TriangleNCT02253316 · OUTCOME
Compare Response Rate Between the Two Maintenance Arms
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
- Through completion of maintenance treatment (estimated to be day 1095 of maintenance treatment)
What was measured
* Response will be determined by the International Myeloma Working Group (IMWG) Uniform Response Criteria. Response includes stringent complete response (sCR) and complete response (CR). * sCR requires all of the following: * CR as defined below * Normal free light chain ratio (0.26-1.65) * Absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence * CR requires all of the following: * Disappearance of monoclonal protein by both protein electrophoresis and immunofixation studies from the blood and urine * If serum and urine monoclonal protein are unmeasurable, Normal free light chain ratio (0.26-1.65) * \<5% plasma cells in the bone marrow * Disappearance of soft tissue plasmacytoma
Analysis population: This outcome measure is only for participants who went onto the maintenance arms. Participants in the maintenance arms were not evaluable for this outcome measure if they were removed from treatment for reasons other than progressive disease prior to Month 13.
Groups in this outcome
Consolidation: Ixazomib, Lenalidomide, & Dexamethasone
Consolidation therapy will begin between Day 80 and Day 120 following ASCT and will consist of four 28-day cycles of IRD (ixazomib, lenalidomide, \& dexamethasone). Barring dose modifications for toxicity, 4 mg of ixazomib and 40 mg of dexamethasone will be administered on Days 1, 8, and 15, and 15 mg of lenalidomide will be administered on daily on Days 1-21.
Maintenance Arm 1: Ixazomib
Ixazomib will be administered on Days 1, 8, and 15 of a 28-day cycle at a starting dose of 4 mg until patient progresses or experiences an unacceptable toxicity. 09/23/2019: Upon review of the interim analysis, there will be no further randomizations into the maintenance portion of the trial. All patients will be enrolled into the lenalidomide arm with the exception of those who discontinue lenalidomide during the consolidation phase due to toxicity. Patients who discontinue lenalidomide may be enrolled into the ixazomib arm following approval from the principal investigator.
Maintenance Arm 2: Lenalidomide
Lenalidomide will be administered daily continuously for a 28-day cycle at a starting dose of 10 mg. If lenalidomide is tolerated well (i.e. no dose modification required) during the first three cycles, lenalidomide dose will be increased to 15 mg daily and will continue until patient progresses or experiences an unacceptable toxicity.
| Group | Source count |
|---|---|
| Consolidation: Ixazomib, Lenalidomide, & Dexamethasone | 0 |
| Maintenance Arm 1: Ixazomib | 91 |
| Maintenance Arm 2: Lenalidomide | 109 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Maintenance Arm 1: Ixazomib | 50 | Not reported | Not reported | Not reported | Not reported |
| Maintenance Arm 2: Lenalidomide | 80 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG001
- value
- 50
- group Id
- OG002
- value
- 80
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 91
- group Id
- OG002
- value
- 109
- units
- Participants
- description
- * Response will be determined by the International Myeloma Working Group (IMWG) Uniform Response Criteria. Response includes stringent complete response (sCR) and complete response (CR). * sCR requires all of the following: * CR as defined below * Normal free light chain ratio (0.26-1.65) * Absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence * CR requires all of the following: * Disappearance of monoclonal protein by both protein electrophoresis and immunofixation studies from the blood and urine * If serum and urine monoclonal protein are unmeasurable, Normal free light chain ratio (0.26-1.65) * \<5% plasma cells in the bone marrow * Disappearance of soft tissue plasmacytoma
- groups
- description
- Consolidation therapy will begin between Day 80 and Day 120 following ASCT and will consist of four 28-day cycles of IRD (ixazomib, lenalidomide, \& dexamethasone). Barring dose modifications for toxicity, 4 mg of ixazomib and 40 mg of dexamethasone will be administered on Days 1, 8, and 15, and 15 mg of lenalidomide will be administered on daily on Days 1-21.
- id
- OG000
- title
- Consolidation: Ixazomib, Lenalidomide, & Dexamethasone
- description
- Ixazomib will be administered on Days 1, 8, and 15 of a 28-day cycle at a starting dose of 4 mg until patient progresses or experiences an unacceptable toxicity. 09/23/2019: Upon review of the interim analysis, there will be no further randomizations into the maintenance portion of the trial. All patients will be enrolled into the lenalidomide arm with the exception of those who discontinue lenalidomide during the consolidation phase due to toxicity. Patients who discontinue lenalidomide may be enrolled into the ixazomib arm following approval from the principal investigator.
- id
- OG001
- title
- Maintenance Arm 1: Ixazomib
- description
- Lenalidomide will be administered daily continuously for a 28-day cycle at a starting dose of 10 mg. If lenalidomide is tolerated well (i.e. no dose modification required) during the first three cycles, lenalidomide dose will be increased to 15 mg daily and will continue until patient progresses or experiences an unacceptable toxicity.
- id
- OG002
- title
- Maintenance Arm 2: Lenalidomide
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- This outcome measure is only for participants who went onto the maintenance arms. Participants in the maintenance arms were not evaluable for this outcome measure if they were removed from treatment for reasons other than progressive disease prior to Month 13.
- reporting Status
- POSTED
- time Frame
- Through completion of maintenance treatment (estimated to be day 1095 of maintenance treatment)
- title
- Compare Response Rate Between the Two Maintenance Arms
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice