TriangleNCT01080391 · OUTCOME
Duration of Disease Control
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 46 months.
What was measured
Duration of disease control (DDC) was calculated for participants who achieved disease control. DDC was defined as the time in months from randomization to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS.
Analysis population: The Intent to treat (ITT) population with participantants who achieved disease control.
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) | 345 |
| Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 367 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenalidomide and Dexamethasone (Rd) | 18.9 | Not reported | 16.6 | 22.2 | Not reported |
| Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 28.7 | Not reported | 24.4 | 31.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 16.6
- upper Limit
- 22.2
- value
- 18.9
- group Id
- OG001
- lower Limit
- 24.4
- upper Limit
- 31.6
- value
- 28.7
- denoms
- counts
- group Id
- OG000
- value
- 345
- group Id
- OG001
- value
- 367
- units
- Participants
- description
- Duration of disease control (DDC) was calculated for participants who achieved disease control. DDC was defined as the time in months from randomization to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS.
- 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
- MEDIAN
- population Description
- The Intent to treat (ITT) population with participantants who achieved disease control.
- reporting Status
- POSTED
- time Frame
- From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 46 months.
- title
- Duration of Disease Control
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice