TriangleNCT04824794 · OUTCOME
Dose Escalation and Expansion Part A: Clinical Benefit Rate (CBR)
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
CBR was defined as the percentage of participants with a best overall response of minimal response (MR), partial response (PR), very good partial response (VGPR), complete response (CR) or stringent complete response (sCR) as determined by the investigator per IMWG response criteria for RRMM participants. MR=≥25% but ≤49% reduction of serum M-protein, reduction of 24-h urine by 50%-89% and if present at baseline, ≥50% reduction in the size (SPD) of soft tissue plasmacytomas. PR=≥50% reduction of serum M-protein, reduction in 24-h urinary M-protein by ≥90% or to \<200mg/24h and if present at baseline,≥50% reduction in SPD of soft tissue plasmacytomas. VGPR=Serum+urine M-protein detectable by IFE but not electrophoresis or ≥90% reduction in serum M-protein+urine M-protein level \<100mg/24h. CR=Negative IFE on serum/urine + disappearance of soft tissue plasmacytomas and ≤5% plasma cells in bone marrow aspirates. sCR=CR+normal FLC ratio, absence of clonal cells in bone marrow biopsy by IHC.
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. As pre-specified, data for CBR was only collected and derived for RRMM participants.
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.
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.
| 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 |
| RRMM Expansion Part A: GEN3014 | 11 |
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 | 33.3 | Not reported | 0.8 | 90.6 | Not reported |
| RRMM Dose Escalation: GEN3014 16 mg/kg | 27.3 | Not reported | 6.0 | 61.0 | Not reported |
| RRMM Dose Escalation: GEN3014 24 mg/kg | 20.0 | Not reported | 0.5 | 71.6 | Not reported |
| RRMM Expansion Part A: GEN3014 | 72.7 | Not reported | 39.0 | 94.0 | 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
- 0.8
- upper Limit
- 90.6
- value
- 33.3
- group Id
- OG004
- lower Limit
- 6.0
- upper Limit
- 61.0
- value
- 27.3
- group Id
- OG005
- lower Limit
- 0.5
- upper Limit
- 71.6
- value
- 20.0
- group Id
- OG006
- lower Limit
- 39.0
- upper Limit
- 94.0
- value
- 72.7
- 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
- 11
- units
- Participants
- description
- CBR was defined as the percentage of participants with a best overall response of minimal response (MR), partial response (PR), very good partial response (VGPR), complete response (CR) or stringent complete response (sCR) as determined by the investigator per IMWG response criteria for RRMM participants. MR=≥25% but ≤49% reduction of serum M-protein, reduction of 24-h urine by 50%-89% and if present at baseline, ≥50% reduction in the size (SPD) of soft tissue plasmacytomas. PR=≥50% reduction of serum M-protein, reduction in 24-h urinary M-protein by ≥90% or to \<200mg/24h and if present at baseline,≥50% reduction in SPD of soft tissue plasmacytomas. VGPR=Serum+urine M-protein detectable by IFE but not electrophoresis or ≥90% reduction in serum M-protein+urine M-protein level \<100mg/24h. CR=Negative IFE on serum/urine + disappearance of soft tissue plasmacytomas and ≤5% plasma cells in bone marrow aspirates. sCR=CR+normal FLC ratio, absence of clonal cells in bone marrow biopsy by IHC.
- 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 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
- OG006
- title
- RRMM 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). Overall number of participants analyzed = participants evaluable for the outcome measure. As pre-specified, data for CBR was only collected and derived for RRMM participants.
- reporting Status
- POSTED
- time Frame
- Up to approximately 4 years 3 months
- title
- Dose Escalation and Expansion Part A: Clinical Benefit Rate (CBR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice