TriangleNCT00150462 · OUTCOME
Best Clinical Response to Treatment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
What was measured
Disease response criteria for NHL were according to the International Working Group Criteria for Non-Hodgkin's Lymphoma. Disease response criteria for Multiple Myeloma were according to the European Group for Blood and Marrow Transplantation (EBMT). Disease response criteria for WM were according to the consensus panel recommendations from the Second International Workshop on Waldenström's Macroglobulinemia. The disease response criteria for Hodgkin's Lymphoma are defined as follows: * Complete response: total resolution of measurable disease parameters. * Partial response: a ≥ 50% resolution without the appearance of new disease. * Stable disease: between \< 50% resolution and ≤ 25% increases in measurable disease parameters without appearance of new disease. * Progressive disease: an increase of \> 25% in measurable disease parameters. Best clinical response is the best response observed from the start of study treatment until disease progression or death.
Analysis population: Biologic response-evaluable: All participants who received at least 1 cycle of carfilzomib and had both baseline and at least 1 post-baseline disease assessment.
Groups in this outcome
CFZ 1.2 mg/m²
Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
CFZ 2.4 mg/m²
Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
CFZ 4.0 mg/m²
Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
CFZ 6.0 mg/m²
Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
CFZ 8.4 mg/m²
Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
CFZ 11.0 mg/m²
Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
CFZ 15.0 mg/m²
Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
CFZ 20.0 mg/m²
Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
CFZ 27.0 mg/m²
Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
CFZ 20/27 mg/m²
Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
CFZ 20/27 mg/m² + DEX
Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
| Group | Source count |
|---|---|
| CFZ 1.2 mg/m² | 1 |
| CFZ 2.4 mg/m² | 2 |
| CFZ 4.0 mg/m² | 3 |
| CFZ 6.0 mg/m² | 2 |
| CFZ 8.4 mg/m² | 3 |
| CFZ 11.0 mg/m² | 3 |
| CFZ 15.0 mg/m² | 2 |
| CFZ 20.0 mg/m² | 6 |
| CFZ 27.0 mg/m² | 5 |
| CFZ 20/27 mg/m² | 6 |
| CFZ 20/27 mg/m² + DEX | 3 |
Reported measurements
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CFZ 1.2 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 2.4 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 4.0 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 6.0 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 8.4 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 11.0 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 15.0 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 20.0 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 27.0 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 20/27 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 20/27 mg/m² + DEX | 0 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CFZ 1.2 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 2.4 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 4.0 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 6.0 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 8.4 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 11.0 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 15.0 mg/m² | 1 | Not reported | Not reported | Not reported | Not reported |
| CFZ 20.0 mg/m² | 1 | Not reported | Not reported | Not reported | Not reported |
| CFZ 27.0 mg/m² | 2 | Not reported | Not reported | Not reported | Not reported |
| CFZ 20/27 mg/m² | 2 | Not reported | Not reported | Not reported | Not reported |
| CFZ 20/27 mg/m² + DEX | 0 | Not reported | Not reported | Not reported | Not reported |
Minimal Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CFZ 1.2 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 2.4 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 4.0 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 6.0 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 8.4 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 11.0 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 15.0 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 20.0 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 27.0 mg/m² | 1 | Not reported | Not reported | Not reported | Not reported |
| CFZ 20/27 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 20/27 mg/m² + DEX | 1 | Not reported | Not reported | Not reported | Not reported |
Stable Disease/No Change
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CFZ 1.2 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 2.4 mg/m² | 1 | Not reported | Not reported | Not reported | Not reported |
| CFZ 4.0 mg/m² | 1 | Not reported | Not reported | Not reported | Not reported |
| CFZ 6.0 mg/m² | 2 | Not reported | Not reported | Not reported | Not reported |
| CFZ 8.4 mg/m² | 1 | Not reported | Not reported | Not reported | Not reported |
| CFZ 11.0 mg/m² | 1 | Not reported | Not reported | Not reported | Not reported |
| CFZ 15.0 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 20.0 mg/m² | 2 | Not reported | Not reported | Not reported | Not reported |
| CFZ 27.0 mg/m² | 1 | Not reported | Not reported | Not reported | Not reported |
| CFZ 20/27 mg/m² | 2 | Not reported | Not reported | Not reported | Not reported |
| CFZ 20/27 mg/m² + DEX | 0 | Not reported | Not reported | Not reported | Not reported |
Progressive Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CFZ 1.2 mg/m² | 1 | Not reported | Not reported | Not reported | Not reported |
| CFZ 2.4 mg/m² | 1 | Not reported | Not reported | Not reported | Not reported |
| CFZ 4.0 mg/m² | 1 | Not reported | Not reported | Not reported | Not reported |
| CFZ 6.0 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 8.4 mg/m² | 2 | Not reported | Not reported | Not reported | Not reported |
| CFZ 11.0 mg/m² | 2 | Not reported | Not reported | Not reported | Not reported |
| CFZ 15.0 mg/m² | 1 | Not reported | Not reported | Not reported | Not reported |
| CFZ 20.0 mg/m² | 3 | Not reported | Not reported | Not reported | Not reported |
| CFZ 27.0 mg/m² | 1 | Not reported | Not reported | Not reported | Not reported |
| CFZ 20/27 mg/m² | 2 | Not reported | Not reported | Not reported | Not reported |
| CFZ 20/27 mg/m² + DEX | 2 | Not reported | Not reported | Not reported | Not reported |
Unknown
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CFZ 1.2 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 2.4 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 4.0 mg/m² | 1 | Not reported | Not reported | Not reported | Not reported |
| CFZ 6.0 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 8.4 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 11.0 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 15.0 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 20.0 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 27.0 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 20/27 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| CFZ 20/27 mg/m² + DEX | 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
- title
- Complete Response
- 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
- 1
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 0
- title
- Partial Response
- 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
- 1
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 1
- title
- Minimal Response
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 0
- title
- Stable Disease/No Change
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 2
- title
- Progressive Disease
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- 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
- title
- Unknown
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 3
- units
- Participants
- description
- Disease response criteria for NHL were according to the International Working Group Criteria for Non-Hodgkin's Lymphoma. Disease response criteria for Multiple Myeloma were according to the European Group for Blood and Marrow Transplantation (EBMT). Disease response criteria for WM were according to the consensus panel recommendations from the Second International Workshop on Waldenström's Macroglobulinemia. The disease response criteria for Hodgkin's Lymphoma are defined as follows: * Complete response: total resolution of measurable disease parameters. * Partial response: a ≥ 50% resolution without the appearance of new disease. * Stable disease: between \< 50% resolution and ≤ 25% increases in measurable disease parameters without appearance of new disease. * Progressive disease: an increase of \> 25% in measurable disease parameters. Best clinical response is the best response observed from the start of study treatment until disease progression or death.
- groups
- description
- Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
- id
- OG000
- title
- CFZ 1.2 mg/m²
- description
- Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
- id
- OG001
- title
- CFZ 2.4 mg/m²
- description
- Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
- id
- OG002
- title
- CFZ 4.0 mg/m²
- description
- Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
- id
- OG003
- title
- CFZ 6.0 mg/m²
- description
- Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
- id
- OG004
- title
- CFZ 8.4 mg/m²
- description
- Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
- id
- OG005
- title
- CFZ 11.0 mg/m²
- description
- Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
- id
- OG006
- title
- CFZ 15.0 mg/m²
- description
- Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
- id
- OG007
- title
- CFZ 20.0 mg/m²
- description
- Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
- id
- OG008
- title
- CFZ 27.0 mg/m²
- description
- Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
- id
- OG009
- title
- CFZ 20/27 mg/m²
- description
- Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
- id
- OG010
- title
- CFZ 20/27 mg/m² + DEX
- param Type
- NUMBER
- population Description
- Biologic response-evaluable: All participants who received at least 1 cycle of carfilzomib and had both baseline and at least 1 post-baseline disease assessment.
- reporting Status
- POSTED
- time Frame
- From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
- title
- Best Clinical Response to Treatment
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice