TriangleNCT00793650 · OUTCOME
Safety and Engraftment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- days
- Interval / dispersion
- Full Range
- Time frame
- Day 30 after transplant
What was measured
Peripheral blood progenitor cells were collected with either chemo-mobilization (27 of 39, 69%) or growth factor mobilization (12 of 39, 31%). Patients received an average of 9.0 × 10\^6/kg CD34+ cells (range, 2.3-65) as their transplant graft.
Analysis population: As per the protocol
Groups in this outcome
Bortezomib Before HD Melphalan
All patients received melphalan (100 mg/m\^2/day × 2; days -3 and -2), for a total dose of 200 mg/m\^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m\^2
Bortezomib After HD melphalanAll
patients received melphalan (100 mg/m\^2/day × 2; days -3 and -2), for a total dose of 200 mg/m\^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m\^2
| Group | Source count |
|---|---|
| Bortezomib Before HD Melphalan | 19 |
| Bortezomib After HD melphalanAll | 20 |
Reported measurements
Median time for platelet recovery
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bortezomib Before HD Melphalan | 16 | Not reported | 8 | 23 | Not reported |
| Bortezomib After HD melphalanAll | 16 | Not reported | 10 | 58 | Not reported |
Median time for neutrophil recovery
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bortezomib Before HD Melphalan | 12 | Not reported | 10 | 18 | Not reported |
| Bortezomib After HD melphalanAll | 12 | Not reported | 9 | 35 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8
- upper Limit
- 23
- value
- 16
- group Id
- OG001
- lower Limit
- 10
- upper Limit
- 58
- value
- 16
- title
- Median time for platelet recovery
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10
- upper Limit
- 18
- value
- 12
- group Id
- OG001
- lower Limit
- 9
- upper Limit
- 35
- value
- 12
- title
- Median time for neutrophil recovery
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 20
- units
- Participants
- description
- Peripheral blood progenitor cells were collected with either chemo-mobilization (27 of 39, 69%) or growth factor mobilization (12 of 39, 31%). Patients received an average of 9.0 × 10\^6/kg CD34+ cells (range, 2.3-65) as their transplant graft.
- dispersion Type
- Full Range
- groups
- description
- All patients received melphalan (100 mg/m\^2/day × 2; days -3 and -2), for a total dose of 200 mg/m\^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m\^2
- id
- OG000
- title
- Bortezomib Before HD Melphalan
- description
- patients received melphalan (100 mg/m\^2/day × 2; days -3 and -2), for a total dose of 200 mg/m\^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m\^2
- id
- OG001
- title
- Bortezomib After HD melphalanAll
- param Type
- MEDIAN
- population Description
- As per the protocol
- reporting Status
- POSTED
- time Frame
- Day 30 after transplant
- title
- Safety and Engraftment
- type
- PRIMARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice