TriangleNCT00560391 · OUTCOME
Number of Participants With Dose-limiting Toxicity (DLT)
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
- 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]).
What was measured
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.
Analysis population: 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.)
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 | 4 |
Reported measurements
Source class 1
| 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 | 1 | 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
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- 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
- 4
- units
- Participants
- description
- 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.
- 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. (Participants included from Cohort 5 are those involved in the dose escalation phase only.)
- reporting Status
- POSTED
- time Frame
- 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]).
- title
- Number of Participants With Dose-limiting Toxicity (DLT)
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice