TriangleNCT00574288 · OUTCOME
Part 2: Duration of Response as Assessed Using the Method of Kaplan-Meier
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- Up to Week 27
What was measured
Duration of response was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the International Myeloma Working Group (IMWG) criteria.
Analysis population: Subset of All-Treated Analysis Set included those who had overall response in Part 2.
Groups in this outcome
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 methylprednisolone 100 mg IV before treatment and 20-25 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 methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
| Group | Source count |
|---|---|
| Daratumumab 8 mg/kg | 3 |
| Daratumumab 16 mg/kg | 15 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Daratumumab 8 mg/kg | 6.9 | Not reported | 6.2 | 10.6 | Not reported |
| Daratumumab 16 mg/kg | NA | Not reported | 5.6 | NA | Median and upper limit of confidence interval (CI) was not estimable due to insufficient number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.2
- upper Limit
- 10.6
- value
- 6.9
- comment
- Median and upper limit of confidence interval (CI) was not estimable due to insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- 5.6
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 15
- units
- Participants
- description
- Duration of response was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the International Myeloma Working Group (IMWG) criteria.
- dispersion Type
- Full Range
- groups
- 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 methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions.
- id
- OG000
- 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 methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
- id
- OG001
- title
- Daratumumab 16 mg/kg
- param Type
- MEDIAN
- population Description
- Subset of All-Treated Analysis Set included those who had overall response in Part 2.
- reporting Status
- POSTED
- time Frame
- Up to Week 27
- title
- Part 2: Duration of Response as Assessed Using the Method of Kaplan-Meier
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice