TriangleNCT01217957 · OUTCOME
Phase 2: 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
- Up to 787 days
What was measured
DOR was measured as the time in months from the date of first documentation of a confirmed response (CR + PR+ VGPR) to the date of the first documented disease progression (PD). Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria. CR=negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 hours.
Analysis population: Participants from the Response Evaluable Population, defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment, with data available for analysis. Patients who did not experience PD were censored at the last response assessment that was SD or better.
Groups in this outcome
Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone
In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone
In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m\^2 in Phase 1.
| Group | Source count |
|---|---|
| Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone | 49 |
| Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone | 52 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone | NA | Not reported | NA | NA | Not estimable due to the low number of participants with events (progressive disease). |
| Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone | NA | Not reported | NA | NA | Not estimable due to the low number of participants with events (progressive disease). |
Complete source fields
- classes
- categories
- measurements
- comment
- Not estimable due to the low number of participants with events (progressive disease).
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Not estimable due to the low number of participants with events (progressive disease).
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 52
- units
- Participants
- description
- DOR was measured as the time in months from the date of first documentation of a confirmed response (CR + PR+ VGPR) to the date of the first documented disease progression (PD). Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria. CR=negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 hours.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone
- description
- In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m\^2 in Phase 1.
- id
- OG001
- title
- Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone
- param Type
- MEDIAN
- population Description
- Participants from the Response Evaluable Population, defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment, with data available for analysis. Patients who did not experience PD were censored at the last response assessment that was SD or better.
- reporting Status
- POSTED
- time Frame
- Up to 787 days
- title
- Phase 2: Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice