuropathy with pain or ≥Grade 3 peripheral neuropathy; 7. Grade 3 or greater nausea and / or emesis despite the use of optimal anti-emetic prophylaxis; 8. Grade 3 or greater diarrhea that occurred despite maximal supportive therapy; 9. Any other Grade 3 or greater nonhematologic toxicity with the following exceptions: Grade 3 arthralgia/myalgia, <1 week Grade 3 fatigue; 10. A delay of >2 weeks in the subsequent cycle of treatment; 11. Other combination study drug-related nonhematologic toxicities ≥Grade 2 that, in the opinion of the investigator, required discontinuation of study drug. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Confirmed Best Response Category | Percentage of participants who achieve or maintain any best response category during the treatment period were reported. Best response includes complete response (CR), very good partial response (VGPR), and partial response (PR). Response was assessed according to IMWG criteria. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow; PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Millennium Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pokfulam | Hong Kong | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26337806 | Derived | Gupta N, Goh YT, Min CK, Lee JH, Kim K, Wong RS, Chim CS, Hanley MJ, Yang H, Venkatakrishnan K, Hui AM, Esseltine DL, Chng WJ. Pharmacokinetics and safety of ixazomib plus lenalidomide-dexamethasone in Asian patients with relapsed/refractory myeloma: a phase 1 study. J Hematol Oncol. 2015 Sep 4;8:103. doi: 10.1186/s13045-015-0198-1. |
Not provided
Not provided
Asian participants with a diagnosis of relapsed and/or refractory multiple myeloma were enrolled and received a combination of ixazomib, lenalidomide and dexamethasone.
Participants took part in the study at 8 investigative sites in Singapore, Hong Kong and South Korea from 17 December 2012 to 11 April 2017. Data cut-off for the analysis was 14 July 2014.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ixazomib+Lenalidomide+Dexamethasone | Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lenalidomide |
| Drug |
Lenalidomide capsules |
|
| Dexamethasone | Drug | Dexamethasone tablets |
|
| Cycle 1 (up to Day 28) |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or was a medically important event. | From the first dose of study drug through 30 days after the last dose of study drug (up to 577 days) |
| Number of Participants With Clinically Significant Laboratory Abnormalities Reported as Adverse Events of ≥Grade 3 Intensity | Clinically significant laboratory abnormalities were defined as any test results which were observed beyond the clinically acceptable limits as per the discretion of investigator. Clinical laboratory tests included chemistry, hematology and urinalysis tests. | From the first dose of study drug through 30 days after the last dose of study drug (up to 577 days) |
| Number of Participants With Clinically Significant Vital Signs Reported as Adverse Events | The number of participants who meet markedly abnormal criteria for vital signs, included diastolic and systolic blood pressure, heart rate, oral temperature, respiratory rate, and body weight. | From the first dose of study drug through 30 days after the last dose of study drug (up to 577 days) |
| From Cycle 1, Day 1 to Cycle 3, Day 1 until disease progression (approximately 20 months) |
| Duration of Response (DOR) | DOR was defined as the length of time between the date of first documented response (PR, VGPR, or CR) and the date of first documented progressive disease (PD). According to IMWG criteria: CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow; PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour. | From date of documentation of a confirmed response to date of progressive disease, (approximately 20 months) |
| Shatin |
| Hong Kong |
| Singapore | Singapore |
| Incheon | South Korea |
| Seoul | South Korea |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Population included all participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ixazomib+Lenalidomide+Dexamethasone | Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles) |
| 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 |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| |||||||||||||||||||||||
| Height at Baseline | Mean | Standard Deviation | cm |
| ||||||||||||||||||||||
| Weight at Baseline | Mean | Standard Deviation | kg |
|
| 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 | Cmax: Maximum Observed Plasma Concentration for Ixazomib | Participants from the Pharmacokinetic (PK)-evaluable population, all participants who received protocol-specified dosing during Cycle 1, did not receive any excluded concomitant medications and had sufficient concentration-time data to permit reliable estimation of PK parameters, with data available for analysis. | Posted | Mean | Standard Deviation | ng/mL | Cycle 1, Day 1 pre-dose and multiple time-points (up to 168 hours) post-dose |
|
|
| ||||||||||||||||||||||||||
| Primary | Cmax: Maximum Observed Plasma Concentration for Ixazomib | PK-evaluable population included all participants who received protocol-specified dosing during Cycle 1, did not receive any excluded concomitant medications and had sufficient concentration-time data to permit reliable estimation of PK parameters. | Posted | Mean | Standard Deviation | ng/mL | Cycle 1, Day 15 pre-dose and multiple time-points (up to 336 hours) post-dose |
|
| |||||||||||||||||||||||||||
| Primary | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib | Participants from the PK-evaluable population, all participants who received protocol-specified dosing during Cycle 1, did not receive any excluded concomitant medications and had sufficient concentration-time data to permit reliable estimation of PK parameters, with data available for analysis. | Posted | Median | Full Range | hours | Cycle 1, Day 1 pre-dose and multiple time-points (up to 168 hours) post-dose |
|
| |||||||||||||||||||||||||||
| Primary | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib | PK-evaluable population included all participants who received protocol-specified dosing during Cycle 1, did not receive any excluded concomitant medications and had sufficient concentration-time data to permit reliable estimation of PK parameters. | Posted | Median | Full Range | hours | Cycle 1, Day 15 pre-dose and multiple time-points (up to 336 hours) post-dose |
|
| |||||||||||||||||||||||||||
| Primary | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for Ixazomib | Participants from the PK-evaluable population, all participants who received protocol-specified dosing during Cycle 1, did not receive any excluded concomitant medications and had sufficient concentration-time data to permit reliable estimation of PK parameters, with data available for analysis. | Posted | Mean | Standard Deviation | hr*ng/mL | Cycle 1, Day 1 pre-dose and multiple time-points (up to 168 hours) post-dose |
|
| |||||||||||||||||||||||||||
| Primary | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for Ixazomib | PK-evaluable population included all participants who received protocol-specified dosing during Cycle 1, did not receive any excluded concomitant medications and had sufficient concentration-time data to permit reliable estimation of PK parameters. | Posted | Mean | Standard Deviation | hr*ng/mL | Cycle 1, Day 15 pre-dose and multiple time-points (up to 336 hours) post-dose |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Dose Limiting Toxicities (DLTs) | DLT was defined as any of the following AEs that were considered by investigator to be possibly related to therapy: 1. Grade 4 neutropenia lasting at least 7 consecutive days; 2. Grade 3 neutropenia with fever and/or infection; 3. Grade 4 thrombocytopenia at least 7 consecutive days; 4. Grade 3 thrombocytopenia with clinically significant bleeding; 5. Platelet count <10,000/mm^3; 6. Grade 2 peripheral neuropathy with pain or ≥Grade 3 peripheral neuropathy; 7. Grade 3 or greater nausea and / or emesis despite the use of optimal anti-emetic prophylaxis; 8. Grade 3 or greater diarrhea that occurred despite maximal supportive therapy; 9. Any other Grade 3 or greater nonhematologic toxicity with the following exceptions: Grade 3 arthralgia/myalgia, <1 week Grade 3 fatigue; 10. A delay of >2 weeks in the subsequent cycle of treatment; 11. Other combination study drug-related nonhematologic toxicities ≥Grade 2 that, in the opinion of the investigator, required discontinuation of study drug. | DLT-evaluable population consisted of participants who either had a DLT during Cycle 1 or received all scheduled doses and completed all study procedures in Cycle 1 without having a DLT. | Posted | Number | participants | Cycle 1 (up to Day 28) |
| ||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or was a medically important event. | Safety population was defined as all participants who received at least 1 dose of study drug. | Posted | Number | participants | From the first dose of study drug through 30 days after the last dose of study drug (up to 577 days) |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Significant Laboratory Abnormalities Reported as Adverse Events of ≥Grade 3 Intensity | Clinically significant laboratory abnormalities were defined as any test results which were observed beyond the clinically acceptable limits as per the discretion of investigator. Clinical laboratory tests included chemistry, hematology and urinalysis tests. | Safety population was defined as all participants who received at least 1 dose of study drug. | Posted | Number | participants | From the first dose of study drug through 30 days after the last dose of study drug (up to 577 days) |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Significant Vital Signs Reported as Adverse Events | The number of participants who meet markedly abnormal criteria for vital signs, included diastolic and systolic blood pressure, heart rate, oral temperature, respiratory rate, and body weight. | Safety population was defined as all participants who received at least 1 dose of study drug. | Posted | Number | participants | From the first dose of study drug through 30 days after the last dose of study drug (up to 577 days) |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Confirmed Best Response Category | Percentage of participants who achieve or maintain any best response category during the treatment period were reported. Best response includes complete response (CR), very good partial response (VGPR), and partial response (PR). Response was assessed according to IMWG criteria. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow; PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour. | Safety population was defined as all participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | From Cycle 1, Day 1 to Cycle 3, Day 1 until disease progression (approximately 20 months) |
|
| |||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR was defined as the length of time between the date of first documented response (PR, VGPR, or CR) and the date of first documented progressive disease (PD). According to IMWG criteria: CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow; PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour. | Safety population was defined as all participants who received at least 1 dose of study drug. | Posted | Median | Full Range | months | From date of documentation of a confirmed response to date of progressive disease, (approximately 20 months) |
|
|
First dose of study drug through 30 days after the last dose of study drug (up to 577 days)
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.
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+Lenalidomide+Dexamethasone | Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles) | 0 | 43 | 18 | 43 | 43 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA version: 16.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA version: 16.0 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA version: 16.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA version: 16.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version: 16.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Gastritis atrophic | Gastrointestinal disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Osteoporotic fracture | Musculoskeletal and connective tissue disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version: 16.0 | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version: 16.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA version: 16.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA version: 16.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version: 16.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version: 16.0 | Systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA version: 16.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version: 16.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version: 16.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version: 16.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version: 16.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version: 16.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA version: 16.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version: 16.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version: 16.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version: 16.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version: 16.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA version: 16.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version: 16.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA version: 16.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA version: 16.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA version: 16.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version: 16.0 | 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 | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C548400 | ixazomib |
| D000077269 | Lenalidomide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| 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 |
Not provided
Not provided
| Korea, Republic Of |
|
|
|
|
|
|
|
|
|
|
|
| Participants |
|
|
|