TriangleNCT01102426 · OUTCOME
Best Overall Response (Independent Review Committee)
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
- From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
What was measured
Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or \>90% reduction in serum M-protein and urine M-protein \<100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to \<200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas Minor response (MR) 25%-49% reduction of serum M-protein and 50-89% reduction of 24h urine M-protein. 25-49% reduction in size of soft tissue plasmacytomas. No increase in size or number of bone lesions Stable disease (SD) No sCR, CR, VGPR, PR, MR or PD Progressive disease (PD) 25% increase from the lowest value: serum M-protein, urine M-protein, BM plasma cell. Increase in size, new bone lesions, soft tissue plasmacytomas or serum calcium \>11.5 mg/dL; NE, not evaluable
Groups in this outcome
Plitidepsin+Dexamethasone
plitidepsin + dexamethasone combination plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
Dexamethasone
dexamethasone single agent dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
| Group | Source count |
|---|---|
| Plitidepsin+Dexamethasone | 171 |
| Dexamethasone | 84 |
Reported measurements
Source class 1
VGR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Plitidepsin+Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Plitidepsin+Dexamethasone | 15 | Not reported | Not reported | Not reported | Not reported |
| Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
MR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Plitidepsin+Dexamethasone | 22 | Not reported | Not reported | Not reported | Not reported |
| Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
SD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Plitidepsin+Dexamethasone | 43 | Not reported | Not reported | Not reported | Not reported |
| Dexamethasone | 21 | Not reported | Not reported | Not reported | Not reported |
PD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Plitidepsin+Dexamethasone | 41 | Not reported | Not reported | Not reported | Not reported |
| Dexamethasone | 35 | Not reported | Not reported | Not reported | Not reported |
NE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Plitidepsin+Dexamethasone | 48 | Not reported | Not reported | Not reported | Not reported |
| Dexamethasone | 25 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- title
- VGR
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 1
- title
- PR
- measurements
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 2
- title
- MR
- measurements
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 21
- title
- SD
- measurements
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 35
- title
- PD
- measurements
- group Id
- OG000
- value
- 48
- group Id
- OG001
- value
- 25
- title
- NE
- denoms
- counts
- group Id
- OG000
- value
- 171
- group Id
- OG001
- value
- 84
- units
- Participants
- description
- Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or \>90% reduction in serum M-protein and urine M-protein \<100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to \<200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas Minor response (MR) 25%-49% reduction of serum M-protein and 50-89% reduction of 24h urine M-protein. 25-49% reduction in size of soft tissue plasmacytomas. No increase in size or number of bone lesions Stable disease (SD) No sCR, CR, VGPR, PR, MR or PD Progressive disease (PD) 25% increase from the lowest value: serum M-protein, urine M-protein, BM plasma cell. Increase in size, new bone lesions, soft tissue plasmacytomas or serum calcium \>11.5 mg/dL; NE, not evaluable
- groups
- description
- plitidepsin + dexamethasone combination plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
- id
- OG000
- title
- Plitidepsin+Dexamethasone
- description
- dexamethasone single agent dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
- id
- OG001
- title
- Dexamethasone
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
- title
- Best Overall Response (Independent Review Committee)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice