TriangleNCT00916058 · OUTCOME
Progression-Free Survival (Phase 2)
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
- From Day 0 to first incidence of disease progression, up to 86 months
What was measured
Time elapsed between Day 0 and disease progression, as defined by the International Myeloma Working Group (IMWG) disease response criteria. Disease progression is defined as an increase of \>25% from lowest response value in any one or more of the following: * 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 h) * Only in patients 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 percentage 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 hypercalcaemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder
Analysis population: Phase 2 includes all patients treated on phase 2 of the study (28 patients), and patients treated at Dose Level 6 of the Phase 1 portion of the study (7 patients). The dose level used during Phase 2 was Dose Level 6.
Groups in this outcome
Phase 2
Bendamustine 225 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
| Group | Source count |
|---|---|
| Phase 2 | 35 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 | 47 | Not reported | 34 | NA | Upper limit was not estimable |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit was not estimable
- group Id
- OG000
- lower Limit
- 34
- upper Limit
- NA
- value
- 47
- denoms
- counts
- group Id
- OG000
- value
- 35
- units
- Participants
- description
- Time elapsed between Day 0 and disease progression, as defined by the International Myeloma Working Group (IMWG) disease response criteria. Disease progression is defined as an increase of \>25% from lowest response value in any one or more of the following: * 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 h) * Only in patients 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 percentage 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 hypercalcaemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Bendamustine 225 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
- id
- OG000
- title
- Phase 2
- param Type
- MEDIAN
- population Description
- Phase 2 includes all patients treated on phase 2 of the study (28 patients), and patients treated at Dose Level 6 of the Phase 1 portion of the study (7 patients). The dose level used during Phase 2 was Dose Level 6.
- reporting Status
- POSTED
- time Frame
- From Day 0 to first incidence of disease progression, up to 86 months
- title
- Progression-Free Survival (Phase 2)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice