TriangleNCT02136134 · 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 the date of randomization to either progressive disease or death, whichever occurred first (approximately 1 year 4 months)
What was measured
PFS was defined as duration from date of randomization to either progressive disease (PD)/death, whichever occurred first. PD was defined as meeting any one 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-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be \>=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of \>=25% in difference between involved and uninvolved 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) that can be attributed solely to PC proliferative disorder.
Analysis population: The intent-to-treat (ITT) population included all randomized participants.
Groups in this outcome
Bortezomib + Dexamethasone (Vd)
Participants received bortezomib 1.3 milligrams per square meter (mg/m\^2) subcutaneous (SC) injection on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone 20 milligrams (mg) orally (PO) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles. Participants who met sponsor-confirmed disease progression eligibility criteria received daratumumab monotherapy as a subsequent antimyeloma therapy as follow: daratumumab 16 milligrams per kilogram (mg/kg) intravenous (IV) infusion or daratumumab SC injection (1800 mg fixed dose) weekly for the first 2 cycles, every 2 weeks from Cycle 3 to 6, and then every 4 weeks thereafter.
Daratumumab + Bortezomib and Dexamethasone (DVd)
Participants received daratumumab 16 mg/kg IV infusion weekly or daratumumab SC injection (1800 mg fixed dose) for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib 1.3 mg/m\^2 SC injection administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
| Group | Source count |
|---|---|
| Bortezomib + Dexamethasone (Vd) | 247 |
| Daratumumab + Bortezomib and Dexamethasone (DVd) | 251 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bortezomib + Dexamethasone (Vd) | 7.16 | Not reported | 6.21 | 7.85 | Not reported |
| Daratumumab + Bortezomib and Dexamethasone (DVd) | NA | Not reported | 12.25 | NA | Median and Upper limit of 95% CI was not estimable due to short follow-up by participants. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.21
- upper Limit
- 7.85
- value
- 7.16
- comment
- Median and Upper limit of 95% CI was not estimable due to short follow-up by participants.
- group Id
- OG001
- lower Limit
- 12.25
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 247
- group Id
- OG001
- value
- 251
- units
- Participants
- description
- PFS was defined as duration from date of randomization to either progressive disease (PD)/death, whichever occurred first. PD was defined as meeting any one 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-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be \>=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of \>=25% in difference between involved and uninvolved 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) that can be attributed solely to PC proliferative disorder.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received bortezomib 1.3 milligrams per square meter (mg/m\^2) subcutaneous (SC) injection on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone 20 milligrams (mg) orally (PO) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles. Participants who met sponsor-confirmed disease progression eligibility criteria received daratumumab monotherapy as a subsequent antimyeloma therapy as follow: daratumumab 16 milligrams per kilogram (mg/kg) intravenous (IV) infusion or daratumumab SC injection (1800 mg fixed dose) weekly for the first 2 cycles, every 2 weeks from Cycle 3 to 6, and then every 4 weeks thereafter.
- id
- OG000
- title
- Bortezomib + Dexamethasone (Vd)
- description
- Participants received daratumumab 16 mg/kg IV infusion weekly or daratumumab SC injection (1800 mg fixed dose) for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib 1.3 mg/m\^2 SC injection administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
- id
- OG001
- title
- Daratumumab + Bortezomib and Dexamethasone (DVd)
- param Type
- MEDIAN
- population Description
- The intent-to-treat (ITT) population included all randomized participants.
- reporting Status
- POSTED
- time Frame
- From the date of randomization to either progressive disease or death, whichever occurred first (approximately 1 year 4 months)
- title
- Progression-free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice