TriangleNCT00743288 · OUTCOME
Overall Response Rate (ORR) and Clinical Benefit Rate (CBR) [ORR= Complete Response (CR) + Very Good Partial Response (VGPR) + Partial Response (PR)]; CBR=ORR + Minimal Response (MR)] Following Treatment With Panobinostat and Melphalan
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- 24 months
What was measured
Responses were evaluated according to criteria modified from those developed by Blade et al., 1998 The reference point for evaluating response improvement is the baseline. This baseline reference point is also valid when a patient has already achieved a response and transitions through into a better response grade.
Groups in this outcome
Melphalan and Panobinostat Schedule A
10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.
Melphalan and Panobinostat Schedule B
Schedules B1 and B2 B1: 10 mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 of a 28 day schedule and 0.04 mg/kg melphalan on days 1, 3 and 5 of week 1. B2:20 mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 of a 28 day schedule and 0.04 mg/kg melphalan on days 1, 3 and 5 of week 1
Melphalan and Panobinostat Schedule C
0.05 mg/kg melphalan on days 1, 3 and 5 of week 1 and 20 mg of LBH589 on days 1, 3, and 5 of weeks 1 and 2.
Melphalan and Panobinostat Schedule D
Schedules D1, D2 and D3 D1:LBH589 15mg/daily and melphalan 0.05mg/kg on days 1, 3 and 5 of week 1 D2: LBH589 15mg and daily melphalan 0.10 mg/kg on days 1, 3 and 5 of week 1 D3: LBH589 20mg daily and melphalan 0.05mg/kg on days days 1, 3 and 5 of week 1
Melphalan and Panobinostat All Patients
Data for all patients irrespective of dosage
| Group | Source count |
|---|---|
| Melphalan and Panobinostat Schedule A | 3 |
| Melphalan and Panobinostat Schedule B | 9 |
| Melphalan and Panobinostat Schedule C | 7 |
| Melphalan and Panobinostat Schedule D | 21 |
| Melphalan and Panobinostat All Patients | 40 |
Reported measurements
CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Melphalan and Panobinostat Schedule A | 0 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat Schedule B | 0 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat Schedule C | 0 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat Schedule D | 0 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat All Patients | 0 | Not reported | Not reported | Not reported | Not reported |
VGPR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Melphalan and Panobinostat Schedule A | 0 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat Schedule B | 2 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat Schedule C | 0 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat Schedule D | 0 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat All Patients | 2 | Not reported | Not reported | Not reported | Not reported |
PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Melphalan and Panobinostat Schedule A | 0 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat Schedule B | 1 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat Schedule C | 0 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat Schedule D | 0 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat All Patients | 1 | Not reported | Not reported | Not reported | Not reported |
MR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Melphalan and Panobinostat Schedule A | 0 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat Schedule B | 0 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat Schedule C | 0 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat Schedule D | 0 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat All Patients | 0 | Not reported | Not reported | Not reported | Not reported |
SD (stable disease)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Melphalan and Panobinostat Schedule A | 1 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat Schedule B | 5 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat Schedule C | 5 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat Schedule D | 12 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat All Patients | 23 | Not reported | Not reported | Not reported | Not reported |
Progressive disease (PD)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Melphalan and Panobinostat Schedule A | 2 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat Schedule B | 1 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat Schedule C | 2 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat Schedule D | 9 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat All Patients | 14 | Not reported | Not reported | Not reported | Not reported |
ORR (CR+VGPR+ PR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Melphalan and Panobinostat Schedule A | 0 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat Schedule B | 3 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat Schedule C | 0 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat Schedule D | 0 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat All Patients | 3 | Not reported | Not reported | Not reported | Not reported |
CBR (ORR+MR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Melphalan and Panobinostat Schedule A | 0 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat Schedule B | 3 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat Schedule C | 0 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat Schedule D | 0 | Not reported | Not reported | Not reported | Not reported |
| Melphalan and Panobinostat All Patients | 3 | 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
- 0
- title
- CR
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 2
- title
- VGPR
- 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
- 1
- title
- PR
- 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
- 0
- title
- MR
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 23
- title
- SD (stable disease)
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 14
- title
- Progressive disease (PD)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 3
- title
- ORR (CR+VGPR+ PR)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 3
- title
- CBR (ORR+MR)
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 21
- group Id
- OG004
- value
- 40
- units
- Participants
- description
- Responses were evaluated according to criteria modified from those developed by Blade et al., 1998 The reference point for evaluating response improvement is the baseline. This baseline reference point is also valid when a patient has already achieved a response and transitions through into a better response grade.
- groups
- description
- 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.
- id
- OG000
- title
- Melphalan and Panobinostat Schedule A
- description
- Schedules B1 and B2 B1: 10 mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 of a 28 day schedule and 0.04 mg/kg melphalan on days 1, 3 and 5 of week 1. B2:20 mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 of a 28 day schedule and 0.04 mg/kg melphalan on days 1, 3 and 5 of week 1
- id
- OG001
- title
- Melphalan and Panobinostat Schedule B
- description
- 0.05 mg/kg melphalan on days 1, 3 and 5 of week 1 and 20 mg of LBH589 on days 1, 3, and 5 of weeks 1 and 2.
- id
- OG002
- title
- Melphalan and Panobinostat Schedule C
- description
- Schedules D1, D2 and D3 D1:LBH589 15mg/daily and melphalan 0.05mg/kg on days 1, 3 and 5 of week 1 D2: LBH589 15mg and daily melphalan 0.10 mg/kg on days 1, 3 and 5 of week 1 D3: LBH589 20mg daily and melphalan 0.05mg/kg on days days 1, 3 and 5 of week 1
- id
- OG003
- title
- Melphalan and Panobinostat Schedule D
- description
- Data for all patients irrespective of dosage
- id
- OG004
- title
- Melphalan and Panobinostat All Patients
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 24 months
- title
- Overall Response Rate (ORR) and Clinical Benefit Rate (CBR) [ORR= Complete Response (CR) + Very Good Partial Response (VGPR) + Partial Response (PR)]; CBR=ORR + Minimal Response (MR)] Following Treatment With Panobinostat and Melphalan
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice