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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01335399
Recruitment Status : Active, not recruiting
First Posted : April 14, 2011
Last Update Posted : February 16, 2018
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Lenalidomide Drug: Dexamethasone Biological: Elotuzumab (BMS-901608; HuLuc63) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma
Actual Study Start Date : May 18, 2011
Estimated Primary Completion Date : May 30, 2018
Estimated Study Completion Date : May 31, 2018

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 Name: 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®
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 Name: Revlimid®
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

Primary Outcome Measures :
  1. Progression-free survival (PFS) - Time from randomization to date of first tumor progression or death due to any cause, provided death is not more than 10 weeks after the last tumor assessment. [ Time Frame: Every 4 weeks (-1/+3 days) relative to the first dose of study medication. ]

Secondary Outcome Measures :
  1. Objective Response Rate - The percentage of patients who have a partial or complete response to study therapy. [ Time Frame: All response endpoints assessed every 4 weeks (-1/+3 days). ]
  2. Overall Survival - The period of time from study entry until the date of death or last known date alive. [ Time Frame: Survival will be assessed every 16 weeks in the Follow Up Phase of the trial. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01335399

  Hide Study Locations
United States, Alabama
Alabama Oncology
Birmingham, Alabama, United States, 35243
University Of South Alabama / Mitchell Cancer Institute
Mobile, Alabama, United States, 36604
Southern Cancer Center, Inc.
Mobile, Alabama, United States, 36608
United States, Arizona
Ironwood Cancer And Research Centers, Pc
Chandler, Arizona, United States, 85224
Acrc/Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States, 85715
United States, California
Comprehensive Blood And Cancer Center
Bakersfield, California, United States, 93309
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States, 94704
Compassionate Cancer Care Medical Group, Inc.
Corona, California, United States, 92879
Compassionate Cancer Res Grp
Corona, California, United States, 92879
Marin Cancer Care, Inc
Greenbrae, California, United States, 94904-2011
Pacific Shores Medical Group
Long Beach, California, United States, 90813
Ucla-Division Of Hematology/Oncology
Los Angeles, California, United States, 90095
Medical Oncology Care Associates
Orange, California, United States, 92868
Sharp Clinical Oncology Research
San Diego, California, United States, 92123
Pacific Hematology Oncology Associates
San Francisco, California, United States, 94115
United States, Connecticut
Yale University School Of Medicine
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Washington Cancer Inst at MedStar Washington Hospital Ctr
Washington, District of Columbia, United States, 20010
United States, Florida
Lynn Cancer Institute Center For Hematology-Oncology
Boca Raton, Florida, United States, 33486
Local Institution
Brooksville, Florida, United States, 34613
Florida Cancer Specialists S.
Fort Myers, Florida, United States, 33916
Memorial Cancer Institute
Hollywood, Florida, United States, 33021
Cancer Specialists, Llc
Jacksonville, Florida, United States, 32256
Local Institution
New Port Richey, Florida, United States, 34652
Florida Cancer Specialists
Saint Petersburg, Florida, United States, 33705
Palm Beach Cancer Institute
West Palm Beach, Florida, United States, 33401
United States, Georgia
Winship Cancer Institute.
Atlanta, Georgia, United States, 30322
United States, Hawaii
Kaiser Permanente Hawaii
Honolulu, Hawaii, United States, 96819
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
The University Of Chicago
Chicago, Illinois, United States, 60637
Loyola University Chicago
Maywood, Illinois, United States, 60153
Illinois Cancercare, Pc
Peoria, Illinois, United States, 61615
Orchard Healthcare Research Inc.
Skokie, Illinois, United States, 60077
Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Premier Healthcare, Llc
Bloomington, Indiana, United States, 47403
Franciscan St. Francis Health
Indianapolis, Indiana, United States, 46237
Investigative Clinical Research Of Indiana, Llc
Indianapolis, Indiana, United States, 46260
Local Institution
Mishawaka, Indiana, United States, 46545
United States, Iowa
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
Baptist Health Lexington
Lexington, Kentucky, United States, 40503
Norton Cancer Institute
Louisville, Kentucky, United States, 40207
United States, Louisiana
Cancer Center Of Acadiana At Lafayette General
Lafayette, Louisiana, United States, 70503
Crescent City Research Consortium, LLC
Marrero, Louisiana, United States, 70072
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Willis Knighton Cancer Center
Shreveport, Louisiana, United States, 71103
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
Harry & Jeanette Weinberg Cancer Institute
Baltimore, Maryland, United States, 21237
United States, Massachusetts
Dana Faber Cancer Institute
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
University Of Michigan
Ann Arbor, Michigan, United States, 48109
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Missouri
Columbia Comprehensive Cancer Care Clinic
Jefferson City, Missouri, United States, 65101
Washington University School Of Medicine
Saint Louis, Missouri, United States, 63110
Mercy Medical Research Institute
Springfield, Missouri, United States, 65807
United States, Nebraska
Local Institution
Lincoln, Nebraska, United States, 68506
University Of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
Local Institution
New York, New York, United States, 10019
St. Luke'S Roosevelt Hospital Center
New York, New York, United States, 10019
St. Luke'S-Roosevelt Hosp. Ctr.
New York, New York, United States, 10019
Weill Cornell Medical College
New York, New York, United States, 10021
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794-8183
United States, North Carolina
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States, 27534
Novant Health Oncology Specialists
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Local Institution
Cleveland, Ohio, United States, 44195
Benson, Md, Don
Columbus, Ohio, United States, 43210
Mid Ohio Onc/Hema, Inc., Dba
Columbus, Ohio, United States, 43219
Signal Point Clinical Research Center, Llc
Middletown, Ohio, United States, 45042
United States, Oklahoma
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma, United States, 74146
United States, Pennsylvania
Cancer Care Associates
Bethlehem, Pennsylvania, United States, 18015
Alliance Cancer Specialists
Langhorne, Pennsylvania, United States, 19047
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
Va Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States, 15240
Donald Guthrie Foundation
Sayre, Pennsylvania, United States, 18840
United States, South Carolina
Charleston Hematology Oncology Associates, Pa
Charleston, South Carolina, United States, 29414
Musc Hollings Cancer Center
Charleston, South Carolina, United States, 29425
GHS Cancer Institute
Greenville, South Carolina, United States, 29615
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Tennessee Cancer Specialists
Knoxville, Tennessee, United States, 37909
Baptist Cancer Center
Memphis, Tennessee, United States, 38120
Tennessee Oncology, Pc
Nashville, Tennessee, United States, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-5505
United States, Texas
Cancer Specialists Of South Texas, Pa
Corpus Christi, Texas, United States, 78412
Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
The University Of Texas Md Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Baylor College Of Medicine
Houston, Texas, United States, 77030
Michael E Debakey VA Medical Center
Houston, Texas, United States, 77030
Northwest Cancer Center
Houston, Texas, United States, 77090
United States, Utah
Northern Utah Associates
Ogden, Utah, United States, 84403
United States, Virginia
Hematology-Oncology Associates Of Fredricksburg, Inc
Fredericksburg, Virginia, United States, 22408
United States, Washington
Va Puget Sound Health Care System
Seattle, Washington, United States, 98108
Fred Hutchinson Cancer Research Ctr
Seattle, Washington, United States, 98109
United States, West Virginia
Edwards Comprehensive Cancer Center
Huntington, West Virginia, United States, 25701
United States, Wisconsin
Gundersen Clinic, Ltd
La Crosse, Wisconsin, United States, 54601
Dean Clinic-Hematology And Oncology
Madison, Wisconsin, United States, 53717
University Of Wisconsin Hospital And Clinics
Madison, Wisconsin, United States, 53792
Australia, Australian Capital Territory
Local Institution
Canberra, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Local Institution
Albury, New South Wales, Australia, 2640
Local Institution
Waratah, New South Wales, Australia, 2298
Local Institution
Westmead, New South Wales, Australia, 2145
Australia, Queensland
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Herston, Queensland, Australia, 4029
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South Brisbane, Queensland, Australia, 4101
Australia, South Australia
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Adelaide, South Australia, Australia, 5000
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Adelaide, South Australia, Australia, 5011
Australia, Victoria
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Fitzroy, Victoria, Australia, 3065
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Frankston, Victoria, Australia, 3199
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Heidelberg Melbourne, Victoria, Australia, 3084
Australia, Western Australia
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Nedlands, Western Australia, Australia, 6009
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Murdoch, Australia, 6150
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Innsbruck, Austria, 6020
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Linz, Austria, 4020
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Rankweil, Austria, 6830
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Wels, Austria, 4600
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Brussels, Belgium, 1000
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Brussels, Belgium, 1020
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Brussels, Belgium, 1090
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Brussles, Belgium, 1200
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Charleroi, Belgium, 6000
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Edegem-antwerp, Belgium, 2650
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Gent, Belgium, 9000
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La Louviere, Belgium, 7100
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Leuven, Belgium, 3000
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Liege, Belgium, 4000
Local Institution
Roeselare, Belgium, 8800
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Yvoir, Belgium, 5530
Canada, Alberta
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Calgary, Alberta, Canada, T2N 4N2
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Edmonton, Alberta, Canada, T6G 1Z2
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
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Saint John, New Brunswick, Canada, E2L 4L2
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
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London, Ontario, Canada, N6A 5W9
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Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
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Greenfield Park, Quebec, Canada, J4V 2H1
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Montral, Quebec, Canada, H3A 1A1
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Montreal, Quebec, Canada, H1T 2M4
Canada, Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 4H4
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Hradec Kralove, Czechia, 500 05
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Praha 10, Czechia, 100 34
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Praha 2, Czechia, 128 08
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Aschaffenburg, Germany, 63739
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Berlin, Germany, 12200
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Chemnitz, Germany, 09113
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Dresden, Germany, 01307
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Hamm, Germany, 59063
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Heidelberg, Germany, 69120
Local Institution
Jena, Germany, 07747
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Koln, Germany, 50937
Local Institution
Mainz, Germany, 55131
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Munchen, Germany, 81377
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Munster, Germany, 48149
Local Institution
Offenbach, Germany, 63069
Local Institution
Stuttgart, Germany, 70376
Local Institution
Tuebingen, Germany, 72076
Local Institution
Ulm, Germany, 89081
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Athens, Greece, 11527
Local Institution
Athens, Greece, 11528
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Ioannina, Greece, 45500
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Larissa, Greece, 41110
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Patras, Greece, 26504
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Budapest, Hungary, 1097
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Budapest, Hungary, 1122
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Debrecen, Hungary, 4032
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Gyor, Hungary, 9024
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Szeged, Hungary, 6720
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Dublin, Ireland, 7
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Dublin, Ireland, 8
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Galway, Ireland
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Afula, Israel, 1834111
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Ashkelon, Israel, 7830604
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Haifa, Israel, 3109601
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Jerusalem, Israel, 91031
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Jerusalem, Israel, 9112001
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Kfar Saba, Israel, 4428164
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Nahariya, Israel, 2210001
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Petah Tikva, Israel, 4941492
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Rehovot, Israel, 76100
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Tel Aviv, Israel, 64239
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Zerifin, Israel, 7030000
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Ancona, Italy, 60126
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Bari, Italy, 70124
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Bergamo, Italy, 24127
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Bologna, Italy, 40138
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Firenze, Italy, 50134
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Genova, Italy, 16132
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Meldola, Italy, 47014
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Milano, Italy, 20122
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Milano, Italy, 20132
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Monza, Italy, 20052
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Napoli, Italy, 80131
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Palermo, Italy, 90146
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Ravenna, Italy, 47923
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Reggio Nell Emilia (RE), Italy, 42100
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Rimini, Italy, 47923
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Roma, Italy, 00144
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Roma, Italy, 00161
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Roma, Italy, 00168
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Terni, Italy, 05100
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Torino, Italy, 10126
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Bialystok, Poland, 15-276
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Chorzow, Poland, 41-500
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Gdansk, Poland, 80-211
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Krakow, Poland, 31-501
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Lodz, Poland, 93-510
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Lublin, Poland, 20-081
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Poznan, Poland, 60-569
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Szczecin, Poland, 70-111
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Warsaw, Poland, 02-776
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Warszawa, Poland, 02-106
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Warszawa, Poland, 02-507
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Wroclaw, Poland, 50-367
Puerto Rico
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Ponce, Puerto Rico, 00716
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San Juan, Puerto Rico, 00918
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Brasov, Romania, 500152
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Bucaresti, Romania, 030171
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Bucuresti, Romania, 020125
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Bucuresti, Romania, 050098
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Bucuresti, Romania, 22328
Local Institution
Lasi, Romania, 700483
Russian Federation
Local Institution
Samara, Russian Federation, 443095
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St Petersburg, Russian Federation, 197089
Local Institution
St. Petersburg, Russian Federation, 197022
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Badalona-barcelona, Spain, 08916
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Barcelona, Spain, 08036
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Barcelona, Spain, 08041
Local Institution
La Laguna- Tenerife, Spain, 38320
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Madrid, Spain, 28006
Local Institution
Madrid, Spain, 28007
Local Institution
Madrid, Spain, 28034
Local Institution
Madrid, Spain, 28041
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Pamplona, Spain, 31008
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Salamanca, Spain, 37007
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San Sebastian, Spain, 20014
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Toledo, Spain, 45004
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Bern, Switzerland, 3010
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St Gallen, Switzerland, 9007
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Zurich, Switzerland, 8028
Local Institution
Zurich, Switzerland, 8091
Local Institution
Izmir, Bornova, Turkey, 35100
Local Institution
Ankara, Dikimevi, Turkey, 06620
Local Institution
Izmir, Inciralti, Turkey, 35340
Local Institution
Gaziantep, Turkey, 27310
United Kingdom
Local Institution
Belfast, Antrim, United Kingdom, BT9 7AB
Local Institution
London, Greater London, United Kingdom, EC1A 7BE
Local Institution
London, Greater London, United Kingdom, NW1 2PG
Local Institution
London, Greater London, United Kingdom, NW3 2QG
Local Institution
London, Greater London, United Kingdom, SE5 9RS
Local Institution
London, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01335399     History of Changes
Other Study ID Numbers: CA204-006
2010-022445-20 ( EudraCT Number )
First Posted: April 14, 2011    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018

Keywords provided by Bristol-Myers Squibb:
Newly Diagnosed
Previously Untreated

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents