NCT02224729 · OUTCOME
Count of Participants That Experience Very Good Partial Remission (VGPR)
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
- Up to 1 year
What was measured
Very good partial remission (VGPR) to induction therapy following 4 cycles of the combination regimen BBd. As defined as no dectable M-protein on SPEP (Serum protein electrophoresis) but positive IFX (Immunofixation) on serum or urine and \>90% reduction of M-protein in serum and urine
Analysis population: 4 were not evaluable - (1 didn't get any therapy on study, 1 received only first cycle and 2 developed medical issues that took them off study during the first cycle)
Groups in this outcome
Bendamustine, Bortezomib, Dexamethasone (Standard)
Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2; bortezomib SC on days 1, 8, 15, and 22; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 35 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than a VGPR or with more than 10% bone marrow plasmacytosis may receive 2 additional courses. Bendamustine hydrochloride: Given IV Bortezomib: Given SC Dexamethasone: Given PO
| Group | Source count |
|---|---|
| Bendamustine, Bortezomib, Dexamethasone (Standard) | 20 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bendamustine, Bortezomib, Dexamethasone (Standard) | 9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 9
- denoms
- counts
- group Id
- OG000
- value
- 20
- units
- Participants
- description
- Very good partial remission (VGPR) to induction therapy following 4 cycles of the combination regimen BBd. As defined as no dectable M-protein on SPEP (Serum protein electrophoresis) but positive IFX (Immunofixation) on serum or urine and \>90% reduction of M-protein in serum and urine
- groups
- description
- Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2; bortezomib SC on days 1, 8, 15, and 22; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 35 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than a VGPR or with more than 10% bone marrow plasmacytosis may receive 2 additional courses. Bendamustine hydrochloride: Given IV Bortezomib: Given SC Dexamethasone: Given PO
- id
- OG000
- title
- Bendamustine, Bortezomib, Dexamethasone (Standard)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- 4 were not evaluable - (1 didn't get any therapy on study, 1 received only first cycle and 2 developed medical issues that took them off study during the first cycle)
- reporting Status
- POSTED
- time Frame
- Up to 1 year
- title
- Count of Participants That Experience Very Good Partial Remission (VGPR)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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