TriangleNCT01009840 · OUTCOME
Percentage of Participants With Overall Disease Response at Month 6
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
- Not reported
- Time frame
- 6 Months
What was measured
The percentage of participants reported in each disease category by International Myeloma Working Group (IMWG) uniform response criteria for Multiple Myeloma 6 months after autologous Hematopoietic stem cell transplant. Overall Disease Response categories were: \[stringent Complete Response (sCR)=CR + normal Free Light Chain (FLC) ratio + absence of clonal cells in bone marrow\], \[Complete Response (CR)=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow\], \[Very Good Partial Response (VGPR)=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein + urine M-protein level \<100 mg/24 hour\], \[Partial Response (PR)=≥50% reduction of serum M-protein and reduction in 24 hour urine M-protein by ≥90% or to \<200 mg per 24 hour\], \[Stable Disease (SD)=Not meeting criteria for CR, VGPR, PR or progressive disease\] or \[Progressive Disease (PD)\].
Analysis population: Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.
Groups in this outcome
IV Busulfan
Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m\^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
| Group | Source count |
|---|---|
| IV Busulfan | 30 |
Reported measurements
sCR or CR or VGPR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| IV Busulfan | 20.0 | Not reported | Not reported | Not reported | Not reported |
PR or SD or PD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| IV Busulfan | 70.0 | Not reported | Not reported | Not reported | Not reported |
Not Assessed
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| IV Busulfan | 10.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 20.0
- title
- sCR or CR or VGPR
- categories
- measurements
- group Id
- OG000
- value
- 70.0
- title
- PR or SD or PD
- categories
- measurements
- group Id
- OG000
- value
- 10.0
- title
- Not Assessed
- denoms
- counts
- group Id
- OG000
- value
- 30
- units
- Participants
- description
- The percentage of participants reported in each disease category by International Myeloma Working Group (IMWG) uniform response criteria for Multiple Myeloma 6 months after autologous Hematopoietic stem cell transplant. Overall Disease Response categories were: \[stringent Complete Response (sCR)=CR + normal Free Light Chain (FLC) ratio + absence of clonal cells in bone marrow\], \[Complete Response (CR)=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow\], \[Very Good Partial Response (VGPR)=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein + urine M-protein level \<100 mg/24 hour\], \[Partial Response (PR)=≥50% reduction of serum M-protein and reduction in 24 hour urine M-protein by ≥90% or to \<200 mg per 24 hour\], \[Stable Disease (SD)=Not meeting criteria for CR, VGPR, PR or progressive disease\] or \[Progressive Disease (PD)\].
- groups
- description
- Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m\^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
- id
- OG000
- title
- IV Busulfan
- param Type
- NUMBER
- population Description
- Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.
- reporting Status
- POSTED
- time Frame
- 6 Months
- title
- Percentage of Participants With Overall Disease Response at Month 6
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice