TriangleNCT02076009 · OUTCOME
Progression-free Survival (PFS)
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 to either disease progression or death whichever occurs first (up to 21 months)
What was measured
PFS: duration from date of randomization to either progressive disease (PD)/death, whichever occurred first. PD: defined as meeting any 1 of following criteria: Increase of greater than equal to (\>=)25 percent(%) in level of serum M-protein from lowest response value and absolute increase must be \>=0.5 gram per deciliter (g/dL); Increase of \>=25% in 24-hours(h) urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be \>=200 mg/24h; Only in participants without measurable serum and urine M-protein levels: increase of \>=25% in difference between involved and uninvolved free light chain (FLC) levels from lowest response value and absolute increase must be \>10 mg/dL; Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) attributed solely to plasma cell (PC) proliferative disorder.
Analysis population: Intent-to-treat (ITT) analysis set included all participants who were randomly assigned to the daratumumab, lenalidomide, dexamethasone (DRd) or lenalidomide, low-dose dexamethasone (Rd) group.
Groups in this outcome
Lenalidomide, Low-dose Dexamethasone (Rd)
Participants received lenalidomide at a dose of 25 milligrams (mg) orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone at a total dose of 40 mg weekly (or 20 mg weekly for participants greater than \[\>\] 75 years old or with a body mass index less than \[\<\] 18.5 kilograms per meter square \[kg/m\^2\]).
Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)
Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks, each 28-day cycle); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks, each 28-day cycle); once only on Day 1 during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone was administered at a total dose of 40 mg weekly (or 20 mg weekly for participants \>75 years old or with a body mass index \< 18.5 kg/m\^2).
| Group | Source count |
|---|---|
| Lenalidomide, Low-dose Dexamethasone (Rd) | 283 |
| Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd) | 286 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenalidomide, Low-dose Dexamethasone (Rd) | 18.43 | Not reported | 13.86 | NA | Upper limit of 95% confidence interval (CI) was not estimable due to short follow-up by participants. |
| Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd) | NA | Not reported | NA | NA | Median and 95% CI was not estimable due to short follow-up by participants. |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit of 95% confidence interval (CI) was not estimable due to short follow-up by participants.
- group Id
- OG000
- lower Limit
- 13.86
- upper Limit
- NA
- value
- 18.43
- comment
- Median and 95% CI was not estimable due to short follow-up by participants.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 283
- group Id
- OG001
- value
- 286
- units
- Participants
- description
- PFS: duration from date of randomization to either progressive disease (PD)/death, whichever occurred first. PD: defined as meeting any 1 of following criteria: Increase of greater than equal to (\>=)25 percent(%) in level of serum M-protein from lowest response value and absolute increase must be \>=0.5 gram per deciliter (g/dL); Increase of \>=25% in 24-hours(h) urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be \>=200 mg/24h; Only in participants without measurable serum and urine M-protein levels: increase of \>=25% in difference between involved and uninvolved free light chain (FLC) levels from lowest response value and absolute increase must be \>10 mg/dL; Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) attributed solely to plasma cell (PC) proliferative disorder.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received lenalidomide at a dose of 25 milligrams (mg) orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone at a total dose of 40 mg weekly (or 20 mg weekly for participants greater than \[\>\] 75 years old or with a body mass index less than \[\<\] 18.5 kilograms per meter square \[kg/m\^2\]).
- id
- OG000
- title
- Lenalidomide, Low-dose Dexamethasone (Rd)
- description
- Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks, each 28-day cycle); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks, each 28-day cycle); once only on Day 1 during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone was administered at a total dose of 40 mg weekly (or 20 mg weekly for participants \>75 years old or with a body mass index \< 18.5 kg/m\^2).
- id
- OG001
- title
- Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)
- param Type
- MEDIAN
- population Description
- Intent-to-treat (ITT) analysis set included all participants who were randomly assigned to the daratumumab, lenalidomide, dexamethasone (DRd) or lenalidomide, low-dose dexamethasone (Rd) group.
- reporting Status
- POSTED
- time Frame
- From randomization to either disease progression or death whichever occurs first (up to 21 months)
- title
- Progression-free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice