TriangleNCT04824794 · OUTCOME
Expansion Part B: Percentage of Participants With Very Good Partial Response (VGPR) or Better
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 approximately 4 years 3 months
What was measured
Based on Investigator Assessment per IMWG 2016 Criteria, VGPR was defined as serum and urine M-protein detectable by immunofixation (IFE) but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level \<100 mg per 24 h. Data are reported for the percentage of participants with a VGPR or better.
Analysis population: Full Analysis set included all enrolled participants who received at least 1 dose of trial drug (GEN3014 or daratumumab SC). Overall number of participants analyzed = participants evaluable for the outcome measure.
Groups in this outcome
RRMM Expansion Part B: Daratumumab
Participants with anti-CD38 mAb-naive RRMM received daratumumab at a dose of 1,800 mg by subcutaneous (SC) injection in 28-day treatment cycles.
RRMM Expansion Part B: GEN3014
Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day treatment cycles.
| Group | Source count |
|---|---|
| RRMM Expansion Part B: Daratumumab | 43 |
| RRMM Expansion Part B: GEN3014 | 45 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RRMM Expansion Part B: Daratumumab | 16.3 | Not reported | 6.8 | 30.7 | Not reported |
| RRMM Expansion Part B: GEN3014 | 26.7 | Not reported | 14.6 | 41.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.8
- upper Limit
- 30.7
- value
- 16.3
- group Id
- OG001
- lower Limit
- 14.6
- upper Limit
- 41.9
- value
- 26.7
- denoms
- counts
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 45
- units
- Participants
- description
- Based on Investigator Assessment per IMWG 2016 Criteria, VGPR was defined as serum and urine M-protein detectable by immunofixation (IFE) but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level \<100 mg per 24 h. Data are reported for the percentage of participants with a VGPR or better.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with anti-CD38 mAb-naive RRMM received daratumumab at a dose of 1,800 mg by subcutaneous (SC) injection in 28-day treatment cycles.
- id
- OG000
- title
- RRMM Expansion Part B: Daratumumab
- description
- Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day treatment cycles.
- id
- OG001
- title
- RRMM Expansion Part B: GEN3014
- param Type
- NUMBER
- population Description
- Full Analysis set included all enrolled participants who received at least 1 dose of trial drug (GEN3014 or daratumumab SC). Overall number of participants analyzed = participants evaluable for the outcome measure.
- reporting Status
- POSTED
- time Frame
- Up to approximately 4 years 3 months
- title
- Expansion Part B: Percentage of Participants With Very Good Partial Response (VGPR) or Better
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice