TriangleNCT02807454 · OUTCOME
Time-To-Response (TTR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Weeks
- Interval / dispersion
- Full Range
- Time frame
- From enrollment to earliest documented response (up to approximately 66 months)
What was measured
Time-to-response is calculated as the time from enrollment to the first date of documented response (partial response or better). Tumor response of partial response (PR) or better was assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. Partial response required ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M protein by ≥ 90% or to \< 200 mg per 24 hours. For those participants where POM + DEX were added, time-to-response was calculated from the date POM and DEX were added to the first date of documented response (PR or better).
Analysis population: All enrolled participants who received at least 1 dose of the study medication, and who have measurable disease at baseline and at least 1 postbaseline efficacy assessment in the D2, D2 + Pomalidomide + Dexamethasone, and PD3 arms.
Groups in this outcome
Simon Stage 1: D2 Arm
Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles
Simon Stage 1: D2 + Pomalidomide + Dexamethasone
Durvalumab 1500 mg IV + Daratumumab IV 16 mg/kg + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) were administered within a 28-day cycle for a maximum of 60 cycles
PD3 Arm
Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles
| Group | Source count |
|---|---|
| Simon Stage 1: D2 Arm | 32 |
| Simon Stage 1: D2 + Pomalidomide + Dexamethasone | 7 |
| PD3 Arm | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Simon Stage 1: D2 Arm | 4.29 | Not reported | 4.0 | 12.0 | Not reported |
| Simon Stage 1: D2 + Pomalidomide + Dexamethasone | 5.07 | Not reported | 4.1 | 8.1 | Not reported |
| PD3 Arm | 8.14 | Not reported | 4.3 | 8.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.0
- upper Limit
- 12.0
- value
- 4.29
- group Id
- OG001
- lower Limit
- 4.1
- upper Limit
- 8.1
- value
- 5.07
- group Id
- OG002
- lower Limit
- 4.3
- upper Limit
- 8.3
- value
- 8.14
- denoms
- counts
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 4
- units
- Participants
- description
- Time-to-response is calculated as the time from enrollment to the first date of documented response (partial response or better). Tumor response of partial response (PR) or better was assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. Partial response required ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M protein by ≥ 90% or to \< 200 mg per 24 hours. For those participants where POM + DEX were added, time-to-response was calculated from the date POM and DEX were added to the first date of documented response (PR or better).
- dispersion Type
- Full Range
- groups
- description
- Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles
- id
- OG000
- title
- Simon Stage 1: D2 Arm
- description
- Durvalumab 1500 mg IV + Daratumumab IV 16 mg/kg + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) were administered within a 28-day cycle for a maximum of 60 cycles
- id
- OG001
- title
- Simon Stage 1: D2 + Pomalidomide + Dexamethasone
- description
- Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles
- id
- OG002
- title
- PD3 Arm
- param Type
- MEDIAN
- population Description
- All enrolled participants who received at least 1 dose of the study medication, and who have measurable disease at baseline and at least 1 postbaseline efficacy assessment in the D2, D2 + Pomalidomide + Dexamethasone, and PD3 arms.
- reporting Status
- POSTED
- time Frame
- From enrollment to earliest documented response (up to approximately 66 months)
- title
- Time-To-Response (TTR)
- type
- SECONDARY
- unit Of Measure
- Weeks
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice