TriangleNCT00322842 · OUTCOME
Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) 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: Participants who had transplants. Fifteen participants had tandem transplants. The date of initial PMN engraftment was missing for 11 transplants, which were later shown to have durable grafts.
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.
All Participants
Not reported
| Group | Source count |
|---|---|
| Non-Hodgkin's Lymphoma (NHL) | 3 |
| Multiple Myeloma (MM) | 30 |
| All Participants | 33 |
| Group | Source count |
|---|---|
| Non-Hodgkin's Lymphoma (NHL) | 3 |
| Multiple Myeloma (MM) | 45 |
| All Participants | 48 |
Reported measurements
≤ Day 12
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM) | 8 | Not reported | Not reported | Not reported | Not reported |
| All Participants | 8 | Not reported | Not reported | Not reported | Not reported |
Day 13 to Day 21
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL) | 2 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM) | 25 | Not reported | Not reported | Not reported | Not reported |
| All Participants | 27 | Not reported | Not reported | Not reported | Not reported |
≥ Day 22
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL) | 1 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM) | 1 | Not reported | Not reported | Not reported | Not reported |
| All Participants | 2 | Not reported | Not reported | Not reported | Not reported |
Unknown
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM) | 11 | Not reported | Not reported | Not reported | Not reported |
| All Participants | 11 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 8
- title
- ≤ Day 12
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 25
- group Id
- OG002
- value
- 27
- title
- Day 13 to Day 21
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- title
- ≥ Day 22
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 11
- title
- Unknown
- denom Units Selected
- Participants
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 30
- group Id
- OG002
- value
- 33
- units
- Participants
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 45
- group Id
- OG002
- value
- 48
- 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)
- id
- OG002
- title
- All Participants
- param Type
- NUMBER
- population Description
- Participants who had transplants. Fifteen participants had tandem transplants. The date of initial PMN engraftment was missing for 11 transplants, which were later shown to have durable grafts.
- reporting Status
- POSTED
- time Frame
- 2 months
- title
- Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) 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