NCT01816971 · OUTCOME
Percentage of Patients Achieving sCR
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
- Day 224
What was measured
The percentage of stringent complete response (CR) (sCR) will be reported along with 95% confidence intervals, adjusted for the two-stage nature of the trial design.
Groups in this outcome
Treatment (Dexamethasone, Carfilzomib, Lenalidomide)
INDUCTION THERAPY: Patients receive dexamethasone IV or PO QD on days 1, 8, 15 and 22; carfilzomib IV over 10-30 minutes on days 1, 2, 8, 9, 15, and 16; and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.. TRANSPLANT: Patients undergo autologous stem cell transplant. CONSOLIDATION THERAPY: Patients receive dexamethasone, carfilzomib, and lenalidomide as in induction. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive dexamethasone and lenalidomide as in induction therapy and carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Treatment repeats every 28 days for 10 courses in the absence of disease progression or unacceptable toxicity. dexamethasone: Given IV or PO carfilzomib: Given IV lenalidomide: Given PO autologous hematopoietic stem cell transplantation: Undergo autologous hematopoietic stem cell transplant laboratory biomarker analysis: Correlative studies
| Group | Source count |
|---|---|
| Treatment (Dexamethasone, Carfilzomib, Lenalidomide) | 76 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Dexamethasone, Carfilzomib, Lenalidomide) | 76 | Not reported | 66 | 84 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 66
- upper Limit
- 84
- value
- 76
- denoms
- counts
- group Id
- OG000
- value
- 76
- units
- Participants
- description
- The percentage of stringent complete response (CR) (sCR) will be reported along with 95% confidence intervals, adjusted for the two-stage nature of the trial design.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- INDUCTION THERAPY: Patients receive dexamethasone IV or PO QD on days 1, 8, 15 and 22; carfilzomib IV over 10-30 minutes on days 1, 2, 8, 9, 15, and 16; and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.. TRANSPLANT: Patients undergo autologous stem cell transplant. CONSOLIDATION THERAPY: Patients receive dexamethasone, carfilzomib, and lenalidomide as in induction. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive dexamethasone and lenalidomide as in induction therapy and carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Treatment repeats every 28 days for 10 courses in the absence of disease progression or unacceptable toxicity. dexamethasone: Given IV or PO carfilzomib: Given IV lenalidomide: Given PO autologous hematopoietic stem cell transplantation: Undergo autologous hematopoietic stem cell transplant laboratory biomarker analysis: Correlative studies
- id
- OG000
- title
- Treatment (Dexamethasone, Carfilzomib, Lenalidomide)
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Day 224
- title
- Percentage of Patients Achieving sCR
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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