TriangleNCT04824794 · OUTCOME
Dose Escalation, Expansion Part A and Expansion Part B: Progression-free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately 4 years 3 months
What was measured
PFS was defined as the time from the date of first dose, or date of randomization for participants in the Expansion Part B, to the date of progression or death (due to any cause), whichever came first.
Analysis population: Full Analysis set=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.
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.
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 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 |
| RRMM Expansion Part A: GEN3014 | 11 |
| R/R DLBCL Expansion Part A: GEN3014 | 2 |
| RRMM Expansion Part B: Daratumumab | 43 |
| RRMM Expansion Part B: GEN3014 | 45 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg | 4.7 | Not reported | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 2 mg/kg | 3.7 | Not reported | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 4 mg/kg | 2.8 | Not reported | 1.9 | NA | Upper limit could not be estimated due to the low number of events. |
| RRMM Dose Escalation: GEN3014 8 mg/kg | 3.7 | Not reported | 1.9 | NA | Upper limit could not be estimated due to the low number of events. |
| RRMM Dose Escalation: GEN3014 16 mg/kg | 3.5 | Not reported | 1.4 | NA | Upper limit could not be estimated due to the low number of events. |
| RRMM Dose Escalation: GEN3014 24 mg/kg | 2.1 | Not reported | 1.0 | NA | Upper limit could not be estimated due to the low number of events. |
| R/R AML Dose Escalation: GEN3014 Dose Level 1 | 1 | Not reported | 0.6 | NA | Upper limit could not be estimated due to the low number of events. |
| RRMM Expansion Part A: GEN3014 | 7.7 | Not reported | 0.6 | 11.1 | Not reported |
| R/R DLBCL Expansion Part A: GEN3014 | 1.7 | Not reported | 0.5 | NA | Upper limit could not be estimated due to the low number of events. |
| RRMM Expansion Part B: Daratumumab | 6.6 | Not reported | 4.9 | 8.5 | Not reported |
| RRMM Expansion Part B: GEN3014 | 5.8 | Not reported | 4.0 | 8.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4.7
- group Id
- OG001
- value
- 3.7
- comment
- Upper limit could not be estimated due to the low number of events.
- group Id
- OG002
- lower Limit
- 1.9
- upper Limit
- NA
- value
- 2.8
- comment
- Upper limit could not be estimated due to the low number of events.
- group Id
- OG003
- lower Limit
- 1.9
- upper Limit
- NA
- value
- 3.7
- comment
- Upper limit could not be estimated due to the low number of events.
- group Id
- OG004
- lower Limit
- 1.4
- upper Limit
- NA
- value
- 3.5
- comment
- Upper limit could not be estimated due to the low number of events.
- group Id
- OG005
- lower Limit
- 1.0
- upper Limit
- NA
- value
- 2.1
- comment
- Upper limit could not be estimated due to the low number of events.
- group Id
- OG006
- lower Limit
- 0.6
- upper Limit
- NA
- value
- 1
- group Id
- OG007
- lower Limit
- 0.6
- upper Limit
- 11.1
- value
- 7.7
- comment
- Upper limit could not be estimated due to the low number of events.
- group Id
- OG008
- lower Limit
- 0.5
- upper Limit
- NA
- value
- 1.7
- group Id
- OG009
- lower Limit
- 4.9
- upper Limit
- 8.5
- value
- 6.6
- group Id
- OG010
- lower Limit
- 4.0
- upper Limit
- 8.5
- value
- 5.8
- 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
- group Id
- OG007
- value
- 11
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 43
- group Id
- OG010
- value
- 45
- units
- Participants
- description
- PFS was defined as the time from the date of first dose, or date of randomization for participants in the Expansion Part B, to the date of progression or death (due to any cause), whichever came first.
- 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
- 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
- OG007
- 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
- OG008
- title
- R/R DLBCL Expansion Part A: GEN3014
- 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
- OG009
- 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
- OG010
- title
- RRMM Expansion Part B: GEN3014
- param Type
- MEDIAN
- population Description
- Full Analysis set=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, Expansion Part A and Expansion Part B: Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice