TriangleNCT07150104 · 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 137 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
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28. Along with 4 mg Pomalidomide orally per day (QD) on Days 1-21 of each 28-day cycle and Dexamethasone 40mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
| Group | Source count |
|---|---|
| 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone | 14 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone | 57 | Not reported | 28.9 | 82.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 28.9
- upper Limit
- 82.3
- value
- 57
- denoms
- counts
- group Id
- OG000
- value
- 14
- 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 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28. Along with 4 mg Pomalidomide orally per day (QD) on Days 1-21 of each 28-day cycle and Dexamethasone 40mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
- id
- OG000
- title
- 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone
- param Type
- NUMBER
- population Description
- Safety population
- reporting Status
- POSTED
- time Frame
- Up to 137 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