TriangleNCT00642954 · OUTCOME
Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD)
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 ~55 months (through pre-specified final statistical analysis cut-off date of 3-Sep-2012)
What was measured
Best overall tumor response consisted of CR (negative M-protein immunofixation \[IF\], \<5% bone marrow \[BM\] plasma cells, no soft tissue plasmacytomas \[STP\]), NCR (positive M-protein IF, \<5% BM plasma cells, no STP), VGPR (≥90% M-protein decrease, \<5% BM plasma cells, no STP), PR (≥50% M-protein, BM plasma cells, STP decrease), MR (25-49% M-protein, BM plasma cells, STP decrease), SD (\<25% decrease-25% increase in M-protein, BM plasma cells; \<25% decrease-increase in definite STP) or PD (≥25% M-protein, BM plasma cells increase; new STP, lesions). Per protocol participants experiencing best overall response by CR, NCR, VGPR, PR, MR, SD or PD were analyzed as a single prespecified analysis at the time of protocol-specified final statistical analysis with a 3-Sep-2012 data cut-off. The number of participants experiencing best overall response by CR, NCR, VGPR, PR, MR, SD or PD is reported here for all participants who got ≥1 dose of study drug and had a post baseline efficacy assessment.
Analysis population: All participants who received ≥1 dose of study treatment and had a post baseline efficacy assessment.
Groups in this outcome
Level 1: Vorinostat 300 mg + Lenalidomide 10 mg
Participants received vorinostat 300 mg orally once-daily (QD) on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
Level 2: Vorinostat 400 mg + Lenalidomide 10 mg
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
Level 3: Vorinostat 400 mg + Lenalidomide 15 mg
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 15 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
Level 4: Vorinostat 400 mg + Lenalidomide 20 mg
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 20 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
Level 5: Vorinostat 400 mg + Lenalidomide 25 mg
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 25 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle. Treatment continued until progressive disease or unacceptable toxicity.
| Group | Source count |
|---|---|
| Level 1: Vorinostat 300 mg + Lenalidomide 10 mg | 4 |
| Level 2: Vorinostat 400 mg + Lenalidomide 10 mg | 4 |
| Level 3: Vorinostat 400 mg + Lenalidomide 15 mg | 3 |
| Level 4: Vorinostat 400 mg + Lenalidomide 20 mg | 3 |
| Level 5: Vorinostat 400 mg + Lenalidomide 25 mg | 16 |
Reported measurements
CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Level 1: Vorinostat 300 mg + Lenalidomide 10 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Level 2: Vorinostat 400 mg + Lenalidomide 10 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Level 3: Vorinostat 400 mg + Lenalidomide 15 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Level 4: Vorinostat 400 mg + Lenalidomide 20 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Level 5: Vorinostat 400 mg + Lenalidomide 25 mg | 1 | Not reported | Not reported | Not reported | Not reported |
NCR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Level 1: Vorinostat 300 mg + Lenalidomide 10 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Level 2: Vorinostat 400 mg + Lenalidomide 10 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Level 3: Vorinostat 400 mg + Lenalidomide 15 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Level 4: Vorinostat 400 mg + Lenalidomide 20 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Level 5: Vorinostat 400 mg + Lenalidomide 25 mg | 0 | Not reported | Not reported | Not reported | Not reported |
VGPR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Level 1: Vorinostat 300 mg + Lenalidomide 10 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Level 2: Vorinostat 400 mg + Lenalidomide 10 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Level 3: Vorinostat 400 mg + Lenalidomide 15 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Level 4: Vorinostat 400 mg + Lenalidomide 20 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Level 5: Vorinostat 400 mg + Lenalidomide 25 mg | 2 | Not reported | Not reported | Not reported | Not reported |
PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Level 1: Vorinostat 300 mg + Lenalidomide 10 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Level 2: Vorinostat 400 mg + Lenalidomide 10 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Level 3: Vorinostat 400 mg + Lenalidomide 15 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Level 4: Vorinostat 400 mg + Lenalidomide 20 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Level 5: Vorinostat 400 mg + Lenalidomide 25 mg | 5 | Not reported | Not reported | Not reported | Not reported |
MR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Level 1: Vorinostat 300 mg + Lenalidomide 10 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Level 2: Vorinostat 400 mg + Lenalidomide 10 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Level 3: Vorinostat 400 mg + Lenalidomide 15 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Level 4: Vorinostat 400 mg + Lenalidomide 20 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Level 5: Vorinostat 400 mg + Lenalidomide 25 mg | 2 | Not reported | Not reported | Not reported | Not reported |
SD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Level 1: Vorinostat 300 mg + Lenalidomide 10 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Level 2: Vorinostat 400 mg + Lenalidomide 10 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Level 3: Vorinostat 400 mg + Lenalidomide 15 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Level 4: Vorinostat 400 mg + Lenalidomide 20 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Level 5: Vorinostat 400 mg + Lenalidomide 25 mg | 5 | Not reported | Not reported | Not reported | Not reported |
PD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Level 1: Vorinostat 300 mg + Lenalidomide 10 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Level 2: Vorinostat 400 mg + Lenalidomide 10 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Level 3: Vorinostat 400 mg + Lenalidomide 15 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Level 4: Vorinostat 400 mg + Lenalidomide 20 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Level 5: Vorinostat 400 mg + Lenalidomide 25 mg | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- title
- CR
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- NCR
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 2
- title
- VGPR
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 5
- title
- PR
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 2
- title
- MR
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 5
- title
- SD
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- title
- PD
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 16
- units
- Participants
- description
- Best overall tumor response consisted of CR (negative M-protein immunofixation \[IF\], \<5% bone marrow \[BM\] plasma cells, no soft tissue plasmacytomas \[STP\]), NCR (positive M-protein IF, \<5% BM plasma cells, no STP), VGPR (≥90% M-protein decrease, \<5% BM plasma cells, no STP), PR (≥50% M-protein, BM plasma cells, STP decrease), MR (25-49% M-protein, BM plasma cells, STP decrease), SD (\<25% decrease-25% increase in M-protein, BM plasma cells; \<25% decrease-increase in definite STP) or PD (≥25% M-protein, BM plasma cells increase; new STP, lesions). Per protocol participants experiencing best overall response by CR, NCR, VGPR, PR, MR, SD or PD were analyzed as a single prespecified analysis at the time of protocol-specified final statistical analysis with a 3-Sep-2012 data cut-off. The number of participants experiencing best overall response by CR, NCR, VGPR, PR, MR, SD or PD is reported here for all participants who got ≥1 dose of study drug and had a post baseline efficacy assessment.
- groups
- description
- Participants received vorinostat 300 mg orally once-daily (QD) on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
- id
- OG000
- title
- Level 1: Vorinostat 300 mg + Lenalidomide 10 mg
- description
- Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
- id
- OG001
- title
- Level 2: Vorinostat 400 mg + Lenalidomide 10 mg
- description
- Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 15 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
- id
- OG002
- title
- Level 3: Vorinostat 400 mg + Lenalidomide 15 mg
- description
- Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 20 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
- id
- OG003
- title
- Level 4: Vorinostat 400 mg + Lenalidomide 20 mg
- description
- Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 25 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle. Treatment continued until progressive disease or unacceptable toxicity.
- id
- OG004
- title
- Level 5: Vorinostat 400 mg + Lenalidomide 25 mg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All participants who received ≥1 dose of study treatment and had a post baseline efficacy assessment.
- reporting Status
- POSTED
- time Frame
- Up to ~55 months (through pre-specified final statistical analysis cut-off date of 3-Sep-2012)
- title
- Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD)
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice