TriangleNCT04272775 · OUTCOME
Number of Participants Who Achieved Complete Response (CR), Very Good Partial Response (VGPR), and Partial Response (PR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline up to 29 days after last dose of study drug (up to Cycle 87 Day 44) (Each Cycle length=28 days)
What was measured
Number of participants who achieved CR, PR, VGPR were assessed in accordance to International Myeloma Working Group Uniform Response Criteria for Multiple Myeloma. CR: No immunofixation on serum and urine, disappearance of soft tissue plasmacytomas and \<5% plasma cells in bone marrow. Normal serum free light chain (SFLC) ratio if disease measurable only by SFLC. VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or greater than or equal to (\>=) 90% decrease in serum M-protein with urine M-protein \<100 milligram per 24 hours (mg/24 hrs). If disease measurable only by SFLC, \>= 90% decrease in the difference between involved and uninvolved FLC levels (dFLC). PR: \>= 50% reduction of serum M-protein and \>= 90% reduction in urine M-protein or to \<200 mg/24 hrs, or a \>= 50% decrease in dFLC. A \>=50% decrease in the size of soft tissue plasmacytomas present at baseline
Analysis population: The response evaluable analysis set consisted of all participants who received at least one dose of ixazomib, have measurable disease at baseline, and at least one postbaseline response assessment.
Groups in this outcome
Cohort 1: Ixazomib 4.0 mg
Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle for up to Cycle 87.
Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone
Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle along with lenalidomide 25 mg/day, capsules, orally, once, from Days 1 to 21 and dexamethasone 40 mg/day, tablets, orally, once, on Days 1, 8, 15, and 22 in a 28-day treatment cycle for up to Cycle 62.
| Group | Source count |
|---|---|
| Cohort 1: Ixazomib 4.0 mg | 7 |
| Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: Ixazomib 4.0 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- Number of participants who achieved CR, PR, VGPR were assessed in accordance to International Myeloma Working Group Uniform Response Criteria for Multiple Myeloma. CR: No immunofixation on serum and urine, disappearance of soft tissue plasmacytomas and \<5% plasma cells in bone marrow. Normal serum free light chain (SFLC) ratio if disease measurable only by SFLC. VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or greater than or equal to (\>=) 90% decrease in serum M-protein with urine M-protein \<100 milligram per 24 hours (mg/24 hrs). If disease measurable only by SFLC, \>= 90% decrease in the difference between involved and uninvolved FLC levels (dFLC). PR: \>= 50% reduction of serum M-protein and \>= 90% reduction in urine M-protein or to \<200 mg/24 hrs, or a \>= 50% decrease in dFLC. A \>=50% decrease in the size of soft tissue plasmacytomas present at baseline
- groups
- description
- Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle for up to Cycle 87.
- id
- OG000
- title
- Cohort 1: Ixazomib 4.0 mg
- description
- Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle along with lenalidomide 25 mg/day, capsules, orally, once, from Days 1 to 21 and dexamethasone 40 mg/day, tablets, orally, once, on Days 1, 8, 15, and 22 in a 28-day treatment cycle for up to Cycle 62.
- id
- OG001
- title
- Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The response evaluable analysis set consisted of all participants who received at least one dose of ixazomib, have measurable disease at baseline, and at least one postbaseline response assessment.
- reporting Status
- POSTED
- time Frame
- Baseline up to 29 days after last dose of study drug (up to Cycle 87 Day 44) (Each Cycle length=28 days)
- title
- Number of Participants Who Achieved Complete Response (CR), Very Good Partial Response (VGPR), and Partial Response (PR)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice