TriangleNCT02003625 · OUTCOME
Number of Patients That Failed to Achieve Stem Cell Mobilization.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 6 days after the start of treatment or up to 12 days for multiple myeloma patients that received cyclophosphamide
What was measured
The number of patients that did not achieve CD34+ count of ≥ 4 x 10\^6 CD34+ cells/kg for multiple myeloma patients or ≥ 2 x 10\^6 CD34+ cells/kg for lymphoma patients.
Groups in this outcome
A. GCSF + Placebo
GCSF + Placebo Patients in this group will receive GCSF 10 ug/kg s.c. daily, beginning 4 days prior to the 1st apheresis \[days -4, -3, -2, -1\] and continued on daily GCSF for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected. They will also receive oral placebo for 5 days on days -6 through -2. Patients will undergo apheresis for 300 minutes to achieve approximately 3 to 4 whole blood volumes processed. This is a standard institutional protocol for autologous HSPC collection at the MGH. GCSF Placebo
B. GCSF + Meloxicam
B. GCSF + meloxicam: Patients in this group will be treated with meloxicam and GCSF in an approximate two-day staggered dose schedule as described in our preclinical studies. Meloxicam will be given orally at a dose of 15 mg/day for 5 days (days -6 through -2). GCSF at 10 ug/kg/day subcutaneously will be started on day -4 and continued daily for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected. GCSF meloxicam
| Group | Source count |
|---|---|
| A. GCSF + Placebo | 15 |
| B. GCSF + Meloxicam | 15 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| A. GCSF + Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
| B. GCSF + Meloxicam | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 15
- units
- Participants
- description
- The number of patients that did not achieve CD34+ count of ≥ 4 x 10\^6 CD34+ cells/kg for multiple myeloma patients or ≥ 2 x 10\^6 CD34+ cells/kg for lymphoma patients.
- groups
- description
- GCSF + Placebo Patients in this group will receive GCSF 10 ug/kg s.c. daily, beginning 4 days prior to the 1st apheresis \[days -4, -3, -2, -1\] and continued on daily GCSF for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected. They will also receive oral placebo for 5 days on days -6 through -2. Patients will undergo apheresis for 300 minutes to achieve approximately 3 to 4 whole blood volumes processed. This is a standard institutional protocol for autologous HSPC collection at the MGH. GCSF Placebo
- id
- OG000
- title
- A. GCSF + Placebo
- description
- B. GCSF + meloxicam: Patients in this group will be treated with meloxicam and GCSF in an approximate two-day staggered dose schedule as described in our preclinical studies. Meloxicam will be given orally at a dose of 15 mg/day for 5 days (days -6 through -2). GCSF at 10 ug/kg/day subcutaneously will be started on day -4 and continued daily for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected. GCSF meloxicam
- id
- OG001
- title
- B. GCSF + Meloxicam
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Up to 6 days after the start of treatment or up to 12 days for multiple myeloma patients that received cyclophosphamide
- title
- Number of Patients That Failed to Achieve Stem Cell Mobilization.
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice