TriangleNCT02807454 · OUTCOME
Overall Response Rate (ORR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- From first dose to up to approximately 66 months
What was measured
Tumor response of partial response (PR) or better was assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. ORR was calculated as the percent of responders (multiplied by 100). 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.
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.
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. POM + DEX could be added to the D2 regimen, at the investigator's discretion, upon confirmed progressive disease for participants who had at least 2 cycles of D2.
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 |
| PD3 Arm | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Simon Stage 1: D2 Arm | 53.1 | Not reported | Not reported | Not reported | Not reported |
| PD3 Arm | 75.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 53.1
- group Id
- OG001
- value
- 75.0
- denoms
- counts
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 4
- units
- Participants
- description
- Tumor response of partial response (PR) or better was assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. ORR was calculated as the percent of responders (multiplied by 100). 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.
- groups
- description
- Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles. POM + DEX could be added to the D2 regimen, at the investigator's discretion, upon confirmed progressive disease for participants who had at least 2 cycles of D2.
- id
- OG000
- title
- Simon Stage 1: D2 Arm
- 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
- OG001
- title
- PD3 Arm
- param Type
- NUMBER
- 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.
- reporting Status
- POSTED
- time Frame
- From first dose to up to approximately 66 months
- title
- Overall Response Rate (ORR)
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice