TriangleNCT01849783 · OUTCOME
Median Progression Free Survival (mPFS)
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 the start of DPACE for all participants who have had at least one day of protocol treatment. Up to 6 years.
What was measured
PFS is defined as the time from the start of DPACE to the date of first documentation of disease progression as assessed by the International Myeloma Working Group response criteria or death due to any cause. Progression is defined using the International Myeloma Working Group response criteria, an increase of greater than or equal to 25% from the lower response value.
Analysis population: Participants who have had at least one day of protocol treatment.
Groups in this outcome
Autologous Stem Cell Transplant
Induction : DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required. After collection, participants will receive dexamethasone x 4 days every 14 days. Transplant: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days. Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide) Maintenance: Year 1 - VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles. dexamethasone: Given PO cisplatin: Given IV doxorubicin: Given IV cyclophosphamide: Given IV or PO etoposide: Given IV bortezomib: Given IV thalidomide: Given PO melphalan: Given IV autologous stem cell transplant
| Group | Source count |
|---|---|
| Autologous Stem Cell Transplant | 41 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Autologous Stem Cell Transplant | 76.4 | Not reported | 43.6 | NA | 1-sided 95% confidence interval reported. Study designed to test whether regimen would increase PFS using 1-sided test at 5% significance level. In accordance with statistical hypothesis,1-sided 95% confidence interval is reported. The form does not provide option for 1-sided confidence interval; only options for 2-sided confidence intervals. Since a 1-sided confidence interval only has 1 bound, NA entered for the upper bound because there is no upper bound. |
Complete source fields
- classes
- categories
- measurements
- comment
- 1-sided 95% confidence interval reported. Study designed to test whether regimen would increase PFS using 1-sided test at 5% significance level. In accordance with statistical hypothesis,1-sided 95% confidence interval is reported. The form does not provide option for 1-sided confidence interval; only options for 2-sided confidence intervals. Since a 1-sided confidence interval only has 1 bound, NA entered for the upper bound because there is no upper bound.
- group Id
- OG000
- lower Limit
- 43.6
- upper Limit
- NA
- value
- 76.4
- denoms
- counts
- group Id
- OG000
- value
- 41
- units
- Participants
- description
- PFS is defined as the time from the start of DPACE to the date of first documentation of disease progression as assessed by the International Myeloma Working Group response criteria or death due to any cause. Progression is defined using the International Myeloma Working Group response criteria, an increase of greater than or equal to 25% from the lower response value.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Induction : DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required. After collection, participants will receive dexamethasone x 4 days every 14 days. Transplant: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days. Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide) Maintenance: Year 1 - VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles. dexamethasone: Given PO cisplatin: Given IV doxorubicin: Given IV cyclophosphamide: Given IV or PO etoposide: Given IV bortezomib: Given IV thalidomide: Given PO melphalan: Given IV autologous stem cell transplant
- id
- OG000
- title
- Autologous Stem Cell Transplant
- param Type
- MEDIAN
- population Description
- Participants who have had at least one day of protocol treatment.
- reporting Status
- POSTED
- time Frame
- From the start of DPACE for all participants who have had at least one day of protocol treatment. Up to 6 years.
- title
- Median Progression Free Survival (mPFS)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice