TriangleNCT00507416 · OUTCOME
Percentage of Participants With a Complete Response or a Very Good Partial Response
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
- Not reported
- Time frame
- Response assessed every other cycle for up to 13 cycles (49 weeks).
What was measured
Complete response is defined by negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. Very good partial response is defined by serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hours. Response was assessed by the Investigator using the IMWG uniform response criteria.
Analysis population: Response-Evaluable population, defined as all participants who received at least 1 dose of any study drug, have measurable disease at baseline, and have at least one post-baseline M-protein measurement.
Groups in this outcome
Bortezomib and Dexamethasone
Participants received bortezomib (Velcade) 1.3 mg/m\^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Bortezomib, Thalidomide, and Dexamethasone
Participants received bortezomib 1.3 mg/m\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Bortezomib, Melphalan and Prednisone
Participants received bortezomib 1.3 mg/m\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m\^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m\^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
| Group | Source count |
|---|---|
| Bortezomib and Dexamethasone | 147 |
| Bortezomib, Thalidomide, and Dexamethasone | 133 |
| Bortezomib, Melphalan and Prednisone | 145 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bortezomib and Dexamethasone | 37 | Not reported | Not reported | Not reported | Not reported |
| Bortezomib, Thalidomide, and Dexamethasone | 51 | Not reported | Not reported | Not reported | Not reported |
| Bortezomib, Melphalan and Prednisone | 41 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 51
- group Id
- OG002
- value
- 41
- denoms
- counts
- group Id
- OG000
- value
- 147
- group Id
- OG001
- value
- 133
- group Id
- OG002
- value
- 145
- units
- Participants
- description
- Complete response is defined by negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. Very good partial response is defined by serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hours. Response was assessed by the Investigator using the IMWG uniform response criteria.
- groups
- description
- Participants received bortezomib (Velcade) 1.3 mg/m\^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
- id
- OG000
- title
- Bortezomib and Dexamethasone
- description
- Participants received bortezomib 1.3 mg/m\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
- id
- OG001
- title
- Bortezomib, Thalidomide, and Dexamethasone
- description
- Participants received bortezomib 1.3 mg/m\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m\^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m\^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
- id
- OG002
- title
- Bortezomib, Melphalan and Prednisone
- param Type
- NUMBER
- population Description
- Response-Evaluable population, defined as all participants who received at least 1 dose of any study drug, have measurable disease at baseline, and have at least one post-baseline M-protein measurement.
- reporting Status
- POSTED
- time Frame
- Response assessed every other cycle for up to 13 cycles (49 weeks).
- title
- Percentage of Participants With a Complete Response or a Very Good Partial Response
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice