TriangleNCT00724568 · OUTCOME
The Percentage of Patients That Achieved Partial or Complete Response to Treatment.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of patients
- Interval / dispersion
- Not reported
- Time frame
- 24 weeks (8, 21-day cycles)
What was measured
Partial Response: * 50% reduction in the level of serum monoclonal protein for at least two determinations six weeks apart. * If present, reduction in 24-hour urinary light chain excretion by either, greater than or equal to 90%, or to \<200 mg for at least two determinations six weeks apart. * 50% reduction in the size of soft tissue plasmacytomas (by clinical or radiographic examination) for at least six weeks. * No increase in size or number of lytic bone lesions (development of compression fracture does not exclude response). Complete Response: * Disappearance of the original monoclonal protein from the blood and urine on at least two determinations for a minimum of six weeks. * \<5% plasma cells in the bone marrow on at least two determinations for a minimum of six weeks. * No increase in the size or number of lytic bone lesions.
Analysis population: 74 patients were enrolled, but 2 were not evaluable for dose limiting toxicities. 72 patients were included in this analysis.
Groups in this outcome
Combination Drug Therapy
Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
| Group | Source count |
|---|---|
| Combination Drug Therapy | 72 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination Drug Therapy | 96 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 96
- denoms
- counts
- group Id
- OG000
- value
- 72
- units
- Participants
- description
- Partial Response: * 50% reduction in the level of serum monoclonal protein for at least two determinations six weeks apart. * If present, reduction in 24-hour urinary light chain excretion by either, greater than or equal to 90%, or to \<200 mg for at least two determinations six weeks apart. * 50% reduction in the size of soft tissue plasmacytomas (by clinical or radiographic examination) for at least six weeks. * No increase in size or number of lytic bone lesions (development of compression fracture does not exclude response). Complete Response: * Disappearance of the original monoclonal protein from the blood and urine on at least two determinations for a minimum of six weeks. * \<5% plasma cells in the bone marrow on at least two determinations for a minimum of six weeks. * No increase in the size or number of lytic bone lesions.
- groups
- description
- Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
- id
- OG000
- title
- Combination Drug Therapy
- param Type
- NUMBER
- population Description
- 74 patients were enrolled, but 2 were not evaluable for dose limiting toxicities. 72 patients were included in this analysis.
- reporting Status
- POSTED
- time Frame
- 24 weeks (8, 21-day cycles)
- title
- The Percentage of Patients That Achieved Partial or Complete Response to Treatment.
- type
- SECONDARY
- unit Of Measure
- percentage of patients
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice