NCT01241292 · OUTCOME
Number of Participants With Worst Toxicity Grade Chemistry Laboratory Tests
Japanese Study of BMS-901608 (Elotuzumab) in Combination With Lenalidomide and Low Dose Dexamethasone · Source last updated 2018-02-15
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
- First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)
What was measured
NCI CTCAE, version 3.0 was used to measure toxicity scale. Sodium high (H) Gr 1:\>ULN - 150; Gr 2: \>150 - 155; Gr 3: \>155 - 160; Gr 4: \>160 mmol/L; Sodium low(L) Gr 1:\<LLN - 130; Gr 3: \<130 - 120; Gr 4: \<120 mmol/L. Potassium (H) Gr 1: \>ULN - 5.5; Gr 2: \>5.5 - 6.0; Gr 3: \> 6.0 - 7.0; Gr 4: \>7.0 mmol/L; Potassium (L) Gr 1 - Gr 2: \<LLN - 3.0; Gr 3: \< 3.0 - 2.5; Gr 4: \<2.5 mmol/L.
Analysis population: All participants who received at least one dose of study medication were summarized.
Groups in this outcome
Elotuzumab 10 mg/kg
Elotuzumab 10 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
Elotuzumab 20 mg/kg
Elotuzumab 20 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Elotuzumab 10 mg/kg | 3 |
|---|
| Elotuzumab 20 mg/kg | 3 |
|---|
Reported measurements
Potassium High, Any Grade
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Elotuzumab 10 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab 20 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Potassium High, Grade 3-4
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Elotuzumab 10 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab 20 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Potassium Low, Any Grade
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Elotuzumab 10 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab 20 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Potassium Low, Grade 3-4
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Elotuzumab 10 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab 20 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Sodium High, Any Grade
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Elotuzumab 10 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab 20 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Sodium High, Grade 3-4
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Elotuzumab 10 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab 20 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Sodium Low, Any Grade
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Elotuzumab 10 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab 20 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Sodium Low, Grade 3-4
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Elotuzumab 10 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab 20 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- title
- Potassium High, Any Grade
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Potassium High, Grade 3-4
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- title
- Potassium Low, Any Grade
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Potassium Low, Grade 3-4
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- title
- Sodium High, Any Grade
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Sodium High, Grade 3-4
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- title
- Sodium Low, Any Grade
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Sodium Low, Grade 3-4
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- NCI CTCAE, version 3.0 was used to measure toxicity scale. Sodium high (H) Gr 1:\>ULN - 150; Gr 2: \>150 - 155; Gr 3: \>155 - 160; Gr 4: \>160 mmol/L; Sodium low(L) Gr 1:\<LLN - 130; Gr 3: \<130 - 120; Gr 4: \<120 mmol/L. Potassium (H) Gr 1: \>ULN - 5.5; Gr 2: \>5.5 - 6.0; Gr 3: \> 6.0 - 7.0; Gr 4: \>7.0 mmol/L; Potassium (L) Gr 1 - Gr 2: \<LLN - 3.0; Gr 3: \< 3.0 - 2.5; Gr 4: \<2.5 mmol/L.
- groups
- description
- Elotuzumab 10 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
- id
- OG000
- title
- Elotuzumab 10 mg/kg
- description
- Elotuzumab 20 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
- id
- OG001
- title
- Elotuzumab 20 mg/kg
- param Type
- NUMBER
- population Description
- All participants who received at least one dose of study medication were summarized.
- reporting Status
- POSTED
- time Frame
- First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)
- title
- Number of Participants With Worst Toxicity Grade Chemistry Laboratory Tests
- type
- PRIMARY
- unit Of Measure
- participants
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