TriangleNCT01311687 · OUTCOME
Progression-free Survival (PFS) - Primary Analysis
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- weeks
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization until the data cut-off date of 07 September 2012. Maximum duration of follow-up for PFS assessments was 57 weeks.
What was measured
Progression-free survival was calculated as the time from randomization to disease progression as determined by the Independent Response Adjudication Committee based on the International Myeloma Working Group Uniform Response criteria (IMWG), or death on study, whichever occurred earlier. Progressive disease required 1 of the following: • Increase of ≥ 25% from nadir in: o Serum M-component (absolute increase ≥ 0.5 g/dl); o Urine M-component (absolute increase ≥ 200 mg/24 hours); o Bone marrow plasma cell percentage (absolute % ≥ 10%); • Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas; • Development of hypercalcemia (corrected serum calcium \> 11.5 mg/dl) attributed solely to plasma cell proliferative disease.
Analysis population: Intent-to-treat population
Groups in this outcome
Pomalidomide Plus Low-Dose Dexamethasone
Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
High-Dose Dexamethasone
Participants received 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
| Group | Source count |
|---|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 302 |
| High-Dose Dexamethasone | 153 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 15.7 | Not reported | 13.0 | 20.1 | Not reported |
| High-Dose Dexamethasone | 8.0 | Not reported | 7.0 | 9.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.35
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.59
- estimate Comment
- Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.45
- statistical Comment
- Stratified by age, disease population, and prior number of anti myeloma therapy.
- statistical Method
- Stratified Log Rank Test
Complete source fields
- analyses
- ci Lower Limit
- 0.35
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.59
- estimate Comment
- Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.45
- statistical Comment
- Stratified by age, disease population, and prior number of anti myeloma therapy.
- statistical Method
- Stratified Log Rank Test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 13.0
- upper Limit
- 20.1
- value
- 15.7
- group Id
- OG001
- lower Limit
- 7.0
- upper Limit
- 9.0
- value
- 8.0
- denoms
- counts
- group Id
- OG000
- value
- 302
- group Id
- OG001
- value
- 153
- units
- Participants
- description
- Progression-free survival was calculated as the time from randomization to disease progression as determined by the Independent Response Adjudication Committee based on the International Myeloma Working Group Uniform Response criteria (IMWG), or death on study, whichever occurred earlier. Progressive disease required 1 of the following: • Increase of ≥ 25% from nadir in: o Serum M-component (absolute increase ≥ 0.5 g/dl); o Urine M-component (absolute increase ≥ 200 mg/24 hours); o Bone marrow plasma cell percentage (absolute % ≥ 10%); • Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas; • Development of hypercalcemia (corrected serum calcium \> 11.5 mg/dl) attributed solely to plasma cell proliferative disease.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
- id
- OG000
- title
- Pomalidomide Plus Low-Dose Dexamethasone
- description
- Participants received 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
- id
- OG001
- title
- High-Dose Dexamethasone
- param Type
- MEDIAN
- population Description
- Intent-to-treat population
- reporting Status
- POSTED
- time Frame
- From randomization until the data cut-off date of 07 September 2012. Maximum duration of follow-up for PFS assessments was 57 weeks.
- title
- Progression-free Survival (PFS) - Primary Analysis
- type
- PRIMARY
- unit Of Measure
- weeks
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Preserved source evidence · Not medical advice