TriangleNCT00920556 · OUTCOME
Number of Participants With Overall Response Rate
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
- Approximately up to 12 cycles of 3 weeks
What was measured
Overall response rate, defines proportion of participants with Complete response (CR), Partial response (PR) or Minimal response (MR) as best response for all cycles. In atleast 2 determinations for minimum of 6 week (Wks) for every criteria listed. CR defined as disappearance of original monoclonal (MC) paraprotein (PP) in blood and urine on immunofixation determinations (IFD); \< 5 % plasma cells in bone marrow; no increase in size or number of lytic bone lesions (LBLs); disappearance of soft tissue plasmacytomas (STP). PR defined as \>= 50% reduction (RE) in level of serum MC PP for 2 IFDs; if present RE in 24 hour urinary light chain excretion (ULCE) by \>= 90% RE or \<200 mg; \>= 50% RE in STP for; no increase in size or number of LBLs. MR criteria defined were \>= 25% to \<=49% RE serum MC PP; if present 50 to 89% RE in 24 hour LCE exceeding 200 mg/24 hour; 25% to 49% RE in size of STP; no increase in size or number of LBLs.
Analysis population: Modified Intent to Treat (mITT), had participants who completed first (2) cycles of SRT501 monotherapy. Participants dropped were not counted; those withdrew after 2nd cycle were considered evaluable regardless of discontinuation reason; alongwith participants discontinued for missing clinical trial material after 2 cycle, were considered.
Groups in this outcome
SRT501 Monotherapy
The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.
SRT501 + Bortezomib
The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy.
| Group | Source count |
|---|---|
| SRT501 Monotherapy | 4 |
| SRT501 + Bortezomib | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SRT501 Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| SRT501 + Bortezomib | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 9
- units
- Participants
- description
- Overall response rate, defines proportion of participants with Complete response (CR), Partial response (PR) or Minimal response (MR) as best response for all cycles. In atleast 2 determinations for minimum of 6 week (Wks) for every criteria listed. CR defined as disappearance of original monoclonal (MC) paraprotein (PP) in blood and urine on immunofixation determinations (IFD); \< 5 % plasma cells in bone marrow; no increase in size or number of lytic bone lesions (LBLs); disappearance of soft tissue plasmacytomas (STP). PR defined as \>= 50% reduction (RE) in level of serum MC PP for 2 IFDs; if present RE in 24 hour urinary light chain excretion (ULCE) by \>= 90% RE or \<200 mg; \>= 50% RE in STP for; no increase in size or number of LBLs. MR criteria defined were \>= 25% to \<=49% RE serum MC PP; if present 50 to 89% RE in 24 hour LCE exceeding 200 mg/24 hour; 25% to 49% RE in size of STP; no increase in size or number of LBLs.
- groups
- description
- The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.
- id
- OG000
- title
- SRT501 Monotherapy
- description
- The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy.
- id
- OG001
- title
- SRT501 + Bortezomib
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Modified Intent to Treat (mITT), had participants who completed first (2) cycles of SRT501 monotherapy. Participants dropped were not counted; those withdrew after 2nd cycle were considered evaluable regardless of discontinuation reason; alongwith participants discontinued for missing clinical trial material after 2 cycle, were considered.
- reporting Status
- POSTED
- time Frame
- Approximately up to 12 cycles of 3 weeks
- title
- Number of Participants With Overall Response Rate
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice