TriangleNCT02136134 · OUTCOME
Time to Disease Progression (TTP)
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 the date of first documented evidence of progression or death due to PD whichever occurred first (approximately 6 years 9 months)
What was measured
TTP was defined as time from date of randomization to date of first documented evidence of progressive disease (PD). PD was defined as meeting any one of following criteria: Increase of \>=25% in level of serum M-protein from lowest response value and absolute increase must be \>=0.5 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 free light chain (FLC) levels from lowest response value and absolute increase must be \>10 milligram per deciliter (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 Plasma Cell (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) | 7.29 | Not reported | 6.41 | 8.08 | 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
- 6.41
- upper Limit
- 8.08
- value
- 7.29
- 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
- TTP was defined as time from date of randomization to date of first documented evidence of progressive disease (PD). PD was defined as meeting any one of following criteria: Increase of \>=25% in level of serum M-protein from lowest response value and absolute increase must be \>=0.5 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 free light chain (FLC) levels from lowest response value and absolute increase must be \>10 milligram per deciliter (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 Plasma Cell (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 the date of first documented evidence of progression or death due to PD whichever occurred first (approximately 6 years 9 months)
- title
- Time to Disease Progression (TTP)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice