TriangleNCT01615029 · OUTCOME
Phase 1: Time to Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Full Range
- Time frame
- Up to 5 years
What was measured
Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment.
Analysis population: Responders in all treated population analysis set included. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure.
Groups in this outcome
Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 2 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
| Group | Source count |
|---|---|
| Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone | 3 |
| Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone | 3 |
| Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone | 3 |
| Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone | 2 |
Reported measurements
Time to first response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone | 0.99 | Not reported | 0.5 | 1.0 | Not reported |
| Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone | 1.02 | Not reported | 0.5 | 1.9 | Not reported |
| Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone | 1.02 | Not reported | 1.0 | 1.8 | Not reported |
| Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone | 2.25 | Not reported | 1.9 | 2.6 | Not reported |
Time to best response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone | 1.9 | Not reported | 1.0 | 6.5 | Not reported |
| Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone | 13.17 | Not reported | 3.7 | 20.7 | Not reported |
| Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone | 8.41 | Not reported | 1.0 | 19.9 | Not reported |
| Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone | 16.72 | Not reported | 6.5 | 26.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.5
- upper Limit
- 1.0
- value
- 0.99
- group Id
- OG001
- lower Limit
- 0.5
- upper Limit
- 1.9
- value
- 1.02
- group Id
- OG002
- lower Limit
- 1.0
- upper Limit
- 1.8
- value
- 1.02
- group Id
- OG003
- lower Limit
- 1.9
- upper Limit
- 2.6
- value
- 2.25
- title
- Time to first response
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.0
- upper Limit
- 6.5
- value
- 1.9
- group Id
- OG001
- lower Limit
- 3.7
- upper Limit
- 20.7
- value
- 13.17
- group Id
- OG002
- lower Limit
- 1.0
- upper Limit
- 19.9
- value
- 8.41
- group Id
- OG003
- lower Limit
- 6.5
- upper Limit
- 26.9
- value
- 16.72
- title
- Time to best response
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 2
- units
- Participants
- description
- Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment.
- dispersion Type
- Full Range
- groups
- description
- Participants administered with daratumumab 2 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
- id
- OG000
- title
- Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone
- description
- Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
- id
- OG001
- title
- Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone
- description
- Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
- id
- OG002
- title
- Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone
- description
- Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
- id
- OG003
- title
- Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
- param Type
- MEDIAN
- population Description
- Responders in all treated population analysis set included. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Up to 5 years
- title
- Phase 1: Time to Response
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice