TriangleNCT07084896 · OUTCOME
CE Phase: Time to Response (TTR)
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 253 weeks
What was measured
TTR is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (confirmed PR or better).
Analysis population: Safety Population. Only those participants with a confirmed PR or better as the best overall response (i.e., PR, VGPR, CR, and sCR) were assessed for this endpoint.
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 | 10 |
| CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W | 14 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat | 1.1 | Not reported | 0.7 | 1.4 | Not reported |
| CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W | 1.4 | Not reported | 0.7 | 2.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.7
- upper Limit
- 1.4
- value
- 1.1
- group Id
- OG001
- lower Limit
- 0.7
- upper Limit
- 2.1
- value
- 1.4
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 14
- units
- Participants
- description
- TTR is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (confirmed PR or better).
- 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
- MEDIAN
- population Description
- Safety Population. Only those participants with a confirmed PR or better as the best overall response (i.e., PR, VGPR, CR, and sCR) were assessed for this endpoint.
- reporting Status
- POSTED
- time Frame
- Up to approximately 253 weeks
- title
- CE Phase: Time to Response (TTR)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice