TriangleNCT00477971 · OUTCOME
3-Year Progression Free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 3 years
What was measured
Percentage of patients who were progression free at 3 years. The 3-year progression free rate was estimated using the Kaplan Meier method. Progression is assessed when one of the following occur: * reappearance of monoclonal protein by immunofixation, * Increase in serum monoclonal paraprotein to \>25% above the lowest response level, * Increase in urine M-protein to \> 25% above the lowest remission value for 24-hour excretion.
Groups in this outcome
Low-Dose Melphalan
Patients receive low-dose melphalan 20 mg/m\^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
High-Dose Melphalan + Autologous HSC
Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m\^2 IV for low risk or 200 mg/m\^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
| Group | Source count |
|---|---|
| Low-Dose Melphalan | 34 |
| High-Dose Melphalan + Autologous HSC | 55 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Low-Dose Melphalan | 29.1 | Not reported | 17.2 | 49.4 | Not reported |
| High-Dose Melphalan + Autologous HSC | 51.7 | Not reported | 39.8 | 67 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 17.2
- upper Limit
- 49.4
- value
- 29.1
- group Id
- OG001
- lower Limit
- 39.8
- upper Limit
- 67
- value
- 51.7
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 55
- units
- Participants
- description
- Percentage of patients who were progression free at 3 years. The 3-year progression free rate was estimated using the Kaplan Meier method. Progression is assessed when one of the following occur: * reappearance of monoclonal protein by immunofixation, * Increase in serum monoclonal paraprotein to \>25% above the lowest response level, * Increase in urine M-protein to \> 25% above the lowest remission value for 24-hour excretion.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive low-dose melphalan 20 mg/m\^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
- id
- OG000
- title
- Low-Dose Melphalan
- description
- Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m\^2 IV for low risk or 200 mg/m\^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
- id
- OG001
- title
- High-Dose Melphalan + Autologous HSC
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 3 years
- title
- 3-Year Progression Free Survival
- type
- POST_HOC
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice