TriangleNCT01572480 · OUTCOME
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
- time measurement criteria are met for best response until the first date that recurrent or progressive disease is met, up to 5 years
What was measured
Overall response is defined as the percentage of participants who have a partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR) defined by the International Myeloma Working Group Criteria for Multiple Myeloma out of all evaluable participants. PR is ≥50% reduction if serum M-protein and reduction in 24-hour(h) urinary M-protein by ≥90% or to \<200mg per 24h. If the serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria. VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis. CR is negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≥5% plasma cells in bone marrow. sCR is complete response plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
Analysis population: 54/55 participants are evaluable for this outcome measure.
Groups in this outcome
All Participants
Carfilzomib (intravenous (IV), Days 1, 2, 8, 9, 15, and 16 of the 28-day cycle); Revlimid (by mouth (PO), Days 1-21 of the 28-day cycle; exception: not given on cycle 1 day 1); and Dexamethasone (PO or IV, Days 1, 2, 8, 9, 15, 16, 22, and 23 of the 28-day cycle; exception: not given on cycle 1 day 1) Carfilzomib intravenous (IV) 20-36 mg/m\^2 per dose on days 1, 2, 8, 9, 15, and 16 of each cycle based on arm; until disease progression or unacceptable toxicity. Revlimid by mouth (PO) 25 mg/day, days 1-21 every 28 days of each cycle based on arm; until disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| All Participants | 54 |
Reported measurements
Overall Response Rate
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 100 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 5.5 | Not reported | Not reported | Not reported | Not reported |
Very Good Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 18.5 | Not reported | Not reported | Not reported | Not reported |
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 0 | Not reported | Not reported | Not reported | Not reported |
Stringent Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 75.9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 100
- title
- Overall Response Rate
- categories
- measurements
- group Id
- OG000
- value
- 5.5
- title
- Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 18.5
- title
- Very Good Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 0
- title
- Complete Response
- categories
- measurements
- group Id
- OG000
- value
- 75.9
- title
- Stringent Complete Response
- denoms
- counts
- group Id
- OG000
- value
- 54
- units
- Participants
- description
- Overall response is defined as the percentage of participants who have a partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR) defined by the International Myeloma Working Group Criteria for Multiple Myeloma out of all evaluable participants. PR is ≥50% reduction if serum M-protein and reduction in 24-hour(h) urinary M-protein by ≥90% or to \<200mg per 24h. If the serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria. VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis. CR is negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≥5% plasma cells in bone marrow. sCR is complete response plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
- groups
- description
- Carfilzomib (intravenous (IV), Days 1, 2, 8, 9, 15, and 16 of the 28-day cycle); Revlimid (by mouth (PO), Days 1-21 of the 28-day cycle; exception: not given on cycle 1 day 1); and Dexamethasone (PO or IV, Days 1, 2, 8, 9, 15, 16, 22, and 23 of the 28-day cycle; exception: not given on cycle 1 day 1) Carfilzomib intravenous (IV) 20-36 mg/m\^2 per dose on days 1, 2, 8, 9, 15, and 16 of each cycle based on arm; until disease progression or unacceptable toxicity. Revlimid by mouth (PO) 25 mg/day, days 1-21 every 28 days of each cycle based on arm; until disease progression or unacceptable toxicity.
- id
- OG000
- title
- All Participants
- param Type
- NUMBER
- population Description
- 54/55 participants are evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- time measurement criteria are met for best response until the first date that recurrent or progressive disease is met, up to 5 years
- title
- Overall Response Rate
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice