TriangleNCT01536145 · OUTCOME
Percentage of Participants With Objective Response (OR)
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
- Not reported
- Time frame
- Baseline, Day 1 at predose/cycle, end of study (30-60 days post last dose)
What was measured
Percentage of participants with OR based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to Southwest Oncology Group (SWOG) criteria. CR were those with absence of bone marrow or blood findings of multiple myeloma. PR were those with a 50-74% reduction in the quantitative immunoglobulin, and if present, a 50-89% reduction in the urine M-component (Bence-Jones protein).
Analysis population: All participants who completed a minimum of 1 cycle of treatment were evaluable for response. Participants who developed early progressive disease (regardless of the duration of study treatment) prior to response evaluation were also evaluable for response.
Groups in this outcome
CP-751,871 0.025 mg/kg
CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
CP-751,871 0.05 mg/kg
CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
CP-751,871 0.1 mg/kg
CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
CP-751,871 0.2 mg/kg
CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
CP-751,871 0.4 mg/kg
CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
CP-751,871 0.8 mg/kg
CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
CP-751,871 1.5 mg/kg
CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
CP-751,871 3 mg/kg
CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
CP-751,871 6 mg/kg
CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
CP-751,871 10 mg/kg
CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
CP-751,871 20 mg/kg
CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
| Group | Source count |
|---|---|
| CP-751,871 0.025 mg/kg | 3 |
| CP-751,871 0.05 mg/kg | 3 |
| CP-751,871 0.1 mg/kg | 3 |
| CP-751,871 0.2 mg/kg | 3 |
| CP-751,871 0.4 mg/kg | 4 |
| CP-751,871 0.8 mg/kg | 3 |
| CP-751,871 1.5 mg/kg | 3 |
| CP-751,871 3 mg/kg | 4 |
| CP-751,871 6 mg/kg | 3 |
| CP-751,871 10 mg/kg | 7 |
| CP-751,871 20 mg/kg | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CP-751,871 0.025 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| CP-751,871 0.05 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| CP-751,871 0.1 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| CP-751,871 0.2 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| CP-751,871 0.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| CP-751,871 0.8 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| CP-751,871 1.5 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| CP-751,871 3 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| CP-751,871 6 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| CP-751,871 10 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| CP-751,871 20 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 4
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 7
- group Id
- OG010
- value
- 9
- units
- Participants
- description
- Percentage of participants with OR based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to Southwest Oncology Group (SWOG) criteria. CR were those with absence of bone marrow or blood findings of multiple myeloma. PR were those with a 50-74% reduction in the quantitative immunoglobulin, and if present, a 50-89% reduction in the urine M-component (Bence-Jones protein).
- groups
- description
- CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
- id
- OG000
- title
- CP-751,871 0.025 mg/kg
- description
- CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
- id
- OG001
- title
- CP-751,871 0.05 mg/kg
- description
- CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
- id
- OG002
- title
- CP-751,871 0.1 mg/kg
- description
- CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
- id
- OG003
- title
- CP-751,871 0.2 mg/kg
- description
- CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
- id
- OG004
- title
- CP-751,871 0.4 mg/kg
- description
- CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
- id
- OG005
- title
- CP-751,871 0.8 mg/kg
- description
- CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
- id
- OG006
- title
- CP-751,871 1.5 mg/kg
- description
- CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
- id
- OG007
- title
- CP-751,871 3 mg/kg
- description
- CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
- id
- OG008
- title
- CP-751,871 6 mg/kg
- description
- CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
- id
- OG009
- title
- CP-751,871 10 mg/kg
- description
- CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
- id
- OG010
- title
- CP-751,871 20 mg/kg
- param Type
- NUMBER
- population Description
- All participants who completed a minimum of 1 cycle of treatment were evaluable for response. Participants who developed early progressive disease (regardless of the duration of study treatment) prior to response evaluation were also evaluable for response.
- reporting Status
- POSTED
- time Frame
- Baseline, Day 1 at predose/cycle, end of study (30-60 days post last dose)
- title
- Percentage of Participants With Objective Response (OR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice