NCT00322387 · OUTCOME
Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ratio
- Interval / dispersion
- Standard Deviation
- Time frame
- Days 4-5 (first dose of plerixafor to apheresis)
What was measured
The fold increase was measured by fluorescence activated cell sorting (FACS) analysis and was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).
Analysis population: Intent to treat population. One participant in the Non-Hodgkin's Lymphoma (NHL): Plerixafor AM treatment group and 3 participants in the Multiple Myeloma (MM): Plerixafor After Chemo treatment group did not have samples taken for PB CD34+ cell counts on Day 1 and therefore could not be included.
Groups in this outcome
Non-Hodgkin's Lymphoma (NHL): Plerixafor PM
Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
Non-Hodgkin's Lymphoma (NHL): Plerixafor AM
Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo
Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached \>= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.
Multiple Myeloma (MM): Plerixafor PM
Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
Multiple Myeloma (MM): Plerixafor AM
Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM
Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of \>=10 cells/µL but \<20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.
Multiple Myeloma (MM): Plerixafor After Chemo
Participants with MM who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached \>= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.
| Group | Source count |
|---|---|
| Non-Hodgkin's Lymphoma (NHL): Plerixafor PM | 7 |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor AM | 5 |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo | 1 |
| Multiple Myeloma (MM): Plerixafor PM | 12 |
| Multiple Myeloma (MM): Plerixafor AM | 9 |
| Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM | 1 |
| Multiple Myeloma (MM): Plerixafor After Chemo | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL): Plerixafor PM | 2.2 | 0.8 | Not reported | Not reported | Not reported |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor AM | 1.5 | 0.8 | Not reported | Not reported | Not reported |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo | 1.2 | 0.0 | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM): Plerixafor PM | 1.8 | 0.4 | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM): Plerixafor AM | 6.5 | 14.7 | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM | 24.0 | 0.0 | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM): Plerixafor After Chemo | 3.1 | 0.0 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.8
- value
- 2.2
- group Id
- OG001
- spread
- 0.8
- value
- 1.5
- group Id
- OG002
- spread
- 0.0
- value
- 1.2
- group Id
- OG003
- spread
- 0.4
- value
- 1.8
- group Id
- OG004
- spread
- 14.7
- value
- 6.5
- group Id
- OG005
- spread
- 0.0
- value
- 24.0
- group Id
- OG006
- spread
- 0.0
- value
- 3.1
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 9
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 1
- units
- Participants
- description
- The fold increase was measured by fluorescence activated cell sorting (FACS) analysis and was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).
- dispersion Type
- Standard Deviation
- groups
- description
- Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
- id
- OG000
- title
- Non-Hodgkin's Lymphoma (NHL): Plerixafor PM
- description
- Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
- id
- OG001
- title
- Non-Hodgkin's Lymphoma (NHL): Plerixafor AM
- description
- Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached \>= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.
- id
- OG002
- title
- Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo
- description
- Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
- id
- OG003
- title
- Multiple Myeloma (MM): Plerixafor PM
- description
- Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
- id
- OG004
- title
- Multiple Myeloma (MM): Plerixafor AM
- description
- Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of \>=10 cells/µL but \<20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.
- id
- OG005
- title
- Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM
- description
- Participants with MM who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached \>= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.
- id
- OG006
- title
- Multiple Myeloma (MM): Plerixafor After Chemo
- param Type
- MEAN
- population Description
- Intent to treat population. One participant in the Non-Hodgkin's Lymphoma (NHL): Plerixafor AM treatment group and 3 participants in the Multiple Myeloma (MM): Plerixafor After Chemo treatment group did not have samples taken for PB CD34+ cell counts on Day 1 and therefore could not be included.
- reporting Status
- POSTED
- time Frame
- Days 4-5 (first dose of plerixafor to apheresis)
- title
- Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL
- type
- SECONDARY
- unit Of Measure
- ratio
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