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Study for the outcome and safety of individualized busulfan dosing with bortezomib for patients preparing for a second stem cell transplant to treat multiple myeloma.
Evaluation of six-month response in relapsed multiple myeloma subjects, who have had a prior autologous HSCT (greater than one year previously) receiving an IV busulfan-based conditioning regimen with the combination of pharmacokinetic (PK)-guided IV busulfan dosing and bortezomib, followed by a second autologous HSCT.
Assessment of the safety profile of this conditioning regimen will also be completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV busulfan | Experimental | Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV busulfan | Drug | PK-directed dosing of IV busulfan for 4 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Overall Disease Response at Month 6 | The percentage of participants reported in each disease category by International Myeloma Working Group (IMWG) uniform response criteria for Multiple Myeloma 6 months after autologous Hematopoietic stem cell transplant. Overall Disease Response categories were: [stringent Complete Response (sCR)=CR + normal Free Light Chain (FLC) ratio + absence of clonal cells in bone marrow], [Complete Response (CR)=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow], [Very Good Partial Response (VGPR)=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein + urine M-protein level <100 mg/24 hour], [Partial Response (PR)=≥50% reduction of serum M-protein and reduction in 24 hour urine M-protein by ≥90% or to <200 mg per 24 hour], [Stable Disease (SD)=Not meeting criteria for CR, VGPR, PR or progressive disease] or [Progressive Disease (PD)]. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Esimated overall survival rate (percentage of participants) at Day 180 | 6 Months |
| Percentage of Participants With Overall Survival Events | Overall Survival Event was death. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Cancer Center | Tucson | Arizona | 85724 | United States | ||
| Blood and Marrow Transplant Group of Georgia |
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| Label | URL |
|---|---|
| Otsuka Clinical Trial Website | View source |
| Otsuka Clinical Trial Transparency | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | IV Busulfan | Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the pharmacokinetic (PK)-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to hematopoietic stem cell transplant (HSCT). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| bortezomib | Drug | Single IV bortezomib at a dose of 1.3 mg/m^2. |
|
|
| Autologous Hematopoietic Stem Cell Transplant (HSCT) | Procedure |
|
| 6 Months |
| Progression-free Survival | Progression-free Survival (PFS) defined as the time from transplantation to the occurrence of the event that was death or first recurrence of progressive disease (PD) by IMWG criteria. PD was defined as an Increase of ≥25% from the lowest response value in any one or more of the following: 1)Serum M-component and/or (the absolute increase must be ≥0.5 g/dL), 2)Urine M-component and/or (the absolute increase must be ≥200 mg/24 hr), 3)In patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be >10 mg/dL, 4)Bone marrow plasma cell percentage; the absolute percentage must be ≥10%, 5)Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas and/or 6)Development of hypercalcaemia that can be attributed solely to the plasma cell proliferative diso | 6 Months |
| Percentage of Participants With Progression-free Survival Events | Progression-free survival events are death or first recurrence of progressive disease by International Myeloma Working Group Criteria. | 6 Months |
| Percent Change in IV Busulfan Dose | The percent change in dose is relative to the busulfan dose administered at the Baseline Visit (Day -12 to -9) when a dose of 0.8 mg/kg was administered and on Day -5 when the Seattle Cancer Care Alliance recommended PK-adjusted dose was administered. | Baseline (Day -12 to -9), Day -5 |
| Ratio Area Under Curve (AUC)/Target AUC | A test dose of IV busulfan 0.8 mg/kg was infused at Baseline (Day -12 to -9) to verify a target busulfan integrated AUC of 20,000 μM*min with a range of 16,000 to 24,000. If necessary the dose could be adjusted. The PK-directed dose recommendation based on the test dose was administered at Day -5. Blood samples for PK analysis were collected at 0, 15, 30 minutes after the End of Infusion and 240, 300, 360 minutes after start of the infusion. Gas chromatography with mass selective detection (GC-MS) was used to determine the busulfan level in plasma. The ratio was calculated: AUC/Target AUC. | Baseline (Day -12 to -9), Day -5 |
| Percent Difference Between Area Under Curve (AUC) and Target AUC | A test dose of IV busulfan 0.8 mg/kg was infused at Baseline (Day -12 to -9) to verify a target busulfan integrated AUC of 20,000 μM*min with a range of 16,000 to 24,000. If necessary the dose could be adjusted. The PK-directed dose recommendation based on the test dose was administered at Day -5. Blood samples for PK analysis were collected at 0, 15, 30 minutes after the End of Infusion and 240, 300, 360 minutes after start of the infusion. GC-MS was used to determine the busulfan level in plasma. The percent difference was calculated between AUC and the Target AUC. | Baseline (Day -12 to -9), Day -5 |
| Percentage of Participants With Transplant-Related Mortality | The percentage of participants with death related to transplant. | 6 Months |
| Percentage of Participants With Hepatic Veno-Occlusive Disease Based on Baltimore Criteria | The Baltimore criteria for veno-occlusive disease was defined as the development of hyperbilirubinemia with serum bilirubin > 2 mg/dl within 21 days after transplantation and at least 2 of the following clinical signs and symptoms: (1) hepatomegaly, usually painful, (2) > 5% weight gain, or (3) ascites. | 6 Months |
| Atlanta |
| Georgia |
| 30342 |
| United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| University of Maryland School of Medicine - Marlene & Stewart Greenebaum Cancer Center | Baltimore | Maryland | 21201 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| University of Pennsylvania -Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| The Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | 15224 | United States |
| South Texas Veterans Health Care System | San Antonio | Texas | 78229 | United States |
| Texas Transplant Physician Group, PLLC | San Antonio | Texas | 78229 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IV Busulfan | Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT. |
| 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/Gender, Customized | Count of Participants | Participants |
|
| 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 | Percentage of Participants With Overall Disease Response at Month 6 | The percentage of participants reported in each disease category by International Myeloma Working Group (IMWG) uniform response criteria for Multiple Myeloma 6 months after autologous Hematopoietic stem cell transplant. Overall Disease Response categories were: [stringent Complete Response (sCR)=CR + normal Free Light Chain (FLC) ratio + absence of clonal cells in bone marrow], [Complete Response (CR)=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow], [Very Good Partial Response (VGPR)=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein + urine M-protein level <100 mg/24 hour], [Partial Response (PR)=≥50% reduction of serum M-protein and reduction in 24 hour urine M-protein by ≥90% or to <200 mg per 24 hour], [Stable Disease (SD)=Not meeting criteria for CR, VGPR, PR or progressive disease] or [Progressive Disease (PD)]. | Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT. | Posted | Number | Percentage of participants | 6 Months |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Esimated overall survival rate (percentage of participants) at Day 180 | Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT. | Posted | Number | percentage of participants | 6 Months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Overall Survival Events | Overall Survival Event was death. | Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT. | Posted | Number | Percentage of participants | 6 Months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival | Progression-free Survival (PFS) defined as the time from transplantation to the occurrence of the event that was death or first recurrence of progressive disease (PD) by IMWG criteria. PD was defined as an Increase of ≥25% from the lowest response value in any one or more of the following: 1)Serum M-component and/or (the absolute increase must be ≥0.5 g/dL), 2)Urine M-component and/or (the absolute increase must be ≥200 mg/24 hr), 3)In patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be >10 mg/dL, 4)Bone marrow plasma cell percentage; the absolute percentage must be ≥10%, 5)Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas and/or 6)Development of hypercalcaemia that can be attributed solely to the plasma cell proliferative diso | Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT. | Posted | Median | 95% Confidence Interval | Days | 6 Months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Progression-free Survival Events | Progression-free survival events are death or first recurrence of progressive disease by International Myeloma Working Group Criteria. | Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT. | Posted | Number | Percentage of participants | 6 Months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in IV Busulfan Dose | The percent change in dose is relative to the busulfan dose administered at the Baseline Visit (Day -12 to -9) when a dose of 0.8 mg/kg was administered and on Day -5 when the Seattle Cancer Care Alliance recommended PK-adjusted dose was administered. | Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT. | Posted | Median | Full Range | Percent change | Baseline (Day -12 to -9), Day -5 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Ratio Area Under Curve (AUC)/Target AUC | A test dose of IV busulfan 0.8 mg/kg was infused at Baseline (Day -12 to -9) to verify a target busulfan integrated AUC of 20,000 μM*min with a range of 16,000 to 24,000. If necessary the dose could be adjusted. The PK-directed dose recommendation based on the test dose was administered at Day -5. Blood samples for PK analysis were collected at 0, 15, 30 minutes after the End of Infusion and 240, 300, 360 minutes after start of the infusion. Gas chromatography with mass selective detection (GC-MS) was used to determine the busulfan level in plasma. The ratio was calculated: AUC/Target AUC. | Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT. | Posted | Median | Full Range | Ratio | Baseline (Day -12 to -9), Day -5 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percent Difference Between Area Under Curve (AUC) and Target AUC | A test dose of IV busulfan 0.8 mg/kg was infused at Baseline (Day -12 to -9) to verify a target busulfan integrated AUC of 20,000 μM*min with a range of 16,000 to 24,000. If necessary the dose could be adjusted. The PK-directed dose recommendation based on the test dose was administered at Day -5. Blood samples for PK analysis were collected at 0, 15, 30 minutes after the End of Infusion and 240, 300, 360 minutes after start of the infusion. GC-MS was used to determine the busulfan level in plasma. The percent difference was calculated between AUC and the Target AUC. | Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT. | Posted | Median | Full Range | Percent difference | Baseline (Day -12 to -9), Day -5 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Transplant-Related Mortality | The percentage of participants with death related to transplant. | Safety population included all participants who received IV busulfan. | Posted | Number | Percentage of participants | 6 Months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Hepatic Veno-Occlusive Disease Based on Baltimore Criteria | The Baltimore criteria for veno-occlusive disease was defined as the development of hyperbilirubinemia with serum bilirubin > 2 mg/dl within 21 days after transplantation and at least 2 of the following clinical signs and symptoms: (1) hepatomegaly, usually painful, (2) > 5% weight gain, or (3) ascites. | Safety population included all participants who received IV busulfan. | Posted | Number | Percentage of participants | 6 Months |
|
|
Not provided
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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 | IV Busulfan | Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT. | 18 | 30 | 30 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Cranial neuropathy | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pulmonary toxicity | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Venoocclusive disease | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Anal inflammation | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hematochezia | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Scrotal erythema | Reproductive system and breast disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| clinical Transparency | Otsuka | 1-800-441-6763 | SMB_ClinicalTranspa@otsuka-us.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 |
|---|---|
| D002066 | Busulfan |
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Title | Measurements |
|---|---|
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| Units |
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| Counts |
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| Participants |
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