TriangleNCT02136134 · OUTCOME
Percentage of Participants With a Very Good Partial Response (VGPR) or Better
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to disease progression (approximately 6 years 9 months)
What was measured
Response rate of VGPR or better was defined as the percentage of participants who achieved VGPR and CR (including sCR) according to the IMWG criteria during or after the study treatment. IMWG criteria for 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, if the serum and urine M-protein are not measurable, a decrease of \>90% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, in addition to the above criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas is also required; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% PCs in bone marrow; sCR: CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2 to 4 color flow cytometry.
Analysis population: The response evaluable analysis set is defined as participants who have a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit, received at least 1 administration of study treatment, and had at least 1 post baseline disease assessment.
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) | 234 |
| Daratumumab + Bortezomib and Dexamethasone (DVd) | 240 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bortezomib + Dexamethasone (Vd) | 29.1 | Not reported | 23.3 | 35.3 | Not reported |
| Daratumumab + Bortezomib and Dexamethasone (DVd) | 59.2 | Not reported | 52.7 | 65.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 23.3
- upper Limit
- 35.3
- value
- 29.1
- group Id
- OG001
- lower Limit
- 52.7
- upper Limit
- 65.4
- value
- 59.2
- denoms
- counts
- group Id
- OG000
- value
- 234
- group Id
- OG001
- value
- 240
- units
- Participants
- description
- Response rate of VGPR or better was defined as the percentage of participants who achieved VGPR and CR (including sCR) according to the IMWG criteria during or after the study treatment. IMWG criteria for 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, if the serum and urine M-protein are not measurable, a decrease of \>90% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, in addition to the above criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas is also required; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% PCs in bone marrow; sCR: CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2 to 4 color flow cytometry.
- 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
- NUMBER
- population Description
- The response evaluable analysis set is defined as participants who have a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit, received at least 1 administration of study treatment, and had at least 1 post baseline disease assessment.
- reporting Status
- POSTED
- time Frame
- Up to disease progression (approximately 6 years 9 months)
- title
- Percentage of Participants With a Very Good Partial Response (VGPR) or Better
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice