TriangleNCT01572480 · OUTCOME
Duration of Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- years
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- through study completion, for a maximum of 12 years and 7 days
What was measured
Duration of response is defined as the time from partial response to disease progression. Response was assessed by the International Myeloma Working Group Criteria for Multiple Myeloma. Partial Response 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. Progression is any one of the following: Increase of ≥25% from lowest response value in the following on 2 consecutive measurements: Serum M-component and/or (the absolute increase must be ≥0.5g/dl). The serum M-component increases of ≥1 gm/dl are sufficient to define relapse if starting M-component is ≥0.5g/dl. Urine M-component and/or (the absolute must be ≥200mg/24h.
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
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 7.9 | Not reported | 6.7 | NA | The upper confidence interval cannot be calculated as it has not reached 50%. |
Complete source fields
- classes
- categories
- measurements
- comment
- The upper confidence interval cannot be calculated as it has not reached 50%.
- group Id
- OG000
- lower Limit
- 6.7
- upper Limit
- NA
- value
- 7.9
- denoms
- counts
- group Id
- OG000
- value
- 54
- units
- Participants
- description
- Duration of response is defined as the time from partial response to disease progression. Response was assessed by the International Myeloma Working Group Criteria for Multiple Myeloma. Partial Response 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. Progression is any one of the following: Increase of ≥25% from lowest response value in the following on 2 consecutive measurements: Serum M-component and/or (the absolute increase must be ≥0.5g/dl). The serum M-component increases of ≥1 gm/dl are sufficient to define relapse if starting M-component is ≥0.5g/dl. Urine M-component and/or (the absolute must be ≥200mg/24h.
- dispersion Type
- 95% Confidence Interval
- 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
- MEDIAN
- reporting Status
- POSTED
- time Frame
- through study completion, for a maximum of 12 years and 7 days
- title
- Duration of Response
- type
- SECONDARY
- unit Of Measure
- years
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice