TriangleNCT01080391 · OUTCOME
Overall Response Rate
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
- From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.
What was measured
Overall response rate is defined as the percentage of participants who achieved either a confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as their best response based on the Independent Review Committee (IRC) assessed response outcome. Response was determined using the International Myeloma Working Group - Uniform Response Criteria (IMWG-URC).
Analysis population: ITT analysis set comprised of all randomized participants
Groups in this outcome
Lenalidomide and Dexamethasone (Rd)
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
| Group | Source count |
|---|---|
| Lenalidomide and Dexamethasone (Rd) | 396 |
| Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 396 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenalidomide and Dexamethasone (Rd) | 66.7 | Not reported | 61.8 | 71.3 | Not reported |
| Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 87.1 | Not reported | 83.4 | 90.3 | Not reported |
Source statistical analyses
- ci Lower Limit
- 2.411
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.001
- estimate Comment
- The odds ratio and 95% CI were estimated using the Mantel-Haenszel method.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.0001
- param Type
- Odds Ratio (OR)
- param Value
- 3.472
- statistical Comment
- Cochran-Mantel Haenszel chi-square test with β2 macroglobulin level, prior bortezomib, and prior lenalidomide as stratification factors.
- statistical Method
- Cochran-Mantel Haenszel chi-square test
Complete source fields
- analyses
- ci Lower Limit
- 2.411
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.001
- estimate Comment
- The odds ratio and 95% CI were estimated using the Mantel-Haenszel method.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.0001
- param Type
- Odds Ratio (OR)
- param Value
- 3.472
- statistical Comment
- Cochran-Mantel Haenszel chi-square test with β2 macroglobulin level, prior bortezomib, and prior lenalidomide as stratification factors.
- statistical Method
- Cochran-Mantel Haenszel chi-square test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 61.8
- upper Limit
- 71.3
- value
- 66.7
- group Id
- OG001
- lower Limit
- 83.4
- upper Limit
- 90.3
- value
- 87.1
- denoms
- counts
- group Id
- OG000
- value
- 396
- group Id
- OG001
- value
- 396
- units
- Participants
- description
- Overall response rate is defined as the percentage of participants who achieved either a confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as their best response based on the Independent Review Committee (IRC) assessed response outcome. Response was determined using the International Myeloma Working Group - Uniform Response Criteria (IMWG-URC).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
- id
- OG000
- title
- Lenalidomide and Dexamethasone (Rd)
- description
- Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
- id
- OG001
- title
- Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
- param Type
- NUMBER
- population Description
- ITT analysis set comprised of all randomized participants
- reporting Status
- POSTED
- time Frame
- From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.
- title
- Overall Response Rate
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice