TriangleNCT01615029 · OUTCOME
Phase 1: Percentage of Participants With Overall Response Rate (ORR)
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
- Up to 3 years
What was measured
ORR is defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). International Myeloma Working Group (IMWG) criteria (2011)- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (\<) 5 percentage (%) plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immuno fluorescence; PR: greater than equal to (\>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>= 90 percentage (%) or to \<200 mg/24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hour.
Analysis population: All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1.
Groups in this outcome
Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 2 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
Phase 1: Daratumumab (2-16 mg/kg) + Lenalidomide and Dexamethasone
Participants were administered Daratumumab at escalating doses of 2 mg/kg, 4 mg/kg, 8 mg/kg, or 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Day 1 of Cycles 3 to 6, and Day 1 of Cycles 7 and beyond. Each cycle consisted of 28 days. Lenalidomide (25 mg was administered orally once daily on Days 1 to 21 of each 28-day cycle) and Dexamethasone (40 mg weekly) were administered concurrently. Dexamethasone dosage could be reduced to 20 mg weekly after Cycle 6 or at the investigator's discretion. Each treatment cycle consisted of 28 days.
| Group | Source count |
|---|---|
| Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone | 3 |
| Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone | 3 |
| Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone | 4 |
| Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone | 3 |
| Phase 1: Daratumumab (2-16 mg/kg) + Lenalidomide and Dexamethasone | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone | 100.0 | Not reported | 29.2 | 100.0 | Not reported |
| Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone | 100.0 | Not reported | 29.2 | 100.0 | Not reported |
| Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone | 75.0 | Not reported | 19.4 | 99.4 | Not reported |
| Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone | 66.7 | Not reported | 9.4 | 99.2 | Not reported |
| Phase 1: Daratumumab (2-16 mg/kg) + Lenalidomide and Dexamethasone | 85.4 | Not reported | 64.8 | 98.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 29.2
- upper Limit
- 100.0
- value
- 100.0
- group Id
- OG001
- lower Limit
- 29.2
- upper Limit
- 100.0
- value
- 100.0
- group Id
- OG002
- lower Limit
- 19.4
- upper Limit
- 99.4
- value
- 75.0
- group Id
- OG003
- lower Limit
- 9.4
- upper Limit
- 99.2
- value
- 66.7
- group Id
- OG004
- lower Limit
- 64.8
- upper Limit
- 98.1
- value
- 85.4
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 13
- units
- Participants
- description
- ORR is defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). International Myeloma Working Group (IMWG) criteria (2011)- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (\<) 5 percentage (%) plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immuno fluorescence; PR: greater than equal to (\>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>= 90 percentage (%) or to \<200 mg/24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hour.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants administered with daratumumab 2 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
- id
- OG000
- title
- Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone
- description
- Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
- id
- OG001
- title
- Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone
- description
- Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
- id
- OG002
- title
- Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone
- description
- Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
- id
- OG003
- title
- Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
- description
- Participants were administered Daratumumab at escalating doses of 2 mg/kg, 4 mg/kg, 8 mg/kg, or 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Day 1 of Cycles 3 to 6, and Day 1 of Cycles 7 and beyond. Each cycle consisted of 28 days. Lenalidomide (25 mg was administered orally once daily on Days 1 to 21 of each 28-day cycle) and Dexamethasone (40 mg weekly) were administered concurrently. Dexamethasone dosage could be reduced to 20 mg weekly after Cycle 6 or at the investigator's discretion. Each treatment cycle consisted of 28 days.
- id
- OG004
- title
- Phase 1: Daratumumab (2-16 mg/kg) + Lenalidomide and Dexamethasone
- param Type
- NUMBER
- population Description
- All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1.
- reporting Status
- POSTED
- time Frame
- Up to 3 years
- title
- Phase 1: Percentage of Participants With Overall Response Rate (ORR)
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice