TriangleNCT01496118 · OUTCOME
Phase II: Overall Response Rate
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 6 years
What was measured
Defined as the percentage of patients with confirmed complete response, very good partial response, or partial response (CR, VGPR, or PR) according to International Myeloma Working Group Uniform Response Criteria. CR=bone marrow contains ≤5% plasma cells; negative fixation on serum and urine; disappearance of soft tissue plasmacytomas. VGPR=≥90% reduction from baseline serum; urine M-protein level 100mg for 24h. PR=≥50% reduction from baseline in serum M-protein; disappearance of any soft tissue plasmacytomas.
Analysis population: All patients receiving dose level 4 and dose level 6 doses (both escalation and expansion phases combined) who had a post-baseline disease assessment per protocol were included in the analysis. 3 patients in dose level 4 and 1 patient in dose level 6 did not have a post-baseline assessment and were excluded from analysis.
Groups in this outcome
Dose Level 4 - Escalation and Expansion
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19
Dose Level 6 - Escalation and Expansion
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
| Group | Source count |
|---|---|
| Dose Level 4 - Escalation and Expansion | 31 |
| Dose Level 6 - Escalation and Expansion | 32 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 4 - Escalation and Expansion | 74 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 6 - Escalation and Expansion | 84 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 74
- group Id
- OG001
- value
- 84
- denoms
- counts
- group Id
- OG000
- value
- 31
- group Id
- OG001
- value
- 32
- units
- Participants
- description
- Defined as the percentage of patients with confirmed complete response, very good partial response, or partial response (CR, VGPR, or PR) according to International Myeloma Working Group Uniform Response Criteria. CR=bone marrow contains ≤5% plasma cells; negative fixation on serum and urine; disappearance of soft tissue plasmacytomas. VGPR=≥90% reduction from baseline serum; urine M-protein level 100mg for 24h. PR=≥50% reduction from baseline in serum M-protein; disappearance of any soft tissue plasmacytomas.
- groups
- description
- Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19
- id
- OG000
- title
- Dose Level 4 - Escalation and Expansion
- description
- Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
- id
- OG001
- title
- Dose Level 6 - Escalation and Expansion
- param Type
- NUMBER
- population Description
- All patients receiving dose level 4 and dose level 6 doses (both escalation and expansion phases combined) who had a post-baseline disease assessment per protocol were included in the analysis. 3 patients in dose level 4 and 1 patient in dose level 6 did not have a post-baseline assessment and were excluded from analysis.
- reporting Status
- POSTED
- time Frame
- up to 6 years
- title
- Phase II: Overall Response Rate
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice