TriangleNCT04824794 · OUTCOME
Expansion Part A: Objective 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
- 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 partial response (PR) or better based on International Myeloma Working Group (IMWG) criteria for RRMM participants and based on Lugano criteria for DLBCL participants. 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 (sum of the product of the diameters \[SPD\]) of soft tissue plasmacytomas was also required. Per Lugano criteria, PR was defined as ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites, absent/normal, regressed, but no increase in non-measurable lesions, spleen regressed \>50% in length beyond normal (13 centimeters \[cm\]), and no new lesions.
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 A: GEN3014
Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.
R/R DLBCL Expansion Part A: GEN3014
Participants with R/R DLBCL received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.
| Group | Source count |
|---|---|
| RRMM Expansion Part A: GEN3014 | 11 |
| R/R DLBCL Expansion Part A: GEN3014 | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RRMM Expansion Part A: GEN3014 | 54.5 | Not reported | 23.4 | 83.3 | Not reported |
| R/R DLBCL Expansion Part A: GEN3014 | 50.0 | Not reported | 1.3 | 98.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 23.4
- upper Limit
- 83.3
- value
- 54.5
- group Id
- OG001
- lower Limit
- 1.3
- upper Limit
- 98.7
- value
- 50.0
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 2
- units
- Participants
- description
- ORR was defined as the percentage of participants with a partial response (PR) or better based on International Myeloma Working Group (IMWG) criteria for RRMM participants and based on Lugano criteria for DLBCL participants. 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 (sum of the product of the diameters \[SPD\]) of soft tissue plasmacytomas was also required. Per Lugano criteria, PR was defined as ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites, absent/normal, regressed, but no increase in non-measurable lesions, spleen regressed \>50% in length beyond normal (13 centimeters \[cm\]), and no new lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.
- id
- OG000
- title
- RRMM Expansion Part A: GEN3014
- description
- Participants with R/R DLBCL received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.
- id
- OG001
- title
- R/R DLBCL Expansion Part A: 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 A: Objective 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