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The purpose of this study is to determine the safety and tolerability of dasatinib with bortezomib in the treatment of relapsed or refractory multiple myeloma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dasatinib + Bortezomib + Dexamethasone | Experimental | Phase I dose escalation study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib | Drug | Tablets; oral; approximately 2 years on study, depending on response; 50 mg once daily (QD), 100 mg QD, 140 mg QD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) and Recommended MTD of Dasatinib in Combination With Bortezomib and Dexamethasone | MTD is defined as the dose level combination below the dose level that produces a dose-limiting toxicity in at least 2 out of 6 or fewer participants in that cohort. If MTD is not reached, the recommended MTD is the maximum dose that the participants received. | Days 1 to 21 |
| MTD and Recommended MTD of Bortezomib in Combination With Dasatinib and Dexamethasone | MTD is defined as the dose level combination below the dose level that produces a dose-limiting toxicity in at least 2 out of 6 or fewer participants in that cohort. If MTD is not reached, the recommended dose is the maximum dose that the participants received. | Days 1 to 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Tumor Response Rate (RR) As Assessed Using International Uniform Response Criteria for Multiple Myeloma and Criteria of the European Bone Marrow Transplant Registry | S=serum; U=urine; MP=M-protein; ST=soft tissue, PC=plasmacytomas; IF=immunofixation; BL=baseline. RR calculated on best response any time. CR=MP undetectable by IF, ≤5% plasma cells in bone marrow, and no ST PC. VGPR=MP detectable by IF, or ≥90% drop in S MP and U MP<100 mg/24h. PR= ≥50% drop in S MP and ≥90% drop in U MP or U protein <200 mg/24h, ≥50% drop in BL ST PC size. MR= ≥25% to <50% drop in S MP and ≥50% to <90% drop in U MP and ≥25% to <50% drop in BL ST PC. SD=Not CR, VGPR, PR, or MR. PD= ≥25% rise in S or U M-component; new/increased size of bone lesions, ST PC, or hypercalcemia. |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Health, Inc. M.D. Anderson Cancer Center Orlando | Orlando | Florida | 32806 | United States | ||
| Winship Cancer Institute, Emory University |
A total of 16 participants were enrolled, and 14 participants received treatment. The study was terminated due to an unexpectedly low recruitment rate, and no participants were enrolled in a planned dose-expansion phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dasatinib, 50 mg BID | Dasatinib, 50 mg administered twice daily (BID), with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg once daily (QD), was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib. |
| FG001 | Dasatinib, 100 mg QD | Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib. |
| FG002 | Dasatinib, 140 mg QD | Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dasatinib, 50 mg BID | Dasatinib, 50 mg administered twice daily (BID), with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg once daily (QD), was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib. |
| 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 | Maximum Tolerated Dose (MTD) and Recommended MTD of Dasatinib in Combination With Bortezomib and Dexamethasone | MTD is defined as the dose level combination below the dose level that produces a dose-limiting toxicity in at least 2 out of 6 or fewer participants in that cohort. If MTD is not reached, the recommended MTD is the maximum dose that the participants received. | All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone | Posted | Number | mg QD | Days 1 to 21 |
|
Continuously from Day 1 until last day of study medication + 30 days (maximum reached: 10 months)
Not provided
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 | Dasatinib, 100 mg QD | Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
The study was terminated due to an unexpectedly low recruitment rate, and no participants were enrolled in a planned dose-expansion phase.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| BMS Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
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 |
|---|---|
| D000069439 | Dasatinib |
| D000069286 | Bortezomib |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Bortezomib | Drug | Powder; intravenous; approximately 2 years on study, depending on response; 1.0 mg/m^2 QD, 1.3 mg/m^2 QD |
|
|
| Dexamethasone | Drug | Tablets; oral; approximately 2 years on study, depending on response; 20 mg QD |
|
| Day 1 until last tumor assessment (maximum reached: 9 months) |
| Duration of Response | Duration of response calculated for those with best response=CR (M-protein [MP] undetectable by immunofixation [IF], ≤5% plasma cells in bone marrow, no soft tissue plasmacytomas); VGPR (MP detectable by IF, or ≥90% drop in serum [S] MP and urine [U] MP<100 mg/24h); PR(≥50% drop in S MP and ≥90% drop in U MP or U protein <200 mg/24h, ≥50% drop in BL ST PC size); or MR (≥25% to <50% drop in S MP and ≥50% to <90% drop in U MP and ≥25% to <50% drop in BL ST PC). Duration of response calculated from day criteria for CR, VGPR, PR, and MR were met until progression or death, whichever came first. | First occurrence of response to disease progression or death, whichever occurred first (maximum reached: 12.2 months) |
| Progression-free Survival | Progression-free survival was defined as the time from start of treatment until progression or death, whichever occurred first. Participants were to be followed-up for 12 months following the last dose of dasatinib for progression and survival. PFS was analyzed for the all-treated population. | Day 1 to disease progression or death, whichever came first (maximum reached: 14 months) |
| Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs) Leading to Discontinuation, AEs Leading to Discontinuation, AEs, and Drug-related AEs by Grade | An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to or of unknown relationship to study treatment. Grade 3=severe; Grade 4=life-threatening. | Continuously from Day 1 until last day of study medication + 30 days (maximum reached: 10 months) |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Local Institution | Nantes | Cedex 1 | 44093 | France |
| Local Institution | Lille | 59037 | France |
| Local Institution | Bari | 70124 | Italy |
| Local Institution | Bologna | 40138 | Italy |
| Local Institution | Salamanca | 37007 | Spain |
| Disease progression |
|
| Withdrawal by Subject |
|
| Maximum clinical benefit |
|
| BG001 | Dasatinib, 100 mg QD | Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib. |
| BG002 | Dasatinib, 140 mg QD | Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Age, Customized | Number | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
|
|
| Secondary | Best Overall Tumor Response Rate (RR) As Assessed Using International Uniform Response Criteria for Multiple Myeloma and Criteria of the European Bone Marrow Transplant Registry | S=serum; U=urine; MP=M-protein; ST=soft tissue, PC=plasmacytomas; IF=immunofixation; BL=baseline. RR calculated on best response any time. CR=MP undetectable by IF, ≤5% plasma cells in bone marrow, and no ST PC. VGPR=MP detectable by IF, or ≥90% drop in S MP and U MP<100 mg/24h. PR= ≥50% drop in S MP and ≥90% drop in U MP or U protein <200 mg/24h, ≥50% drop in BL ST PC size. MR= ≥25% to <50% drop in S MP and ≥50% to <90% drop in U MP and ≥25% to <50% drop in BL ST PC. SD=Not CR, VGPR, PR, or MR. PD= ≥25% rise in S or U M-component; new/increased size of bone lesions, ST PC, or hypercalcemia. | All response-evaluable participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone | Posted | Number | Percentage of participants | Day 1 until last tumor assessment (maximum reached: 9 months) |
|
|
|
| Secondary | Duration of Response | Duration of response calculated for those with best response=CR (M-protein [MP] undetectable by immunofixation [IF], ≤5% plasma cells in bone marrow, no soft tissue plasmacytomas); VGPR (MP detectable by IF, or ≥90% drop in serum [S] MP and urine [U] MP<100 mg/24h); PR(≥50% drop in S MP and ≥90% drop in U MP or U protein <200 mg/24h, ≥50% drop in BL ST PC size); or MR (≥25% to <50% drop in S MP and ≥50% to <90% drop in U MP and ≥25% to <50% drop in BL ST PC). Duration of response calculated from day criteria for CR, VGPR, PR, and MR were met until progression or death, whichever came first. | All response-evaluable participants who achieved a response. | Posted | Number | Months | First occurrence of response to disease progression or death, whichever occurred first (maximum reached: 12.2 months) |
|
|
|
| Secondary | Progression-free Survival | Progression-free survival was defined as the time from start of treatment until progression or death, whichever occurred first. Participants were to be followed-up for 12 months following the last dose of dasatinib for progression and survival. PFS was analyzed for the all-treated population. | All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone | Posted | Median | 95% Confidence Interval | Months | Day 1 to disease progression or death, whichever came first (maximum reached: 14 months) |
|
|
|
| Secondary | Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs) Leading to Discontinuation, AEs Leading to Discontinuation, AEs, and Drug-related AEs by Grade | An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to or of unknown relationship to study treatment. Grade 3=severe; Grade 4=life-threatening. | All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone. | Posted | Number | Participants | Continuously from Day 1 until last day of study medication + 30 days (maximum reached: 10 months) |
|
|
|
| Primary | MTD and Recommended MTD of Bortezomib in Combination With Dasatinib and Dexamethasone | MTD is defined as the dose level combination below the dose level that produces a dose-limiting toxicity in at least 2 out of 6 or fewer participants in that cohort. If MTD is not reached, the recommended dose is the maximum dose that the participants received. | All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone | Posted | Number | mg/m^2 | Days 1 to 21 |
|
|
|
| 2 |
| 3 |
| 3 |
| 3 |
| EG001 | Dasatinib, 140 mg QD | Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib. | 1 | 4 | 4 | 4 |
| EG002 | Dasatinib, 50 mg BID | Dasatinib, 50 mg administered twice daily (BID), with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg once daily (QD), was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib. | 6 | 7 | 6 | 7 |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Enterococcal bacteraemia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Gastrointestinal candidiasis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Urine flow decreased | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| 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 |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D011719 | Pyrazines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
|
| Partial response (PR) |
|
| Minimal response (MR) |
|
| Stable disease (SD) |
|
| Progressive disease (PD) |
|
| Unable to determine |
|
| Not reported |
|
| Title | Measurements |
|---|---|
|
| Drug-related SAEs |
|
| Drug-related AEs leading to discontinuation |
|
| AEs leading to discontinuation |
|
| AEs |
|
| AEs, Grades 3 and 4 |
|
| Drug-related AEs |
|
| Drug-related AEs, Grades 3 and 4 |
|