TriangleNCT01246063 · OUTCOME
Median Duration of Overall Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Through completion of follow-up (median follow-up was 23.3 months)
What was measured
* For participants with confirmed tumor responses * A confirmed response is defined to be a complete response (CR), very good partial response (VGPR), or partial response (PR) per IMWG Criteria
Groups in this outcome
Phase I - Part 1 Dose Level 0 (Carfilzomib 20/27 mg/m^2)
Dose Level 0: Carfilzomib IV (20 mg/m2) D1\&D2 of C1 and carfilzomib IV (27 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
Phase I - Part 1 Dose Level 1 (Carfilzomib 20/36 mg/m^2)
Dose Level 1: Carfilzomib IV (20 mg/m2) D1\&D2 of C1 and carfilzomib IV (36 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
Phase I - Part 1 Dose Level 2 (Carfilzomib 20/45 mg/m^2)
Dose Level 2: Carfilzomib IV (20 mg/m2) D1\&D2 of C1 and carfilzomib IV (45 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)
Dose Level 3: Carfilzomib IV (20 mg/m2) D1\&D2 of C1 and carfilzomib IV (56 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
Phase I-Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)
Cohort 0: Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)
Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
| Group | Source count |
|---|---|
| Phase I - Part 1 Dose Level 0 (Carfilzomib 20/27 mg/m^2) | 1 |
| Phase I - Part 1 Dose Level 1 (Carfilzomib 20/36 mg/m^2) | 2 |
| Phase I - Part 1 Dose Level 2 (Carfilzomib 20/45 mg/m^2) | 2 |
| Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2) | 4 |
| Phase I-Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone) | 5 |
| Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone) | 15 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I - Part 1 Dose Level 0 (Carfilzomib 20/27 mg/m^2) | 6.090 | Not reported | NA | NA | The 95% confidence interval was not estimable as no one was censored so the numbers are actuals and not estimates. |
| Phase I - Part 1 Dose Level 1 (Carfilzomib 20/36 mg/m^2) | 6.840 | Not reported | NA | NA | The 95% confidence interval was not estimable as no one was censored so the numbers are actuals and not estimates. |
| Phase I - Part 1 Dose Level 2 (Carfilzomib 20/45 mg/m^2) | 3.420 | Not reported | NA | NA | The 95% confidence interval was not estimable as no one was censored so the numbers are actuals and not estimates. |
| Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2) | 13.130 | Not reported | .000 | 27.761 | Not reported |
| Phase I-Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone) | 9.440 | Not reported | 3.580 | 15.300 | Not reported |
| Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone) | 23.950 | Not reported | 14.072 | 33.828 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- The 95% confidence interval was not estimable as no one was censored so the numbers are actuals and not estimates.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 6.090
- comment
- The 95% confidence interval was not estimable as no one was censored so the numbers are actuals and not estimates.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 6.840
- comment
- The 95% confidence interval was not estimable as no one was censored so the numbers are actuals and not estimates.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- 3.420
- group Id
- OG003
- lower Limit
- .000
- upper Limit
- 27.761
- value
- 13.130
- group Id
- OG004
- lower Limit
- 3.580
- upper Limit
- 15.300
- value
- 9.440
- group Id
- OG005
- lower Limit
- 14.072
- upper Limit
- 33.828
- value
- 23.950
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 15
- units
- Participants
- description
- * For participants with confirmed tumor responses * A confirmed response is defined to be a complete response (CR), very good partial response (VGPR), or partial response (PR) per IMWG Criteria
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Dose Level 0: Carfilzomib IV (20 mg/m2) D1\&D2 of C1 and carfilzomib IV (27 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
- id
- OG000
- title
- Phase I - Part 1 Dose Level 0 (Carfilzomib 20/27 mg/m^2)
- description
- Dose Level 1: Carfilzomib IV (20 mg/m2) D1\&D2 of C1 and carfilzomib IV (36 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
- id
- OG001
- title
- Phase I - Part 1 Dose Level 1 (Carfilzomib 20/36 mg/m^2)
- description
- Dose Level 2: Carfilzomib IV (20 mg/m2) D1\&D2 of C1 and carfilzomib IV (45 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
- id
- OG002
- title
- Phase I - Part 1 Dose Level 2 (Carfilzomib 20/45 mg/m^2)
- description
- Dose Level 3: Carfilzomib IV (20 mg/m2) D1\&D2 of C1 and carfilzomib IV (56 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
- id
- OG003
- title
- Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)
- description
- Cohort 0: Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
- id
- OG004
- title
- Phase I-Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)
- description
- Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
- id
- OG005
- title
- Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- Through completion of follow-up (median follow-up was 23.3 months)
- title
- Median Duration of Overall Response
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice