TriangleNCT07217184 · OUTCOME
DE Phase: Overall 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 194 weeks
What was measured
Overall Response Rate (ORR) was defined as the percentage of participants with a confirmed Partial Response (PR) or better as the best overall response (i.e., PR, Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\]), as assessed by the investigator per international myeloma working group (IMWG) (2016). PR is defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h. CR is defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow. sCR is defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
Analysis population: Safety population
Groups in this outcome
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin end of infusion (EOI), administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W), and thereafter on day 1, 8, 15 and 22 of each 28-day cycle.
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab
Participants with RRMM received 1.4 mg/kg of belantamab mafodotin IV infusion, once every 8 weeks (Q8W) infused over 30- 60 minutes on day 1 of each 56 day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin EOI administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W) and thereafter on days 1, 8, 15, and 22 of each 28-day cycle.
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab
Participants with RRMM received 1.9 mg/kg of belantamab mafodotin IV infusion, Q8W infused over 30- 60 minutes on day 1 of each 56 day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin EOI administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W) and thereafter on days 1, 8, 15, and 22 of each 28-day cycle.
| Group | Source count |
|---|---|
| 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab | 10 |
| 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab | 10 |
| 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab | 20 | Not reported | 2.5 | 55.6 | Not reported |
| 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab | 30 | Not reported | 6.7 | 65.2 | Not reported |
| 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab | 30 | Not reported | 6.7 | 65.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.5
- upper Limit
- 55.6
- value
- 20
- group Id
- OG001
- lower Limit
- 6.7
- upper Limit
- 65.2
- value
- 30
- group Id
- OG002
- lower Limit
- 6.7
- upper Limit
- 65.2
- value
- 30
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 10
- units
- Participants
- description
- Overall Response Rate (ORR) was defined as the percentage of participants with a confirmed Partial Response (PR) or better as the best overall response (i.e., PR, Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\]), as assessed by the investigator per international myeloma working group (IMWG) (2016). PR is defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h. CR is defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow. sCR is defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin end of infusion (EOI), administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W), and thereafter on day 1, 8, 15 and 22 of each 28-day cycle.
- id
- OG000
- title
- 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab
- description
- Participants with RRMM received 1.4 mg/kg of belantamab mafodotin IV infusion, once every 8 weeks (Q8W) infused over 30- 60 minutes on day 1 of each 56 day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin EOI administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W) and thereafter on days 1, 8, 15, and 22 of each 28-day cycle.
- id
- OG001
- title
- 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab
- description
- Participants with RRMM received 1.9 mg/kg of belantamab mafodotin IV infusion, Q8W infused over 30- 60 minutes on day 1 of each 56 day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin EOI administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W) and thereafter on days 1, 8, 15, and 22 of each 28-day cycle.
- id
- OG002
- title
- 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab
- param Type
- NUMBER
- population Description
- Safety population
- reporting Status
- POSTED
- time Frame
- Up to approximately 194 weeks
- title
- DE Phase: Overall Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice