Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma (ELOQUENT - 1)

A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma

The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS)

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Lenalidomide; Drug: Dexamethasone; Drug: Dexamethasone; Drug: Dexamethasone; Drug: Dexamethasone; Biological: Elotuzumab (BMS-901608; HuLuc63); Biological: Elotuzumab (BMS-901608; HuLuc63)

• Study Type: Interventional
• Enrollment (Actual): 748
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Murdoch, Australia, 6150
    • Local Institution - 3605
  • Nedlands, Australia, 6009
    • Local Institution - 3611
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia, 2605
      • Local Institution - 3600
  • New South Wales
    • Waratah, New South Wales, Australia, 2298
      • Local Institution - 3607
    • Westmead, New South Wales, Australia, 2145
      • Local Institution - 3610
  • Queensland
    • Herston, Queensland, Australia, 4029
      • Local Institution - 3609
    • Milton, Queensland, Australia, 4064
      • Local Institution - 3608
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Local Institution - 3612
    • Woodville South, South Australia, Australia, 5001
      • Local Institution - 3606
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • Local Institution - 3601
    • Frankston, Victoria, Australia, 3199
      • Local Institution - 3602
    • Heidelberg Melbourne, Victoria, Australia, 3084
      • Local Institution - 3603
    • Wodonga, Victoria, Australia, 3690
      • Local Institution - 3604
• Austria
  • Fadingerstraße 1, Austria, 4020
    • Local Institution - 4052
  • Innsbruck, Austria, 6020
    • Local Institution - 4051
  • Rankweil, Austria, 6830
    • Local Institution - 4054
  • Wels, Austria, 4600
    • Local Institution - 4053
• Belgium
  • Brussels, Belgium, 1020
    • Local Institution - 4160
  • Brussels, Belgium, 1090
    • Local Institution - 4156
  • Brussles, Belgium, 1200
    • Local Institution - 4157
  • Charleroi, Belgium, 6000
    • Local Institution - 4154
  • Haine St Paul, Belgium, 7100
    • Local Institution - 4159
  • Leuven, Belgium, 3000
    • Local Institution - 4158
  • Liege, Belgium, 4000
    • Local Institution - 4150
  • Roeselare, Belgium, 8800
    • Local Institution - 4153
  • Yvoir, Belgium, 5530
    • Local Institution - 4151
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Local Institution - 2601
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Local Institution - 2600
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • Local Institution - 2602
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Local Institution - 2611
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Local Institution - 2610
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • Local Institution - 2606
    • Toronto, Ontario, Canada, M5G 2M9
      • Local Institution - 2612
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Local Institution - 2603
    • Montreal, Quebec, Canada, H1T 2M4
      • Local Institution - 2605
    • Montreal, Quebec, Canada, H3A 1A1
      • Local Institution - 2607
• Czechia
  • Hradec Kralove, Czechia, 500 05
    • Local Institution - 4252
  • Praha 10, Czechia, 100 34
    • Local Institution - 4250
  • Praha 2, Czechia, 128 08
    • Local Institution - 4251
• Germany
  • Aschaffenburg, Germany, 63739
    • Local Institution - 4565
  • Berlin, Germany, 12200
    • Local Institution - 4550
  • Chemnitz, Germany, 09113
    • Local Institution - 4555
  • Dresden, Germany, 01307
    • Local Institution - 4562
  • Hamm, Germany, 59063
    • Local Institution - 4552
  • Heidelberg, Germany, 69120
    • Local Institution - 4553
  • Jena, Germany, 07747
    • Local Institution - 4560
  • Koln, Germany, 50937
    • Local Institution - 4563
  • Mainz, Germany, 55101
    • Local Institution - 4554
  • Munchen, Germany, 81377
    • Local Institution - 4561
  • Munster, Germany, 48149
    • Local Institution - 4558
  • Offenbach, Germany, 63069
    • Local Institution - 4551
  • Stuttgart, Germany, 70376
    • Local Institution - 4556
  • Tuebingen, Germany, 72076
    • Local Institution - 4564
  • Ulm, Germany, 89081
    • Local Institution - 4559
• Greece
  • Athens, Greece, 11527
    • Local Institution - 4653
  • Athens, Greece, 11528
    • Local Institution - 4651
  • Ioannina, Greece, 45500
    • Local Institution - 4650
  • Larissa, Greece, 41110
    • Local Institution - 4652
  • Patras, Greece, 26504
    • Local Institution - 4654
• Hungary
  • Budapest, Hungary, 1097
    • Local Institution - 4751
  • Budapest, Hungary, 1122
    • Local Institution - 4754
  • Debrecen, Hungary, 4012
    • Local Institution - 4750
  • Gyor, Hungary, 9024
    • Local Institution - 4753
  • Szeged, Hungary, 6720
    • Local Institution - 4752
• Ireland
  • Dublin, Ireland, 7
    • Local Institution - 4852
  • Dublin, Ireland, 8
    • Local Institution - 4850
  • Galway, Ireland
    • Local Institution - 4851
• Israel
  • Afula, Israel, 1834111
    • Local Institution - 4950
  • Ashkelon, Israel, 7830604
    • Local Institution - 4956
  • Haifa, Israel, 3109601
    • Local Institution - 4960
  • Jerusalem, Israel, 91031
    • Local Institution - 4958
  • Jerusalem, Israel, 91120
    • Local Institution - 4951
  • Kfar Saba, Israel, 4428164
    • Local Institution - 4959
  • Nahariya, Israel, 2210001
    • Local Institution - 4954
  • Petah Tikva, Israel, 4941492
    • Local Institution - 4952
  • Tel Aviv, Israel, 64239
    • Local Institution - 4957
  • Zerifin, Israel, 70300
    • Local Institution - 4955
• Italy
  • Ancona, Italy, 60126
    • Local Institution - 5067
  • Bari, Italy, 70124
    • Local Institution - 5065
  • Bergamo, Italy, 24127
    • Local Institution - 5053
  • Bologna, Italy, 40138
    • Local Institution - 5070
  • Firenze, Italy, 50134
    • Local Institution - 5066
  • Genova, Italy, 16132
    • Local Institution - 5050
  • Meldola, Italy, 47014
    • Local Institution - 5057
  • Milan, Italy, 20132
    • Local Institution - 5069
  • Milano, Italy, 20122
    • Local Institution - 5075
  • Monza, Italy, 20052
    • Local Institution - 5052
  • Napoli, Italy, 80131
    • Local Institution - 5062
  • Napoli, Italy, 80131
    • Local Institution - 5068
  • Palermo, Italy, 90146
    • Local Institution - 5055
  • Ravenna, Italy, 48100
    • Local Institution - 5063
  • Reggio Nell Emilia (RE), Italy, 42100
    • Local Institution - 5073
  • Rimini, Italy, 47923
    • Local Institution - 5064
  • Roma, Italy, 00144
    • Local Institution - 5058
  • Roma, Italy, 00168
    • Local Institution - 5054
  • Rome, Italy, 00161
    • Local Institution - 5056
  • Terni, Italy, 05100
    • Local Institution - 5072
  • Torino, Italy, 10126
    • Local Institution - 5051
• Poland
  • Bialystok, Poland, 15-276
    • Local Institution - 5250
  • Chorzow, Poland, 41-500
    • Local Institution - 5252
  • Gdansk, Poland, 80-952
    • Local Institution - 5254
  • Krakow, Poland, 31-531
    • Local Institution - 7626
  • Lodz, Poland, 93-510
    • Local Institution - 5258
  • Lublin, Poland, 20-081
    • Local Institution - 5257
  • Poznan, Poland, 60-569
    • Local Institution - 5259
  • Szczecin, Poland, 70-111
    • Local Institution - 5255
  • Warszawa, Poland, 02-106
    • Local Institution - 5256
  • Warszawa, Poland, 02-507
    • Local Institution - 5253
  • Warszawa, Poland, 02-776
    • Local Institution - 5260
  • Wroclaw, Poland, 50-367
    • Local Institution - 5251
• Puerto Rico
  • Ponce, Puerto Rico, 00716
    • Local Institution - 7600
  • San Juan, Puerto Rico, 00918
    • Local Institution - 7602
• Romania
  • Brasov, Romania, 500152
    • Local Institution - 5356
  • Bucaresti, Romania, 030171
    • Local Institution - 5350
  • Bucuresti, Romania, 020125
    • Local Institution - 5355
  • Bucuresti, Romania, 050098
    • Local Institution - 5353
  • Bucuresti, Romania, 22328
    • Local Institution - 5352
  • Lasi, Romania, 700483
    • Local Institution - 5351
• Russian Federation
  • Samara, Russian Federation, 443095
    • Local Institution - 5453
  • St. Petersburg, Russian Federation, 197022
    • Local Institution - 5450
  • St. Petersburg, Russian Federation, 197022
    • Local Institution - 5452
• Spain
  • Badalona-barcelona, Spain, 08916
    • Local Institution - 5552
  • Barcelona, Spain, 08036
    • Local Institution - 5559
  • Barcelona, Spain, 08041
    • Local Institution - 5555
  • La Laguna- Tenerife, Spain, 38320
    • Local Institution - 5561
  • Madrid, Spain, 28006
    • Local Institution - 5553
  • Madrid, Spain, 28007
    • Local Institution - 5551
  • Madrid, Spain, 28034
    • Local Institution - 5560
  • Madrid, Spain, 28041
    • Local Institution - 5554
  • Pamplona, Spain, 31008
    • Local Institution - 5558
  • Salamanca, Spain, 37007
    • Local Institution - 5550
  • San Sebastian, Spain, 20014
    • Local Institution - 5557
  • Toledo, Spain, 45004
    • Local Institution - 5556
• Switzerland
  • Bern, Switzerland, 3010
    • Local Institution - 5751
  • St Gallen, Switzerland, 9007
    • Local Institution - 5750
  • Zurich, Switzerland, 8028
    • Local Institution - 5753
  • Zurich, Switzerland, 8091
    • Local Institution - 5752
• Turkey
  • Gaziantep, Turkey, 27310
    • Local Institution - 5856
  • Bornova
    • Izmir, Bornova, Turkey, 35100
      • Local Institution - 5853
  • Dikimevi
    • Ankara, Dikimevi, Turkey, 06620
      • Local Institution - 5851
  • Inciralti
    • Izmir, Inciralti, Turkey, 35340
      • Local Institution - 5854
• United Kingdom
  • London, United Kingdom, EC1A 7BE
    • Local Institution - 5950
  • London, United Kingdom, HA1 3UJ
    • Local Institution - 5954
  • London, United Kingdom, NW1 2PG
    • Local Institution - 5952
  • London, United Kingdom, NW3 2QG
    • Local Institution - 5955
  • Antrim
    • Belfast, Antrim, United Kingdom, BT9 7AB
      • Local Institution - 5951
  • Greater London
    • London, Greater London, United Kingdom, SE5 9RS
      • Local Institution - 5953
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Local Institution - 1628
    • Mobile, Alabama, United States, 36604
      • Local Institution - 7619
    • Mobile, Alabama, United States, 36608
      • Local Institution - 7618
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Local Institution - 7617
    • Tucson, Arizona, United States, 85715
      • Local Institution - 1644
  • California
    • Bakersfield, California, United States, 93309
      • Local Institution - 1618
    • Berkeley, California, United States, 94704
      • Local Institution - 1602
    • Corona, California, United States, 92879
      • Local Institution - 1636
    • Corona, California, United States, 92879
      • Local Institution - 1668
    • Greenbrae, California, United States, 94904
      • Local Institution - 1616
    • Long Beach, California, United States, 90813
      • Local Institution - 7609
    • Los Angeles, California, United States, 90095
      • Local Institution - 1660
    • Orange, California, United States, 92868
      • Local Institution - 1673
    • San Diego, California, United States, 92123
      • Local Institution - 1613
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Local Institution - 1621
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Local Institution - 1612
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Local Institution - 1682
    • Brooksville, Florida, United States, 34613
      • Local Institution - 1617
    • Fort Myers, Florida, United States, 33916
      • Local Institution - 1648
    • Hollywood, Florida, United States, 33021
      • Local Institution - 7613
    • Jacksonville, Florida, United States, 32256
      • Local Institution - 1623
    • New Port Richey, Florida, United States, 34652
      • Local Institution - 1625
    • Saint Petersburg, Florida, United States, 33705
      • Local Institution - 1649
    • West Palm Beach, Florida, United States, 33401
      • Local Institution - 1611
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Local Institution - 1630
  • Hawaii
    • Honolulu, Hawaii, United States, 96819
      • Local Institution - 1684
  • Illinois
    • Chicago, Illinois, United States, 19123
      • Local Institution - 1607
    • Chicago, Illinois, United States, 60612
      • Local Institution - 1635
    • Maywood, Illinois, United States, 60153
      • Local Institution - 1632
    • Peoria, Illinois, United States, 61615
      • Local Institution - 7606
    • Skokie, Illinois, United States, 60077
      • Local Institution - 7610
    • Urbana, Illinois, United States, 61801
      • Local Institution - 1603
  • Indiana
    • Bloomington, Indiana, United States, 47403
      • Local Institution - 7616
    • Indianapolis, Indiana, United States, 46237
      • Local Institution - 7620
    • Indianapolis, Indiana, United States, 46260
      • Local Institution - 1669
    • Mishawaka, Indiana, United States, 46545
      • Local Institution - 1656
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Local Institution - 1633
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Local Institution - 1674
    • Louisville, Kentucky, United States, 40207
      • Local Institution - 1683
  • Louisiana
    • Lafayette, Louisiana, United States, 70503
      • Local Institution - 1646
    • Marrero, Louisiana, United States, 70072
      • Local Institution - 7614
    • New Orleans, Louisiana, United States, 70121
      • Local Institution - 1626
    • Shreveport, Louisiana, United States, 71103
      • Local Institution - 1652
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Local Institution - 1676
    • Baltimore, Maryland, United States, 21237
      • Local Institution - 1650
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Local Institution - 1619
    • Boston, Massachusetts, United States, 02215
      • Local Institution - 1699
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Local Institution - 1604
  • Missouri
    • Jefferson City, Missouri, United States, 65101
      • Local Institution - 1667
    • Saint Louis, Missouri, United States, 63110
      • Local Institution - 1645
    • Springfield, Missouri, United States, 65804
      • Local Institution - 1651
  • Nebraska
    • Omaha, Nebraska, United States, 68198-7680
      • Local Institution - 1637
  • New York
    • Mineola, New York, United States, 11501
      • Local Institution - 7621
    • New York, New York, United States, 10019
      • Local Institution - 1615
    • Stony Brook, New York, United States, 11794-8183
      • Local Institution - 1671
  • North Carolina
    • Goldsboro, North Carolina, United States, 27534
      • Local Institution - 7604
    • Winston-Salem, North Carolina, United States, 27103
      • Local Institution - 1610
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Local Institution - 1608
    • Cleveland, Ohio, United States, 44195
      • Local Institution - 1693
    • Columbus, Ohio, United States, 43210
      • Local Institution - 1638
    • Columbus, Ohio, United States, 43219
      • Local Institution - 1664
    • Middletown, Ohio, United States, 45042
      • Local Institution - 1690
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74146
      • Local Institution - 1655
  • Pennsylvania
    • Langhorne, Pennsylvania, United States, 19047
      • Local Institution - 7611
    • Pittsburgh, Pennsylvania, United States, 15224
      • Local Institution - 1647
    • Pittsburgh, Pennsylvania, United States, 15240
      • Local Institution - 1679
    • Sayre, Pennsylvania, United States, 18840
      • Local Institution - 1677
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Local Institution - 1629
    • Charleston, South Carolina, United States, 29425
      • Local Institution - 7615
    • Greenville, South Carolina, United States, 29615
      • Local Institution - 1624
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Local Institution - 7607
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • Local Institution - 1600
    • Memphis, Tennessee, United States, 38120
      • Local Institution - 7628
    • Nashville, Tennessee, United States, 37203
      • Local Institution - 1627
    • Nashville, Tennessee, United States, 37232-5505
      • Local Institution - 1670
  • Texas
    • Corpus Christi, Texas, United States, 78412
      • Local Institution - 1634
    • Dallas, Texas, United States, 75246
      • Local Institution - 7612
    • Houston, Texas, United States, 77030
      • Local Institution - 1643
    • Houston, Texas, United States, 77030
      • Local Institution - 1686
    • Houston, Texas, United States, 77090
      • Local Institution - 1642
  • Utah
    • Ogden, Utah, United States, 84405
      • Local Institution - 7623
  • Virginia
    • Fredericksburg, Virginia, United States, 22408
      • Local Institution - 1657
  • Washington
    • Seattle, Washington, United States, 98108
      • Local Institution - 1640
    • Seattle, Washington, United States, 98109
      • Local Institution - 1631
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • Local Institution - 1601
  • Wisconsin
    • La Crosse, Wisconsin, United States, 54601
      • Gundersen Clinic, Ltd
    • Madison, Wisconsin, United States, 53717
      • Local Institution - 1663
    • Madison, Wisconsin, United States, 53792
      • Local Institution - 1609

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

• Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who:

  • have not received any prior systemic anti-myeloma therapy AND
  • have measurable disease AND
  • are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because of age (≥ 65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204006 for a subject < 65 years old. There must be a comorbidity that prevents SCT for a subject < 65 years old

Exclusion Criteria:

• Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
• Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
• Monoclonal Gammopathy of Undetermined Significance (MGUS)
• Active plasma cell leukemia
• Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lenalidomide + Dexamethasone	Drug: Lenalidomide; Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug; Other Names: Revlimid®; Drug: Dexamethasone; Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug; Other Names: Decadron®; Dexamethasone Intensol®; Dexpak®; Taperpak®; Drug: Dexamethasone; Tablets, Oral, 28 mg, once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug; Other Names: Decadron®; Dexamethasone Intensol®; Dexpak®; Taperpak®; Drug: Dexamethasone; Tablets, Oral, 40 mg, once daily, on Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug; Other Names: Decadron®; Dexamethasone Intensol®; Dexpak®; Taperpak®; Drug: Dexamethasone; Solution, Intravenous (IV), 8 mg, Once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug; Other Names: Decadron®; Dexamethasone Intensol®; Dexpak®; Taperpak®
Experimental: Lenalidomide + Dexamethasone + Elotuzumab	Drug: Lenalidomide; Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug; Other Names: Revlimid®; Drug: Dexamethasone; Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug; Other Names: Decadron®; Dexamethasone Intensol®; Dexpak®; Taperpak®; Drug: Dexamethasone; Tablets, Oral, 28 mg, once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug; Other Names: Decadron®; Dexamethasone Intensol®; Dexpak®; Taperpak®; Drug: Dexamethasone; Tablets, Oral, 40 mg, once daily, on Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug; Other Names: Decadron®; Dexamethasone Intensol®; Dexpak®; Taperpak®; Drug: Dexamethasone; Solution, Intravenous (IV), 8 mg, Once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug; Other Names: Decadron®; Dexamethasone Intensol®; Dexpak®; Taperpak®; Biological: Elotuzumab (BMS-901608; HuLuc63); Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug; Biological: Elotuzumab (BMS-901608; HuLuc63); Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	PFS is defined as the time from randomization to the date of the first documented tumor progression (as determined by the Independent Review Committee (IRC)) or death due to any cause. The IRC conducted a blinded, independent review of the tumor assessments based on the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Censoring rules applied: Participants receiving subsequent systemic anti-myeloma therapy prior to documented progression were censored at the date of the last adequate tumor assessment prior to new therapy.; Participants who had an event (progression or death) > 10 weeks after their last tumor assessment were censored at their last adequate tumor assessment prior to the event.; Participants without progression or death (and not receiving subsequent therapy prior to progression) were censored at their last adequate tumor assessment.; Participants without any post-baseline tumor assessments were censored on the date of randomization	From randomization to date of first documented tumor progression or death due to any cause (up to 8 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	ORR is defined as the percentage of participants with objective response among all randomized subjects. Participants with an objective response are those participants experiencing a partial response (PR) or better, based on Independent Review Committee (IRC) assessment, as per EBMT criteria.	From randomization to primary completion date (approximately 8 years)
Overall Survival (OS)	Survival is defined as the time from randomization to the date of death. A participant who did not die had his or her survival duration censored at the date of last contact ('last known date alive").	From randomization to the date of death (up to 8 years)
Mean Change From Baseline of Pain Severity Score and Pain Interference Score	Pain severity (sensory dimension) and pain interference (reactive dimension, assessing the degree to which pain interferes with function) are measured using the Brief Pain Inventory- Short Form (BPI-SF). BPI-SF numeric rating scale goes from 0 (No pain) to 10 (Pain as bad as you can imagine).	From Baseline to End of Treatment (approximately 8 years)
Progression Free Survival (PFS) Rate at Specific Time-points	PFS rate is defined as the percentage of participants experiencing PFS at the defined time-points.	From randomization to the specified time-point (up to 5 years)

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: AbbVie

Publications and helpful links

General Publications

• Dimopoulos MA, Richardson PG, Bahlis NJ, Grosicki S, Cavo M, Beksac M, Legiec W, Liberati AM, Goldschmidt H, Belch A, Magen H, Larocca A, Laubach JP, Petrucci MT, Reece D, White D, Mateos MV, Spicka I, Lazaroiu M, Berdeja J, Kaufman JL, Jou YM, Ganetsky A, Popa McKiver M, Lonial S, Weisel K; ELOQUENT-1 investigators. Addition of elotuzumab to lenalidomide and dexamethasone for patients with newly diagnosed, transplantation ineligible multiple myeloma (ELOQUENT-1): an open-label, multicentre, randomised, phase 3 trial. Lancet Haematol. 2022 Jun;9(6):e403-e414. doi: 10.1016/S2352-3026(22)00103-X. Epub 2022 May 9.

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2011
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): September 3, 2021

Study Registration Dates

• First Submitted: April 13, 2011
• First Submitted That Met QC Criteria: April 13, 2011
• First Posted (Estimate): April 14, 2011

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 2, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Newly Diagnosed; Previously Untreated
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Immunologic Factors; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101; Lenalidomide; Elotuzumab
• Other Study ID Numbers: CA204-006; 2010-022445-20 (EudraCT Number)