NCT01393964 · OUTCOME
Number of Participants With Worst Toxicity Grade Renal and Liver Function Laboratory Tests
Study of Elotuzumab in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma and Various Levels of Renal Function · Source last updated 2017-08-03
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
- From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)
What was measured
NCI CTCAE, version 3.0 was used to measure toxicity scale. Lower Limits of Normal (LLN). Upper Limits of Normal (ULN). Alanine transaminase (ALT); Aspartate aminotransferase (AST); Alkaline phosphatase (ALP). ALT Grade (Gr)1:\>1.0 to 2.5\*ULN; Gr 2: \>2.5 to 5.0\*ULN; Gr 3: \>5.0 to 20.0\*ULN; Gr 4: \>20.0\*ULN. AST Gr 1: \>1.0 to 2.5\*ULN; Gr 2: \>2.5 to 5.0\*ULN; Gr 3: \>5.0 to 20.0\*ULN; Gr 4: \>20.0\*ULN. Total bilirubin Gr 1: \>1.0 to 1.5\*ULN; Gr 2: \>1.5 to 3.0\*ULN; Gr 3: \>3.0 to 10..0\*ULN; Gr 4: \>10.0.0\*ULN. ALP (U/L) Gr1:\>1.0 to 2.5\*ULN, Gr2:\>2.5 to 5.0\*ULN, Gr3:\>5.0 to 20.0\*ULN, Gr4:\>20.0\*ULN. Albumin (low) Gr 1:\<LLN to 3 grams per deciliter (g/dL); Gr 2: \<3.0 - 2.0 g/L; Gr 3: \< 2 g/dL. Creatinine Gr 1: \>1 - 1.5\*baseline (BL)to \>ULN - 1.5\*ULN; Gr 2: \>1.5 - 3.0\*BL to \> 1.5 - 3.0\*ULN; Gr 3: \>3.0\*BL to \> 3.0 - 6.0\*ULN; Gr 4: \>6.0\*ULN.
Analysis population: All participants who received at least one dose of study treatment (at least one dose of any drug) were summarized.
Groups in this outcome
Elotuzumab + LD in Normal Renal Function (NRF) Participants
LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants
Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl \< 30 ml/min but no dialysis.
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants
Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
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 + LD in Normal Renal Function (NRF) Participants | 8 |
|---|
| Elotuzumab + LD in Severe Renal Impairment (SRI) Participants | 9 |
|---|
| Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants | 9 |
|---|
Reported measurements
ALP Any Grade
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Elotuzumab + LD in Normal Renal Function (NRF) Participants | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab + LD in Severe Renal Impairment (SRI) Participants | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
ALP Grade 3-4
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Elotuzumab + LD in Normal Renal Function (NRF) Participants | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab + LD in Severe Renal Impairment (SRI) Participants | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
AST Any Grade
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Elotuzumab + LD in Normal Renal Function (NRF) Participants | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab + LD in Severe Renal Impairment (SRI) Participants | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
AST Grade 3-4
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Elotuzumab + LD in Normal Renal Function (NRF) Participants | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab + LD in Severe Renal Impairment (SRI) Participants | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
ALT Any Grade
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Elotuzumab + LD in Normal Renal Function (NRF) Participants | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab + LD in Severe Renal Impairment (SRI) Participants | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
ALT Grade 3-4
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Elotuzumab + LD in Normal Renal Function (NRF) Participants | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab + LD in Severe Renal Impairment (SRI) Participants | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Bilirubin Any Grade
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Elotuzumab + LD in Normal Renal Function (NRF) Participants | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab + LD in Severe Renal Impairment (SRI) Participants | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Bilirubin Grade 3-4
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Elotuzumab + LD in Normal Renal Function (NRF) Participants | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab + LD in Severe Renal Impairment (SRI) Participants | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Creatinine Any Grade
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Elotuzumab + LD in Normal Renal Function (NRF) Participants | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab + LD in Severe Renal Impairment (SRI) Participants | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
Creatinine Grade 3-4
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Elotuzumab + LD in Normal Renal Function (NRF) Participants | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab + LD in Severe Renal Impairment (SRI) Participants | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
Albumin Any Grade
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Elotuzumab + LD in Normal Renal Function (NRF) Participants | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab + LD in Severe Renal Impairment (SRI) Participants | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
Albumin Grade 3-4
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Elotuzumab + LD in Normal Renal Function (NRF) Participants | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab + LD in Severe Renal Impairment (SRI) Participants | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 7
- title
- ALP Any Grade
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- ALP Grade 3-4
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 5
- title
- AST Any Grade
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- AST Grade 3-4
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 5
- title
- ALT Any Grade
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- ALT Grade 3-4
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- title
- Bilirubin Any Grade
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Bilirubin Grade 3-4
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 9
- title
- Creatinine Any Grade
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 9
- title
- Creatinine Grade 3-4
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 7
- title
- Albumin Any Grade
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Albumin Grade 3-4
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 9
- units
- Participants
- description
- NCI CTCAE, version 3.0 was used to measure toxicity scale. Lower Limits of Normal (LLN). Upper Limits of Normal (ULN). Alanine transaminase (ALT); Aspartate aminotransferase (AST); Alkaline phosphatase (ALP). ALT Grade (Gr)1:\>1.0 to 2.5\*ULN; Gr 2: \>2.5 to 5.0\*ULN; Gr 3: \>5.0 to 20.0\*ULN; Gr 4: \>20.0\*ULN. AST Gr 1: \>1.0 to 2.5\*ULN; Gr 2: \>2.5 to 5.0\*ULN; Gr 3: \>5.0 to 20.0\*ULN; Gr 4: \>20.0\*ULN. Total bilirubin Gr 1: \>1.0 to 1.5\*ULN; Gr 2: \>1.5 to 3.0\*ULN; Gr 3: \>3.0 to 10..0\*ULN; Gr 4: \>10.0.0\*ULN. ALP (U/L) Gr1:\>1.0 to 2.5\*ULN, Gr2:\>2.5 to 5.0\*ULN, Gr3:\>5.0 to 20.0\*ULN, Gr4:\>20.0\*ULN. Albumin (low) Gr 1:\<LLN to 3 grams per deciliter (g/dL); Gr 2: \<3.0 - 2.0 g/L; Gr 3: \< 2 g/dL. Creatinine Gr 1: \>1 - 1.5\*baseline (BL)to \>ULN - 1.5\*ULN; Gr 2: \>1.5 - 3.0\*BL to \> 1.5 - 3.0\*ULN; Gr 3: \>3.0\*BL to \> 3.0 - 6.0\*ULN; Gr 4: \>6.0\*ULN.
- groups
- description
- LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
- id
- OG000
- title
- Elotuzumab + LD in Normal Renal Function (NRF) Participants
- description
- Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl \< 30 ml/min but no dialysis.
- id
- OG001
- title
- Elotuzumab + LD in Severe Renal Impairment (SRI) Participants
- description
- Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
- id
- OG002
- title
- Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants
- param Type
- NUMBER
- population Description
- All participants who received at least one dose of study treatment (at least one dose of any drug) were summarized.
- reporting Status
- POSTED
- time Frame
- From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)
- title
- Number of Participants With Worst Toxicity Grade Renal and Liver Function Laboratory Tests
- type
- SECONDARY
- unit Of Measure
- participants
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Preserved source evidence · Not medical advice