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The purpose of this study was to determine the safety and tolerability of dasatinib when given in combination with lenalidomide and a low dose dexamethasone for the treatment of relapsed or refractory multiple myeloma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mg | Experimental | Participants received a combination of dasatinib, 70 mg QD, lenalidomide, 15 mg QD, and dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22, in 28-day cycles. |
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| Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg | Experimental | Participants received a combination of dasatinib, 70 mg QD, lenalidomide, 20 mg QD, and dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22, in 28-day cycles. |
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| Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg | Experimental | Participants received a combination of dasatinib, 100 mg QD, lenalidomide, 20 mg QD, and dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22, in 28-day cycles. |
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| Dasatinib, 100 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg | Experimental | Participants received a combination of dasatinib, 100 mg QD, lenalidomide, 25 mg QD, and dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22, in 28-day cycles. |
|
| Dasatinib, 140 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mg | Drug | Participants received dasatinib, 70 mg once daily (QD), for 28 days plus lenalidomide, 15 mg QD, for 21 days plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22. |
| Measure | Description | Time Frame |
|---|---|---|
| Recommended Phase II Dose (RP2D) of the Combination (Dasatinib + Lenalidomide + Dexamethasone) | The RP2D was based on the MTD which was defined as the maximum combined dose producing dose limiting toxicity (DLT) in < 33% of participants treated at the individual dose levels in the combination. The MTD is considered the last dose level combination tested just below the maximum administered dose (MAD) level combination and for which DLTs were observed in less than or equal to 33% of participants during the escalation and expansion phase. If MTD was not reached Please refer to Outcome Measure 2 for the complete definition of DLT. | From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]). |
| Number of Participants With Dose-limiting Toxicity (DLT) | DLTs: At least possibly drug-related AEs occurring during the first cycle of treatment and are:GR4 neutropenia >5 days/neutropenic fever;platelet count <10000mm^3 on >1 occasion;GR4 fatigue,or 2-point decline in ECOG performance status;>=GR3 nausea,diarrhea,and vomiting despite medical intervention;Any other clinically significant non-hematologic toxicity of >=GR3 considered not related to underlying MM;Any GR3/4 laboratory abnormality requiring hospitalization;dose interruption of either dasatinib and/or lenalidomide for >15 days due to any toxicity related to treatment with the combination. | From the date of first dose until at least 30 days after the last dose of study drug (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]). |
| Number of Participants in the Dose Escalation Phase Who Reached Maximum Tolerated Dose (MTD) of Dasatinib With Lenalidomide and Dexamethasone | The MTD is considered the last dose level combination tested just below the maximum administered dose (MAD) level combination and for which DLTs were observed in less than 33% of participants during the escalation and expansion phase. Please refer to outcome 2 for the complete definition of DLT. If the MTD was not reached at the highest dose administered as defined by protocol, the highest dose (dasatinib 140 mg QD + lenalidomide 25 mg QD) administered was selected for the dose expansion phase of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complete Response and Very Good Partial Response | Response criteria were based on The International Uniform Response Criteria for Multiple Myeloma (with a slight modification). Complete response was achieved when there was 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 was achieved when serum and urine M-component was detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-component plus urine M-component < 100 mg per 24 hour. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Scottsdale | Arizona | 85259 | United States | ||
| Local Institution |
Of 39 participants were enrolled in this study, 4 never received treatment due to screening failure. A total of 35 participants received treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Experimental |
Participants received a combination of dasatinib, lenalidomide, and dexamethasone in varying doses in 28-day cycles. |
|
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| Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg | Drug | Participants received dasatinib, 70 mg QD, for 28 days plus lenalidomide, 20 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22. |
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|
| Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg | Drug | Participants received dasatinib, 100 mg QD, for 28 days, plus lenalidomide, 20 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22. |
|
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| Dasatinib, 100 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg | Drug | Participants received dasatinib, 100 mg QD, for 28 days, plus lenalidomide, 25 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22. |
|
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| Dasatinib, 140 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg | Drug | Participants received dasatinib, 140 mg QD, for 28 days, plus lenalidomide, 25 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22. Cohort includes 4 participants who received treatment during the dose-finding phase and 13 participants who received treatment in the dose-expansion phase. |
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| From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]). |
| Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade 1= Mild; Grade 2= Moderate; Grade 3= Severe; Grade 4 = Life-threatening or disabling. | Baseline (pretreatment), from the date of first dose until at least 30 days after the last dose of study drug (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]). |
| Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | As per NCI CTCAE Version 3.0 criteria. Grade (GR)1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. White blood cell (WBC):GR1=\ | Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo]) |
| Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | Grading as per NCI CTCAE Version 3.0 criteria. GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Aspartate aminotransferase (AST) and alanine aminotransferase(ALT): GR1=>ULN-2.5*ULN (upper limit of normal); GR2=>2.5-5.0*ULN; GR3=>5.0-20.0*ULN; GR4:>20.0*ULN; TB:GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN; SC: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3.0-6.0*ULN, GR4=>6.0*ULN. BL=Baseline; PBL=post baseline. | Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo]) |
| Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Grading as per NCI CTCAE Version 3.0 criteria. GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Calcium (low): GR1: <LLN - 8.0 mg/dL, GR2: <8.0 - 7.0 mg/dL, GR3: <7.0 - 6.0 mg/dL, GR4: <6.0 mg/dL. Calcium (High): GR1: >ULN - 11.5 mg/dL, GR2: >11.5 - 12.5 mg/dL, GR3: >12.5 - 13.5 mg/dL, GR4: >13.5 mg/dL. Magnesium (Low): GR1: \ | Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo]) |
| Baseline, At the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]). |
| Number of Participants With Partial Response | Partial response was achieved when there was ≥50% reduction of serum M-protein (Mpr)and reduction in 24 hour urinary Mpr by ≥90% or to <200 mg/24 hr. If the serum and urine Mpr were unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC) levels was required in place of the Mpr criteria. If serum, urine Mpr, and serum FLC assay were unmeasurable, ≥50% reduction in plasma cells was required in place of Mpr, provided baseline bone marrow plasma cell percentage was ≥30%; a ≥50% reduction in the size of soft tissue plasmacytomas was also required. | Baseline, at the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]). |
| Number of Participants With Minimal Response | Response criteria was based on The International Uniform Response Criteria for Multiple Myeloma (with a slight modification). Minimal Response was achieved when there was 25% to 49% reduction of serum M-Protein, 50% to 89% reduction in 24 hour urinary M-protein which still exceeded 200 mg/24 hour. If the serum and urine M-protein were unmeasurable, 25% to 49% reduction in plasma cells was required. In addition, if present at baseline, a 25% to 49% reduction in the size of soft tissue plasmacytomas was also required. | Baseline, at the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]). |
| Prahran |
| Victoria |
| 3181 |
| Australia |
| Local Institution | Toulouse | 31059 | France |
| Local Institution | Vandœuvre-lès-Nancy | 54511 | France |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg |
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). |
| FG002 | Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). |
| FG003 | Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). |
| FG004 | Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). |
| BG001 | Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). |
| BG002 | Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). |
| BG003 | Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). |
| BG004 | Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| International Staging System (ISS) | The ISS is an updated staging system for multiple myeloma. ISS divides multiple myeloma into three stages, which indicate the effect the disease is having on the body and how quickly or slowly it may develop. The ISS is based on the levels of blood proteins beta-2 microglobulin (β2M) and albumin. Stage I= β2M: <3.5 mg/L, albumin: >=3.5 g/dL; Stage II= β2M level: < 3.5 mg/L and albumin: < 3.5 g/dL, or β2M =3.5 to 5.5 mg/dL; Stage III: β2M level: >=5.5 mg/L. | Number | participants |
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| Durie-Salmon Staging System | Myeloma is classified into 3 stages. Stage I: hemoglobin (Hb) >10g/dL, normal calcium levels, normal skeletal survey or single plasmacytoma or osteoporosis, serum paraprotein level<5g/dL if immunoglobulin G(IgG), <3g/dL if IgA, urinary light chain excretion<4g/24h. Stage II: fulfilling the criteria of neither I nor III. Stage III: Hb<8.5g/dL, high calcium >12mg/dL, Skeletal survey of 3 or more lytic bone lesions, serum paraprotein >7g/dL if IgG,>5g/dL if IgA, urinary light chain excretion >12g/24h. Each stage further subdivided: A= serum creatinine <2mg/dL and B= serum creatinine >2mg/dL. | Number | participants |
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| Time from diagnosis to first dosing | Median | Full Range | years |
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| 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 | ||||||||||||||||||||||||||||||
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| Primary | Recommended Phase II Dose (RP2D) of the Combination (Dasatinib + Lenalidomide + Dexamethasone) | The RP2D was based on the MTD which was defined as the maximum combined dose producing dose limiting toxicity (DLT) in < 33% of participants treated at the individual dose levels in the combination. The MTD is considered the last dose level combination tested just below the maximum administered dose (MAD) level combination and for which DLTs were observed in less than or equal to 33% of participants during the escalation and expansion phase. If MTD was not reached Please refer to Outcome Measure 2 for the complete definition of DLT. | All treated participants, participants who received at least 1 dose of dasatinib. | Posted | Number | mg | From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]). |
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| Primary | Number of Participants With Dose-limiting Toxicity (DLT) | DLTs: At least possibly drug-related AEs occurring during the first cycle of treatment and are:GR4 neutropenia >5 days/neutropenic fever;platelet count <10000mm^3 on >1 occasion;GR4 fatigue,or 2-point decline in ECOG performance status;>=GR3 nausea,diarrhea,and vomiting despite medical intervention;Any other clinically significant non-hematologic toxicity of >=GR3 considered not related to underlying MM;Any GR3/4 laboratory abnormality requiring hospitalization;dose interruption of either dasatinib and/or lenalidomide for >15 days due to any toxicity related to treatment with the combination. | All treated participants, participants who received at least 1 dose of dasatinib. (Participants included from Cohort 5 are those involved in the dose escalation phase only.) | Posted | Number | participants | From the date of first dose until at least 30 days after the last dose of study drug (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]). |
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| Primary | Number of Participants in the Dose Escalation Phase Who Reached Maximum Tolerated Dose (MTD) of Dasatinib With Lenalidomide and Dexamethasone | The MTD is considered the last dose level combination tested just below the maximum administered dose (MAD) level combination and for which DLTs were observed in less than 33% of participants during the escalation and expansion phase. Please refer to outcome 2 for the complete definition of DLT. If the MTD was not reached at the highest dose administered as defined by protocol, the highest dose (dasatinib 140 mg QD + lenalidomide 25 mg QD) administered was selected for the dose expansion phase of the study. | All treated participants, participants who received at least 1 dose of dasatinib. (Participants included from Cohort 5 are those involved in the dose escalation phase only.) | Posted | Number | participants | From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]). |
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| Secondary | Number of Participants With Complete Response and Very Good Partial Response | Response criteria were based on The International Uniform Response Criteria for Multiple Myeloma (with a slight modification). Complete response was achieved when there was 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 was achieved when serum and urine M-component was detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-component plus urine M-component < 100 mg per 24 hour. | All treated participants, participants who received at least 1 dose of dasatinib. | Posted | Number | participants | Baseline, At the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]). |
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| Primary | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade 1= Mild; Grade 2= Moderate; Grade 3= Severe; Grade 4 = Life-threatening or disabling. | All treated participants, participants who received at least 1 dose of dasatinib. | Posted | Number | participants | Baseline (pretreatment), from the date of first dose until at least 30 days after the last dose of study drug (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]). |
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| Primary | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | As per NCI CTCAE Version 3.0 criteria. Grade (GR)1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. White blood cell (WBC):GR1=\ | All treated participants, participants who received at least 1 dose of dasatinib. | Posted | Number | participants | Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo]) |
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| Primary | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | Grading as per NCI CTCAE Version 3.0 criteria. GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Aspartate aminotransferase (AST) and alanine aminotransferase(ALT): GR1=>ULN-2.5*ULN (upper limit of normal); GR2=>2.5-5.0*ULN; GR3=>5.0-20.0*ULN; GR4:>20.0*ULN; TB:GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN; SC: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3.0-6.0*ULN, GR4=>6.0*ULN. BL=Baseline; PBL=post baseline. | All treated participants, participants who received at least 1 dose of dasatinib. | Posted | Number | participants | Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo]) |
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| Secondary | Number of Participants With Partial Response | Partial response was achieved when there was ≥50% reduction of serum M-protein (Mpr)and reduction in 24 hour urinary Mpr by ≥90% or to <200 mg/24 hr. If the serum and urine Mpr were unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC) levels was required in place of the Mpr criteria. If serum, urine Mpr, and serum FLC assay were unmeasurable, ≥50% reduction in plasma cells was required in place of Mpr, provided baseline bone marrow plasma cell percentage was ≥30%; a ≥50% reduction in the size of soft tissue plasmacytomas was also required. | All treated participants, participants who received at least 1 dose of dasatinib. | Posted | Number | participants | Baseline, at the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]). |
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| Secondary | Number of Participants With Minimal Response | Response criteria was based on The International Uniform Response Criteria for Multiple Myeloma (with a slight modification). Minimal Response was achieved when there was 25% to 49% reduction of serum M-Protein, 50% to 89% reduction in 24 hour urinary M-protein which still exceeded 200 mg/24 hour. If the serum and urine M-protein were unmeasurable, 25% to 49% reduction in plasma cells was required. In addition, if present at baseline, a 25% to 49% reduction in the size of soft tissue plasmacytomas was also required. | All treated participants, participants who received at least 1 dose of dasatinib. | Posted | Number | participants | Baseline, at the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]). |
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| Primary | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Grading as per NCI CTCAE Version 3.0 criteria. GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Calcium (low): GR1: <LLN - 8.0 mg/dL, GR2: <8.0 - 7.0 mg/dL, GR3: <7.0 - 6.0 mg/dL, GR4: <6.0 mg/dL. Calcium (High): GR1: >ULN - 11.5 mg/dL, GR2: >11.5 - 12.5 mg/dL, GR3: >12.5 - 13.5 mg/dL, GR4: >13.5 mg/dL. Magnesium (Low): GR1: \ | All treated participants, participants who received at least 1 dose of dasatinib. | Posted | Number | participants | Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo]) |
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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 | Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). | 2 | 3 | 3 | 3 | ||
| EG001 | Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). | 5 | 6 | 6 | 6 | ||
| EG002 | Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase. | 9 | 17 | 17 | 17 | ||
| EG003 | Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). | 0 | 6 | 0 | 6 | ||
| EG004 | Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). | 0 | 3 | 0 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Blood viscosity increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Neutropenic infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cyst | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Hair growth abnormal | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Crying | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dysacusis | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Effusion | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| IIIrd nerve disorder | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nocturnal dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Mood swings | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Anger | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bronchopneumopathy | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Lip dry | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Lip injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Periodontal disease | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Blood blister | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Gingival infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Tongue ulceration | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 15.1 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| BMS Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.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 |
|---|---|
| D000069439 | Dasatinib |
| D000077269 | Lenalidomide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010881 | Piperidones |
| D010880 | Piperidines |
| 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
| 46 - 65 years |
|
| 66 - 75 years |
|
| >75 years |
|
| Male |
|
| Asian |
|
| Stage II |
|
| Stage III |
|
| Not assessed |
|
| Stage IB |
|
| Stage IIA |
|
| Stage IIB |
|
| Stage IIIA |
|
| Stage IIIB |
|
| Not Assessed |
|
| Title | Measurements |
|---|---|
|
| OG002 | Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). |
| OG003 | Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). |
| OG004 | Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase. |
|
|
| OG002 | Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). |
| OG003 | Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). |
| OG004 | Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase. |
|
|
| OG002 | Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). |
| OG003 | Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). |
| OG004 | Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase. |
|
|
| OG002 | Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). |
| OG003 | Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). |
| OG004 | Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase. |
|
|
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). |
| OG002 | Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). |
| OG003 | Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). |
| OG004 | Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase. |
|
|
| OG002 | Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). |
| OG003 | Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). |
| OG004 | Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase. |
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| OG002 | Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). |
| OG003 | Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). |
| OG004 | Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase. |
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| OG002 | Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). |
| OG003 | Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). |
| OG004 | Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase. |
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Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
| OG002 | Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). |
| OG003 | Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). |
| OG004 | Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase. |
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