TriangleNCT03170882 · OUTCOME
Time to Progression (TTP)
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
- From date of randomization until first occurrence of confirmed disease progression or death due to any cause, whichever occurs first (Up to approximately 3 years)
What was measured
TTP was defined as the time from the date of randomization to first documentation of PD. Per IMWG criteria, PD required 1 of the following: Increase of \>=25% from nadir in: Serum M-component (increase must be \>=0.5 g/dl; Urine M-component (increase must be \>=200 mg/24-hour); In participants without measurable serum and urine M-protein levels difference between involved and uninvolved FLC levels increase of \>10 mg/dl; In participants without measurable serum and urine M protein levels and without measurable disease by FLC level: Bone marrow plasma cell percentage must be \>=10%; Development of new or increase in size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (\>11.5 mg/dL corrected serum calcium) attributed solely to plasma cell proliferative disease.
Analysis population: ITT Population included all participants who were randomized. Participants without documentation of PD at the time of analysis are censored at the date of last response assessment that is SD or better.
Groups in this outcome
Pomalidomide 4 mg + Dexamethasone 40 mg
Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
Ixazomib 4 mg + Dexamethasone 20 mg
Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
| Group | Source count |
|---|---|
| Pomalidomide 4 mg + Dexamethasone 40 mg | 49 |
| Ixazomib 4 mg + Dexamethasone 20 mg | 73 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pomalidomide 4 mg + Dexamethasone 40 mg | 5.1 | Not reported | 3.844 | 12.485 | Not reported |
| Ixazomib 4 mg + Dexamethasone 20 mg | 8.4 | Not reported | 5.684 | 13.306 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.506
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.361
- estimate Comment
- HR: obtained by unadjusted Cox's proportional hazard regression model stratified by age,ISS,prior lines of therapy. HR\<1 was deemed to indicate better disease progression prevention in Ixazomib+Dexamethasone arm over Pomalidomide+Dexamethasone arm.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.459
- param Type
- Hazard Ratio (HR)
- param Value
- 0.830
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.506
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.361
- estimate Comment
- HR: obtained by unadjusted Cox's proportional hazard regression model stratified by age,ISS,prior lines of therapy. HR\<1 was deemed to indicate better disease progression prevention in Ixazomib+Dexamethasone arm over Pomalidomide+Dexamethasone arm.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.459
- param Type
- Hazard Ratio (HR)
- param Value
- 0.830
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.844
- upper Limit
- 12.485
- value
- 5.1
- group Id
- OG001
- lower Limit
- 5.684
- upper Limit
- 13.306
- value
- 8.4
- denoms
- counts
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 73
- units
- Participants
- description
- TTP was defined as the time from the date of randomization to first documentation of PD. Per IMWG criteria, PD required 1 of the following: Increase of \>=25% from nadir in: Serum M-component (increase must be \>=0.5 g/dl; Urine M-component (increase must be \>=200 mg/24-hour); In participants without measurable serum and urine M-protein levels difference between involved and uninvolved FLC levels increase of \>10 mg/dl; In participants without measurable serum and urine M protein levels and without measurable disease by FLC level: Bone marrow plasma cell percentage must be \>=10%; Development of new or increase in size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (\>11.5 mg/dL corrected serum calcium) attributed solely to plasma cell proliferative disease.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
- id
- OG000
- title
- Pomalidomide 4 mg + Dexamethasone 40 mg
- description
- Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
- id
- OG001
- title
- Ixazomib 4 mg + Dexamethasone 20 mg
- param Type
- MEDIAN
- population Description
- ITT Population included all participants who were randomized. Participants without documentation of PD at the time of analysis are censored at the date of last response assessment that is SD or better.
- reporting Status
- POSTED
- time Frame
- From date of randomization until first occurrence of confirmed disease progression or death due to any cause, whichever occurs first (Up to approximately 3 years)
- title
- Time to Progression (TTP)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice