TriangleNCT02597062 · OUTCOME
Overall Response Rate After 4 Cycles
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
- 4 months
What was measured
Response rate to protocol treatment after 4 cycles is define by stringent complete response, complete response, partial response, very good partial response, minimal response. Complete response: Negative immunofixation on the serum and urine and Disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow biopsy Stringent complete response: Complete response plus Absence of clonal cells in bone marrow d by immunohistochemistry or immunofluorescence Very good partial response: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein with urine M-protein level \<100 mg/24 hours. Partial response: ≥50% reduction in serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 hours Minimal response: 25-49% reduction in serum M-protein, and 50-89% reduction in 24-hour urinary M-protein, if ≥ 200 mg/24 hours at baseline
Analysis population: All eligible patients how have received treatment.
Groups in this outcome
Carfilzomib Plus Cyclophosphamide Plus Dexamethasone
20 mg/m2 day 1 of first cycle then escalated to 70 mg/m2 for all subsequent doses) given on days 1, 8, and 15 of a 28 day cycle plus weekly oral dexamethasone (\< 70 years, 40 mg; ≥ 70 years 20mg) and cyclophosphamide 300 mg/m2 capped at 500 mg Carfilzomib Cyclophosphamide Dexamethasone
| Group | Source count |
|---|---|
| Carfilzomib Plus Cyclophosphamide Plus Dexamethasone | 75 |
Reported measurements
Source class 1
stringent complete response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib Plus Cyclophosphamide Plus Dexamethasone | 4 | Not reported | Not reported | Not reported | Not reported |
complete response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib Plus Cyclophosphamide Plus Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
very good partial response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib Plus Cyclophosphamide Plus Dexamethasone | 32 | Not reported | Not reported | Not reported | Not reported |
partial response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib Plus Cyclophosphamide Plus Dexamethasone | 21 | Not reported | Not reported | Not reported | Not reported |
minimal response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib Plus Cyclophosphamide Plus Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
no response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib Plus Cyclophosphamide Plus Dexamethasone | 14 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- title
- stringent complete response
- measurements
- group Id
- OG000
- value
- 3
- title
- complete response
- measurements
- group Id
- OG000
- value
- 32
- title
- very good partial response
- measurements
- group Id
- OG000
- value
- 21
- title
- partial response
- measurements
- group Id
- OG000
- value
- 1
- title
- minimal response
- measurements
- group Id
- OG000
- value
- 14
- title
- no response
- denoms
- counts
- group Id
- OG000
- value
- 75
- units
- Participants
- description
- Response rate to protocol treatment after 4 cycles is define by stringent complete response, complete response, partial response, very good partial response, minimal response. Complete response: Negative immunofixation on the serum and urine and Disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow biopsy Stringent complete response: Complete response plus Absence of clonal cells in bone marrow d by immunohistochemistry or immunofluorescence Very good partial response: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein with urine M-protein level \<100 mg/24 hours. Partial response: ≥50% reduction in serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 hours Minimal response: 25-49% reduction in serum M-protein, and 50-89% reduction in 24-hour urinary M-protein, if ≥ 200 mg/24 hours at baseline
- groups
- description
- 20 mg/m2 day 1 of first cycle then escalated to 70 mg/m2 for all subsequent doses) given on days 1, 8, and 15 of a 28 day cycle plus weekly oral dexamethasone (\< 70 years, 40 mg; ≥ 70 years 20mg) and cyclophosphamide 300 mg/m2 capped at 500 mg Carfilzomib Cyclophosphamide Dexamethasone
- id
- OG000
- title
- Carfilzomib Plus Cyclophosphamide Plus Dexamethasone
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All eligible patients how have received treatment.
- reporting Status
- POSTED
- time Frame
- 4 months
- title
- Overall Response Rate After 4 Cycles
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice