TriangleNCT03710603 · OUTCOME
Progression Free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From the date of randomization to either progressive disease or death whichever occurred first, up to a maximum follow-up time of 54.41 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 the following criteria: Increase of \>= 25 % in level of serum M-protein form 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/24 hours; 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: Randomized population, intention-to-treat
Groups in this outcome
Velcade Lenalidomide Dexamethasone (VRd)
Arm A: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
Daratumumab + VRd (D-VRd)
Arm B: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with subcutaneous daratumumab in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by subcutaneous daratumumab in combination with lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
| Group | Source count |
|---|---|
| Velcade Lenalidomide Dexamethasone (VRd) | 354 |
| Daratumumab + VRd (D-VRd) | 355 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Velcade Lenalidomide Dexamethasone (VRd) | 103 | Not reported | Not reported | Not reported | Not reported |
| Daratumumab + VRd (D-VRd) | 50 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 103
- group Id
- OG001
- value
- 50
- denoms
- counts
- group Id
- OG000
- value
- 354
- group Id
- OG001
- value
- 355
- 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 the following criteria: Increase of \>= 25 % in level of serum M-protein form 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/24 hours; 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.
- groups
- description
- Arm A: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
- id
- OG000
- title
- Velcade Lenalidomide Dexamethasone (VRd)
- description
- Arm B: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with subcutaneous daratumumab in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by subcutaneous daratumumab in combination with lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
- id
- OG001
- title
- Daratumumab + VRd (D-VRd)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Randomized population, intention-to-treat
- reporting Status
- POSTED
- time Frame
- From the date of randomization to either progressive disease or death whichever occurred first, up to a maximum follow-up time of 54.41 months.
- title
- Progression Free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice