TriangleNCT03170882 · OUTCOME
Duration of Response (DOR)
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 first documentation of CR, VGPR or PR until first occurrence of confirmed disease progression or death due to any cause, whichever occurs first (Up to approximately 3 years)
What was measured
DOR: Time from first documentation of CR/PR/VGPR to first documentation of PD. Per IMWG criteria, PR:\>=50% reduction of serum M protein+reduction in 24-hour urinary M protein by \>=90% to \<200 mg/24-hour or \>=50% decrease in difference between involved and uninvolved FLC levels/ \>=50% reduction in bone marrow plasma cells, if \>=30% at Baseline/ \>=50% reduction in size of soft tissue plasmacytomas. VGPR: serum+urine M-protein detectable by immunofixation but not on electrophoresis/ \>=90% reduction in serum M-protein + urine M-protein level \<100 mg/24-hour. CR:negative immunofixation on serum + urine+disappearance of soft tissue plasmacytomas+\<5% plasma cells in bone marrow. PD:serum M-component increase \>=0.5 g/dl or urine M-component increase \>=200 mg/24-hour/ difference between involved and uninvolved FLC levels increase \>10 mg/dl or bone marrow plasma cell \>=10%/development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.
Analysis population: Response Evaluable Population included all participants with multiple myeloma who had documentation of a confirmed PR, or PR/VGPR/CR. Only responders were reported for this outcome measure.
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 | 20 |
| Ixazomib 4 mg + Dexamethasone 20 mg | 28 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pomalidomide 4 mg + Dexamethasone 40 mg | 14.3 | Not reported | 3.713 | NA | Upper limit of 95% CI was not estimable due to low number of responders with events. |
| Ixazomib 4 mg + Dexamethasone 20 mg | 14.8 | Not reported | 10.152 | 19.614 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit of 95% CI was not estimable due to low number of responders with events.
- group Id
- OG000
- lower Limit
- 3.713
- upper Limit
- NA
- value
- 14.3
- group Id
- OG001
- lower Limit
- 10.152
- upper Limit
- 19.614
- value
- 14.8
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 28
- units
- Participants
- description
- DOR: Time from first documentation of CR/PR/VGPR to first documentation of PD. Per IMWG criteria, PR:\>=50% reduction of serum M protein+reduction in 24-hour urinary M protein by \>=90% to \<200 mg/24-hour or \>=50% decrease in difference between involved and uninvolved FLC levels/ \>=50% reduction in bone marrow plasma cells, if \>=30% at Baseline/ \>=50% reduction in size of soft tissue plasmacytomas. VGPR: serum+urine M-protein detectable by immunofixation but not on electrophoresis/ \>=90% reduction in serum M-protein + urine M-protein level \<100 mg/24-hour. CR:negative immunofixation on serum + urine+disappearance of soft tissue plasmacytomas+\<5% plasma cells in bone marrow. PD:serum M-component increase \>=0.5 g/dl or urine M-component increase \>=200 mg/24-hour/ difference between involved and uninvolved FLC levels increase \>10 mg/dl or bone marrow plasma cell \>=10%/development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.
- 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
- Response Evaluable Population included all participants with multiple myeloma who had documentation of a confirmed PR, or PR/VGPR/CR. Only responders were reported for this outcome measure.
- reporting Status
- POSTED
- time Frame
- From date of first documentation of CR, VGPR or PR until first occurrence of confirmed disease progression or death due to any cause, whichever occurs first (Up to approximately 3 years)
- title
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice