TriangleNCT00560391 · OUTCOME
Number of Participants With Complete Response and Very Good Partial Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline, At the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
What was measured
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.
Analysis population: All treated participants, participants who received at least 1 dose of dasatinib.
Groups in this outcome
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).
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).
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).
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).
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.
| Group | Source count |
|---|---|
| Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg | 6 |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 3 |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 3 |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 6 |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 17 |
Reported measurements
Complete response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
Very good partial response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 3 | Not reported | Not reported | Not reported | Not reported |
No response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg | 4 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 11 | Not reported | Not reported | Not reported | Not reported |
Not reported
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
Response Undetermined
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- Complete response
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 3
- title
- Very good partial response
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 11
- title
- No response
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- Not reported
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- Response Undetermined
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 17
- units
- Participants
- description
- 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.
- groups
- description
- 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).
- id
- OG000
- title
- Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg
- description
- 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).
- id
- OG001
- title
- Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
- description
- 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).
- id
- OG002
- title
- Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
- description
- 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).
- id
- OG003
- title
- Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
- description
- 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.
- id
- OG004
- title
- Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
- param Type
- NUMBER
- population Description
- All treated participants, participants who received at least 1 dose of dasatinib.
- reporting Status
- POSTED
- time Frame
- Baseline, At the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
- title
- Number of Participants With Complete Response and Very Good Partial Response
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice