TriangleNCT00916058 · OUTCOME
Progression-Free Survival (Phase 1)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From Day 0 to first incidence of disease progression, up to 1,128 days
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 1 includes all patients treated on Phase 1 of the study (Dose Levels 1-6). All cohorts were evaluated as one group for assessment of progression-free survival (PFS), as PFS is a secondary endpoint and there was no intent to stratify by cohort for the analysis. The number of patients per cohort is also too small for to evaluate by cohort.
Groups in this outcome
Phase 1
Patients treated on Dose Level 1 through Dose Level 6. All patients received Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min). Dose Level 1; Bendamustine 30 mg/m\^2 total Dose Level 2; Bendamustine 60 mg/m\^2 total Dose Level 3; Bendamustine 90 mg/m\^2 total Dose Level 4; Bendamustine 120 mg/m\^2 total Dose Level 5; Bendamustine 150 mg/m\^2 total Dose Level 6; Bendamustine 225 mg/m\^2 total
| Group | Source count |
|---|---|
| Phase 1 | 25 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 | 791 | Not reported | 351 | NA | Upper limit not estimable |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit not estimable
- group Id
- OG000
- lower Limit
- 351
- upper Limit
- NA
- value
- 791
- denoms
- counts
- group Id
- OG000
- value
- 25
- 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
- Patients treated on Dose Level 1 through Dose Level 6. All patients received Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min). Dose Level 1; Bendamustine 30 mg/m\^2 total Dose Level 2; Bendamustine 60 mg/m\^2 total Dose Level 3; Bendamustine 90 mg/m\^2 total Dose Level 4; Bendamustine 120 mg/m\^2 total Dose Level 5; Bendamustine 150 mg/m\^2 total Dose Level 6; Bendamustine 225 mg/m\^2 total
- id
- OG000
- title
- Phase 1
- param Type
- MEDIAN
- population Description
- Phase 1 includes all patients treated on Phase 1 of the study (Dose Levels 1-6). All cohorts were evaluated as one group for assessment of progression-free survival (PFS), as PFS is a secondary endpoint and there was no intent to stratify by cohort for the analysis. The number of patients per cohort is also too small for to evaluate by cohort.
- reporting Status
- POSTED
- time Frame
- From Day 0 to first incidence of disease progression, up to 1,128 days
- title
- Progression-Free Survival (Phase 1)
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice