Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma (ELOQUENT - 2)

• ClinicalTrials.gov Identifier: NCT01239797
• Recruitment Status: Completed
• First Posted: November 11, 2010
• Results First Posted: January 5, 2017
• Last Update Posted: June 1, 2022
• Sponsor: Bristol-Myers Squibb
• Collaborator: AbbVie
• Information provided by (Responsible Party): Bristol-Myers Squibb

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Lymphoma; Multiple Myeloma
• Interventions: Drug: Lenalidomide; Drug: Dexamethasone; Drug: Dexamethasone (Oral); Drug: Dexamethasone (IV); Biological: Elotuzumab (BMS-901608; HuLuc63)
• Enrollment: 646

Participant Flow

Recruitment Details
Pre-assignment Details	646 participants were randomized and 635 were treated

Arm/Group Title	Lenalidomide + Dexamethasone + Elotuzumab	Lenalidomide + Dexamethasone
Arm/Group Description	Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug	Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
Period Title: Randomized Participants
Started	321	325
Completed	319	316
Not Completed	2	9
Reason Not Completed
Participant no longer meets study criteria	1	1
Participant withdrew consent	1	7
Adverse event unrelated to study drug	0	1
Period Title: Treated Participants
Started [1]	318 [2]	317 [2]
Completed [3]	0	0
Not Completed	318	317
Reason Not Completed
Disease progression	185	185
Study drug toxicity	39	45
Adverse event unrelated to study drug	31	37
Participants request to discontinue study treatment	28	18
Administrative reason by sponsor	13	4
Other reasons	14	14
Participant withdrew consent	6	11
Death	1	1
Participant no longer meets study criteria	1	1
Poor/non-compliance	0	1
[1] Participants treated; [2] 1 participant was randomized to treatment E-Ld but received treatment Ld; [3] Participants still on treatment

Baseline Characteristics

Arm/Group Title		Lenalidomide + Dexamethasone + Elotuzumab	Lenalidomide + Dexamethasone	Total
Arm/Group Description		Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug	Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug	Total of all reporting groups
Overall Number of Baseline Participants		321	325	646
Baseline Analysis Population Description		Randomized: all participants randomized to any treatment group
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	321 participants	325 participants	646 participants
		66.2 (9.34)	65.3 (10.26)	65.7 (9.81)
Age, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	321 participants	325 participants	646 participants
	< 65 years old	134 41.7%	142 43.7%	276 42.7%
	>= 65 and < 75 years old	119 37.1%	122 37.5%	241 37.3%
	>= 75 years old	68 21.2%	61 18.8%	129 20.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	321 participants	325 participants	646 participants
	Female	129 40.2%	132 40.6%	261 40.4%
	Male	192 59.8%	193 59.4%	385 59.6%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	321 participants	325 participants	646 participants
	Hispanic or Latino	5 1.6%	1 0.3%	6 0.9%
	Not Hispanic or Latino	28 8.7%	33 10.2%	61 9.4%
	Unknown or Not Reported	288 89.7%	291 89.5%	579 89.6%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	321 participants	325 participants	646 participants
	White	264 82.2%	280 86.2%	544 84.2%
	Black or African American	13 4.0%	10 3.1%	23 3.6%
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	33 10.3%	31 9.5%	64 9.9%
	Native Hawaiian or Other Pacific Islander	1 0.3%	0 0.0%	1 0.2%
	Other	9 2.8%	4 1.2%	13 2.0%
	Not Reported	1 0.3%	0 0.0%	1 0.2%

Outcome Measures

1. Primary Outcome

Title	Median Progression Free Survival (PFS)
Description	Primary definition of Progression-free survival (PFS) defined as the time from randomization to the date of first documented tumor progression or death due to any cause. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. The primary analysis of PFS was based on the primary definition using the Independent Review Committee (IRC) tumor assessment using the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Tumor assessments were made every 4 weeks (±1 week) relative to the first dose of study medication.
Time Frame	From randomization up to 326 events (up to approximately 38 months)

Outcome Measure Data

Analysis Population Description

All randomized participants

Arm/Group Title	Lenalidomide + Dexamethasone + Elotuzumab	Lenalidomide + Dexamethasone
Arm/Group Description:	Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug	Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
Overall Number of Participants Analyzed	321	325
Median (95% Confidence Interval); Unit of Measure: Months
	19.35; (16.62 to 22.18)	14.85; (12.09 to 17.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lenalidomide + Dexamethasone + Elotuzumab, Lenalidomide + Dexamethasone
	Comments	Hazard Ratio of Lenalidomide + Dexamethasone + Elotuzumab to Lenalidomide + Dexamethasone
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0014
	Comments	[Not Specified]
	Method	Log Rank
	Comments	2-sided p-value for stratified log rank test
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.73
	Confidence Interval	(2-Sided) 95%; 0.60 to 0.89
	Estimation Comments	[Not Specified]

2. Primary Outcome

Title	Objective Response Rate (ORR)
Description	Objective response rate (ORR) defined as the percentage of participants with a best response on-study of partial response (PR) or better (stringent CR [sCR], complete response [CR], very good partial response [VGPR], and partial response [PR]) based on the Independent Review Committee (IRC) assessment of best response using the European Group for Blood and Bone Marrow Transplant (EBMT) assessment criteria. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. Assessments were made every 4 weeks.
Time Frame	From randomization up to approximately 38 months

Outcome Measure Data

Analysis Population Description

All randomized participants

Arm/Group Title	Lenalidomide + Dexamethasone + Elotuzumab	Lenalidomide + Dexamethasone
Arm/Group Description:	Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug	Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
Overall Number of Participants Analyzed	321	325
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	78.5; (73.6 to 82.9)	65.5; (60.1 to 70.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lenalidomide + Dexamethasone + Elotuzumab, Lenalidomide + Dexamethasone
	Comments	Ratio of Lenalidomide + Dexamethasone + Elotuzumab to Lenalidomide + Dexamethasone
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0002
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified by B2 microglobulin (<3.5 mg/L vs >=3.5 mg/L), number of prior lines of therapy (1 vs >=2), and immunomodulatory drug use at randomization
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.95
	Confidence Interval	(2-Sided) 95%; 1.36 to 2.78
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Lenalidomide + Dexamethasone + Elotuzumab, Lenalidomide + Dexamethasone
	Comments	Difference of Lenalidomide + Dexamethasone + Elotuzumab minus Lenalidomide + Dexamethasone computed using the method of DerSimonian and Laird (weighted average over the strata)
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in ORR
	Estimated Value	12.7
	Confidence Interval	(2-Sided) 95%; 6.2 to 19.3
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Median Overall Survival (OS)
Description	Overall survival is defined as the time from randomization to the date of death from any cause. If a subject has not died, their survival time will be censored at the date of last contact ("last known alive date"). A subject will be censored at the date of randomization if they were randomized but had no follow-up. (Based on Kaplan Meier estimates)
Time Frame	Randomization to the date of death from any cause (up to approximately 9 years)

Outcome Measure Data

Analysis Population Description

All randomized participants

Arm/Group Title	Lenalidomide + Dexamethasone + Elotuzumab	Lenalidomide + Dexamethasone
Arm/Group Description:	Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug	Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
Overall Number of Participants Analyzed	321	325
Median (95% Confidence Interval); Unit of Measure: Months
	48.30; (40.34 to 51.94)	39.62; (33.25 to 45.27)

4. Secondary Outcome

Title	Change From Baseline of Mean Score Pain Severity (BPI-SF)
Description	The change from baseline of the mean score of pain severity at the end of treatment using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 0 ("No pain", "No interference") to 10 ("Pain as bad as you can imagine", "Highest imaginable interference") numeric rating scale.
Time Frame	From baseline up to approximately 38 months

Outcome Measure Data

Analysis Population Description

All randomized participants with baseline and end of treatment scores

Arm/Group Title	Lenalidomide + Dexamethasone + Elotuzumab	Lenalidomide + Dexamethasone
Arm/Group Description:	Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug	Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
Overall Number of Participants Analyzed	114	152
Mean (Standard Deviation); Unit of Measure: Score on a scale
	0.52 (2.237)	-0.04 (2.408)

5. Secondary Outcome

Title	Change From Baseline of Mean Score Pain Interference (BPI-SF)
Description	The change from baseline of the mean score of pain interference at the end of treatment using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 0 ("No pain", "No interference") to 10 ("Pain as bad as you can imagine", "Highest imaginable interference") numeric rating scale.
Time Frame	From baseline up to approximately 38 months

Outcome Measure Data

Analysis Population Description

All randomized participants with baseline and end of treatment scores

Arm/Group Title	Lenalidomide + Dexamethasone + Elotuzumab	Lenalidomide + Dexamethasone
Arm/Group Description:	Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug	Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
Overall Number of Participants Analyzed	113	150
Mean (Standard Deviation); Unit of Measure: Score on a scale
	0.95 (2.466)	0.48 (2.868)

6. Post-Hoc Outcome

Title	Median Progression Free Survival (PFS) - Extended Collection
Description	The time from randomization to the date of first documented tumor progression or death due to any cause. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. Tumor assessments were made every 4 weeks (±1 week) relative to the first dose of study medication based on Independent Review Committee (IRC) tumor assessment using the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date. (Assessments were made until 06-Jul-2018)
Time Frame	From randomization up to to the date of first documented tumor progression or death (up to approximately 85 months)

Outcome Measure Data

Analysis Population Description

All randomized participants

Arm/Group Title	Lenalidomide + Dexamethasone + Elotuzumab	Lenalidomide + Dexamethasone
Arm/Group Description:	Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug	Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
Overall Number of Participants Analyzed	321	325
Median (95% Confidence Interval); Unit of Measure: Months
	19.42; (16.62 to 22.31)	14.92; (12.25 to 17.31)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lenalidomide + Dexamethasone + Elotuzumab, Lenalidomide + Dexamethasone
	Comments	Hazard Ratio of Lenalidomide + Dexamethasone + Elotuzumab to Lenalidomide + Dexamethasone
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0005
	Comments	[Not Specified]
	Method	Log Rank
	Comments	2-sided p-value for stratified log rank test
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.72
	Confidence Interval	(2-Sided) 95%; 0.60 to 0.87
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years)
Adverse Event Reporting Description	Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Arm/Group Title	Lenalidomide + Dexamethasone + Elotuzumab	Lenalidomide + Dexamethasone
Arm/Group Description	Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug	Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
All-Cause Mortality
	Lenalidomide + Dexamethasone + Elotuzumab	Lenalidomide + Dexamethasone
	Affected / at Risk (%)	Affected / at Risk (%)
Total	226/321 (70.40%)	249/325 (76.62%)
Serious Adverse Events
	Lenalidomide + Dexamethasone + Elotuzumab	Lenalidomide + Dexamethasone
	Affected / at Risk (%)	Affected / at Risk (%)
Total	238/318 (74.84%)	194/317 (61.20%)
Blood and lymphatic system disorders
Anaemia † 1	11/318 (3.46%)	8/317 (2.52%)
Bone marrow failure † 1	1/318 (0.31%)	0/317 (0.00%)
Eosinophilia † 1	1/318 (0.31%)	0/317 (0.00%)
Febrile neutropenia † 1	5/318 (1.57%)	4/317 (1.26%)
Microangiopathic haemolytic anaemia † 1	1/318 (0.31%)	0/317 (0.00%)
Neutropenia † 1	1/318 (0.31%)	4/317 (1.26%)
Pancytopenia † 1	2/318 (0.63%)	0/317 (0.00%)
Splenic infarction † 1	0/318 (0.00%)	1/317 (0.32%)
Thrombocytopenia † 1	5/318 (1.57%)	2/317 (0.63%)
Cardiac disorders
Acute coronary syndrome † 1	1/318 (0.31%)	2/317 (0.63%)
Acute left ventricular failure † 1	1/318 (0.31%)	0/317 (0.00%)
Acute myocardial infarction † 1	1/318 (0.31%)	2/317 (0.63%)
Angina pectoris † 1	1/318 (0.31%)	0/317 (0.00%)
Angina unstable † 1	1/318 (0.31%)	0/317 (0.00%)
Arrhythmia † 1	0/318 (0.00%)	1/317 (0.32%)
Atrial fibrillation † 1	6/318 (1.89%)	9/317 (2.84%)
Atrioventricular block complete † 1	2/318 (0.63%)	0/317 (0.00%)
Brugada syndrome † 1	1/318 (0.31%)	0/317 (0.00%)
Cardiac aneurysm † 1	0/318 (0.00%)	1/317 (0.32%)
Cardiac arrest † 1	3/318 (0.94%)	1/317 (0.32%)
Cardiac failure † 1	3/318 (0.94%)	3/317 (0.95%)
Cardiac failure congestive † 1	2/318 (0.63%)	1/317 (0.32%)
Cardio-respiratory arrest † 1	1/318 (0.31%)	0/317 (0.00%)
Cardiogenic shock † 1	2/318 (0.63%)	0/317 (0.00%)
Left ventricular failure † 1	0/318 (0.00%)	1/317 (0.32%)
Myocardial infarction † 1	0/318 (0.00%)	3/317 (0.95%)
Myocardial ischaemia † 1	0/318 (0.00%)	2/317 (0.63%)
Pericarditis † 1	1/318 (0.31%)	1/317 (0.32%)
Sinus node dysfunction † 1	0/318 (0.00%)	1/317 (0.32%)
Supraventricular tachycardia † 1	1/318 (0.31%)	0/317 (0.00%)
Endocrine disorders
Hypothyroidism † 1	0/318 (0.00%)	1/317 (0.32%)
Eye disorders
Cataract † 1	6/318 (1.89%)	6/317 (1.89%)
Cataract nuclear † 1	1/318 (0.31%)	0/317 (0.00%)
Visual impairment † 1	1/318 (0.31%)	0/317 (0.00%)
Gastrointestinal disorders
Abdominal pain † 1	3/318 (0.94%)	0/317 (0.00%)
Abdominal pain upper † 1	2/318 (0.63%)	0/317 (0.00%)
Colitis † 1	1/318 (0.31%)	2/317 (0.63%)
Constipation † 1	1/318 (0.31%)	2/317 (0.63%)
Diarrhoea † 1	7/318 (2.20%)	12/317 (3.79%)
Diverticulum † 1	1/318 (0.31%)	0/317 (0.00%)
Enteritis † 1	2/318 (0.63%)	0/317 (0.00%)
Enterocolitis † 1	1/318 (0.31%)	0/317 (0.00%)
Enterocutaneous fistula † 1	0/318 (0.00%)	1/317 (0.32%)
Gastric haemorrhage † 1	1/318 (0.31%)	0/317 (0.00%)
Gastric ulcer † 1	0/318 (0.00%)	1/317 (0.32%)
Gastrointestinal haemorrhage † 1	2/318 (0.63%)	1/317 (0.32%)
Haemorrhoids † 1	0/318 (0.00%)	1/317 (0.32%)
Hiatus hernia † 1	0/318 (0.00%)	1/317 (0.32%)
Ileus † 1	0/318 (0.00%)	1/317 (0.32%)
Ileus paralytic † 1	0/318 (0.00%)	1/317 (0.32%)
Inguinal hernia † 1	1/318 (0.31%)	1/317 (0.32%)
Inguinal hernia, obstructive † 1	0/318 (0.00%)	1/317 (0.32%)
Intestinal haemorrhage † 1	0/318 (0.00%)	1/317 (0.32%)
Intestinal ischaemia † 1	1/318 (0.31%)	0/317 (0.00%)
Intestinal obstruction † 1	1/318 (0.31%)	0/317 (0.00%)
Irritable bowel syndrome † 1	0/318 (0.00%)	1/317 (0.32%)
Large intestinal ulcer † 1	0/318 (0.00%)	1/317 (0.32%)
Large intestine perforation † 1	1/318 (0.31%)	0/317 (0.00%)
Lower gastrointestinal haemorrhage † 1	0/318 (0.00%)	1/317 (0.32%)
Mouth haemorrhage † 1	1/318 (0.31%)	0/317 (0.00%)
Nausea † 1	1/318 (0.31%)	1/317 (0.32%)
Pancreatitis † 1	1/318 (0.31%)	1/317 (0.32%)
Pancreatitis acute † 1	2/318 (0.63%)	0/317 (0.00%)
Rectal haemorrhage † 1	1/318 (0.31%)	0/317 (0.00%)
Subileus † 1	0/318 (0.00%)	1/317 (0.32%)
Upper gastrointestinal haemorrhage † 1	0/318 (0.00%)	1/317 (0.32%)
Vomiting † 1	2/318 (0.63%)	4/317 (1.26%)
General disorders
Asthenia † 1	4/318 (1.26%)	0/317 (0.00%)
Chest pain † 1	1/318 (0.31%)	0/317 (0.00%)
Chills † 1	0/318 (0.00%)	1/317 (0.32%)
Death † 1	1/318 (0.31%)	1/317 (0.32%)
Disease progression † 1	15/318 (4.72%)	10/317 (3.15%)
Fatigue † 1	1/318 (0.31%)	0/317 (0.00%)
General physical health deterioration † 1	5/318 (1.57%)	4/317 (1.26%)
Hernia † 1	0/318 (0.00%)	1/317 (0.32%)
Malaise † 1	1/318 (0.31%)	0/317 (0.00%)
Multiple organ dysfunction syndrome † 1	1/318 (0.31%)	0/317 (0.00%)
Pain † 1	1/318 (0.31%)	0/317 (0.00%)
Pyrexia † 1	25/318 (7.86%)	17/317 (5.36%)
Hepatobiliary disorders
Cholangitis † 1	1/318 (0.31%)	0/317 (0.00%)
Cholecystitis † 1	1/318 (0.31%)	0/317 (0.00%)
Cholecystitis acute † 1	4/318 (1.26%)	0/317 (0.00%)
Cholecystitis chronic † 1	1/318 (0.31%)	0/317 (0.00%)
Cholelithiasis † 1	1/318 (0.31%)	0/317 (0.00%)
Hepatic failure † 1	1/318 (0.31%)	0/317 (0.00%)
Hepatic function abnormal † 1	0/318 (0.00%)	1/317 (0.32%)
Hepatitis † 1	1/318 (0.31%)	0/317 (0.00%)
Hyperbilirubinaemia † 1	2/318 (0.63%)	0/317 (0.00%)
Immune system disorders
Haemophagocytic lymphohistiocytosis † 1	1/318 (0.31%)	1/317 (0.32%)
Infections and infestations
Abdominal abscess † 1	0/318 (0.00%)	1/317 (0.32%)
Abscess oral † 1	0/318 (0.00%)	1/317 (0.32%)
Acute sinusitis † 1	0/318 (0.00%)	1/317 (0.32%)
Appendicitis † 1	0/318 (0.00%)	1/317 (0.32%)
Arthritis bacterial † 1	0/318 (0.00%)	2/317 (0.63%)
Atypical pneumonia † 1	3/318 (0.94%)	0/317 (0.00%)
Bacteraemia † 1	1/318 (0.31%)	1/317 (0.32%)
Bacterial sepsis † 1	1/318 (0.31%)	0/317 (0.00%)
Biliary sepsis † 1	1/318 (0.31%)	0/317 (0.00%)
Brain abscess † 1	1/318 (0.31%)	0/317 (0.00%)
Bronchitis † 1	8/318 (2.52%)	8/317 (2.52%)
Bronchopulmonary aspergillosis † 1	1/318 (0.31%)	0/317 (0.00%)
Bursitis infective † 1	0/318 (0.00%)	1/317 (0.32%)
Campylobacter gastroenteritis † 1	0/318 (0.00%)	1/317 (0.32%)
Catheter site abscess † 1	0/318 (0.00%)	1/317 (0.32%)
Cellulitis † 1	8/318 (2.52%)	1/317 (0.32%)
Cerebral aspergillosis † 1	1/318 (0.31%)	0/317 (0.00%)
Clostridium colitis † 1	1/318 (0.31%)	0/317 (0.00%)
Clostridium difficile colitis † 1	1/318 (0.31%)	0/317 (0.00%)
Clostridium difficile infection † 1	0/318 (0.00%)	1/317 (0.32%)
Cytomegalovirus chorioretinitis † 1	1/318 (0.31%)	0/317 (0.00%)
Cytomegalovirus infection † 1	1/318 (0.31%)	0/317 (0.00%)
Device related infection † 1	1/318 (0.31%)	0/317 (0.00%)
Device related sepsis † 1	0/318 (0.00%)	1/317 (0.32%)
Diverticulitis † 1	2/318 (0.63%)	0/317 (0.00%)
Endocarditis † 1	1/318 (0.31%)	2/317 (0.63%)
Enteritis infectious † 1	1/318 (0.31%)	0/317 (0.00%)
Enterocolitis viral † 1	1/318 (0.31%)	0/317 (0.00%)
Epididymitis † 1	1/318 (0.31%)	0/317 (0.00%)
Escherichia urinary tract infection † 1	1/318 (0.31%)	0/317 (0.00%)
Febrile infection † 1	1/318 (0.31%)	0/317 (0.00%)
Gastroenteritis † 1	1/318 (0.31%)	2/317 (0.63%)
Gastroenteritis clostridial † 1	1/318 (0.31%)	0/317 (0.00%)
Gastroenteritis norovirus † 1	0/318 (0.00%)	1/317 (0.32%)
Gastroenteritis viral † 1	1/318 (0.31%)	4/317 (1.26%)
Genital abscess † 1	0/318 (0.00%)	1/317 (0.32%)
H1N1 influenza † 1	1/318 (0.31%)	1/317 (0.32%)
Hepatitis B † 1	1/318 (0.31%)	0/317 (0.00%)
Herpes zoster † 1	4/318 (1.26%)	1/317 (0.32%)
Herpes zoster reactivation † 1	0/318 (0.00%)	1/317 (0.32%)
Infection † 1	3/318 (0.94%)	1/317 (0.32%)
Infective exacerbation of chronic obstructive airways disease † 1	0/318 (0.00%)	1/317 (0.32%)
Influenza † 1	3/318 (0.94%)	4/317 (1.26%)
Intervertebral discitis † 1	0/318 (0.00%)	1/317 (0.32%)
Large intestine infection † 1	1/318 (0.31%)	0/317 (0.00%)
Listeriosis † 1	0/318 (0.00%)	1/317 (0.32%)
Localised infection † 1	0/318 (0.00%)	1/317 (0.32%)
Lower respiratory tract infection † 1	8/318 (2.52%)	4/317 (1.26%)
Lung abscess † 1	0/318 (0.00%)	1/317 (0.32%)
Meningitis staphylococcal † 1	1/318 (0.31%)	0/317 (0.00%)
Metapneumovirus infection † 1	1/318 (0.31%)	0/317 (0.00%)
Neutropenic sepsis † 1	1/318 (0.31%)	1/317 (0.32%)
Ophthalmic herpes zoster † 1	0/318 (0.00%)	1/317 (0.32%)
Osteomyelitis † 1	1/318 (0.31%)	1/317 (0.32%)
Otitis media chronic † 1	0/318 (0.00%)	1/317 (0.32%)
Parvovirus B19 infection † 1	0/318 (0.00%)	1/317 (0.32%)
Periodontitis † 1	0/318 (0.00%)	1/317 (0.32%)
Peritonitis † 1	0/318 (0.00%)	1/317 (0.32%)
Pharyngitis † 1	1/318 (0.31%)	2/317 (0.63%)
Pneumococcal sepsis † 1	1/318 (0.31%)	0/317 (0.00%)
Pneumocystis jirovecii pneumonia † 1	2/318 (0.63%)	1/317 (0.32%)
Pneumonia † 1	56/318 (17.61%)	40/317 (12.62%)
Pneumonia bacterial † 1	1/318 (0.31%)	0/317 (0.00%)
Pneumonia fungal † 1	2/318 (0.63%)	0/317 (0.00%)
Pneumonia influenzal † 1	2/318 (0.63%)	2/317 (0.63%)
Pneumonia pneumococcal † 1	3/318 (0.94%)	1/317 (0.32%)
Post procedural infection † 1	0/318 (0.00%)	1/317 (0.32%)
Pseudomonal sepsis † 1	1/318 (0.31%)	0/317 (0.00%)
Pseudomonas infection † 1	1/318 (0.31%)	0/317 (0.00%)
Pulmonary sepsis † 1	1/318 (0.31%)	0/317 (0.00%)
Pyelonephritis † 1	1/318 (0.31%)	0/317 (0.00%)
Pyelonephritis acute † 1	0/318 (0.00%)	1/317 (0.32%)
Respiratory syncytial virus infection † 1	1/318 (0.31%)	1/317 (0.32%)
Respiratory tract infection † 1	11/318 (3.46%)	4/317 (1.26%)
Retinitis † 1	1/318 (0.31%)	0/317 (0.00%)
Rotavirus infection † 1	1/318 (0.31%)	0/317 (0.00%)
Sepsis † 1	5/318 (1.57%)	8/317 (2.52%)
Septic shock † 1	2/318 (0.63%)	5/317 (1.58%)
Sinusitis † 1	2/318 (0.63%)	1/317 (0.32%)
Skin infection † 1	0/318 (0.00%)	1/317 (0.32%)
Staphylococcal bacteraemia † 1	0/318 (0.00%)	1/317 (0.32%)
Staphylococcal sepsis † 1	1/318 (0.31%)	1/317 (0.32%)
Streptococcal bacteraemia † 1	0/318 (0.00%)	1/317 (0.32%)
Systemic infection † 1	1/318 (0.31%)	0/317 (0.00%)
Tooth abscess † 1	0/318 (0.00%)	1/317 (0.32%)
Upper respiratory tract infection † 1	2/318 (0.63%)	1/317 (0.32%)
Urinary tract infection † 1	3/318 (0.94%)	5/317 (1.58%)
Urinary tract infection enterococcal † 1	0/318 (0.00%)	1/317 (0.32%)
Urosepsis † 1	1/318 (0.31%)	0/317 (0.00%)
Varicella zoster virus infection † 1	2/318 (0.63%)	0/317 (0.00%)
Viral diarrhoea † 1	1/318 (0.31%)	0/317 (0.00%)
Viral infection † 1	1/318 (0.31%)	0/317 (0.00%)
Wound infection † 1	1/318 (0.31%)	0/317 (0.00%)
Injury, poisoning and procedural complications
Accidental overdose † 1	1/318 (0.31%)	0/317 (0.00%)
Ankle fracture † 1	0/318 (0.00%)	1/317 (0.32%)
Chemical burn † 1	1/318 (0.31%)	0/317 (0.00%)
Compression fracture † 1	0/318 (0.00%)	1/317 (0.32%)
Craniocerebral injury † 1	0/318 (0.00%)	2/317 (0.63%)
Fall † 1	1/318 (0.31%)	1/317 (0.32%)
Femoral neck fracture † 1	1/318 (0.31%)	1/317 (0.32%)
Femur fracture † 1	1/318 (0.31%)	1/317 (0.32%)
Hip fracture † 1	2/318 (0.63%)	2/317 (0.63%)
Humerus fracture † 1	2/318 (0.63%)	0/317 (0.00%)
Ilium fracture † 1	1/318 (0.31%)	0/317 (0.00%)
Joint dislocation † 1	1/318 (0.31%)	0/317 (0.00%)
Limb injury † 1	1/318 (0.31%)	0/317 (0.00%)
Lip injury † 1	1/318 (0.31%)	0/317 (0.00%)
Lumbar vertebral fracture † 1	2/318 (0.63%)	1/317 (0.32%)
Overdose † 1	1/318 (0.31%)	1/317 (0.32%)
Pelvic fracture † 1	1/318 (0.31%)	2/317 (0.63%)
Post procedural haemorrhage † 1	0/318 (0.00%)	2/317 (0.63%)
Procedural pain † 1	0/318 (0.00%)	1/317 (0.32%)
Rib fracture † 1	2/318 (0.63%)	0/317 (0.00%)
Road traffic accident † 1	0/318 (0.00%)	1/317 (0.32%)
Seroma † 1	0/318 (0.00%)	1/317 (0.32%)
Skin laceration † 1	0/318 (0.00%)	1/317 (0.32%)
Soft tissue injury † 1	0/318 (0.00%)	1/317 (0.32%)
Spinal compression fracture † 1	3/318 (0.94%)	1/317 (0.32%)
Spinal fracture † 1	1/318 (0.31%)	0/317 (0.00%)
Stenosis of vesicourethral anastomosis † 1	0/318 (0.00%)	1/317 (0.32%)
Subdural haematoma † 1	0/318 (0.00%)	1/317 (0.32%)
Tendon rupture † 1	0/318 (0.00%)	1/317 (0.32%)
Thoracic vertebral fracture † 1	0/318 (0.00%)	1/317 (0.32%)
Toxicity to various agents † 1	0/318 (0.00%)	1/317 (0.32%)
Traumatic fracture † 1	0/318 (0.00%)	2/317 (0.63%)
Upper limb fracture † 1	1/318 (0.31%)	0/317 (0.00%)
Investigations
Blood creatinine increased † 1	0/318 (0.00%)	1/317 (0.32%)
Clostridium test positive † 1	1/318 (0.31%)	0/317 (0.00%)
Escherichia test positive † 1	1/318 (0.31%)	0/317 (0.00%)
General physical condition abnormal † 1	1/318 (0.31%)	0/317 (0.00%)
Haemoglobin decreased † 1	0/318 (0.00%)	1/317 (0.32%)
Hepatic enzyme increased † 1	0/318 (0.00%)	1/317 (0.32%)
Influenza A virus test positive † 1	1/318 (0.31%)	1/317 (0.32%)
Influenza B virus test positive † 1	2/318 (0.63%)	1/317 (0.32%)
International normalised ratio increased † 1	1/318 (0.31%)	0/317 (0.00%)
Liver function test abnormal † 1	1/318 (0.31%)	0/317 (0.00%)
Polymerase chain reaction positive † 1	0/318 (0.00%)	1/317 (0.32%)
Viral test positive † 1	1/318 (0.31%)	0/317 (0.00%)
Metabolism and nutrition disorders
Decreased appetite † 1	2/318 (0.63%)	1/317 (0.32%)
Dehydration † 1	2/318 (0.63%)	1/317 (0.32%)
Diabetes mellitus † 1	1/318 (0.31%)	0/317 (0.00%)
Failure to thrive † 1	1/318 (0.31%)	0/317 (0.00%)
Fluid retention † 1	1/318 (0.31%)	0/317 (0.00%)
Hypercalcaemia † 1	3/318 (0.94%)	2/317 (0.63%)
Hyperglycaemia † 1	3/318 (0.94%)	1/317 (0.32%)
Hypocalcaemia † 1	0/318 (0.00%)	1/317 (0.32%)
Hypoglycaemia † 1	0/318 (0.00%)	1/317 (0.32%)
Hypokalaemia † 1	3/318 (0.94%)	2/317 (0.63%)
Hyponatraemia † 1	0/318 (0.00%)	1/317 (0.32%)
Ketoacidosis † 1	1/318 (0.31%)	0/317 (0.00%)
Tumour lysis syndrome † 1	0/318 (0.00%)	1/317 (0.32%)
Type 2 diabetes mellitus † 1	1/318 (0.31%)	0/317 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	2/318 (0.63%)	2/317 (0.63%)
Arthritis † 1	1/318 (0.31%)	0/317 (0.00%)
Back pain † 1	7/318 (2.20%)	5/317 (1.58%)
Bone cyst † 1	1/318 (0.31%)	0/317 (0.00%)
Bone lesion † 1	1/318 (0.31%)	0/317 (0.00%)
Bone pain † 1	3/318 (0.94%)	0/317 (0.00%)
Cervical spinal stenosis † 1	0/318 (0.00%)	1/317 (0.32%)
Exostosis † 1	0/318 (0.00%)	1/317 (0.32%)
Muscle mass † 1	1/318 (0.31%)	0/317 (0.00%)
Muscular weakness † 1	2/318 (0.63%)	0/317 (0.00%)
Musculoskeletal chest pain † 1	1/318 (0.31%)	1/317 (0.32%)
Musculoskeletal pain † 1	1/318 (0.31%)	0/317 (0.00%)
Osteoarthritis † 1	1/318 (0.31%)	0/317 (0.00%)
Osteonecrosis † 1	1/318 (0.31%)	1/317 (0.32%)
Osteonecrosis of jaw † 1	0/318 (0.00%)	6/317 (1.89%)
Pain in extremity † 1	1/318 (0.31%)	0/317 (0.00%)
Pathological fracture † 1	0/318 (0.00%)	1/317 (0.32%)
Rhabdomyolysis † 1	0/318 (0.00%)	3/317 (0.95%)
Spinal stenosis † 1	1/318 (0.31%)	0/317 (0.00%)
Tendonitis † 1	1/318 (0.31%)	0/317 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute erythroid leukaemia † 1	1/318 (0.31%)	0/317 (0.00%)
Acute myeloid leukaemia † 1	1/318 (0.31%)	0/317 (0.00%)
Adenocarcinoma of colon † 1	1/318 (0.31%)	1/317 (0.32%)
Atypical fibroxanthoma † 1	1/318 (0.31%)	0/317 (0.00%)
Basal cell carcinoma † 1	10/318 (3.14%)	4/317 (1.26%)
Bladder transitional cell carcinoma † 1	1/318 (0.31%)	0/317 (0.00%)
Breast cancer stage I † 1	1/318 (0.31%)	0/317 (0.00%)
Cervix carcinoma † 1	1/318 (0.31%)	0/317 (0.00%)
Chronic lymphocytic leukaemia † 1	1/318 (0.31%)	0/317 (0.00%)
Colorectal adenocarcinoma † 1	1/318 (0.31%)	0/317 (0.00%)
Endometrial cancer † 1	0/318 (0.00%)	1/317 (0.32%)
External ear neoplasm malignant † 1	0/318 (0.00%)	1/317 (0.32%)
Gastrointestinal neoplasm † 1	1/318 (0.31%)	0/317 (0.00%)
Haemangioma † 1	0/318 (0.00%)	1/317 (0.32%)
Haemangioma of bone † 1	0/318 (0.00%)	1/317 (0.32%)
Lip squamous cell carcinoma † 1	0/318 (0.00%)	1/317 (0.32%)
Lung cancer metastatic † 1	0/318 (0.00%)	1/317 (0.32%)
Lung neoplasm malignant † 1	4/318 (1.26%)	0/317 (0.00%)
Malignant melanoma in situ † 1	0/318 (0.00%)	1/317 (0.32%)
Malignant neoplasm of unknown primary site † 1	0/318 (0.00%)	1/317 (0.32%)
Malignant neoplasm progression † 1	5/318 (1.57%)	4/317 (1.26%)
Malignant pleural effusion † 1	1/318 (0.31%)	0/317 (0.00%)
Meningioma † 1	1/318 (0.31%)	0/317 (0.00%)
Mesothelioma † 1	1/318 (0.31%)	0/317 (0.00%)
Myelodysplastic syndrome † 1	2/318 (0.63%)	3/317 (0.95%)
Neoplasm malignant † 1	1/318 (0.31%)	0/317 (0.00%)
Non-small cell lung cancer † 1	1/318 (0.31%)	0/317 (0.00%)
Plasma cell myeloma † 1	6/318 (1.89%)	5/317 (1.58%)
Plasma cell myeloma recurrent † 1	0/318 (0.00%)	1/317 (0.32%)
Plasmacytoma † 1	2/318 (0.63%)	3/317 (0.95%)
Prostate cancer † 1	1/318 (0.31%)	2/317 (0.63%)
Prostatic adenoma † 1	1/318 (0.31%)	1/317 (0.32%)
Rectal adenocarcinoma † 1	0/318 (0.00%)	1/317 (0.32%)
Sarcoma † 1	1/318 (0.31%)	0/317 (0.00%)
Squamous cell carcinoma † 1	2/318 (0.63%)	3/317 (0.95%)
Squamous cell carcinoma of skin † 1	12/318 (3.77%)	3/317 (0.95%)
Tonsil cancer † 1	0/318 (0.00%)	1/317 (0.32%)
Tumour associated fever † 1	0/318 (0.00%)	1/317 (0.32%)
Vulval cancer † 1	1/318 (0.31%)	0/317 (0.00%)
Nervous system disorders
Cerebral haemorrhage † 1	0/318 (0.00%)	1/317 (0.32%)
Cerebral infarction † 1	1/318 (0.31%)	0/317 (0.00%)
Cerebral ischaemia † 1	2/318 (0.63%)	1/317 (0.32%)
Cerebrospinal fluid leakage † 1	1/318 (0.31%)	0/317 (0.00%)
Cerebrovascular accident † 1	2/318 (0.63%)	3/317 (0.95%)
Dementia † 1	2/318 (0.63%)	0/317 (0.00%)
Dizziness † 1	2/318 (0.63%)	0/317 (0.00%)
Encephalopathy † 1	0/318 (0.00%)	2/317 (0.63%)
Hemiparesis † 1	0/318 (0.00%)	1/317 (0.32%)
Hepatic encephalopathy † 1	1/318 (0.31%)	0/317 (0.00%)
Hypoaesthesia † 1	1/318 (0.31%)	0/317 (0.00%)
Ischaemic stroke † 1	1/318 (0.31%)	0/317 (0.00%)
Nervous system disorder † 1	1/318 (0.31%)	0/317 (0.00%)
Neuropathy peripheral † 1	0/318 (0.00%)	1/317 (0.32%)
Optic neuritis † 1	1/318 (0.31%)	0/317 (0.00%)
Paraesthesia † 1	0/318 (0.00%)	1/317 (0.32%)
Paraparesis † 1	1/318 (0.31%)	1/317 (0.32%)
Presyncope † 1	1/318 (0.31%)	0/317 (0.00%)
Sciatica † 1	1/318 (0.31%)	0/317 (0.00%)
Seizure † 1	1/318 (0.31%)	0/317 (0.00%)
Somnolence † 1	1/318 (0.31%)	0/317 (0.00%)
Spinal cord compression † 1	1/318 (0.31%)	2/317 (0.63%)
Spinal cord disorder † 1	0/318 (0.00%)	1/317 (0.32%)
Status epilepticus † 1	0/318 (0.00%)	1/317 (0.32%)
Syncope † 1	3/318 (0.94%)	2/317 (0.63%)
Transient ischaemic attack † 1	2/318 (0.63%)	1/317 (0.32%)
Product Issues
Device dislocation † 1	0/318 (0.00%)	1/317 (0.32%)
Psychiatric disorders
Completed suicide † 1	1/318 (0.31%)	0/317 (0.00%)
Confusional state † 1	4/318 (1.26%)	1/317 (0.32%)
Delirium † 1	1/318 (0.31%)	0/317 (0.00%)
Depression † 1	1/318 (0.31%)	0/317 (0.00%)
Mental status changes † 1	1/318 (0.31%)	0/317 (0.00%)
Renal and urinary disorders
Acute kidney injury † 1	11/318 (3.46%)	8/317 (2.52%)
Haematuria † 1	0/318 (0.00%)	1/317 (0.32%)
Haemorrhage urinary tract † 1	1/318 (0.31%)	0/317 (0.00%)
Myeloma cast nephropathy † 1	1/318 (0.31%)	0/317 (0.00%)
Nephrolithiasis † 1	0/318 (0.00%)	1/317 (0.32%)
Neurogenic bladder † 1	1/318 (0.31%)	0/317 (0.00%)
Prerenal failure † 1	1/318 (0.31%)	0/317 (0.00%)
Renal failure † 1	4/318 (1.26%)	5/317 (1.58%)
Renal impairment † 1	3/318 (0.94%)	0/317 (0.00%)
Renal tubular acidosis † 1	1/318 (0.31%)	0/317 (0.00%)
Urinary retention † 1	1/318 (0.31%)	3/317 (0.95%)
Urinary tract obstruction † 1	1/318 (0.31%)	1/317 (0.32%)
Reproductive system and breast disorders
Benign prostatic hyperplasia † 1	0/318 (0.00%)	1/317 (0.32%)
Ovarian cyst † 1	0/318 (0.00%)	1/317 (0.32%)
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema † 1	0/318 (0.00%)	1/317 (0.32%)
Acute respiratory distress syndrome † 1	1/318 (0.31%)	1/317 (0.32%)
Acute respiratory failure † 1	1/318 (0.31%)	0/317 (0.00%)
Asthma † 1	1/318 (0.31%)	1/317 (0.32%)
Bronchial disorder † 1	0/318 (0.00%)	1/317 (0.32%)
Bronchial hyperreactivity † 1	2/318 (0.63%)	0/317 (0.00%)
Chronic obstructive pulmonary disease † 1	5/318 (1.57%)	3/317 (0.95%)
Cough † 1	1/318 (0.31%)	0/317 (0.00%)
Dyspnoea † 1	4/318 (1.26%)	4/317 (1.26%)
Epistaxis † 1	1/318 (0.31%)	0/317 (0.00%)
Haemoptysis † 1	0/318 (0.00%)	1/317 (0.32%)
Hypoxia † 1	1/318 (0.31%)	1/317 (0.32%)
Interstitial lung disease † 1	1/318 (0.31%)	3/317 (0.95%)
Lung disorder † 1	4/318 (1.26%)	1/317 (0.32%)
Obliterative bronchiolitis † 1	1/318 (0.31%)	0/317 (0.00%)
Organising pneumonia † 1	2/318 (0.63%)	0/317 (0.00%)
Pleural effusion † 1	2/318 (0.63%)	1/317 (0.32%)
Pneumonitis † 1	1/318 (0.31%)	2/317 (0.63%)
Pulmonary alveolar haemorrhage † 1	1/318 (0.31%)	0/317 (0.00%)
Pulmonary artery thrombosis † 1	1/318 (0.31%)	0/317 (0.00%)
Pulmonary embolism † 1	11/318 (3.46%)	8/317 (2.52%)
Pulmonary fibrosis † 1	1/318 (0.31%)	0/317 (0.00%)
Respiratory failure † 1	2/318 (0.63%)	1/317 (0.32%)
Skin and subcutaneous tissue disorders
Dermal cyst † 1	1/318 (0.31%)	0/317 (0.00%)
Pustular psoriasis † 1	1/318 (0.31%)	0/317 (0.00%)
Rash maculo-papular † 1	1/318 (0.31%)	0/317 (0.00%)
Skin haemorrhage † 1	1/318 (0.31%)	0/317 (0.00%)
Skin ulcer † 1	0/318 (0.00%)	1/317 (0.32%)
Surgical and medical procedures
Hip arthroplasty † 1	1/318 (0.31%)	0/317 (0.00%)
Vascular disorders
Aortic aneurysm rupture † 1	1/318 (0.31%)	0/317 (0.00%)
Deep vein thrombosis † 1	10/318 (3.14%)	4/317 (1.26%)
Embolism † 1	0/318 (0.00%)	1/317 (0.32%)
Hypotension † 1	1/318 (0.31%)	1/317 (0.32%)
Hypovolaemic shock † 1	1/318 (0.31%)	0/317 (0.00%)
Orthostatic hypotension † 1	0/318 (0.00%)	1/317 (0.32%)
Pelvic venous thrombosis † 1	1/318 (0.31%)	0/317 (0.00%)
Peripheral artery thrombosis † 1	1/318 (0.31%)	0/317 (0.00%)
Peripheral ischaemia † 1	1/318 (0.31%)	0/317 (0.00%)
Subclavian vein thrombosis † 1	1/318 (0.31%)	0/317 (0.00%)
Thrombophlebitis † 1	0/318 (0.00%)	2/317 (0.63%)
Thrombophlebitis superficial † 1	0/318 (0.00%)	1/317 (0.32%)
Thrombosis † 1	0/318 (0.00%)	1/317 (0.32%)
Venous thrombosis † 1	0/318 (0.00%)	2/317 (0.63%)
Venous thrombosis limb † 1	1/318 (0.31%)	0/317 (0.00%)
1 Term from vocabulary, 24.0; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Lenalidomide + Dexamethasone + Elotuzumab	Lenalidomide + Dexamethasone
	Affected / at Risk (%)	Affected / at Risk (%)
Total	314/318 (98.74%)	309/317 (97.48%)
Blood and lymphatic system disorders
Anaemia † 1	135/318 (42.45%)	118/317 (37.22%)
Leukopenia † 1	26/318 (8.18%)	26/317 (8.20%)
Lymphopenia † 1	41/318 (12.89%)	23/317 (7.26%)
Neutropenia † 1	114/318 (35.85%)	137/317 (43.22%)
Thrombocytopenia † 1	91/318 (28.62%)	72/317 (22.71%)
Eye disorders
Cataract † 1	58/318 (18.24%)	36/317 (11.36%)
Vision blurred † 1	31/318 (9.75%)	18/317 (5.68%)
Gastrointestinal disorders
Abdominal pain † 1	44/318 (13.84%)	31/317 (9.78%)
Abdominal pain upper † 1	30/318 (9.43%)	20/317 (6.31%)
Constipation † 1	115/318 (36.16%)	89/317 (28.08%)
Diarrhoea † 1	159/318 (50.00%)	122/317 (38.49%)
Dry mouth † 1	16/318 (5.03%)	10/317 (3.15%)
Dyspepsia † 1	36/318 (11.32%)	19/317 (5.99%)
Nausea † 1	82/318 (25.79%)	73/317 (23.03%)
Stomatitis † 1	30/318 (9.43%)	14/317 (4.42%)
Toothache † 1	18/318 (5.66%)	11/317 (3.47%)
Vomiting † 1	58/318 (18.24%)	32/317 (10.09%)
General disorders
Asthenia † 1	80/318 (25.16%)	54/317 (17.03%)
Chest pain † 1	28/318 (8.81%)	14/317 (4.42%)
Chills † 1	31/318 (9.75%)	12/317 (3.79%)
Fatigue † 1	154/318 (48.43%)	131/317 (41.32%)
Influenza like illness † 1	27/318 (8.49%)	16/317 (5.05%)
Malaise † 1	19/318 (5.97%)	12/317 (3.79%)
Oedema peripheral † 1	97/318 (30.50%)	78/317 (24.61%)
Pain † 1	17/318 (5.35%)	7/317 (2.21%)
Pyrexia † 1	121/318 (38.05%)	74/317 (23.34%)
Infections and infestations
Bronchitis † 1	66/318 (20.75%)	52/317 (16.40%)
Gastroenteritis † 1	18/318 (5.66%)	9/317 (2.84%)
Herpes zoster † 1	18/318 (5.66%)	5/317 (1.58%)
Influenza † 1	25/318 (7.86%)	17/317 (5.36%)
Lower respiratory tract infection † 1	32/318 (10.06%)	16/317 (5.05%)
Nasopharyngitis † 1	83/318 (26.10%)	60/317 (18.93%)
Oral herpes † 1	20/318 (6.29%)	13/317 (4.10%)
Pharyngitis † 1	17/318 (5.35%)	16/317 (5.05%)
Pneumonia † 1	30/318 (9.43%)	23/317 (7.26%)
Respiratory tract infection † 1	36/318 (11.32%)	32/317 (10.09%)
Rhinitis † 1	30/318 (9.43%)	13/317 (4.10%)
Sinusitis † 1	23/318 (7.23%)	15/317 (4.73%)
Upper respiratory tract infection † 1	86/318 (27.04%)	62/317 (19.56%)
Urinary tract infection † 1	36/318 (11.32%)	31/317 (9.78%)
Viral infection † 1	18/318 (5.66%)	10/317 (3.15%)
Injury, poisoning and procedural complications
Contusion † 1	44/318 (13.84%)	28/317 (8.83%)
Fall † 1	21/318 (6.60%)	14/317 (4.42%)
Investigations
Alanine aminotransferase increased † 1	25/318 (7.86%)	33/317 (10.41%)
Aspartate aminotransferase increased † 1	21/318 (6.60%)	31/317 (9.78%)
Blood creatinine increased † 1	36/318 (11.32%)	27/317 (8.52%)
C-reactive protein increased † 1	13/318 (4.09%)	16/317 (5.05%)
Platelet count decreased † 1	16/318 (5.03%)	5/317 (1.58%)
Weight decreased † 1	52/318 (16.35%)	20/317 (6.31%)
Metabolism and nutrition disorders
Decreased appetite † 1	71/318 (22.33%)	42/317 (13.25%)
Hyperglycaemia † 1	61/318 (19.18%)	45/317 (14.20%)
Hypoalbuminaemia † 1	17/318 (5.35%)	11/317 (3.47%)
Hypocalcaemia † 1	48/318 (15.09%)	28/317 (8.83%)
Hypokalaemia † 1	67/318 (21.07%)	47/317 (14.83%)
Hypomagnesaemia † 1	22/318 (6.92%)	5/317 (1.58%)
Hyponatraemia † 1	18/318 (5.66%)	10/317 (3.15%)
Hypophosphataemia † 1	19/318 (5.97%)	10/317 (3.15%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	98/318 (30.82%)	63/317 (19.87%)
Back pain † 1	105/318 (33.02%)	97/317 (30.60%)
Bone pain † 1	33/318 (10.38%)	43/317 (13.56%)
Muscle spasms † 1	99/318 (31.13%)	85/317 (26.81%)
Muscular weakness † 1	42/318 (13.21%)	28/317 (8.83%)
Musculoskeletal chest pain † 1	39/318 (12.26%)	30/317 (9.46%)
Myalgia † 1	26/318 (8.18%)	22/317 (6.94%)
Neck pain † 1	23/318 (7.23%)	13/317 (4.10%)
Pain in extremity † 1	64/318 (20.13%)	35/317 (11.04%)
Nervous system disorders
Dizziness † 1	48/318 (15.09%)	38/317 (11.99%)
Headache † 1	54/318 (16.98%)	29/317 (9.15%)
Hypoaesthesia † 1	28/318 (8.81%)	12/317 (3.79%)
Neuropathy peripheral † 1	51/318 (16.04%)	31/317 (9.78%)
Paraesthesia † 1	35/318 (11.01%)	29/317 (9.15%)
Peripheral sensory neuropathy † 1	33/318 (10.38%)	39/317 (12.30%)
Taste disorder † 1	18/318 (5.66%)	14/317 (4.42%)
Tremor † 1	30/318 (9.43%)	29/317 (9.15%)
Psychiatric disorders
Anxiety † 1	26/318 (8.18%)	24/317 (7.57%)
Confusional state † 1	18/318 (5.66%)	10/317 (3.15%)
Depression † 1	18/318 (5.66%)	14/317 (4.42%)
Insomnia † 1	79/318 (24.84%)	83/317 (26.18%)
Mood altered † 1	23/318 (7.23%)	8/317 (2.52%)
Renal and urinary disorders
Dysuria † 1	16/318 (5.03%)	9/317 (2.84%)
Respiratory, thoracic and mediastinal disorders
Cough † 1	109/318 (34.28%)	62/317 (19.56%)
Dysphonia † 1	25/318 (7.86%)	32/317 (10.09%)
Dyspnoea † 1	72/318 (22.64%)	60/317 (18.93%)
Dyspnoea exertional † 1	20/318 (6.29%)	15/317 (4.73%)
Epistaxis † 1	22/318 (6.92%)	19/317 (5.99%)
Oropharyngeal pain † 1	32/318 (10.06%)	15/317 (4.73%)
Productive cough † 1	25/318 (7.86%)	5/317 (1.58%)
Skin and subcutaneous tissue disorders
Erythema † 1	26/318 (8.18%)	16/317 (5.05%)
Hyperhidrosis † 1	38/318 (11.95%)	25/317 (7.89%)
Night sweats † 1	24/318 (7.55%)	10/317 (3.15%)
Pruritus † 1	36/318 (11.32%)	29/317 (9.15%)
Rash † 1	63/318 (19.81%)	58/317 (18.30%)
Vascular disorders
Deep vein thrombosis † 1	19/318 (5.97%)	10/317 (3.15%)
Flushing † 1	16/318 (5.03%)	6/317 (1.89%)
Haematoma † 1	17/318 (5.35%)	8/317 (2.52%)
Hypertension † 1	40/318 (12.58%)	23/317 (7.26%)
Hypotension † 1	33/318 (10.38%)	12/317 (3.79%)
1 Term from vocabulary, 24.0; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

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
• EMail: Clinical.Trials@bms.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dimopoulos MA, Lonial S, Betts KA, Chen C, Zichlin ML, Brun A, Signorovitch JE, Makenbaeva D, Mekan S, Sy O, Weisel K, Richardson PG. Elotuzumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: Extended 4-year follow-up and analysis of relative progression-free survival from the randomized ELOQUENT-2 trial. Cancer. 2018 Oct 15;124(20):4032-4043. doi: 10.1002/cncr.31680. Epub 2018 Sep 11.

Passey C, Mora J, Dodge R, Gibiansky L, Sheng J, Roy A, Bello A, Gupta M. An Integrated Assessment of the Effects of Immunogenicity on the Pharmacokinetics, Safety, and Efficacy of Elotuzumab. AAPS J. 2017 Mar;19(2):557-567. doi: 10.1208/s12248-016-0033-9. Epub 2017 Jan 9.

Lonial S, Dimopoulos M, Palumbo A, White D, Grosicki S, Spicka I, Walter-Croneck A, Moreau P, Mateos MV, Magen H, Belch A, Reece D, Beksac M, Spencer A, Oakervee H, Orlowski RZ, Taniwaki M, Rollig C, Einsele H, Wu KL, Singhal A, San-Miguel J, Matsumoto M, Katz J, Bleickardt E, Poulart V, Anderson KC, Richardson P; ELOQUENT-2 Investigators. Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2015 Aug 13;373(7):621-31. doi: 10.1056/NEJMoa1505654. Epub 2015 Jun 2.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT01239797
• Other Study ID Numbers: CA204-004; 2010-020347-12 ( EudraCT Number )
• First Submitted: November 8, 2010
• First Posted: November 11, 2010
• Results First Submitted: August 4, 2016
• Results First Posted: January 5, 2017
• Last Update Posted: June 1, 2022