TriangleNCT01830816 · OUTCOME
Duration of Response (DOR) in RRMM Participants
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- days
- Interval / dispersion
- Full Range
- Time frame
- Day 1 of every other cycle from cycle 1 (each cycle of 28 days) up to progression of disease (approximately up to 855 days)
What was measured
DOR was defined as time from date of first documentation of a PR or better to date of first documentation of progressive disease (PD) for responders. Increase of \>25% from lowest response value in any one or more of following: Serum M-component and/or (absolute increase must be \>0.5 g/dL); Urine M-component and/or (the absolute increase must be \>200 mg/24 h); difference between involved and uninvolved free light chain (FLC) levels and the absolute increase must be \> 10 mg/dL; Bone marrow plasma cell percentage; absolute percentage must be \> 5%; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcaemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. Responders without PD were censored at the date of the last response assessment that was stable disease (SD) or better.
Analysis population: Response evaluable population is defined as participants who received at least 1 cycle of Ixazomib treatment in Part B and at least 1 post-baseline response assessment. Here, number of participants analyzed is the participants who had confirmed response.
Groups in this outcome
Normal Renal Function: Ixazomib
After part A the participant has the option to participate in Part B start with ixazomib capsules, orally on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Severe Renal Impairment: Ixazomib
After part A the participant has the option to participate in Part B start with ixazomib capsules, orally on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
End-stage Renal Disease: Ixazomib
After part A the participant has the option to participate in Part B start with ixazomib capsules, orally on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Normal Renal Function: Ixazomib | 4 |
| Severe Renal Impairment: Ixazomib | 2 |
| End-stage Renal Disease: Ixazomib | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Normal Renal Function: Ixazomib | 134 | Not reported | 72 | 233 | Not reported |
| Severe Renal Impairment: Ixazomib | 225 | Not reported | 225 | 225 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 72
- upper Limit
- 233
- value
- 134
- group Id
- OG001
- lower Limit
- 225
- upper Limit
- 225
- value
- 225
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- units
- Participants
- description
- DOR was defined as time from date of first documentation of a PR or better to date of first documentation of progressive disease (PD) for responders. Increase of \>25% from lowest response value in any one or more of following: Serum M-component and/or (absolute increase must be \>0.5 g/dL); Urine M-component and/or (the absolute increase must be \>200 mg/24 h); difference between involved and uninvolved free light chain (FLC) levels and the absolute increase must be \> 10 mg/dL; Bone marrow plasma cell percentage; absolute percentage must be \> 5%; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcaemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. Responders without PD were censored at the date of the last response assessment that was stable disease (SD) or better.
- dispersion Type
- Full Range
- groups
- description
- After part A the participant has the option to participate in Part B start with ixazomib capsules, orally on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Normal Renal Function: Ixazomib
- description
- After part A the participant has the option to participate in Part B start with ixazomib capsules, orally on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
- id
- OG001
- title
- Severe Renal Impairment: Ixazomib
- description
- After part A the participant has the option to participate in Part B start with ixazomib capsules, orally on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
- id
- OG002
- title
- End-stage Renal Disease: Ixazomib
- param Type
- MEDIAN
- population Description
- Response evaluable population is defined as participants who received at least 1 cycle of Ixazomib treatment in Part B and at least 1 post-baseline response assessment. Here, number of participants analyzed is the participants who had confirmed response.
- reporting Status
- POSTED
- time Frame
- Day 1 of every other cycle from cycle 1 (each cycle of 28 days) up to progression of disease (approximately up to 855 days)
- title
- Duration of Response (DOR) in RRMM Participants
- type
- SECONDARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice