TriangleNCT01080391 · OUTCOME
Disease Control 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
Disease control rate was defined as the percentage of participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), or stable disease (SD) lasting ≥ 8 weeks according to International Myeloma Working Group - Uniform Response Criteria (IMWG-URC) (MR was determined using European Group for Blood and Marrow Transplantation criteria).
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) | 87.1 | Not reported | 83.4 | 90.3 | Not reported |
| Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 92.7 | Not reported | 89.7 | 95.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.17
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.08
- 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
- 0.0044
- param Type
- Odds Ratio (OR)
- param Value
- 1.897
- 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
- 1.17
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.08
- 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
- 0.0044
- param Type
- Odds Ratio (OR)
- param Value
- 1.897
- 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
- 83.4
- upper Limit
- 90.3
- value
- 87.1
- group Id
- OG001
- lower Limit
- 89.7
- upper Limit
- 95.0
- value
- 92.7
- denoms
- counts
- group Id
- OG000
- value
- 396
- group Id
- OG001
- value
- 396
- units
- Participants
- description
- Disease control rate was defined as the percentage of participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), or stable disease (SD) lasting ≥ 8 weeks according to International Myeloma Working Group - Uniform Response Criteria (IMWG-URC) (MR was determined using European Group for Blood and Marrow Transplantation criteria).
- 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
- Disease Control Rate
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice