TriangleNCT00920556 · OUTCOME
Number of Participants With Progressive Disease (PD) PD as Best Response (BR)
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
- Up to 12 cycles of 3 weeks each
What was measured
PD includes one or more of the following criteria: \>25% increase in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation, \>25% increase in 24 hr urinary light chain excretion, which must also be an absolute increase of at least 200 mg/24 hr and confirmed on a repeat investigation, \>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%., Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas, Development of new bone lesions or soft tissue plasmacytomas (not including compression fracture), Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL or 2.8 mmol/L not attributable to any other cause).
Analysis population: mITT Population.
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 | 1 | Not reported | Not reported | Not reported | Not reported |
| SRT501 + Bortezomib | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 9
- units
- Participants
- description
- PD includes one or more of the following criteria: \>25% increase in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation, \>25% increase in 24 hr urinary light chain excretion, which must also be an absolute increase of at least 200 mg/24 hr and confirmed on a repeat investigation, \>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%., Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas, Development of new bone lesions or soft tissue plasmacytomas (not including compression fracture), Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL or 2.8 mmol/L not attributable to any other cause).
- 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
- mITT Population.
- reporting Status
- POSTED
- time Frame
- Up to 12 cycles of 3 weeks each
- title
- Number of Participants With Progressive Disease (PD) PD as Best Response (BR)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice