TriangleNCT00531284 · OUTCOME
Percentage of Participants With an Overall Response Throughout the Study
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
- 95% Confidence Interval
- Time frame
- Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.
What was measured
Solid tumor participants were evaluated for disease response according to RECIST, Version 1.1. Multiple myeloma participants were evaluated using the International Myeloma Working Group (IMWG) Uniform Response Criteria with the addition of minimal response (MR) based on the European Group for Blood and Marrow Transplant Group (EBMT). Non-Hodgkin lymphoma (NHL) participants were evaluated using the International Workshop NHL criteria. Waldenström macroglobulinemia (WM) participants were evaluated using Criteria from the Sixth International Workshop for WM. Overall response is defined in Outcome Measure 2 for participants with solid tumors. For NHL, overall response is defined as a best overall response of CR or PR. For multiple myeloma and WM, overall response is defined as participants with a best overall response of stringent complete response (sCR), CR, very good partial response (VGPR) or PR.
Analysis population: Safety Population
Groups in this outcome
P1B ST: CFZ 20 mg/m² Bolus
Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
P1B ST: CFZ 20/27 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
P1B ST: CFZ 20/36 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
P2 ST: CFZ 20/36 mg/m² Bolus
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
P1B ST: CFZ 36 mg/m²
Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
P1B ST: CFZ 45 mg/m²
Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
P1B ST: CFZ 20/45 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
P1B ST: CFZ 20/56 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
P1B ST: CFZ 20/70 mg/m²
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
P1B MM: CFZ 20/36 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
P1B MM: CFZ 20/45 mg/m²
Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
P1b MM: CFZ 20/56 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
P1B MM: CFZ 20/70 mg/m²
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
P1B NHL: CFZ 20/56 mg/m²
Participants with non-Hodgkin's lymphoma (NHL) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
P1B NHL: CFZ 20/70 mg/m²
Participants with non-Hodgkin's lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
P1B WM: CFZ 20/56 mg/m²
Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
P1B WM: CFZ 20/70 mg/m²
Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
P1B MM: CFZ 20/45 mg/m² + Dex
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
P1B MM: CFZ 20/56 mg/m² + Dex
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
| Group | Source count |
|---|---|
| P1B ST: CFZ 20 mg/m² Bolus | 3 |
| P1B ST: CFZ 20/27 mg/m² Bolus | 4 |
| P1B ST: CFZ 20/36 mg/m² Bolus | 7 |
| P2 ST: CFZ 20/36 mg/m² Bolus | 65 |
| P1B ST: CFZ 36 mg/m² | 6 |
| P1B ST: CFZ 45 mg/m² | 7 |
| P1B ST: CFZ 20/45 mg/m² | 6 |
| P1B ST: CFZ 20/56 mg/m² | 10 |
| P1B ST: CFZ 20/70 mg/m² | 11 |
| P1B MM: CFZ 20/36 mg/m² | 4 |
| P1B MM: CFZ 20/45 mg/m² | 3 |
| P1b MM: CFZ 20/56 mg/m² | 24 |
| P1B MM: CFZ 20/70 mg/m² | 2 |
| P1B NHL: CFZ 20/56 mg/m² | 2 |
| P1B NHL: CFZ 20/70 mg/m² | 3 |
| P1B WM: CFZ 20/56 mg/m² | 1 |
| P1B WM: CFZ 20/70 mg/m² | 4 |
| P1B MM: CFZ 20/45 mg/m² + Dex | 14 |
| P1B MM: CFZ 20/56 mg/m² + Dex | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| P1B ST: CFZ 20 mg/m² Bolus | 100.0 | Not reported | 29.2 | 100.0 | Not reported |
| P1B ST: CFZ 20/27 mg/m² Bolus | 0.0 | Not reported | 0.0 | 60.2 | Not reported |
| P1B ST: CFZ 20/36 mg/m² Bolus | 42.9 | Not reported | 9.9 | 81.6 | Not reported |
| P2 ST: CFZ 20/36 mg/m² Bolus | 38.5 | Not reported | 26.7 | 51.4 | Not reported |
| P1B ST: CFZ 36 mg/m² | 33.3 | Not reported | 4.3 | 77.7 | Not reported |
| P1B ST: CFZ 45 mg/m² | 28.6 | Not reported | 3.7 | 71.0 | Not reported |
| P1B ST: CFZ 20/45 mg/m² | 50.0 | Not reported | 11.8 | 88.2 | Not reported |
| P1B ST: CFZ 20/56 mg/m² | 10.0 | Not reported | 0.3 | 44.5 | Not reported |
| P1B ST: CFZ 20/70 mg/m² | 36.4 | Not reported | 10.9 | 69.2 | Not reported |
| P1B MM: CFZ 20/36 mg/m² | 50.0 | Not reported | 6.8 | 93.2 | Not reported |
| P1B MM: CFZ 20/45 mg/m² | 33.3 | Not reported | 0.8 | 90.6 | Not reported |
| P1b MM: CFZ 20/56 mg/m² | 50.0 | Not reported | 29.1 | 70.9 | Not reported |
| P1B MM: CFZ 20/70 mg/m² | 50.0 | Not reported | 1.3 | 98.7 | Not reported |
| P1B NHL: CFZ 20/56 mg/m² | 0.0 | Not reported | 0.0 | 0.0 | Not reported |
| P1B NHL: CFZ 20/70 mg/m² | 0.0 | Not reported | 0.0 | 0.0 | Not reported |
| P1B WM: CFZ 20/56 mg/m² | 100.0 | Not reported | 2.5 | 100.0 | Not reported |
| P1B WM: CFZ 20/70 mg/m² | 100.0 | Not reported | 39.8 | 100.0 | Not reported |
| P1B MM: CFZ 20/45 mg/m² + Dex | 64.3 | Not reported | 35.1 | 87.2 | Not reported |
| P1B MM: CFZ 20/56 mg/m² + Dex | 37.5 | Not reported | 8.5 | 75.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 29.2
- upper Limit
- 100.0
- value
- 100.0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 60.2
- value
- 0.0
- group Id
- OG002
- lower Limit
- 9.9
- upper Limit
- 81.6
- value
- 42.9
- group Id
- OG003
- lower Limit
- 26.7
- upper Limit
- 51.4
- value
- 38.5
- group Id
- OG004
- lower Limit
- 4.3
- upper Limit
- 77.7
- value
- 33.3
- group Id
- OG005
- lower Limit
- 3.7
- upper Limit
- 71.0
- value
- 28.6
- group Id
- OG006
- lower Limit
- 11.8
- upper Limit
- 88.2
- value
- 50.0
- group Id
- OG007
- lower Limit
- 0.3
- upper Limit
- 44.5
- value
- 10.0
- group Id
- OG008
- lower Limit
- 10.9
- upper Limit
- 69.2
- value
- 36.4
- group Id
- OG009
- lower Limit
- 6.8
- upper Limit
- 93.2
- value
- 50.0
- group Id
- OG010
- lower Limit
- 0.8
- upper Limit
- 90.6
- value
- 33.3
- group Id
- OG011
- lower Limit
- 29.1
- upper Limit
- 70.9
- value
- 50.0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 65
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 7
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 10
- group Id
- OG008
- value
- 11
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 24
- units
- Participants
- description
- Solid tumor participants were evaluated for disease response according to RECIST, Version 1.1. Multiple myeloma participants were evaluated using the International Myeloma Working Group (IMWG) Uniform Response Criteria with the addition of minimal response (MR) based on the European Group for Blood and Marrow Transplant Group (EBMT). Non-Hodgkin lymphoma (NHL) participants were evaluated using the International Workshop NHL criteria. Waldenström macroglobulinemia (WM) participants were evaluated using Criteria from the Sixth International Workshop for WM. Overall response is defined in Outcome Measure 2 for participants with solid tumors. For NHL, overall response is defined as a best overall response of CR or PR. For multiple myeloma and WM, overall response is defined as participants with a best overall response of stringent complete response (sCR), CR, very good partial response (VGPR) or PR.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- OG000
- title
- P1B ST: CFZ 20 mg/m² Bolus
- description
- Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- OG001
- title
- P1B ST: CFZ 20/27 mg/m² Bolus
- description
- Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- OG002
- title
- P1B ST: CFZ 20/36 mg/m² Bolus
- description
- Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- OG003
- title
- P2 ST: CFZ 20/36 mg/m² Bolus
- description
- Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- OG004
- title
- P1B ST: CFZ 36 mg/m²
- description
- Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- OG005
- title
- P1B ST: CFZ 45 mg/m²
- description
- Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- OG006
- title
- P1B ST: CFZ 20/45 mg/m²
- description
- Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- OG007
- title
- P1B ST: CFZ 20/56 mg/m²
- description
- Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- OG008
- title
- P1B ST: CFZ 20/70 mg/m²
- description
- Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- OG009
- title
- P1B MM: CFZ 20/36 mg/m²
- description
- Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- OG010
- title
- P1B MM: CFZ 20/45 mg/m²
- description
- Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- OG011
- title
- P1b MM: CFZ 20/56 mg/m²
- param Type
- NUMBER
- population Description
- Safety Population
- reporting Status
- POSTED
- time Frame
- Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.
- title
- Percentage of Participants With an Overall Response Throughout the Study
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice