TriangleNCT01830816 · OUTCOME
Percentage of Participants With Overall Response (OR) in Relapsed/Refractory Multiple Myeloma (RRMM) Participants
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- 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
Overall response rate defined as percentage of relapsed/refractory multiple myeloma participants who achieved partial response (PR), complete response (CR) and very good partial response (VGPR) according to International Myeloma Working Group Criteria. PR=\>50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or \<200 mg/24 h. If serum and urine M-protein are unmeasurable, \>50% decrease in difference between involved and uninvolved free light chain levels in place of M-protein criteria. If serum and urine M-protein and serum free light assay are not measurable, \>50% reduction in plasma cells in place of M-protein, provided baseline bone marrow plasma cell \>0%; CR=negative immunofixation on 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% reduction in serum M-protein plus urine M-protein level \<100 mg/24 h.
Analysis population: Response evaluable is defined as participants who received at least 1 cycle of ixazomib treatment in Part B and at least 1 post-baseline response assessment.
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 | 14 |
| Severe Renal Impairment: Ixazomib | 11 |
| End-stage Renal Disease: Ixazomib | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Normal Renal Function: Ixazomib | 29 | Not reported | 8 | 58 | Not reported |
| Severe Renal Impairment: Ixazomib | 18 | Not reported | 2 | 52 | Not reported |
| End-stage Renal Disease: Ixazomib | 0 | Not reported | NA | NA | No participant had overall response. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8
- upper Limit
- 58
- value
- 29
- group Id
- OG001
- lower Limit
- 2
- upper Limit
- 52
- value
- 18
- comment
- No participant had overall response.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 4
- units
- Participants
- description
- Overall response rate defined as percentage of relapsed/refractory multiple myeloma participants who achieved partial response (PR), complete response (CR) and very good partial response (VGPR) according to International Myeloma Working Group Criteria. PR=\>50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or \<200 mg/24 h. If serum and urine M-protein are unmeasurable, \>50% decrease in difference between involved and uninvolved free light chain levels in place of M-protein criteria. If serum and urine M-protein and serum free light assay are not measurable, \>50% reduction in plasma cells in place of M-protein, provided baseline bone marrow plasma cell \>0%; CR=negative immunofixation on 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% reduction in serum M-protein plus urine M-protein level \<100 mg/24 h.
- dispersion Type
- 95% Confidence Interval
- 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
- NUMBER
- population Description
- Response evaluable is defined as participants who received at least 1 cycle of ixazomib treatment in Part B and at least 1 post-baseline response assessment.
- 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
- Percentage of Participants With Overall Response (OR) in Relapsed/Refractory Multiple Myeloma (RRMM) Participants
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice