TriangleNCT01548573 · OUTCOME
Event-Free Survival (EFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- 8 years
What was measured
To determine whether, in comparison to Total Therapy II, the median Event-Free Survival (EFS) can be increased from 4.8 years to 7.2 years, which represents an increase in median EFS of approximately 50%, based on an intent-to-treat analysis.
Analysis population: Enrollment halted prematurely. Study met stopping rules (3 or more of the first 20 participants died due to treatment-related toxicity). Data for outcome measure 1 were not collected.
Groups in this outcome
Tandem Autologous Stem Cell Transplant
Induction and PBSC Collection:1 cycle of combination D-PACE (and peripheral blood stem cell collection. After collection, participants may receive interim dexamethasone at 20mg days 1-4 every 14 days. Transplant 1: 6 weeks after first day of D-PACE , but can occur as early as 4 weeks and as late as 6 months. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days. Transplant 2: 8 weeks-6 months after the first transplant, participants will have second transplant. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days. Consolidation Phase (if administered): 4 weeks-4 months after second transplant, participants may receive consolidation chemotherapy. Maintenance Phase year 1 and 2:The first year of maintenance will commence between 6 weeks-6 months after consolidation or 4 weeks-6 months after transplant if consolidation is skipped. DP
| Group | Source count |
|---|---|
| Tandem Autologous Stem Cell Transplant | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tandem Autologous Stem Cell Transplant | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 0
- units
- Participants
- description
- To determine whether, in comparison to Total Therapy II, the median Event-Free Survival (EFS) can be increased from 4.8 years to 7.2 years, which represents an increase in median EFS of approximately 50%, based on an intent-to-treat analysis.
- groups
- description
- Induction and PBSC Collection:1 cycle of combination D-PACE (and peripheral blood stem cell collection. After collection, participants may receive interim dexamethasone at 20mg days 1-4 every 14 days. Transplant 1: 6 weeks after first day of D-PACE , but can occur as early as 4 weeks and as late as 6 months. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days. Transplant 2: 8 weeks-6 months after the first transplant, participants will have second transplant. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days. Consolidation Phase (if administered): 4 weeks-4 months after second transplant, participants may receive consolidation chemotherapy. Maintenance Phase year 1 and 2:The first year of maintenance will commence between 6 weeks-6 months after consolidation or 4 weeks-6 months after transplant if consolidation is skipped. DP
- id
- OG000
- title
- Tandem Autologous Stem Cell Transplant
- population Description
- Enrollment halted prematurely. Study met stopping rules (3 or more of the first 20 participants died due to treatment-related toxicity). Data for outcome measure 1 were not collected.
- reporting Status
- POSTED
- time Frame
- 8 years
- title
- Event-Free Survival (EFS)
- type
- PRIMARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice