TriangleNCT06956170 · OUTCOME
Progression-Free Survival (PFS)
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 120 weeks
What was measured
PFS is defined as time from randomization until earliest date of disease progression (PD), determined by Independent Review Committee (IRC), according to the International Myeloma Working Group (IMWG) Response Criteria, or death due to any cause. PD is defined as increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5 grams per deciliter {g/dL}\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; urine M-protein \[absolute increase \>=200 milligrams per 24 hours {mg/24h}\]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved serum free light chains (sFLC) levels \[absolute increase \>10mg/dL\]; appearance of new lesion,\>=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 longest diameter of previous lesion \>1 centimeter (cm) in short axis.
Analysis population: Intent-to-Treat (ITT) Population included all randomized participants whether or not randomized treatment was administered.
Groups in this outcome
Belantamab Mafodotin+Pomalidomide+Dexamethasone
Japanese participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of Cycle 1 and 1.9 mg/kg on Day 1 of Cycle 2 onwards in each 28-day cycle, in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 21 of each 28-day cycle; and oral 40 mg per day Dexamethasone tablet on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.
Bortezomib + Pomalidomide + Dexamethasone
Japanese participants with RRMM received subcutaneous (SC) injection of 1.3 mg/meter\^2(m\^2) Bortezomib on Days 1, 4, 8, 11, of each 21-day cycle for Cycles 1 through 8, and on Days 1, 8, of each 21-day cycle for Cycles 9+ in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 14 of each 21-day cycle, and oral 20 mg Dexamethasone tablet on Days 1, 2, 4, 5, 8, 9, 11, 12, of each 21-day cycle for Cycles 1 through 8 and then on Days 1, 2, 8, 9, every 3 Weeks (Q3W) from Cycles 9 onwards until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.
| Group | Source count |
|---|---|
| Belantamab Mafodotin+Pomalidomide+Dexamethasone | 10 |
| Bortezomib + Pomalidomide + Dexamethasone | 11 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Belantamab Mafodotin+Pomalidomide+Dexamethasone | NA | Not reported | 0.2 | NA | The median and upper limit of 95% Confidence Interval were not estimable due to an insufficient number of participants with events within the length of follow-up in assessing the number of events. |
| Bortezomib + Pomalidomide + Dexamethasone | 14.8 | Not reported | 1.9 | NA | The upper limit of 95% Confidence Interval was not estimable due to an insufficient number of participants with events within the length of follow-up in assessing the number of events. |
Source statistical analyses
- ci Lower Limit
- 0.10
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.78
- estimate Comment
- Hazard ratio was estimated using an unstratified Cox Proportional Hazard model with treatment arm as an explanatory variable.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 0.53
Complete source fields
- analyses
- ci Lower Limit
- 0.10
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.78
- estimate Comment
- Hazard ratio was estimated using an unstratified Cox Proportional Hazard model with treatment arm as an explanatory variable.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 0.53
- classes
- categories
- measurements
- comment
- The median and upper limit of 95% Confidence Interval were not estimable due to an insufficient number of participants with events within the length of follow-up in assessing the number of events.
- group Id
- OG000
- lower Limit
- 0.2
- upper Limit
- NA
- value
- NA
- comment
- The upper limit of 95% Confidence Interval was not estimable due to an insufficient number of participants with events within the length of follow-up in assessing the number of events.
- group Id
- OG001
- lower Limit
- 1.9
- upper Limit
- NA
- value
- 14.8
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 11
- units
- Participants
- description
- PFS is defined as time from randomization until earliest date of disease progression (PD), determined by Independent Review Committee (IRC), according to the International Myeloma Working Group (IMWG) Response Criteria, or death due to any cause. PD is defined as increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5 grams per deciliter {g/dL}\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; urine M-protein \[absolute increase \>=200 milligrams per 24 hours {mg/24h}\]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved serum free light chains (sFLC) levels \[absolute increase \>10mg/dL\]; appearance of new lesion,\>=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 longest diameter of previous lesion \>1 centimeter (cm) in short axis.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Japanese participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of Cycle 1 and 1.9 mg/kg on Day 1 of Cycle 2 onwards in each 28-day cycle, in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 21 of each 28-day cycle; and oral 40 mg per day Dexamethasone tablet on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.
- id
- OG000
- title
- Belantamab Mafodotin+Pomalidomide+Dexamethasone
- description
- Japanese participants with RRMM received subcutaneous (SC) injection of 1.3 mg/meter\^2(m\^2) Bortezomib on Days 1, 4, 8, 11, of each 21-day cycle for Cycles 1 through 8, and on Days 1, 8, of each 21-day cycle for Cycles 9+ in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 14 of each 21-day cycle, and oral 20 mg Dexamethasone tablet on Days 1, 2, 4, 5, 8, 9, 11, 12, of each 21-day cycle for Cycles 1 through 8 and then on Days 1, 2, 8, 9, every 3 Weeks (Q3W) from Cycles 9 onwards until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.
- id
- OG001
- title
- Bortezomib + Pomalidomide + Dexamethasone
- param Type
- MEDIAN
- population Description
- Intent-to-Treat (ITT) Population included all randomized participants whether or not randomized treatment was administered.
- reporting Status
- POSTED
- time Frame
- Up to approximately 120 weeks
- title
- Progression-Free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice