NCT02078102 · OUTCOME
Summary Statistics for Graft Composition of Peripheral Blood Stem Cell Collection at Each Time Point
A Phase II Trial Using Meloxicam Plus Filgrastim in Patients With Multiple Myeloma and Non-Hodgkin's Lymphoma · Source last updated 2021-02-21
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- x10^6cells/kg
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycle 2, Days 1-4, within 100 days of transplant
What was measured
Mean and Standard Deviation of the Graft Composition of Peripheral Blood Stem Cell Collection (CD34 (x10\^6cells/kg)) at each time point collected during Cycle 2.
Analysis population: Patients with available post-transplant CD34 (x10\^6/kg) data.
Groups in this outcome
Multiple Myeloma
This is for the patients with Multiple Myeloma.
Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.
15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.
10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.
Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.
Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
Non Hodgkins Lymphoma
This is for the patients with Non Hodgkins Lymphoma.
Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.
15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.
10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.
Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.
Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Multiple Myeloma | 25 |
|---|
| Non Hodgkins Lymphoma | 12 |
|---|
Reported measurements
Cycle 2 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Multiple Myeloma | 25 |
|---|
| Non Hodgkins Lymphoma | 12 |
|---|
Values in x10^6cells/kg · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Multiple Myeloma | 3.42 | 2.72 | Not reported | Not reported | Not reported |
|---|
| Non Hodgkins Lymphoma | 3.22 | 2.20 | Not reported | Not reported | Not reported |
|---|
Cycle 2 Day 2
Analysis denominator · Participants
| Group | Source count |
|---|
| Multiple Myeloma | 23 |
|---|
| Non Hodgkins Lymphoma | 9 |
|---|
Values in x10^6cells/kg · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Multiple Myeloma | 4.92 | 2.86 | Not reported | Not reported | Not reported |
|---|
| Non Hodgkins Lymphoma | 3.51 | 2.67 | Not reported | Not reported | Not reported |
|---|
Cycle 2 Day 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Multiple Myeloma | 9 |
|---|
| Non Hodgkins Lymphoma | 3 |
|---|
Values in x10^6cells/kg · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Multiple Myeloma | 2.63 | 1.70 | Not reported | Not reported | Not reported |
|---|
| Non Hodgkins Lymphoma | 0.89 | 0.45 | Not reported | Not reported | Not reported |
|---|
Cycle 2 Day 4
Analysis denominator · Participants
| Group | Source count |
|---|
| Multiple Myeloma | 2 |
|---|
| Non Hodgkins Lymphoma | 1 |
|---|
Values in x10^6cells/kg · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Multiple Myeloma | 1.55 | 0.35 | Not reported | Not reported | Not reported |
|---|
| Non Hodgkins Lymphoma | 0.90 | NA | Not reported | Not reported | Only 1 patient had a result at this time point and the standard deviation was not calculated. |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 2.72
- value
- 3.42
- group Id
- OG001
- spread
- 2.20
- value
- 3.22
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 12
- units
- Participants
- title
- Cycle 2 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 2.86
- value
- 4.92
- group Id
- OG001
- spread
- 2.67
- value
- 3.51
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 9
- units
- Participants
- title
- Cycle 2 Day 2
- categories
- measurements
- group Id
- OG000
- spread
- 1.70
- value
- 2.63
- group Id
- OG001
- spread
- 0.45
- value
- 0.89
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 3
- units
- Participants
- title
- Cycle 2 Day 3
- categories
- measurements
- group Id
- OG000
- spread
- 0.35
- value
- 1.55
- comment
- Only 1 patient had a result at this time point and the standard deviation was not calculated.
- group Id
- OG001
- spread
- NA
- value
- 0.90
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- units
- Participants
- title
- Cycle 2 Day 4
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 12
- units
- Participants
- description
- Mean and Standard Deviation of the Graft Composition of Peripheral Blood Stem Cell Collection (CD34 (x10\^6cells/kg)) at each time point collected during Cycle 2.
- dispersion Type
- Standard Deviation
- groups
- description
- This is for the patients with Multiple Myeloma.
Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.
15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.
10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.
Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.
Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
- id
- OG000
- title
- Multiple Myeloma
- description
- This is for the patients with Non Hodgkins Lymphoma.
Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.
15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.
10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.
Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.
Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
- id
- OG001
- title
- Non Hodgkins Lymphoma
- param Type
- MEAN
- population Description
- Patients with available post-transplant CD34 (x10\^6/kg) data.
- reporting Status
- POSTED
- time Frame
- Cycle 2, Days 1-4, within 100 days of transplant
- title
- Summary Statistics for Graft Composition of Peripheral Blood Stem Cell Collection at Each Time Point
- type
- SECONDARY
- unit Of Measure
- x10^6cells/kg
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