TriangleNCT00790647 · OUTCOME
Number of Participants With Hematologic Response
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
- one year
What was measured
complete and partial hematologic response defined as: Complete response: absence of detectable monoclonal protein in serum and urine, and bone marrow biopsy \<5% plasma cells with no clonal predominance of kappa or lambda isotype. Partial response: any one of the following 1. For patients with detectable and quantifiable marrow plasmacytosis, a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. 2. For patients with a detectable monoclonal peak on serum protein electropheresis or urine protein electropheresis, a reduction in the peak height of 50% or more. 3. For patients with quantifiable urinary kappa or lambda chain concentration, a reduction in daily light chain excretion (concentration x 24-hr urine volume).
Groups in this outcome
Stem Cell Transplant With Bortezomib and Melphalan
Mobilization with Filgrastim Stem Cell Collection Bortezomib Melphalan Stem Cell infusion filgrastim: 16 mcg/kg daily beginning 3 days before Stem Cell Collectionthrough day before final Stem Cell Collection bortezomib: 1.0 mg/m2/dose D -6, D-3, D +1, D + 4 melphalan: 100 mg/m2/dose D -2, D -1 Stem Cell Infusion: infusion of previously collected autologous stem cells
| Group | Source count |
|---|---|
| Stem Cell Transplant With Bortezomib and Melphalan | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stem Cell Transplant With Bortezomib and Melphalan | 6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6
- denoms
- counts
- group Id
- OG000
- value
- 9
- units
- Participants
- description
- complete and partial hematologic response defined as: Complete response: absence of detectable monoclonal protein in serum and urine, and bone marrow biopsy \<5% plasma cells with no clonal predominance of kappa or lambda isotype. Partial response: any one of the following 1. For patients with detectable and quantifiable marrow plasmacytosis, a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. 2. For patients with a detectable monoclonal peak on serum protein electropheresis or urine protein electropheresis, a reduction in the peak height of 50% or more. 3. For patients with quantifiable urinary kappa or lambda chain concentration, a reduction in daily light chain excretion (concentration x 24-hr urine volume).
- groups
- description
- Mobilization with Filgrastim Stem Cell Collection Bortezomib Melphalan Stem Cell infusion filgrastim: 16 mcg/kg daily beginning 3 days before Stem Cell Collectionthrough day before final Stem Cell Collection bortezomib: 1.0 mg/m2/dose D -6, D-3, D +1, D + 4 melphalan: 100 mg/m2/dose D -2, D -1 Stem Cell Infusion: infusion of previously collected autologous stem cells
- id
- OG000
- title
- Stem Cell Transplant With Bortezomib and Melphalan
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- one year
- title
- Number of Participants With Hematologic Response
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice