TriangleNCT02020941 · OUTCOME
Overall Response Rate (ORR) After 4 Courses of Treatment
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
- At 16 weeks
What was measured
Evaluate the overall response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better. The percentage of patients achieving this and the exact 95% confidence interval will be calculated. Responses will be defined using the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC).
Analysis population: All patients receiving at least one dose of study drug and having at least one evaluable post-baseline visit
Groups in this outcome
Treatment (Carfilzomib, Dexamethasone)
TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8. MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. carfilzomib: Given IV dexamethasone: Given IV or PO laboratory biomarker analysis: Correlative studies
| Group | Source count |
|---|---|
| Treatment (Carfilzomib, Dexamethasone) | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Carfilzomib, Dexamethasone) | 77.8 | Not reported | 40.0 | 97.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 40.0
- upper Limit
- 97.2
- value
- 77.8
- denoms
- counts
- group Id
- OG000
- value
- 9
- units
- Participants
- description
- Evaluate the overall response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better. The percentage of patients achieving this and the exact 95% confidence interval will be calculated. Responses will be defined using the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8. MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. carfilzomib: Given IV dexamethasone: Given IV or PO laboratory biomarker analysis: Correlative studies
- id
- OG000
- title
- Treatment (Carfilzomib, Dexamethasone)
- param Type
- NUMBER
- population Description
- All patients receiving at least one dose of study drug and having at least one evaluable post-baseline visit
- reporting Status
- POSTED
- time Frame
- At 16 weeks
- title
- Overall Response Rate (ORR) After 4 Courses of Treatment
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice