TriangleNCT02078102 · OUTCOME
Percent of Patients Who Mobilize and Collect at Least Half of the Total Target CD34+ Cell Dose in the First Apheresis
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- within 100 days of transplant
What was measured
Percent of patients who mobilize and collect at least half of the total target CD34+ cell dose in the first apheresis with binomial exact confidence intervals according to disease: Multiple myeloma patients: percent of patients with \>= 5x106 CD34 cells/kg in the first day's apheresis. Non-Hodgkin's lymphoma patients: percent of patients with \>= 2.5x106 CD34 cells/kg in the first day's apheresis.
Analysis population: Patients with available post-transplant CD34+ results.
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 | Source count |
|---|---|
| Multiple Myeloma | 25 |
| Non Hodgkins Lymphoma | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Multiple Myeloma | 32.0 | Not reported | 15.0 | 53.5 | Not reported |
| Non Hodgkins Lymphoma | 58.3 | Not reported | 27.7 | 84.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 15.0
- upper Limit
- 53.5
- value
- 32.0
- group Id
- OG001
- lower Limit
- 27.7
- upper Limit
- 84.8
- value
- 58.3
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 12
- units
- Participants
- description
- Percent of patients who mobilize and collect at least half of the total target CD34+ cell dose in the first apheresis with binomial exact confidence intervals according to disease: Multiple myeloma patients: percent of patients with \>= 5x106 CD34 cells/kg in the first day's apheresis. Non-Hodgkin's lymphoma patients: percent of patients with \>= 2.5x106 CD34 cells/kg in the first day's apheresis.
- dispersion Type
- 95% Confidence Interval
- 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
- NUMBER
- population Description
- Patients with available post-transplant CD34+ results.
- reporting Status
- POSTED
- time Frame
- within 100 days of transplant
- title
- Percent of Patients Who Mobilize and Collect at Least Half of the Total Target CD34+ Cell Dose in the First Apheresis
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice