TriangleNCT01177683 · OUTCOME
Phase II : Time to Progression
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 C1D1 up to a maximum of 54 months or until death
What was measured
The time from the start of treatment (i.e., first dose) of MM patients treated with bendamustine, bortezomib and pegylated liposomal doxorubicin to disease progression, with disease progression and death due to disease progression as events and deaths due to causes other than progression as censored. Censoring date will be the last disease evaluation date for patient without progression/death or date of death due to other diseases for patients' deaths due to other causes.Per modified International Myeloma Working Group criteria: Progressive disease (PD) is reported if any one of the following criteria is met: Increase of 25% or more in serum or urine M-protein from baseline;Serum M-protein and/or the absolute increase must be ≥0.5 g/dL;Urine M-protein and/or absolute increase must be ≥200 mg/24 hours ; 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 hyperc.
Analysis population: Two subjects never received treatment. Therefore, they were not included in any assessment of objectives.
Groups in this outcome
Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin.
Bendamustine: At phase II, Bendamustine will be administered at 90mg/m\^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Doxorubicin: Pegylated liposomal doxorubicin at phase II will be administered at 30 mg/m2 by IV over 1 hour,at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase II will be administered at 1.3 mg/m2 by IV bolus or SQ injection on days 1, 4, 8, and 11 of the 28 day cycle.
| Group | Source count |
|---|---|
| Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin. | 24 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin. | 20.53 | Not reported | 6.47 | 27.47 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.47
- upper Limit
- 27.47
- value
- 20.53
- denoms
- counts
- group Id
- OG000
- value
- 24
- units
- Participants
- description
- The time from the start of treatment (i.e., first dose) of MM patients treated with bendamustine, bortezomib and pegylated liposomal doxorubicin to disease progression, with disease progression and death due to disease progression as events and deaths due to causes other than progression as censored. Censoring date will be the last disease evaluation date for patient without progression/death or date of death due to other diseases for patients' deaths due to other causes.Per modified International Myeloma Working Group criteria: Progressive disease (PD) is reported if any one of the following criteria is met: Increase of 25% or more in serum or urine M-protein from baseline;Serum M-protein and/or the absolute increase must be ≥0.5 g/dL;Urine M-protein and/or absolute increase must be ≥200 mg/24 hours ; 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 hyperc.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Bendamustine: At phase II, Bendamustine will be administered at 90mg/m\^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Doxorubicin: Pegylated liposomal doxorubicin at phase II will be administered at 30 mg/m2 by IV over 1 hour,at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase II will be administered at 1.3 mg/m2 by IV bolus or SQ injection on days 1, 4, 8, and 11 of the 28 day cycle.
- id
- OG000
- title
- Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin.
- param Type
- MEDIAN
- population Description
- Two subjects never received treatment. Therefore, they were not included in any assessment of objectives.
- reporting Status
- POSTED
- time Frame
- From C1D1 up to a maximum of 54 months or until death
- title
- Phase II : Time to Progression
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice