TriangleNCT00679367 · 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 hematologic response: Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, bone marrow biopsy with less than 5% plasma cells without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay. Partial hematologic response: Amyloid patients have highly individualized measures of disease burden. For patients with detectable and quantifiable monoclonal marrow plasmacytosis, a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. For patients with a detectable monoclonal peak on serum or urine protein electrophoresis, a reduction in the peak height of 50% or more. For patients with quantifiable urinary kappa or lambda chain concentration, a 50% reduction in daily light chain excretion (concentration x 24 hour urine volume). For patients with an elevated serum free light chain assay, reduction of 50% or more.
Analysis population: Participants who completed at least 3 cycles of treatment
Groups in this outcome
Melphalan Revlimid and Dexamethasone
Melphalan Lenalidomide Dexamethasone dexamethasone: 40 mg once weekly lenalidomide: 10 mg/day Days 1-21 melphalan: 5 mg/m2 Days 1-4
| Group | Source count |
|---|---|
| Melphalan Revlimid and Dexamethasone | 14 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Melphalan Revlimid and Dexamethasone | 7 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 7
- denoms
- counts
- group Id
- OG000
- value
- 14
- units
- Participants
- description
- Complete hematologic response: Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, bone marrow biopsy with less than 5% plasma cells without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay. Partial hematologic response: Amyloid patients have highly individualized measures of disease burden. For patients with detectable and quantifiable monoclonal marrow plasmacytosis, a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. For patients with a detectable monoclonal peak on serum or urine protein electrophoresis, a reduction in the peak height of 50% or more. For patients with quantifiable urinary kappa or lambda chain concentration, a 50% reduction in daily light chain excretion (concentration x 24 hour urine volume). For patients with an elevated serum free light chain assay, reduction of 50% or more.
- groups
- description
- Melphalan Lenalidomide Dexamethasone dexamethasone: 40 mg once weekly lenalidomide: 10 mg/day Days 1-21 melphalan: 5 mg/m2 Days 1-4
- id
- OG000
- title
- Melphalan Revlimid and Dexamethasone
- param Type
- NUMBER
- population Description
- Participants who completed at least 3 cycles of treatment
- 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