TriangleNCT01212952 · OUTCOME
Number of Participants With a Hematologic Response (PR, VGPR, or CR)
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
- 2.5 years
What was measured
The number of participants who achieve PR, VGPR, or CR as defined by The International Myeloma Working Group uniform response criteria(2011). sCR: CR as defined below plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \> 90% reduction in serum M-protein plus urine M-protein level \< 100 mg/24 h. PR: \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or to \< 200 mg/24 h. MR: NA. SD: Not meeting criteria for CR, VGPR, PR, or progressive disease. PD: Increase of \> 25% from lowest response value in any one or more of the following: Serum M-component and/or (the absolute increase must be \> 0.5 g/dL), Urine M-component and/or (the absolute increase must be \> 200 mg/24 h)
Groups in this outcome
Phase I - Dose Level 1
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.0 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
Phase I - Dose Level 2
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.3 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
Phase II
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.3 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
| Group | Source count |
|---|---|
| Phase I - Dose Level 1 | 3 |
| Phase I - Dose Level 2 | 6 |
| Phase II | 41 |
Reported measurements
Source class 1
CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I - Dose Level 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I - Dose Level 2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase II | 4 | Not reported | Not reported | Not reported | Not reported |
PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I - Dose Level 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I - Dose Level 2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase II | 17 | Not reported | Not reported | Not reported | Not reported |
VGPR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I - Dose Level 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I - Dose Level 2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase II | 12 | Not reported | Not reported | Not reported | Not reported |
SD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I - Dose Level 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase I - Dose Level 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase II | 5 | Not reported | Not reported | Not reported | Not reported |
MR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I - Dose Level 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I - Dose Level 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase II | 1 | Not reported | Not reported | Not reported | Not reported |
sCR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I - Dose Level 1 | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase I - Dose Level 2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase II | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 4
- title
- CR
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 17
- title
- PR
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 12
- title
- VGPR
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 5
- title
- SD
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- title
- MR
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- title
- sCR
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 41
- units
- Participants
- description
- The number of participants who achieve PR, VGPR, or CR as defined by The International Myeloma Working Group uniform response criteria(2011). sCR: CR as defined below plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \> 90% reduction in serum M-protein plus urine M-protein level \< 100 mg/24 h. PR: \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or to \< 200 mg/24 h. MR: NA. SD: Not meeting criteria for CR, VGPR, PR, or progressive disease. PD: Increase of \> 25% from lowest response value in any one or more of the following: Serum M-component and/or (the absolute increase must be \> 0.5 g/dL), Urine M-component and/or (the absolute increase must be \> 200 mg/24 h)
- groups
- description
- Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.0 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
- id
- OG000
- title
- Phase I - Dose Level 1
- description
- Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.3 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
- id
- OG001
- title
- Phase I - Dose Level 2
- description
- Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.3 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
- id
- OG002
- title
- Phase II
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- 2.5 years
- title
- Number of Participants With a Hematologic Response (PR, VGPR, or CR)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice