TriangleNCT01311687 · OUTCOME
Time to Progression
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 01 March 2013. Maximum time on follow-up was 93 weeks.
What was measured
Time to progression (TTP) is calculated as the time from randomization to the first documented progression confirmed by a blinded, independent Response Adjudication Committee and based on the International Myeloma Working Group Uniform Response criteria (IMWG). Progressive disease requires 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 | 20.0 | Not reported | 16.1 | 24.0 | Not reported |
| High-Dose Dexamethasone | 9.0 | Not reported | 8.0 | 10.9 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.36
- 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
- 0.46
- statistical Comment
- Stratified by age, diseases population, and prior number of anti myeloma therapy.
- statistical Method
- Stratified Log Rank Test
Complete source fields
- analyses
- ci Lower Limit
- 0.36
- 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
- 0.46
- statistical Comment
- Stratified by age, diseases population, and prior number of anti myeloma therapy.
- statistical Method
- Stratified Log Rank Test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 16.1
- upper Limit
- 24.0
- value
- 20.0
- group Id
- OG001
- lower Limit
- 8.0
- upper Limit
- 10.9
- value
- 9.0
- denoms
- counts
- group Id
- OG000
- value
- 302
- group Id
- OG001
- value
- 153
- units
- Participants
- description
- Time to progression (TTP) is calculated as the time from randomization to the first documented progression confirmed by a blinded, independent Response Adjudication Committee and based on the International Myeloma Working Group Uniform Response criteria (IMWG). Progressive disease requires 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 01 March 2013. Maximum time on follow-up was 93 weeks.
- title
- Time to Progression
- type
- SECONDARY
- unit Of Measure
- weeks
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice