TriangleNCT00701103 · OUTCOME
Percentage of Participants Who Experienced a Complete Response (CR) or Partial Response (PR)
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
- Up to 2 years
What was measured
Tumor responses were measured by using Response Evaluation Criteria in Solid Tumors (RECIST) criteria in participants with solid tumors and using European Group for Blood and Marrow Transplantation (EBMT) criteria in participants with multiple myeloma. RECIST criteria for CR: Disappearance of all target lesions. RECIST criteria for PR: ≥30% decrease in the sum of diameters of target lesions. EBMT criteria for CR: Disappearance of the original mAb protein from the blood and urine AND \<5% plasma cells in the bone marrow AND no increase in the size or number of lytic bone lesions AND disappearance of soft tissue plasmacytomas AND normal serum calcium levels. EMBT criteria for PR: ≥50% reduction in the serum mAb protein level AND if a urine M-component is present, a reduction in 24-hour urinary light chain excretion by either ≥90% or to \<200 mg AND ≥50% reduction in the size of soft tissue plasmacytomas AND no increase in size or number of lytic bone lesions.
Analysis population: The population consisted of all evaluable participants who received \>90% of intended drug volume and had efficacy measurements at Baseline and at least once during treatment.
Groups in this outcome
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
| Group | Source count |
|---|---|
| Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL) | 5 |
| Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL) | 3 |
| Dalotuzumab 5 mg/kg Q1W (10 mg/mL) | 8 |
| Dalotuzumab 10 mg/kg Q1W (10 mg/mL) | 6 |
| Dalotuzumab 10 mg/kg Q1W (20 mg/mL) | 6 |
| Dalotuzumab 15 mg/kg Q1W (10 mg/mL) | 6 |
| Dalotuzumab 15 mg/kg Q1W (20 mg/mL) | 8 |
| Dalotuzumab 20 mg/kg Q1W (10 mg/mL) | 7 |
| Dalotuzumab 20 mg/kg Q1W (20 mg/mL) | 9 |
| Dalotuzumab 20 mg/kg Q2W (20 mg/mL) | 11 |
| Dalotuzumab 30 mg/kg Q3W (20 mg/mL) | 11 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dalotuzumab 5 mg/kg Q1W (10 mg/mL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dalotuzumab 10 mg/kg Q1W (10 mg/mL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dalotuzumab 10 mg/kg Q1W (20 mg/mL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dalotuzumab 15 mg/kg Q1W (10 mg/mL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dalotuzumab 15 mg/kg Q1W (20 mg/mL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dalotuzumab 20 mg/kg Q1W (10 mg/mL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dalotuzumab 20 mg/kg Q1W (20 mg/mL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dalotuzumab 20 mg/kg Q2W (20 mg/mL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dalotuzumab 30 mg/kg Q3W (20 mg/mL) | 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
- 5
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 7
- group Id
- OG008
- value
- 9
- group Id
- OG009
- value
- 11
- group Id
- OG010
- value
- 11
- units
- Participants
- description
- Tumor responses were measured by using Response Evaluation Criteria in Solid Tumors (RECIST) criteria in participants with solid tumors and using European Group for Blood and Marrow Transplantation (EBMT) criteria in participants with multiple myeloma. RECIST criteria for CR: Disappearance of all target lesions. RECIST criteria for PR: ≥30% decrease in the sum of diameters of target lesions. EBMT criteria for CR: Disappearance of the original mAb protein from the blood and urine AND \<5% plasma cells in the bone marrow AND no increase in the size or number of lytic bone lesions AND disappearance of soft tissue plasmacytomas AND normal serum calcium levels. EMBT criteria for PR: ≥50% reduction in the serum mAb protein level AND if a urine M-component is present, a reduction in 24-hour urinary light chain excretion by either ≥90% or to \<200 mg AND ≥50% reduction in the size of soft tissue plasmacytomas AND no increase in size or number of lytic bone lesions.
- groups
- description
- Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
- id
- OG000
- title
- Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
- description
- Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
- id
- OG001
- title
- Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
- description
- Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
- id
- OG002
- title
- Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
- description
- Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
- id
- OG003
- title
- Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
- description
- Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
- id
- OG004
- title
- Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
- description
- Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
- id
- OG005
- title
- Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
- description
- Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
- id
- OG006
- title
- Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
- description
- Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
- id
- OG007
- title
- Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
- description
- Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
- id
- OG008
- title
- Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
- description
- Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
- id
- OG009
- title
- Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
- description
- Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
- id
- OG010
- title
- Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
- param Type
- NUMBER
- population Description
- The population consisted of all evaluable participants who received \>90% of intended drug volume and had efficacy measurements at Baseline and at least once during treatment.
- reporting Status
- POSTED
- time Frame
- Up to 2 years
- title
- Percentage of Participants Who Experienced a Complete Response (CR) or Partial Response (PR)
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice