TriangleNCT07084896 · OUTCOME
CE Phase: 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 253 weeks
What was measured
Clinical benefit rate was defined as the percentage of participants with a confirmed minimal response (MR) or better according to the IMWG Response Criteria. MR is defined as \>= 25% but \< 49% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 50-89%.
Analysis population: Safety Population
Groups in this outcome
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 3 weeks (Q3W), infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W
In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
| Group | Source count |
|---|---|
| CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat | 34 |
| CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W | 37 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat | 35 | Not reported | 19.7 | 53.5 | Not reported |
| CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W | 49 | Not reported | 31.9 | 65.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 19.7
- upper Limit
- 53.5
- value
- 35
- group Id
- OG001
- lower Limit
- 31.9
- upper Limit
- 65.6
- value
- 49
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 37
- units
- Participants
- description
- Clinical benefit rate was defined as the percentage of participants with a confirmed minimal response (MR) or better according to the IMWG Response Criteria. MR is defined as \>= 25% but \< 49% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 50-89%.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 3 weeks (Q3W), infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
- id
- OG000
- title
- CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
- description
- In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
- id
- OG001
- title
- CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W
- param Type
- NUMBER
- population Description
- Safety Population
- reporting Status
- POSTED
- time Frame
- Up to approximately 253 weeks
- title
- CE Phase: 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