TriangleNCT03439293 · OUTCOME
Percentage of Participants With Very Good Partial Response (VGPR) or Better (Complete Response + VGPR)
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
- 95% Confidence Interval
- Time frame
- Up to 5 years
What was measured
Response was assessed using International Myeloma Working Group (IMWG) Criteria. VGPR is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 milligram (mg) per 24 hours. The percentage of participants were rounded off to the single decimal point.
Analysis population: Response-evaluable population included participants who received at least 1 dose of ixazomib, had measurable disease during the screening period, and have at least 1 postbaseline disease assessment.
Groups in this outcome
Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg
Ixazomib, 4 mg, capsules, orally, on Days 1, 8 and 15 of each 28-day cycle along with daratumumab, 16 mg/kg, intravenously (IV), on Days 1, 8, 15 and 22 of Cycles 1 and 2, on Days 1 and 15 (every 2 weeks) for Cycles 3 to 6 and on Day 1 (every 4 weeks) for Cycle 7 and beyond along with dexamethasone, 20 mg, tablets, orally on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle until progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or up to 5 years.
| Group | Source count |
|---|---|
| Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg | 59 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg | 32.2 | Not reported | 20.62 | 45.64 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 20.62
- upper Limit
- 45.64
- value
- 32.2
- denoms
- counts
- group Id
- OG000
- value
- 59
- units
- Participants
- description
- Response was assessed using International Myeloma Working Group (IMWG) Criteria. VGPR is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 milligram (mg) per 24 hours. The percentage of participants were rounded off to the single decimal point.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Ixazomib, 4 mg, capsules, orally, on Days 1, 8 and 15 of each 28-day cycle along with daratumumab, 16 mg/kg, intravenously (IV), on Days 1, 8, 15 and 22 of Cycles 1 and 2, on Days 1 and 15 (every 2 weeks) for Cycles 3 to 6 and on Day 1 (every 4 weeks) for Cycle 7 and beyond along with dexamethasone, 20 mg, tablets, orally on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle until progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or up to 5 years.
- id
- OG000
- title
- Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg
- param Type
- NUMBER
- population Description
- Response-evaluable population included participants who received at least 1 dose of ixazomib, had measurable disease during the screening period, and have at least 1 postbaseline disease assessment.
- reporting Status
- POSTED
- time Frame
- Up to 5 years
- title
- Percentage of Participants With Very Good Partial Response (VGPR) or Better (Complete Response + VGPR)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice