TriangleNCT00396266 · OUTCOME
Number of Transplants Resulting In Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post-Transplant
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- number of transplants
- Interval / dispersion
- Not reported
- Time frame
- 2 months
What was measured
Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.
Analysis population: Intent to treat population of participants who had transplants. One participant received a tandem transplant.
Groups in this outcome
Non-Hodgkin's Lymphoma (NHL)
Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
Multiple Myeloma (MM)
Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
Total
All patients.
| Group | Source count |
|---|---|
| Non-Hodgkin's Lymphoma (NHL) | 8 |
| Multiple Myeloma (MM) | 14 |
| Total | 22 |
| Group | Source count |
|---|---|
| Non-Hodgkin's Lymphoma (NHL) | 8 |
| Multiple Myeloma (MM) | 15 |
| Total | 23 |
Reported measurements
≤ Day 12
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL) | 7 | 1.5 | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM) | 10 | 2.8 | Not reported | Not reported | Not reported |
| Total | 17 | Not reported | Not reported | Not reported | Not reported |
Day 13 to Day 21
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL) | 1 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM) | 5 | Not reported | Not reported | Not reported | Not reported |
| Total | 6 | Not reported | Not reported | Not reported | Not reported |
≥ Day 22
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM) | 0 | Not reported | Not reported | Not reported | Not reported |
| Total | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.5
- value
- 7
- group Id
- OG001
- spread
- 2.8
- value
- 10
- group Id
- OG002
- value
- 17
- title
- ≤ Day 12
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 6
- title
- Day 13 to Day 21
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- ≥ Day 22
- denom Units Selected
- Participants
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 22
- units
- Participants
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 23
- units
- transplants
- description
- Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.
- groups
- description
- Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
- id
- OG000
- title
- Non-Hodgkin's Lymphoma (NHL)
- description
- Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
- id
- OG001
- title
- Multiple Myeloma (MM)
- description
- All patients.
- id
- OG002
- title
- Total
- param Type
- NUMBER
- population Description
- Intent to treat population of participants who had transplants. One participant received a tandem transplant.
- reporting Status
- POSTED
- time Frame
- 2 months
- title
- Number of Transplants Resulting In Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post-Transplant
- type
- SECONDARY
- type Units Analyzed
- transplants
- unit Of Measure
- number of transplants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice