TriangleNCT01615029 · OUTCOME
Phase 2: Time to Progression (TTP)
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 5 years
What was measured
TTP was defined as the number of days from the date of first infusion (Day 1) to the date of first record of disease progression. Disease progression (IMWG criteria 2011): increase of \>=25 percent (%) from lowest response level in Serum M-component and/or (the absolute increase must be \>=0.5 g/dL) Urine M-component and/or (the absolute increase must be \>=200 mg/24 hour; only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be \>10 mg/dL; Bone marrow plasma cell percentage: the absolute % must be \>=10 %; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. Median TTP was estimated by using the Kaplan-Meier method.
Analysis population: ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2.
Groups in this outcome
Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
| Group | Source count |
|---|---|
| Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone | 32 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone | NA | Not reported | 27.0 | NA | Median and the upper bound of the 95% CI were not estimable due to insufficient number of participants and/or events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median and the upper bound of the 95% CI were not estimable due to insufficient number of participants and/or events.
- group Id
- OG000
- lower Limit
- 27.0
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 32
- units
- Participants
- description
- TTP was defined as the number of days from the date of first infusion (Day 1) to the date of first record of disease progression. Disease progression (IMWG criteria 2011): increase of \>=25 percent (%) from lowest response level in Serum M-component and/or (the absolute increase must be \>=0.5 g/dL) Urine M-component and/or (the absolute increase must be \>=200 mg/24 hour; only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be \>10 mg/dL; Bone marrow plasma cell percentage: the absolute % must be \>=10 %; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. Median TTP was estimated by using the Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
- id
- OG000
- title
- Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
- param Type
- MEDIAN
- population Description
- ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2.
- reporting Status
- POSTED
- time Frame
- Up to 5 years
- title
- Phase 2: Time to Progression (TTP)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice