TriangleNCT00477971 · OUTCOME
Hematologic Response Rate
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
- 10 years
What was measured
Response that was confirmed on 2 consecutive evaluations during treatment. A hematologic response consisted of a Complete response, Very Good Partial Response or Partial Response. * Complete Response (CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and \<5% plasma cells in bone marrow. * Very Good Partial Response (VGPR): \>=90% reduction in serum M-component; Urine M-Component \<=100 mg per 24 hours. * Partial Response (PR): \>=50% reduction in serum M-component and/or Urine M-Component \>=90% reduction or \<200 mg per 24 hours; or \>=50% decrease in difference between involved and uninvolved FLC levels.
Groups in this outcome
Low-Dose Melphalan
Patients receive low-dose melphalan 20 mg/m\^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
High-Dose Melphalan + Autologous HSC
Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m\^2 IV for low risk or 200 mg/m\^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
| Group | Source count |
|---|---|
| Low-Dose Melphalan | 34 |
| High-Dose Melphalan + Autologous HSC | 55 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Low-Dose Melphalan | 55.9 | Not reported | 37.9 | 72.8 | Not reported |
| High-Dose Melphalan + Autologous HSC | 69.1 | Not reported | 55.2 | 80.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 37.9
- upper Limit
- 72.8
- value
- 55.9
- group Id
- OG001
- lower Limit
- 55.2
- upper Limit
- 80.9
- value
- 69.1
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 55
- units
- Participants
- description
- Response that was confirmed on 2 consecutive evaluations during treatment. A hematologic response consisted of a Complete response, Very Good Partial Response or Partial Response. * Complete Response (CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and \<5% plasma cells in bone marrow. * Very Good Partial Response (VGPR): \>=90% reduction in serum M-component; Urine M-Component \<=100 mg per 24 hours. * Partial Response (PR): \>=50% reduction in serum M-component and/or Urine M-Component \>=90% reduction or \<200 mg per 24 hours; or \>=50% decrease in difference between involved and uninvolved FLC levels.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive low-dose melphalan 20 mg/m\^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
- id
- OG000
- title
- Low-Dose Melphalan
- description
- Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m\^2 IV for low risk or 200 mg/m\^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
- id
- OG001
- title
- High-Dose Melphalan + Autologous HSC
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 10 years
- title
- Hematologic Response Rate
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice