Multiple Myeloma
Conditions
Brief summary
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.
Interventions
DRUGDasatinib
Tablets; oral; approximately 2 years on study, depending on response; 50 mg once daily (QD), 100 mg QD, 140 mg QD
DRUGBortezomib
Powder; intravenous; approximately 2 years on study, depending on response; 1.0 mg/m\^2 QD, 1.3 mg/m\^2 QD
DRUGDexamethasone
Tablets; oral; approximately 2 years on study, depending on response; 20 mg QD
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Confirmed diagnosis of multiple myeloma with measurable disease * Evidence of relapsed or refractory disease and at least 2 prior therapies for multiple myeloma * Eastern Cooperative Oncology Group Performance Status of 0 - 2 * Last treatment for multiple myeloma not within 21 days prior to study treatment initiation * Bone marrow transplant not within 3 months prior to study treatment initiation * Required baseline hematology and chemistry parameters. Key
Exclusion criteria
* Clinically significant cardiac disease (New York Heart Association Class III or IV) * Abnormal QT interval corrected for heart rate using Fridericia's formula prolonged (\>450 msec) after electrolytes have been corrected on baseline electrocardiogram * Malabsorption syndrome or uncontrolled gastrointestinal toxicities * Dementia, chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation * Clinically significant pleural effusion in the previous 12 months or current ascites * Clinically significant coagulation or platelet function disorder * Intolerance to dasatinib and/or bortezomib * Acute diffuse infiltrative pulmonary disease * Prior or concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer currently in complete remission, cervical carcinoma in situ, or any other cancer from which the participant has been disease-free for 3 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose (MTD) and Recommended MTD of Dasatinib in Combination With Bortezomib and Dexamethasone | Days 1 to 21 | 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. |
| MTD and Recommended MTD of Bortezomib in Combination With Dasatinib and Dexamethasone | Days 1 to 21 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 1 until last tumor assessment (maximum reached: 9 months) | 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. |
| Duration of Response | First occurrence of response to disease progression or death, whichever occurred first (maximum reached: 12.2 months) | 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. |
| Progression-free Survival | Day 1 to disease progression or death, whichever came first (maximum reached: 14 months) | 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. |
| 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 | Continuously from Day 1 until last day of study medication + 30 days (maximum reached: 10 months) | 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. |
Countries
France, Italy, Spain, United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 7 |
| 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. | 3 |
| 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. | 4 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse event unrelated to study drug | 2 | 1 | 1 |
| Overall Study | Disease progression | 0 | 1 | 1 |
| Overall Study | Maximum clinical benefit | 1 | 0 | 0 |
| Overall Study | Study drug toxicity | 3 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Dasatinib, 50 mg BID | Dasatinib, 100 mg QD | Dasatinib, 140 mg QD | Total |
|---|---|---|---|---|
| Age, Continuous | 72 Years | 74 Years | 59.5 Years | 71 Years |
| Age, Customized 46 to 65 years | 1 Participants | 1 Participants | 3 Participants | 5 Participants |
| Age, Customized 66 to 75 years | 6 Participants | 2 Participants | 1 Participants | 9 Participants |
| Age, Customized Older than 75 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 6 Participants | 3 Participants | 4 Participants | 13 Participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 5 Participants | 2 Participants | 1 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 3 | 4 / 4 | 6 / 7 |
| serious Total, serious adverse events | 2 / 3 | 1 / 4 | 6 / 7 |
Outcome results
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.
Time frame: Days 1 to 21
Population: All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Treated | Maximum Tolerated Dose (MTD) and Recommended MTD of Dasatinib in Combination With Bortezomib and Dexamethasone | MTD dasatinib | NA mg QD |
| All Treated | Maximum Tolerated Dose (MTD) and Recommended MTD of Dasatinib in Combination With Bortezomib and Dexamethasone | Recommended MTD dasatinib | 140 mg QD |
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.
Time frame: Days 1 to 21
Population: All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Treated | MTD and Recommended MTD of Bortezomib in Combination With Dasatinib and Dexamethasone | MTD of bortezomib | NA mg/m^2 |
| All Treated | MTD and Recommended MTD of Bortezomib in Combination With Dasatinib and Dexamethasone | Recommended MTD of bortezomib | 1.3 mg/m^2 |
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.
Time frame: Day 1 until last tumor assessment (maximum reached: 9 months)
Population: All response-evaluable participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Treated | 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 | Very good partial response (VGPR) | 0 Percentage of participants |
| All Treated | 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 | Minimal response (MR) | 0 Percentage of participants |
| All Treated | 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 | Progressive disease (PD) | 14.3 Percentage of participants |
| All Treated | 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 | Not reported | 14.3 Percentage of participants |
| All Treated | 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 | Stable disease (SD) | 57.1 Percentage of participants |
| All Treated | 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 | Partial response (PR) | 14.3 Percentage of participants |
| All Treated | 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 | Unable to determine | 0 Percentage of participants |
| All Treated | 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 | Complete response (CR) | 0 Percentage of participants |
| Dasatinib, 100 mg QD | 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 | Complete response (CR) | 0 Percentage of participants |
| Dasatinib, 100 mg QD | 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 | Stable disease (SD) | 0 Percentage of participants |
| Dasatinib, 100 mg QD | 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 | Progressive disease (PD) | 33.3 Percentage of participants |
| Dasatinib, 100 mg QD | 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 | Unable to determine | 33.3 Percentage of participants |
| Dasatinib, 100 mg QD | 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 | Minimal response (MR) | 0 Percentage of participants |
| Dasatinib, 100 mg QD | 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 | Very good partial response (VGPR) | 0 Percentage of participants |
| Dasatinib, 100 mg QD | 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 | Not reported | 33.3 Percentage of participants |
| Dasatinib, 100 mg QD | 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 | Partial response (PR) | 0 Percentage of participants |
| Dasatinib, 140 mg QD | 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 | Not reported | 50 Percentage of participants |
| Dasatinib, 140 mg QD | 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 | Very good partial response (VGPR) | 0 Percentage of participants |
| Dasatinib, 140 mg QD | 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 | Partial response (PR) | 0 Percentage of participants |
| Dasatinib, 140 mg QD | 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 | Minimal response (MR) | 25 Percentage of participants |
| Dasatinib, 140 mg QD | 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 | Progressive disease (PD) | 0 Percentage of participants |
| Dasatinib, 140 mg QD | 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 | Stable disease (SD) | 0 Percentage of participants |
| Dasatinib, 140 mg QD | 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 | Unable to determine | 25 Percentage of participants |
| Dasatinib, 140 mg QD | 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 | Complete response (CR) | 0 Percentage of participants |
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.
Time frame: First occurrence of response to disease progression or death, whichever occurred first (maximum reached: 12.2 months)
Population: All response-evaluable participants who achieved a response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Treated | Duration of Response | Partial response (PR) | 5.4 Months |
| All Treated | Duration of Response | Minimal response (MR) | NA Months |
| Dasatinib, 140 mg QD | Duration of Response | Partial response (PR) | 0 Months |
| Dasatinib, 140 mg QD | Duration of Response | Minimal response (MR) | 12.2 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.
Time frame: Continuously from Day 1 until last day of study medication + 30 days (maximum reached: 10 months)
Population: All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Treated | 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 | SAEs | 6 Participants |
| All Treated | 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 | Drug-related AEs leading to discontinuation | 3 Participants |
| All Treated | 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 | Drug-related AEs | 6 Participants |
| All Treated | 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 | Death | 3 Participants |
| All Treated | 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 | Drug-related SAEs | 2 Participants |
| All Treated | 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 | AEs leading to discontinuation | 5 Participants |
| All Treated | 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 | AEs | 7 Participants |
| All Treated | 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 | AEs, Grades 3 and 4 | 3 Participants |
| All Treated | 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 | Drug-related AEs, Grades 3 and 4 | 4 Participants |
| Dasatinib, 100 mg QD | 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 | Drug-related AEs | 2 Participants |
| Dasatinib, 100 mg QD | 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 | Death | 2 Participants |
| Dasatinib, 100 mg QD | 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 | Drug-related AEs leading to discontinuation | 0 Participants |
| Dasatinib, 100 mg QD | 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 | AEs leading to discontinuation | 1 Participants |
| Dasatinib, 100 mg QD | 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 | SAEs | 2 Participants |
| Dasatinib, 100 mg QD | 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 | Drug-related SAEs | 0 Participants |
| Dasatinib, 100 mg QD | 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 | AEs | 3 Participants |
| Dasatinib, 100 mg QD | 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 | Drug-related AEs, Grades 3 and 4 | 2 Participants |
| Dasatinib, 100 mg QD | 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 | AEs, Grades 3 and 4 | 3 Participants |
| Dasatinib, 140 mg QD | 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 | Drug-related AEs, Grades 3 and 4 | 4 Participants |
| Dasatinib, 140 mg QD | 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 | AEs leading to discontinuation | 2 Participants |
| Dasatinib, 140 mg QD | 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 | Death | 2 Participants |
| Dasatinib, 140 mg QD | 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 | SAEs | 1 Participants |
| Dasatinib, 140 mg QD | 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 | AEs, Grades 3 and 4 | 4 Participants |
| Dasatinib, 140 mg QD | 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 | Drug-related SAEs | 0 Participants |
| Dasatinib, 140 mg QD | 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 | AEs | 4 Participants |
| Dasatinib, 140 mg QD | 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 | Drug-related AEs leading to discontinuation | 1 Participants |
| Dasatinib, 140 mg QD | 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 | Drug-related AEs | 4 Participants |
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.
Time frame: Day 1 to disease progression or death, whichever came first (maximum reached: 14 months)
Population: All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Treated | Progression-free Survival | 6.3 Months |