TriangleNCT00792142 · OUTCOME
Count of Response in Patients Started on Maintenance Therapy
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Post-Thalidomide at 1 year.
What was measured
Complete Response (CR): Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \< 100mg per 24-h. Partial Response (PR): \> 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by \> 90% or to \< 200mg per 24-h In addition to the above listed criteria, if present at baseline, a . 50% reduction in the size of soft tissue plasmacytomas is also required. Stable Disease (SD): Not meeting criteria for CR, VGPR, PR or progressive disease. Relapse: Any of the following: Reappearance of serum or urine M-protein by immunofixation or electrophoresis Development of \> 5% plasma cells in the bone marrow. Appearance of any other sign of progression (i.e., new plasmacytoma, lytic bone lesion)
Analysis population: Five patients did not start the maintenance phase of the study because of neurotoxicity (n=3), thrombocytopenia (n=1), or withdrawal of consent (n=1).
Groups in this outcome
Treatment (Stem Cell Transplant, Maintenance Treatment)
Patients receive high-dose melphalan IV 200mg/m\^2 over 30 minutes on days -2 and -1 and undergo autologous peripheral blood stem cell transplantation (Minimum dose of 2 X 10(6) CD34 + cells/kg ) on day 0. Patients receive filgrastim 5ug/kg IV or SQ beginning on day 5 and continuing until blood counts recover. Beginning 4 to 8 weeks after transplantation, patients receive maintenance therapy comprising 1.3 mg/m\^2 of bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive 40mg of oral dexamethasone on days 1 to 4. Treatment with dexamethasone repeats every month for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of bortezomib, patients receive 50mg/day of oral thalidomide once daily until disease progression.
| Group | Source count |
|---|---|
| Treatment (Stem Cell Transplant, Maintenance Treatment) | 40 |
Reported measurements
Source class 1
CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Stem Cell Transplant, Maintenance Treatment) | 20 | Not reported | Not reported | Not reported | Not reported |
VPR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Stem Cell Transplant, Maintenance Treatment) | 2 | Not reported | Not reported | Not reported | Not reported |
PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Stem Cell Transplant, Maintenance Treatment) | 3 | Not reported | Not reported | Not reported | Not reported |
Relapsed
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Stem Cell Transplant, Maintenance Treatment) | 6 | Not reported | Not reported | Not reported | Not reported |
Not Assessed
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Stem Cell Transplant, Maintenance Treatment) | 9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 20
- title
- CR
- measurements
- group Id
- OG000
- value
- 2
- title
- VPR
- measurements
- group Id
- OG000
- value
- 3
- title
- PR
- measurements
- group Id
- OG000
- value
- 6
- title
- Relapsed
- measurements
- group Id
- OG000
- value
- 9
- title
- Not Assessed
- denoms
- counts
- group Id
- OG000
- value
- 40
- units
- Participants
- description
- Complete Response (CR): Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \< 100mg per 24-h. Partial Response (PR): \> 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by \> 90% or to \< 200mg per 24-h In addition to the above listed criteria, if present at baseline, a . 50% reduction in the size of soft tissue plasmacytomas is also required. Stable Disease (SD): Not meeting criteria for CR, VGPR, PR or progressive disease. Relapse: Any of the following: Reappearance of serum or urine M-protein by immunofixation or electrophoresis Development of \> 5% plasma cells in the bone marrow. Appearance of any other sign of progression (i.e., new plasmacytoma, lytic bone lesion)
- groups
- description
- Patients receive high-dose melphalan IV 200mg/m\^2 over 30 minutes on days -2 and -1 and undergo autologous peripheral blood stem cell transplantation (Minimum dose of 2 X 10(6) CD34 + cells/kg ) on day 0. Patients receive filgrastim 5ug/kg IV or SQ beginning on day 5 and continuing until blood counts recover. Beginning 4 to 8 weeks after transplantation, patients receive maintenance therapy comprising 1.3 mg/m\^2 of bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive 40mg of oral dexamethasone on days 1 to 4. Treatment with dexamethasone repeats every month for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of bortezomib, patients receive 50mg/day of oral thalidomide once daily until disease progression.
- id
- OG000
- title
- Treatment (Stem Cell Transplant, Maintenance Treatment)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Five patients did not start the maintenance phase of the study because of neurotoxicity (n=3), thrombocytopenia (n=1), or withdrawal of consent (n=1).
- reporting Status
- POSTED
- time Frame
- Post-Thalidomide at 1 year.
- title
- Count of Response in Patients Started on Maintenance Therapy
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice