TriangleNCT03710603 · OUTCOME
Percentage of Participants With Overall Response Rate (ORR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants with response
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization to the clinical cutoff date. Maximum follow up was 54.41 months
What was measured
ORR- percentage of participants who achieved partial response (PR) or better (PR, Very Good Partial Response \[VGPR\], CR or sCR) based on computerized algorithm as per IMWG 2011 criteria. PR -greater than or equal to (\>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \<200 mg//24 hours. If serum and urine M-protein are not measurable, a decrease of \>=50% in the difference between involved and uninvolved FLC levels is required. A \>=50% reduction in the size of soft tissue plasmacytomas is also required; VGPR-serum and urine M-component detectable by immunofixation but not on electrophoresis, or \>= 90% reduction in serum M-protein plus urine M-protein \<100 mg/24 hours; CR-negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and \<5% PCs in bone marrow. sCR- in addition to CR a normal FLC ratio, and absence of clonal PCs by immunohistochemistry or immunofluorescence or 2 to 4-color flow cytometry.
Analysis population: The intent-to-treat (ITT) population included all randomized participants
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) | 93.8 | Not reported | 90.7 | 96.1 | Not reported |
| Daratumumab + VRd (D-VRd) | 96.6 | Not reported | 94.2 | 98.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 90.7
- upper Limit
- 96.1
- value
- 93.8
- group Id
- OG001
- lower Limit
- 94.2
- upper Limit
- 98.2
- value
- 96.6
- denoms
- counts
- group Id
- OG000
- value
- 354
- group Id
- OG001
- value
- 355
- units
- Participants
- description
- ORR- percentage of participants who achieved partial response (PR) or better (PR, Very Good Partial Response \[VGPR\], CR or sCR) based on computerized algorithm as per IMWG 2011 criteria. PR -greater than or equal to (\>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \<200 mg//24 hours. If serum and urine M-protein are not measurable, a decrease of \>=50% in the difference between involved and uninvolved FLC levels is required. A \>=50% reduction in the size of soft tissue plasmacytomas is also required; VGPR-serum and urine M-component detectable by immunofixation but not on electrophoresis, or \>= 90% reduction in serum M-protein plus urine M-protein \<100 mg/24 hours; CR-negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and \<5% PCs in bone marrow. sCR- in addition to CR a normal FLC ratio, and absence of clonal PCs by immunohistochemistry or immunofluorescence or 2 to 4-color flow cytometry.
- dispersion Type
- 95% Confidence Interval
- 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
- NUMBER
- population Description
- The intent-to-treat (ITT) population included all randomized participants
- reporting Status
- POSTED
- time Frame
- From randomization to the clinical cutoff date. Maximum follow up was 54.41 months
- title
- Percentage of Participants With Overall Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants with response
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice