TriangleNCT04162210 · OUTCOME
Progression-Free Survival (PFS) Based on Investigator-Assessed Response as Per International Myeloma Working Group (IMWG)
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 27 months
What was measured
PFS is time from randomization until earliest date of progressive disease (PD), or death due to any cause per investigator-assessed response per IMWG. PD is ≥25% increase from nadir in any of following: serum M-protein (absolute increase ≥0.5 gram per deciliter \[g/dL\]),urine M-protein(absolute increase ≥200 mg/24hr),difference between involved/uninvolved FLC levels (absolute increase \>10 mg/dL) in patients without measurable serum and urine M-protein levels, or bone marrow plasma-cell percentage irrespective of baseline status (absolute increase ≥10%) in patients without measurable serum and urine M-protein levels and without measurable involved FLC levels; appearance of new lesion,≥50% increase in longest diameter of a lesion previously measured \>1cm in short axis, or ≥50% increase from nadir in sum of products of two longest perpendicular diameters of more than 1 lesion; ≥50% increase in circulating plasma cells (minimum of 200 cells/microliter) if this is only measure of disease.
Analysis population: Intent-to-treat (ITT) population included all randomized participants whether or not randomized treatment was administered.
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 | 11.2 | Not reported | 6.4 | 14.5 | Not reported |
| Pomalidomide Plus Dexamethasone | 7.0 | Not reported | 4.6 | 10.6 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.72
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.47
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.558
- param Type
- Hazard Ratio (HR)
- param Value
- 1.03
- statistical Comment
- One-sided p-value from stratified log-rank test were adjusted for previous treatment with anti-CD38,ISS staging and number of prior lines of therapy.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.72
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.47
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.558
- param Type
- Hazard Ratio (HR)
- param Value
- 1.03
- statistical Comment
- One-sided p-value from stratified log-rank test were adjusted for previous treatment with anti-CD38,ISS staging and number of prior lines of therapy.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.4
- upper Limit
- 14.5
- value
- 11.2
- group Id
- OG001
- lower Limit
- 4.6
- upper Limit
- 10.6
- value
- 7.0
- denoms
- counts
- group Id
- OG000
- value
- 218
- group Id
- OG001
- value
- 107
- units
- Participants
- description
- PFS is time from randomization until earliest date of progressive disease (PD), or death due to any cause per investigator-assessed response per IMWG. PD is ≥25% increase from nadir in any of following: serum M-protein (absolute increase ≥0.5 gram per deciliter \[g/dL\]),urine M-protein(absolute increase ≥200 mg/24hr),difference between involved/uninvolved FLC levels (absolute increase \>10 mg/dL) in patients without measurable serum and urine M-protein levels, or bone marrow plasma-cell percentage irrespective of baseline status (absolute increase ≥10%) in patients without measurable serum and urine M-protein levels and without measurable involved FLC levels; appearance of new lesion,≥50% increase in longest diameter of a lesion previously measured \>1cm in short axis, or ≥50% increase from nadir in sum of products of two longest perpendicular diameters of more than 1 lesion; ≥50% increase in circulating plasma cells (minimum of 200 cells/microliter) if this is only measure of disease.
- 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
- Intent-to-treat (ITT) population included all randomized participants whether or not randomized treatment was administered.
- reporting Status
- POSTED
- time Frame
- Up to 27 months
- title
- Progression-Free Survival (PFS) Based on Investigator-Assessed Response as Per International Myeloma Working Group (IMWG)
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice