TriangleNCT04824794 · OUTCOME
Dose Escalation: 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. The response in RRMM Cohorts was assessed following IMWG criteria 2016. 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). Overall number of participants analyzed = participants evaluable for the outcome measure.
Groups in this outcome
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg
Participants with RRMM received GEN3014 at a dose of 0.2/0.6 mg/kg by IV infusion in 28-day treatment cycles. Intraparticipant dose escalation was performed in this arm (i.e., dose was escalated from 0.2-0.6 mg/kg).
RRMM Dose Escalation: GEN3014 2 mg/kg
Participants with RRMM received GEN3014 at a dose of 2 mg/kg by IV infusion in 28-day treatment cycles.
RRMM Dose Escalation: GEN3014 4 mg/kg
Participants with RRMM received GEN3014 at a dose of 4 mg/kg by IV infusion in 28-day treatment cycles.
RRMM Dose Escalation: GEN3014 8 mg/kg
Participants with RRMM received GEN3014 at a dose of 8 mg/kg by IV infusion in 28-day treatment cycles.
RRMM Dose Escalation: GEN3014 16 mg/kg
Participants with RRMM received GEN3014 at a dose of 16 mg/kg by IV infusion in 28-day treatment cycles.
RRMM Dose Escalation: GEN3014 24 mg/kg
Participants with RRMM received GEN3014 at a dose of 24 mg/kg by IV infusion in 28-day treatment cycles.
R/R AML Dose Escalation: GEN3014 Dose Level 1
Participants with R/R AML received GEN3014 at dose level 1 (low dose) in 28-day treatment cycles.
| Group | Source count |
|---|---|
| RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg | 1 |
| RRMM Dose Escalation: GEN3014 2 mg/kg | 1 |
| RRMM Dose Escalation: GEN3014 4 mg/kg | 3 |
| RRMM Dose Escalation: GEN3014 8 mg/kg | 3 |
| RRMM Dose Escalation: GEN3014 16 mg/kg | 11 |
| RRMM Dose Escalation: GEN3014 24 mg/kg | 5 |
| R/R AML Dose Escalation: GEN3014 Dose Level 1 | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg | 0.0 | Not reported | 0.0 | 97.5 | Not reported |
| RRMM Dose Escalation: GEN3014 2 mg/kg | 0.0 | Not reported | 0.0 | 97.5 | Not reported |
| RRMM Dose Escalation: GEN3014 4 mg/kg | 33.3 | Not reported | 0.8 | 90.6 | Not reported |
| RRMM Dose Escalation: GEN3014 8 mg/kg | 0.0 | Not reported | 0.0 | 70.8 | Not reported |
| RRMM Dose Escalation: GEN3014 16 mg/kg | 9.1 | Not reported | 0.2 | 41.3 | Not reported |
| RRMM Dose Escalation: GEN3014 24 mg/kg | 20.0 | Not reported | 0.5 | 71.6 | Not reported |
| R/R AML Dose Escalation: GEN3014 Dose Level 1 | 0.0 | Not reported | 0.0 | 52.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 97.5
- value
- 0.0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 97.5
- value
- 0.0
- group Id
- OG002
- lower Limit
- 0.8
- upper Limit
- 90.6
- value
- 33.3
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 70.8
- value
- 0.0
- group Id
- OG004
- lower Limit
- 0.2
- upper Limit
- 41.3
- value
- 9.1
- group Id
- OG005
- lower Limit
- 0.5
- upper Limit
- 71.6
- value
- 20.0
- group Id
- OG006
- lower Limit
- 0.0
- upper Limit
- 52.2
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 11
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 5
- units
- Participants
- description
- ORR was defined as the percentage of participants with a PR or better. The response in RRMM Cohorts was assessed following IMWG criteria 2016. 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 RRMM received GEN3014 at a dose of 0.2/0.6 mg/kg by IV infusion in 28-day treatment cycles. Intraparticipant dose escalation was performed in this arm (i.e., dose was escalated from 0.2-0.6 mg/kg).
- id
- OG000
- title
- RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg
- description
- Participants with RRMM received GEN3014 at a dose of 2 mg/kg by IV infusion in 28-day treatment cycles.
- id
- OG001
- title
- RRMM Dose Escalation: GEN3014 2 mg/kg
- description
- Participants with RRMM received GEN3014 at a dose of 4 mg/kg by IV infusion in 28-day treatment cycles.
- id
- OG002
- title
- RRMM Dose Escalation: GEN3014 4 mg/kg
- description
- Participants with RRMM received GEN3014 at a dose of 8 mg/kg by IV infusion in 28-day treatment cycles.
- id
- OG003
- title
- RRMM Dose Escalation: GEN3014 8 mg/kg
- description
- Participants with RRMM received GEN3014 at a dose of 16 mg/kg by IV infusion in 28-day treatment cycles.
- id
- OG004
- title
- RRMM Dose Escalation: GEN3014 16 mg/kg
- description
- Participants with RRMM received GEN3014 at a dose of 24 mg/kg by IV infusion in 28-day treatment cycles.
- id
- OG005
- title
- RRMM Dose Escalation: GEN3014 24 mg/kg
- description
- Participants with R/R AML received GEN3014 at dose level 1 (low dose) in 28-day treatment cycles.
- id
- OG006
- title
- R/R AML Dose Escalation: GEN3014 Dose Level 1
- 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
- Dose Escalation: ORR
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice