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Trial record 18 of 50 for:    Elotuzumab

Japanese Study of BMS-901608 (Elotuzumab) in Combination With Lenalidomide and Low Dose Dexamethasone

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ClinicalTrials.gov Identifier: NCT01241292
Recruitment Status : Completed
First Posted : November 16, 2010
Results First Posted : January 22, 2016
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Biological: BMS-901608 (Elotuzumab) 10 mg
Biological: BMS-901608 (Elotuzumab) 20 mg
Enrollment 7
Recruitment Details  
Pre-assignment Details Seven participants were enrolled and 6 entered the treatment period. Reason for 1 participant not entering treatment period: participant no longer met study criteria.
Arm/Group Title Elotuzumab 10 mg/kg Elotuzumab 20 mg/kg
Hide Arm/Group 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). 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).
Period Title: Overall Study
Started 3 3
Entered Treatment Period 3 3
Completed 0 [1] 0 [1]
Not Completed 3 3
Reason Not Completed
Administrative Reason by Sponsor             1             0
Disease Progression             2             0
Study Drug Toxicity             0             1
Participant Discontinued Treatment             0             2
[1]
completed=treatment on-going
Arm/Group Title Elotuzumab 10 mg/kg Elotuzumab 20 mg/kg Total
Hide Arm/Group Description Elotuzumab was intravenously (IV) injected 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 orally 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 as a single dose of 40 mg PO. 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 was intravenously (IV) injected 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 orally 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 as a single dose of 40 mg PO. 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). Total of all reporting groups
Overall Number of Baseline Participants 3 3 6
Hide Baseline Analysis Population Description
All participants who received at least one dose of study drug were summarized.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 6 participants
61.0
(52 to 66)
66.0
(60 to 75)
63.5
(52 to 75)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
Less than (<) 65 2 1 3
65 to < 75 1 1 2
Greater than, equal to 75 0 1 1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
Female
1
  33.3%
2
  66.7%
3
  50.0%
Male
2
  66.7%
1
  33.3%
3
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 3 participants 3 participants 6 participants
3 3 6
1.Primary Outcome
Title Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Deaths
Hide Description AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Data cut-off February 2014.
Time Frame First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study medication were summarized (Treated Participants).
Arm/Group Title Elotuzumab 10 mg/kg Elotuzumab 20 mg/kg
Hide Arm/Group Description:
Elotuzumab was intravenously (IV) injected 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 orally 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 as a single dose of 40 mg PO. 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 was intravenously (IV) injected 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 orally 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 as a single dose of 40 mg PO. 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).
Overall Number of Participants Analyzed 3 3
Measure Type: Number
Unit of Measure: participants
All SAEs Any Grade 2 3
Grade 3-4 SAEs 1 3
AEs Leading to Discontinuation 0 1
Grade 3-4 AEs 3 3
Deaths 0 0
2.Primary Outcome
Title Number of Participants With Clinically Relevant Vital Sign Findings
Hide Description Vital signs (body temperature, seated blood pressure, heart rate, and respiration rate) were recorded at screening on Days 1, 8, 15, and 22 of Cycles 1 and 2, on Days 1 and 15 of Cycle 3, and at the end of treatment. Blood pressure (Diastolic and Systolic) and heart rate were recorded after the participant sat quietly for at least 5 minutes. Clinical relevance of vital sign data was determined by the investigator.
Time Frame First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study medication were summarized.
Arm/Group Title Elotuzumab 10 mg/kg Elotuzumab 20 mg/kg
Hide Arm/Group 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).
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).
Overall Number of Participants Analyzed 3 3
Measure Type: Number
Unit of Measure: participants
0 0
3.Primary Outcome
Title Number of Participants With Worst Toxicity Grade Hematology Laboratory Tests
Hide 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.
Time Frame First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study medication were summarized.
Arm/Group Title Elotuzumab 10 mg/kg Elotuzumab 20 mg/kg
Hide Arm/Group 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).
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).
Overall Number of Participants Analyzed 3 3
Measure Type: Number
Unit of Measure: participants
Hemoglobin Any Grade 3 3
Hemoglobin Grade 3-4 0 1
Lymphocytes Any Grade 3 3
Lymphocytes Grade 3-4 3 3
Neutrophils Any Grade 3 3
Neutrophils Grade 3-4 2 3
Platelet Count Any Grade 3 2
Platelet Count Grade 3-4 1 0
Leukocytes Any Grade 3 3
Leukocytes Grade 3-4 2 1
4.Primary Outcome
Title Number of Participants With Worst Toxicity Grade Renal and Liver Function Laboratory Tests
Hide 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). 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.
Time Frame First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study medication were summarized.
Arm/Group Title Elotuzumab 10 mg/kg Elotuzumab 20 mg/kg
Hide Arm/Group 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).
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).
Overall Number of Participants Analyzed 3 3
Measure Type: Number
Unit of Measure: participants
Albumin Any Grade 3 3
Albumin Grade 3-4 0 0
ALP Any Grade 1 2
ALP Grade 3-4 0 0
ALT Any Grade 2 2
ALT Grade 3-4 1 1
AST Any Grade 1 2
AST Grade 3-4 1 1
Creatinine Any Grade 0 2
Creatinine Grade 3-4 0 0
Bilirubin Total Any Grade 1 0
Bilirubin Total Grade 3-4 0 0
5.Primary Outcome
Title Number of Participants With Worst Toxicity Grade Chemistry Laboratory Tests
Hide 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.
Time Frame First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study medication were summarized.
Arm/Group Title Elotuzumab 10 mg/kg Elotuzumab 20 mg/kg
Hide Arm/Group 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).
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).
Overall Number of Participants Analyzed 3 3
Measure Type: Number
Unit of Measure: participants
Potassium High, Any Grade 0 2
Potassium High, Grade 3-4 0 0
Potassium Low, Any Grade 3 2
Potassium Low, Grade 3-4 0 1
Sodium High, Any Grade 1 2
Sodium High, Grade 3-4 0 0
Sodium Low, Any Grade 2 3
Sodium Low, Grade 3-4 0 0
6.Secondary Outcome
Title Number of Participants With Best Overall Response - Treated Participants
Hide Description Complete response (CR) and Partial Response (PR) were based on the European Group for Blood and Bone Marrow Transplant (EBMT) Criteria. Very Good Partial response was derived from the International Myeloma Working Group (IMWG) criteria. Participants who had a reduction in M-protein or plasmacytoma but did not meet the EBMT criteria for PR were classified as minimal response (MR). Hematologic, radiologic and/or clinical assessments were done every cycle starting with cycle 2. Each cycle is 4 weeks in length (Day 1, Day 8, Day 15, Day 22). Cycle 2 began on study Day 29. CR=negative immunofixation 6 weeks, <5% plasma cells, no increase in size or number of lytic lesions, complete disappearance of extramedullary plasmacytoma. PR=≥50%reduction in M-protein for 6 weeks, ≥90% reduction of urinary light chain excretion or < 200 mg/24hours for 6 weeks, ≥50% reduction in size of extramedullary plasmacytoma present at baseline, no increase in size or number of lytic lesions.
Time Frame Cycle 2 (Study Day 29) to last dose (assessed up to January 2017, approximately 71 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study medication were summarized (Treated Participants).
Arm/Group Title Elotuzumab 10 mg/kg Elotuzumab 20 mg/kg
Hide Arm/Group 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).
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).
Overall Number of Participants Analyzed 3 3
Measure Type: Number
Unit of Measure: participants
Complete Response 0 1
Very Good Partial Response 1 2
Partial Response 1 0
Minimal Response 1 0
7.Secondary Outcome
Title Geometric Mean Maximum Observed Serum Elotuzumab Concentration (Cmax) During Cycles 1, 2, and 3
Hide Description The quantification of elotuzumab in human serum was performed using a validated enzyme-linked immunosorbent assay (ELISA). Cmax was measured in micrograms per milliliter (µg/mL). Samples of serum were obtained at: Cycle 1, Day 1: 0 hour (h), 30 minutes (min) 2 h post dose; Day 8: 0h, 2 h; Day 15: 0h, 30 min; Day 22: 0h, 30min, 2h. Cycle 2, Day 1, 22 0h, 2h. Cycle 3, Day 1: 0h, 30h, 2h; Day 15: 0h.
Time Frame Days 1, 8, 15 and 22 of cycle 1, Days 1 and 22 of cycle 2, Days 1 and 15 of cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study medication and had adequate Pharmacokinetic (PK) concentration profiles were summarized.
Arm/Group Title Elotuzumab 10 mg/kg Elotuzumab 20 mg/kg
Hide Arm/Group 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).
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).
Overall Number of Participants Analyzed 3 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
Cycle 1 Day 1 (n=3,3)
173
(9%)
376
(14%)
Cycle 1 Day 8 (n=3,3)
237
(19%)
549
(18%)
Cycle 1 Day 15 (n=3,3)
297
(10%)
652
(21%)
Cycle 1 Day 22 (n=3,2)
234
(14%)
724
(45%)
Cycle 2 Day 1 (n=3,3)
240
(28%)
671
(51%)
Cycle 2 Day 22 (n=3,3)
270
(32%)
844
(26%)
Cycle 3 Day 1 (n=3,3)
286
(32%)
972
(32%)
8.Secondary Outcome
Title Geometric Mean Minimum Observed Serum Elotuzumab Concentration (Cmin) During Cycles 1, 2, and 3
Hide Description The quantification of elotuzumab in human serum was performed using a validated enzyme-linked immunosorbent assay (ELISA). Cmin was measured in micrograms per milliliter (µg/mL). Samples of serum were obtained at: Cycle 1, Day 1: 0 hour (h), 30 minutes (min) 2 h post dose; Day 8: 0h, 2 h; Day 15: 0h, 30 min; Day 22: 0h, 30min, 2h. Cycle 2, Day 1, 22 0h, 2h. Cycle 3, Day 1: 0h, 30h, 2h; Day 15: 0h.
Time Frame Days 8, 15 and 22 of cycle 1, Days 1 and 22 of cycle 2, Days 1 and 15 of cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study medication and had adequate PK concentration profiles were summarized.
Arm/Group Title Elotuzumab 10 mg/kg Elotuzumab 20 mg/kg
Hide Arm/Group 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).
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).
Overall Number of Participants Analyzed 3 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
Cycle 1 Day 8 (n=3,3)
59.1
(28%)
165
(20%)
Cycle 1 Day 15 (n=3,3)
97.0
(12%)
252
(30%)
Cycle 1 Day 22 (n=3,2)
24.6
(87%)
280
(62%)
Cycle 2 Day 1 (n=3,2)
25.8
(95%)
389
(64%)
Cycle 2 Day 22 (n=3,3)
57.8
(82%)
547
(41%)
Cycle 3 Day 1 (n=3,3)
77.2
(78%)
579
(46%)
Cycle 3 Day 15 (n=3,3)
59.4
(78%)
466
(38%)
9.Secondary Outcome
Title Number of Participants Positive for Anti-Elotuzumab Anti-drug Antibodies - Treated Participants
Hide Description The detection of anti-elotuzumab anti-drug antibodies (ADAs) in human serum was performed using a validated bridging electrochemiluminescence immunoassay (ECLA) on the Meso Scale Discovery (MSD) platform. Sample collection was performed prior to administration of elotuzumab at Day 1 of each cycle.
Time Frame First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study medication were summarized.
Arm/Group Title Elotuzumab 10 mg/kg Elotuzumab 20 mg/kg
Hide Arm/Group 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).
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).
Overall Number of Participants Analyzed 3 3
Measure Type: Number
Unit of Measure: participants
3 0
Time Frame First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BMS 10mg/kg + Ld BMS 20mg/kg + Ld
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
BMS 10mg/kg + Ld BMS 20mg/kg + Ld
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
BMS 10mg/kg + Ld BMS 20mg/kg + Ld
Affected / at Risk (%) Affected / at Risk (%)
Total   2/3 (66.67%)   3/3 (100.00%) 
Eye disorders     
Cataract  1  1/3 (33.33%)  1/3 (33.33%) 
Hepatobiliary disorders     
Cholelithiasis  1  0/3 (0.00%)  1/3 (33.33%) 
Hepatitis  1  1/3 (33.33%)  0/3 (0.00%) 
Infections and infestations     
Pneumonia  1  0/3 (0.00%)  1/3 (33.33%) 
Investigations     
Alanine aminotransferase increased  1  0/3 (0.00%)  1/3 (33.33%) 
Aspartate aminotransferase increased  1  0/3 (0.00%)  1/3 (33.33%) 
Blood alkaline phosphatase increased  1  0/3 (0.00%)  1/3 (33.33%) 
Gamma-glutamyltransferase increased  1  0/3 (0.00%)  1/3 (33.33%) 
Respiratory, thoracic and mediastinal disorders     
Interstitial lung disease  1  0/3 (0.00%)  1/3 (33.33%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BMS 10mg/kg + Ld BMS 20mg/kg + Ld
Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   3/3 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  1/3 (33.33%)  0/3 (0.00%) 
Granulocytopenia  1  0/3 (0.00%)  1/3 (33.33%) 
Leukopenia  1  3/3 (100.00%)  3/3 (100.00%) 
Lymphopenia  1  3/3 (100.00%)  3/3 (100.00%) 
Neutropenia  1  3/3 (100.00%)  2/3 (66.67%) 
Thrombocytopenia  1  2/3 (66.67%)  0/3 (0.00%) 
Cardiac disorders     
Atrioventricular block first degree  1  0/3 (0.00%)  1/3 (33.33%) 
Eye disorders     
Cataract  1  1/3 (33.33%)  1/3 (33.33%) 
Conjunctival haemorrhage  1  0/3 (0.00%)  1/3 (33.33%) 
Eye discharge  1  0/3 (0.00%)  1/3 (33.33%) 
Gastrointestinal disorders     
Constipation  1  2/3 (66.67%)  2/3 (66.67%) 
Dental caries  1  0/3 (0.00%)  2/3 (66.67%) 
Diarrhoea  1  2/3 (66.67%)  2/3 (66.67%) 
Epigastric discomfort  1  1/3 (33.33%)  0/3 (0.00%) 
Eructation  1  0/3 (0.00%)  1/3 (33.33%) 
Gingival erosion  1  0/3 (0.00%)  1/3 (33.33%) 
Nausea  1  2/3 (66.67%)  0/3 (0.00%) 
Proctalgia  1  0/3 (0.00%)  1/3 (33.33%) 
Stomatitis  1  1/3 (33.33%)  1/3 (33.33%) 
Vomiting  1  1/3 (33.33%)  1/3 (33.33%) 
General disorders     
Chest pain  1  0/3 (0.00%)  1/3 (33.33%) 
Fatigue  1  1/3 (33.33%)  1/3 (33.33%) 
Malaise  1  0/3 (0.00%)  2/3 (66.67%) 
Oedema  1  1/3 (33.33%)  0/3 (0.00%) 
Pyrexia  1  3/3 (100.00%)  1/3 (33.33%) 
Immune system disorders     
Seasonal allergy  1  1/3 (33.33%)  0/3 (0.00%) 
Infections and infestations     
Cystitis  1  0/3 (0.00%)  1/3 (33.33%) 
Herpes simplex  1  1/3 (33.33%)  0/3 (0.00%) 
Herpes zoster  1  0/3 (0.00%)  1/3 (33.33%) 
Infection  1  0/3 (0.00%)  1/3 (33.33%) 
Influenza  1  1/3 (33.33%)  0/3 (0.00%) 
Nasopharyngitis  1  2/3 (66.67%)  2/3 (66.67%) 
Oral fungal infection  1  0/3 (0.00%)  1/3 (33.33%) 
Periodontitis  1  0/3 (0.00%)  1/3 (33.33%) 
Pneumonia  1  0/3 (0.00%)  1/3 (33.33%) 
Injury, poisoning and procedural complications     
Arthropod sting  1  1/3 (33.33%)  0/3 (0.00%) 
Contusion  1  1/3 (33.33%)  0/3 (0.00%) 
Laceration  1  1/3 (33.33%)  0/3 (0.00%) 
Skin abrasion  1  0/3 (0.00%)  1/3 (33.33%) 
Wound  1  0/3 (0.00%)  1/3 (33.33%) 
Investigations     
Alanine aminotransferase increased  1  1/3 (33.33%)  1/3 (33.33%) 
Amylase increased  1  0/3 (0.00%)  1/3 (33.33%) 
Aspartate aminotransferase increased  1  1/3 (33.33%)  1/3 (33.33%) 
Blood alkaline phosphatase increased  1  1/3 (33.33%)  0/3 (0.00%) 
Blood creatine phosphokinase increased  1  1/3 (33.33%)  0/3 (0.00%) 
Creatinine renal clearance decreased  1  1/3 (33.33%)  1/3 (33.33%) 
Electrocardiogram qt prolonged  1  1/3 (33.33%)  0/3 (0.00%) 
Haemoglobin decreased  1  0/3 (0.00%)  1/3 (33.33%) 
Weight decreased  1  0/3 (0.00%)  1/3 (33.33%) 
Metabolism and nutrition disorders     
Glucose tolerance impaired  1  1/3 (33.33%)  0/3 (0.00%) 
Hypertriglyceridaemia  1  1/3 (33.33%)  1/3 (33.33%) 
Hypoalbuminaemia  1  0/3 (0.00%)  1/3 (33.33%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/3 (33.33%)  0/3 (0.00%) 
Musculoskeletal pain  1  0/3 (0.00%)  1/3 (33.33%) 
Myalgia  1  1/3 (33.33%)  1/3 (33.33%) 
Nervous system disorders     
Dizziness  1  1/3 (33.33%)  0/3 (0.00%) 
Dysgeusia  1  2/3 (66.67%)  3/3 (100.00%) 
Headache  1  1/3 (33.33%)  1/3 (33.33%) 
Neuropathy peripheral  1  0/3 (0.00%)  1/3 (33.33%) 
Somnolence  1  0/3 (0.00%)  1/3 (33.33%) 
Psychiatric disorders     
Insomnia  1  2/3 (66.67%)  1/3 (33.33%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis  1  0/3 (0.00%)  1/3 (33.33%) 
Hiccups  1  1/3 (33.33%)  0/3 (0.00%) 
Skin and subcutaneous tissue disorders     
Dry skin  1  0/3 (0.00%)  2/3 (66.67%) 
Haemorrhage subcutaneous  1  1/3 (33.33%)  0/3 (0.00%) 
Haemorrhage subepidermal  1  1/3 (33.33%)  0/3 (0.00%) 
Penile ulceration  1  1/3 (33.33%)  0/3 (0.00%) 
Rash  1  2/3 (66.67%)  2/3 (66.67%) 
Vascular disorders     
Flushing  1  0/3 (0.00%)  2/3 (66.67%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01241292     History of Changes
Other Study ID Numbers: CA204-005
First Submitted: November 4, 2010
First Posted: November 16, 2010
Results First Submitted: December 16, 2015
Results First Posted: January 22, 2016
Last Update Posted: February 15, 2018