TriangleNCT01383928 · 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
- Baseline until end of treatment (Up to treatment Cycle 74 - approximately 1875 days)
What was measured
DOR was measured as the time from the date of first documentation of a confirmed response to the date of first documented PD. PD is defined as \>=25% increase from lowest value in: serum/urine M-component; difference between involved, uninvolved FLC levels; bone marrow plasma cell percent; development of new bone lesions or soft tissue plasmacytomas development or increase in the size of existing bone lesions or soft tissue plasmacytomas; hypercalcaemia development.
Analysis population: Included a subset of response-evaluable population who achieved response.
Groups in this outcome
Phase 2: Ixazomib 3 mg
Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received in this cohort was 74 cycles (approximately 1875 days).
| Group | Source count |
|---|---|
| Phase 2: Ixazomib 3 mg | 49 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Ixazomib 3 mg | 29.0 | Not reported | 16.72 | NA | Upper limit of 95% confidence interval was not estimable as majority of the participants were censored. |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit of 95% confidence interval was not estimable as majority of the participants were censored.
- group Id
- OG000
- lower Limit
- 16.72
- upper Limit
- NA
- value
- 29.0
- denoms
- counts
- group Id
- OG000
- value
- 49
- units
- Participants
- description
- DOR was measured as the time from the date of first documentation of a confirmed response to the date of first documented PD. PD is defined as \>=25% increase from lowest value in: serum/urine M-component; difference between involved, uninvolved FLC levels; bone marrow plasma cell percent; development of new bone lesions or soft tissue plasmacytomas development or increase in the size of existing bone lesions or soft tissue plasmacytomas; hypercalcaemia development.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received in this cohort was 74 cycles (approximately 1875 days).
- id
- OG000
- title
- Phase 2: Ixazomib 3 mg
- param Type
- MEDIAN
- population Description
- Included a subset of response-evaluable population who achieved response.
- reporting Status
- POSTED
- time Frame
- Baseline until end of treatment (Up to treatment Cycle 74 - approximately 1875 days)
- title
- Phase 2: Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice