TriangleNCT03029234 · OUTCOME
Duration of Overall Response (DOR)
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
- Response was assessed every 28 days until disease progression; the data cut-off date was 15 March 2019; median follow-up time for progression assessed by independent review committee and by investigators were 12.8 months and 13.1 months, respectively.
What was measured
Duration of response (DOR) is defined as the time from first evidence of PR or better to disease progression (PD) or death due to any cause per the IMWG-URC criteria. PD: * Increase of 25% from lowest response value in any of the following: * Serum M-component (absolute increase ≥ 0.5 g/dL) and/or * Urine M-component (absolute increase ≥ 200 mg/24 hours) * In patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels (absolute increase \>10 mg/dL) * Definite development of new or increase in size of existing bone lesions or soft tissue plasmacytomas * Development of hypercalcemia attributed solely to the plasma cell proliferative disorder. DOR was analyzed using the Kaplan-Meier method; Participants with no documented progression or death were censored at the date of their last disease assessment. DOR was determined based on both investigator and independent review committee response assessments.
Analysis population: Safety population participants who achieved an overall response (best response of PR or better)
Groups in this outcome
Carfilzomib With Dexamethasone
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter). Participants also received 20 mg dexamethasone IV or orally on days 1, 2, 8, 9, 15, 16, 22, and 23. Participants received treatment until disease progression, unacceptable toxicity, initiation of new antimyeloma therapy, withdrawal of consent, subject noncompliance, or intercurrent illness or worsening of a chronic condition, whichever occurred first.
| Group | Source count |
|---|---|
| Carfilzomib With Dexamethasone | 44 |
Reported measurements
Independent Review Committee Assessment
| Group | Source count |
|---|---|
| Carfilzomib With Dexamethasone | 44 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib With Dexamethasone | 12.2 | Not reported | 7.4 | NA | Could not be estimated due to the low number of events at the analysis cut-off date |
Investigator Assessment
| Group | Source count |
|---|---|
| Carfilzomib With Dexamethasone | 43 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib With Dexamethasone | 9.7 | Not reported | 7.4 | NA | Could not be estimated due to the low number of events at the analysis cut-off date |
Complete source fields
- classes
- categories
- measurements
- comment
- Could not be estimated due to the low number of events at the analysis cut-off date
- group Id
- OG000
- lower Limit
- 7.4
- upper Limit
- NA
- value
- 12.2
- denoms
- counts
- group Id
- OG000
- value
- 44
- units
- Participants
- title
- Independent Review Committee Assessment
- categories
- measurements
- comment
- Could not be estimated due to the low number of events at the analysis cut-off date
- group Id
- OG000
- lower Limit
- 7.4
- upper Limit
- NA
- value
- 9.7
- denoms
- counts
- group Id
- OG000
- value
- 43
- units
- Participants
- title
- Investigator Assessment
- denoms
- counts
- group Id
- OG000
- value
- 44
- units
- Participants
- description
- Duration of response (DOR) is defined as the time from first evidence of PR or better to disease progression (PD) or death due to any cause per the IMWG-URC criteria. PD: * Increase of 25% from lowest response value in any of the following: * Serum M-component (absolute increase ≥ 0.5 g/dL) and/or * Urine M-component (absolute increase ≥ 200 mg/24 hours) * In patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels (absolute increase \>10 mg/dL) * Definite development of new or increase in size of existing bone lesions or soft tissue plasmacytomas * Development of hypercalcemia attributed solely to the plasma cell proliferative disorder. DOR was analyzed using the Kaplan-Meier method; Participants with no documented progression or death were censored at the date of their last disease assessment. DOR was determined based on both investigator and independent review committee response assessments.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter). Participants also received 20 mg dexamethasone IV or orally on days 1, 2, 8, 9, 15, 16, 22, and 23. Participants received treatment until disease progression, unacceptable toxicity, initiation of new antimyeloma therapy, withdrawal of consent, subject noncompliance, or intercurrent illness or worsening of a chronic condition, whichever occurred first.
- id
- OG000
- title
- Carfilzomib With Dexamethasone
- param Type
- MEDIAN
- population Description
- Safety population participants who achieved an overall response (best response of PR or better)
- reporting Status
- POSTED
- time Frame
- Response was assessed every 28 days until disease progression; the data cut-off date was 15 March 2019; median follow-up time for progression assessed by independent review committee and by investigators were 12.8 months and 13.1 months, respectively.
- title
- Duration of Overall Response (DOR)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice