TriangleNCT00742560 · OUTCOME
Plasma Cell Myeloma Cytogenetic Subtype
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
- Screening (up to 14 days prior to dosing)
What was measured
Plasma cell myeloma cytogenetic subtype was assessed at the screening visit using standard karyotyping and/or fluorescence in situ hybridization. The number of participants in each cytogenetic risk category are provided: High Risk (International Staging System \[ISS\] stage II or III and t(4;14) or del(17p) abnormality); Standard Risk (not high or low risk); and Low Risk (ISS stage I or II and absence of t(4;14), del(17p) and 1q21 abnormalities AND age \< 55).
Analysis population: Safety population: All randomized participants who received at least 1 dose of study drug
Groups in this outcome
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
| Group | Source count |
|---|---|
| Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 3 |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 3 |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 22 |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 36 |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 37 |
Reported measurements
High Risk
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 1 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 3 | Not reported | Not reported | Not reported | Not reported |
Standard Risk
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 17 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 30 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 24 | Not reported | Not reported | Not reported | Not reported |
Low Risk
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 2 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 3 | Not reported | Not reported | Not reported | Not reported |
Not Reported
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 3 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 7 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- 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
- 3
- title
- High Risk
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 17
- group Id
- OG003
- value
- 30
- group Id
- OG004
- value
- 24
- title
- Standard Risk
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- title
- Low Risk
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 7
- title
- Not Reported
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 22
- group Id
- OG003
- value
- 36
- group Id
- OG004
- value
- 37
- units
- Participants
- description
- Plasma cell myeloma cytogenetic subtype was assessed at the screening visit using standard karyotyping and/or fluorescence in situ hybridization. The number of participants in each cytogenetic risk category are provided: High Risk (International Staging System \[ISS\] stage II or III and t(4;14) or del(17p) abnormality); Standard Risk (not high or low risk); and Low Risk (ISS stage I or II and absence of t(4;14), del(17p) and 1q21 abnormalities AND age \< 55).
- groups
- description
- Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
- id
- OG000
- title
- Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
- description
- Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
- id
- OG001
- title
- Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
- description
- Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
- id
- OG002
- title
- Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
- description
- Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
- id
- OG003
- title
- Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
- description
- Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
- id
- OG004
- title
- Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
- param Type
- NUMBER
- population Description
- Safety population: All randomized participants who received at least 1 dose of study drug
- reporting Status
- POSTED
- time Frame
- Screening (up to 14 days prior to dosing)
- title
- Plasma Cell Myeloma Cytogenetic Subtype
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice