TriangleNCT00396266 · OUTCOME
Number of Participants Who Had a ≥ 2-fold Increase in Circulating CD34+ Cells
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Time 0 to 11 hours after the first dose of plerixafor
What was measured
To determine if NHL and MM patients mobilized with G-CSF (10 µg/kg QD) plus plerixafor will have a ≥2-fold increase in circulating CD34+ cells from time 0 to 11 hours after a dose of plerixafor.
Analysis population: The intent-to-treat population (defined as participants who received at least 1 dose of plerixafor). One participant excluded from the analysis because data was missing.
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) | 13 |
| Total | 21 |
Reported measurements
≥ 2-fold Increase
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL) | 8 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM) | 13 | Not reported | Not reported | Not reported | Not reported |
| Total | 21 | Not reported | Not reported | Not reported | Not reported |
< 2-fold Increase
| 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
- value
- 8
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 21
- title
- ≥ 2-fold Increase
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- < 2-fold Increase
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 21
- units
- Participants
- description
- To determine if NHL and MM patients mobilized with G-CSF (10 µg/kg QD) plus plerixafor will have a ≥2-fold increase in circulating CD34+ cells from time 0 to 11 hours after a dose of plerixafor.
- 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
- The intent-to-treat population (defined as participants who received at least 1 dose of plerixafor). One participant excluded from the analysis because data was missing.
- reporting Status
- POSTED
- time Frame
- Time 0 to 11 hours after the first dose of plerixafor
- title
- Number of Participants Who Had a ≥ 2-fold Increase in Circulating CD34+ Cells
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice