TriangleNCT04824794 · OUTCOME
Expansion Part B: 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
- 95% Confidence Interval
- Time frame
- Up to approximately 4 years 3 months
What was measured
ORR was defined as the percentage of participants with a PR or better based on IMWG criteria. Per IMWG criteria, PR was defined as ≥50% reduction of serum M-protein plus reduction in 24-h urinary M-protein by ≥90% or to \<200 mg per 24 h. In addition to these criteria, if present at baseline, a ≥50% reduction in the size (SPD) of soft tissue plasmacytomas was also required.
Analysis population: Full Analysis set included all enrolled participants who received at least 1 dose of trial drug (GEN3014 or daratumumab SC).
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 | 51.2 | Not reported | 35.5 | 66.7 | Not reported |
| RRMM Expansion Part B: GEN3014 | 51.1 | Not reported | 35.8 | 66.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 35.5
- upper Limit
- 66.7
- value
- 51.2
- group Id
- OG001
- lower Limit
- 35.8
- upper Limit
- 66.3
- value
- 51.1
- denoms
- counts
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 45
- units
- Participants
- description
- ORR was defined as the percentage of participants with a PR or better based on IMWG criteria. Per IMWG criteria, PR was defined as ≥50% reduction of serum M-protein plus reduction in 24-h urinary M-protein by ≥90% or to \<200 mg per 24 h. In addition to these criteria, if present at baseline, a ≥50% reduction in the size (SPD) of soft tissue plasmacytomas was also required.
- 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).
- reporting Status
- POSTED
- time Frame
- Up to approximately 4 years 3 months
- title
- Expansion Part B: ORR
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice