TriangleNCT00135200 · OUTCOME
Number of Participants With Complete Response (CR)
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
- 6 months
What was measured
Determine the rate of conversion to complete response (CR). CR requires all of the following: * Absence of the original monoclonal protein in serum and urine on at least 2 determinations by immunofixation. The presence of oligoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR. * Less than 5% plasma cells in the bone marrow on at least 2 determinations. Repeat bone marrow is not required for patients with secretory myeloma who have sustained absence of monoclonal protein on immunofixation. * No increase in size or number of lytic bone lesions (development of a compression fracture does not exclude response). * Disappearance of all soft tissue plasmacytomas. * Patients in whom some, but not all the criteria for CR are fulfilled are classified as nCR or PR or VGPR (see below), providing the remaining criteria for nCR, VGPR, or PR are satisfied.
Groups in this outcome
Bexxar Therapeutic
The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the "dosimetric" infusion and the "therapeutic" infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose.
| Group | Source count |
|---|---|
| Bexxar Therapeutic | 16 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bexxar Therapeutic | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 16
- units
- Participants
- description
- Determine the rate of conversion to complete response (CR). CR requires all of the following: * Absence of the original monoclonal protein in serum and urine on at least 2 determinations by immunofixation. The presence of oligoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR. * Less than 5% plasma cells in the bone marrow on at least 2 determinations. Repeat bone marrow is not required for patients with secretory myeloma who have sustained absence of monoclonal protein on immunofixation. * No increase in size or number of lytic bone lesions (development of a compression fracture does not exclude response). * Disappearance of all soft tissue plasmacytomas. * Patients in whom some, but not all the criteria for CR are fulfilled are classified as nCR or PR or VGPR (see below), providing the remaining criteria for nCR, VGPR, or PR are satisfied.
- groups
- description
- The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the "dosimetric" infusion and the "therapeutic" infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose.
- id
- OG000
- title
- Bexxar Therapeutic
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 6 months
- title
- Number of Participants With Complete Response (CR)
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice