TriangleNCT04484623 · 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 174 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
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.
Pomalidomide+Bortezomib+Dexamethasone
Participants with RRMM received oral 4 mg per day Pomalidomide capsule on Days 1 to 14 of each 21-day cycle, in combination with 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+, 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 | 155 |
| Pomalidomide+Bortezomib+Dexamethasone | 147 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Belantamab Mafodotin+Pomalidomide+Dexamethasone | NA | Not reported | 20.6 | NA | NA indicates median and upper limit of 95% CI which were not estimable due to low number of participants with events. |
| Pomalidomide+Bortezomib+Dexamethasone | 12.7 | Not reported | 9.1 | 18.5 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.37
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.73
- estimate Comment
- Hazard ratio was estimated using a Cox Proportional Hazards model stratified by the number of lines of prior therapy (1 vs. 2/3 vs. \>=4) and prior bortezomib (yes or no) according to IVRS strata with a covariate of treatment.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- p Value Comment
- P-Value presented to 3 decimal places from one-sided stratified Log-Rank test adjusting for the number of lines of prior therapy (1 vs. 2/3 vs. \>=4) and prior bortezomib (yes or no) according to IVRS strata.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.52
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.37
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.73
- estimate Comment
- Hazard ratio was estimated using a Cox Proportional Hazards model stratified by the number of lines of prior therapy (1 vs. 2/3 vs. \>=4) and prior bortezomib (yes or no) according to IVRS strata with a covariate of treatment.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- p Value Comment
- P-Value presented to 3 decimal places from one-sided stratified Log-Rank test adjusting for the number of lines of prior therapy (1 vs. 2/3 vs. \>=4) and prior bortezomib (yes or no) according to IVRS strata.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.52
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- NA indicates median and upper limit of 95% CI which were not estimable due to low number of participants with events.
- group Id
- OG000
- lower Limit
- 20.6
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 9.1
- upper Limit
- 18.5
- value
- 12.7
- denoms
- counts
- group Id
- OG000
- value
- 155
- group Id
- OG001
- value
- 147
- 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
- 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
- Participants with RRMM received oral 4 mg per day Pomalidomide capsule on Days 1 to 14 of each 21-day cycle, in combination with 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+, 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
- Pomalidomide+Bortezomib+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 174 weeks
- title
- Progression-Free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice