TriangleNCT00948922 · OUTCOME
Progression Free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- End of 2 year, post transplant follow-up
What was measured
PFS: Number of participants, per treatment arm with progression free survival at time of analysis. Survival time will be measured from the date of transplant to the date of progression, death or the last follow-up, whichever comes first. Progressive Disease (PD): Increase of ≥ 25% from lowest response value in any one or more of the following: Serum M-component and/or; Urine M-component and/or; Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be \> 10 mg/dL; Bone marrow plasma cell percentage; absolute percentage ≥ 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 that can be attributed solely to the plasma cell proliferative disorder.
Analysis population: All participants evaluable at time of analysis
Groups in this outcome
A: Allogeneic Stem Cell Transplant
Allogeneic Stem Cell Transplant: Fludarabine+Melphalan+Bortezomib followed by Allogeneic Rescue.
B: Autologous Stem Cell Transplant
Autologous Stem Cell Transplant: Melphalan+Bortezomib followed by Autologous Rescue.
BE: Group B Expansion
Group B Expansion on Bortezomib Maintenance: Autologous Only.
| Group | Source count |
|---|---|
| A: Allogeneic Stem Cell Transplant | 26 |
| B: Autologous Stem Cell Transplant | 37 |
| BE: Group B Expansion | 38 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| A: Allogeneic Stem Cell Transplant | 17 | Not reported | Not reported | Not reported | Not reported |
| B: Autologous Stem Cell Transplant | 25 | Not reported | Not reported | Not reported | Not reported |
| BE: Group B Expansion | 19 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 25
- group Id
- OG002
- value
- 19
- denoms
- counts
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 37
- group Id
- OG002
- value
- 38
- units
- Participants
- description
- PFS: Number of participants, per treatment arm with progression free survival at time of analysis. Survival time will be measured from the date of transplant to the date of progression, death or the last follow-up, whichever comes first. Progressive Disease (PD): Increase of ≥ 25% from lowest response value in any one or more of the following: Serum M-component and/or; Urine M-component and/or; Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be \> 10 mg/dL; Bone marrow plasma cell percentage; absolute percentage ≥ 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 that can be attributed solely to the plasma cell proliferative disorder.
- groups
- description
- Allogeneic Stem Cell Transplant: Fludarabine+Melphalan+Bortezomib followed by Allogeneic Rescue.
- id
- OG000
- title
- A: Allogeneic Stem Cell Transplant
- description
- Autologous Stem Cell Transplant: Melphalan+Bortezomib followed by Autologous Rescue.
- id
- OG001
- title
- B: Autologous Stem Cell Transplant
- description
- Group B Expansion on Bortezomib Maintenance: Autologous Only.
- id
- OG002
- title
- BE: Group B Expansion
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All participants evaluable at time of analysis
- reporting Status
- POSTED
- time Frame
- End of 2 year, post transplant follow-up
- title
- Progression Free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice