TriangleNCT00574288 · OUTCOME
Part 1: Time to Response
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
- Up to Week 28
What was measured
Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment. Kaplan-Meier method was used to estimate the distribution of time to response and time to best response.
Analysis population: All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug. For Part 1, only participants treated with \>= 4 mg/kg daratumumab were used for efficacy analyses and less than (\<) 4 mg/kg doses were considered under the therapeutic levels.
Groups in this outcome
Part 1: Daratumumab 4 mg/kg
Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
Daratumumab 8 mg/kg
Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions.
Daratumumab 16 mg/kg
Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
Part 1:Daratumumab 24 mg/kg
Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
| Group | Source count |
|---|---|
| Part 1: Daratumumab 4 mg/kg | 3 |
| Daratumumab 8 mg/kg | 3 |
| Daratumumab 16 mg/kg | 3 |
| Part 1:Daratumumab 24 mg/kg | 3 |
Reported measurements
Time to first response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Daratumumab 4 mg/kg | NA | Not reported | 1.2 | NA | Median and upper limit of confidence interval (CI) was not estimable due to insufficient number of participants with events. |
| Daratumumab 8 mg/kg | NA | Not reported | NA | NA | Median and CI was not estimable due to insufficient number of participants with events. |
| Daratumumab 16 mg/kg | 8.4 | Not reported | NA | NA | Among the 3 participants on 16 mg/kg, only one participant had event, the median was set to this single uncensored value of "time to event" (defaults in PROC LIFETEST), no lower or upper bound of 95% CI calculated. |
| Part 1:Daratumumab 24 mg/kg | 1.9 | Not reported | 0.5 | 1.9 | Not reported |
Time to best response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Daratumumab 4 mg/kg | NA | Not reported | 1.2 | NA | Median and upper limit of CI was not estimable due to insufficient number of participants with events. |
| Daratumumab 8 mg/kg | NA | Not reported | NA | NA | Median and CI was not estimable due to insufficient number of participants with events. |
| Daratumumab 16 mg/kg | 8.4 | Not reported | NA | NA | Among the 3 participants on 16 mg/kg, only one participant had event, the median was set to this single uncensored value of "time to event" (defaults in PROC LIFETEST), no lower or upper bound of 95% CI calculated. |
| Part 1:Daratumumab 24 mg/kg | 1.9 | Not reported | 0.5 | 1.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Median and upper limit of confidence interval (CI) was not estimable due to insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- 1.2
- upper Limit
- NA
- value
- NA
- comment
- Median and CI was not estimable due to insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Among the 3 participants on 16 mg/kg, only one participant had event, the median was set to this single uncensored value of "time to event" (defaults in PROC LIFETEST), no lower or upper bound of 95% CI calculated.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- 8.4
- group Id
- OG003
- lower Limit
- 0.5
- upper Limit
- 1.9
- value
- 1.9
- title
- Time to first response
- categories
- measurements
- comment
- Median and upper limit of CI was not estimable due to insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- 1.2
- upper Limit
- NA
- value
- NA
- comment
- Median and CI was not estimable due to insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Among the 3 participants on 16 mg/kg, only one participant had event, the median was set to this single uncensored value of "time to event" (defaults in PROC LIFETEST), no lower or upper bound of 95% CI calculated.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- 8.4
- group Id
- OG003
- lower Limit
- 0.5
- upper Limit
- 1.9
- value
- 1.9
- title
- Time to best response
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- units
- Participants
- description
- Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment. Kaplan-Meier method was used to estimate the distribution of time to response and time to best response.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
- id
- OG000
- title
- Part 1: Daratumumab 4 mg/kg
- description
- Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions.
- id
- OG001
- title
- Daratumumab 8 mg/kg
- description
- Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
- id
- OG002
- title
- Daratumumab 16 mg/kg
- description
- Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
- id
- OG003
- title
- Part 1:Daratumumab 24 mg/kg
- param Type
- MEDIAN
- population Description
- All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug. For Part 1, only participants treated with \>= 4 mg/kg daratumumab were used for efficacy analyses and less than (\<) 4 mg/kg doses were considered under the therapeutic levels.
- reporting Status
- POSTED
- time Frame
- Up to Week 28
- title
- Part 1: Time to Response
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice