NCT01241292 · OUTCOME
Number of Participants With Worst Toxicity Grade Hematology 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
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 was used to measure toxicity scale. Lower Limits of Normal (LLN). Hemoglobin Gr 1:\<LLN to 10.0 g/dL, Gr 2:\<10.0 to 8.0 g/dL, Gr 3:\<8.0 to 6.5 g/dL, Gr 4:\<6.5 g/dL. Lymphocytes (absolute) Gr 1: \<1.5 to 0.8 \*10\^3 c/µL, Gr 2 \<0.8 to 0.5 \*10\^3 c/µL, Gr 3: \<0.5 to 0.2 \*10\^3 c/µL, Gr 4: \<0.2\*10\^3 c/µL. Neutrophils (absolute): Gr 1:\<LLN to 1.5\*10\^9/L, Gr 2:\<1.5 to 1.0\*10\^9/L, Gr 3:\<1.0 to 0.5\*10\^9/L, Gr 4:\<0.5\*10\^9/L. Platelet count Gr 1:LLN to 75.0\*10\^9/L, Gr 2:\<75.0 to 50.0\*10\^9/L, Gr 3:\<50.0 to 25.0\*10\^9/L, Gr 4:\<25.0 to 10\^9/L. Leukocytes Gr 1:\<LLN to 3.0 \*10\^3 c/µL, Gr 2; \<3.0 to 2.0 \*10\^3 c/µL, Gr 3: \<2.0 to 1.0 \*10\^3 c/µL, Gr 4: \<1.0 \*10\^3 c/µL.
Analysis population: All participants who received at least one dose of study medication were summarized.
Groups in this outcome
Elotuzumab 10 mg/kg
Elotuzumab was administered IV at a dose of 10 mg/kg 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 became apparent. Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
Elotuzumab 20 mg/kg
Elotuzumab was administered IV at a dose of 20 mg/kg 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 became apparent. Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
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
Hemoglobin 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 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Hemoglobin 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 |
|---|
Lymphocytes 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 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Lymphocytes Grade 3-4
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 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Neutrophils 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 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Neutrophils Grade 3-4
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 |
|---|
Platelet Count 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 |
|---|
Platelet Count Grade 3-4
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 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Leukocytes 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 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Leukocytes Grade 3-4
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 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- title
- Hemoglobin Any Grade
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Hemoglobin Grade 3-4
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- title
- Lymphocytes Any Grade
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- title
- Lymphocytes Grade 3-4
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- title
- Neutrophils Any Grade
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- title
- Neutrophils Grade 3-4
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- title
- Platelet Count Any Grade
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Platelet Count Grade 3-4
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- title
- Leukocytes Any Grade
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- title
- Leukocytes Grade 3-4
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 was used to measure toxicity scale. Lower Limits of Normal (LLN). Hemoglobin Gr 1:\<LLN to 10.0 g/dL, Gr 2:\<10.0 to 8.0 g/dL, Gr 3:\<8.0 to 6.5 g/dL, Gr 4:\<6.5 g/dL. Lymphocytes (absolute) Gr 1: \<1.5 to 0.8 \*10\^3 c/µL, Gr 2 \<0.8 to 0.5 \*10\^3 c/µL, Gr 3: \<0.5 to 0.2 \*10\^3 c/µL, Gr 4: \<0.2\*10\^3 c/µL. Neutrophils (absolute): Gr 1:\<LLN to 1.5\*10\^9/L, Gr 2:\<1.5 to 1.0\*10\^9/L, Gr 3:\<1.0 to 0.5\*10\^9/L, Gr 4:\<0.5\*10\^9/L. Platelet count Gr 1:LLN to 75.0\*10\^9/L, Gr 2:\<75.0 to 50.0\*10\^9/L, Gr 3:\<50.0 to 25.0\*10\^9/L, Gr 4:\<25.0 to 10\^9/L. Leukocytes Gr 1:\<LLN to 3.0 \*10\^3 c/µL, Gr 2; \<3.0 to 2.0 \*10\^3 c/µL, Gr 3: \<2.0 to 1.0 \*10\^3 c/µL, Gr 4: \<1.0 \*10\^3 c/µL.
- groups
- description
- Elotuzumab was administered IV at a dose of 10 mg/kg 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 became apparent. Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
- id
- OG000
- title
- Elotuzumab 10 mg/kg
- description
- Elotuzumab was administered IV at a dose of 20 mg/kg 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 became apparent. Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
- 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 Hematology Laboratory Tests
- type
- PRIMARY
- unit Of Measure
- participants
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