TriangleNCT04162210 · OUTCOME
Time to Progression (TTP)
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 263 weeks
What was measured
TTP is defined as the time from the date of randomization until the earliest date of documented PD (per IMWG Response Criteria) or death due to PD. PD: increase of \>=25% from lowest confirmed value in any 1 of following criteria: serum M-protein (absolute increase must be \>=0.5 g/dL), serum M-protein increase \>=1g/dL if lowest M component was \>=5g/dL; urine M-component (absolute increase must be \>=200mg/24 hour),appearance of new lesion(s), \>=50% increase from nadir in Sum of the Products of the maximal perpendicular Diameters of measured lesions (SPD) of \>1 lesion, or \>=50% increase in the longest diameter of previous lesion \>1 cm in short axis.
Analysis population: ITT Population
Groups in this outcome
Belantamab Mafodotin
Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle
Pomalidomide Plus Dexamethasone
Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants \>75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22)
| Group | Source count |
|---|---|
| Belantamab Mafodotin | 218 |
| Pomalidomide Plus Dexamethasone | 107 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Belantamab Mafodotin | 11.3 | Not reported | 7.0 | 14.6 | Not reported |
| Pomalidomide Plus Dexamethasone | 8.6 | Not reported | 5.7 | 11.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.0
- upper Limit
- 14.6
- value
- 11.3
- group Id
- OG001
- lower Limit
- 5.7
- upper Limit
- 11.8
- value
- 8.6
- denoms
- counts
- group Id
- OG000
- value
- 218
- group Id
- OG001
- value
- 107
- units
- Participants
- description
- TTP is defined as the time from the date of randomization until the earliest date of documented PD (per IMWG Response Criteria) or death due to PD. PD: increase of \>=25% from lowest confirmed value in any 1 of following criteria: serum M-protein (absolute increase must be \>=0.5 g/dL), serum M-protein increase \>=1g/dL if lowest M component was \>=5g/dL; urine M-component (absolute increase must be \>=200mg/24 hour),appearance of new lesion(s), \>=50% increase from nadir in Sum of the Products of the maximal perpendicular Diameters of measured lesions (SPD) of \>1 lesion, or \>=50% increase in the longest diameter of previous lesion \>1 cm in short axis.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle
- id
- OG000
- title
- Belantamab Mafodotin
- description
- Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants \>75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22)
- id
- OG001
- title
- Pomalidomide Plus Dexamethasone
- param Type
- MEDIAN
- population Description
- ITT Population
- reporting Status
- POSTED
- time Frame
- Up to approximately 263 weeks
- title
- Time to Progression (TTP)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice