Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma
ELOQUENT - 2
Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma (MM)
2 other identifiers
interventional
646
22 countries
212
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 lymphoma
Started Jun 2011
Typical duration for phase_3 lymphoma
212 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2010
CompletedFirst Posted
Study publicly available on registry
November 11, 2010
CompletedStudy Start
First participant enrolled
June 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 2, 2014
CompletedResults Posted
Study results publicly available
January 5, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 21, 2021
CompletedJune 1, 2022
May 1, 2022
3.2 years
November 8, 2010
August 4, 2016
May 5, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Median Progression Free Survival (PFS)
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.
From randomization up to 326 events (up to approximately 38 months)
Objective Response Rate (ORR)
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.
From randomization up to approximately 38 months
Secondary Outcomes (3)
Median Overall Survival (OS)
Randomization to the date of death from any cause (up to approximately 9 years)
Change From Baseline of Mean Score Pain Severity (BPI-SF)
From baseline up to approximately 38 months
Change From Baseline of Mean Score Pain Interference (BPI-SF)
From baseline up to approximately 38 months
Study Arms (2)
Lenalidomide + Dexamethasone
ACTIVE COMPARATORLenalidomide + Dexamethasone +Elotuzumab
EXPERIMENTALInterventions
Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug
Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug
On weeks without Elotuzumab dosing: Tablets, Oral, 40mg, Repeat every 28 days until subject meets criteria for discontinuation of study drug. On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg, Repeat every 28 days until subject meets criteria for discontinuation of study drug
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 subject meets criteria for discontinuation of study drug
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 subject meets criteria for discontinuation of study drug
Eligibility Criteria
You may qualify if:
- Documented progression from most recent line of therapy
- prior lines of therapy
- Measurable disease
- Life expectancy ≥3 months
- Prior treatment with Lenalidomide permitted if:
- Best response achieved was ≥Partial Response (PR)
- Patient was not refractory
- Patient did not discontinue due to a Grade ≥3 related adverse event
- Subject did not receive more than 9 cycles of Lenalidomide and had at least 9 months between the last dose of Lenalidomide and progression
You may not qualify if:
- Subjects with non-secretory or oligo-secretory or serum free light-chain only myeloma
- Active plasma cell leukemia
- Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- AbbViecollaborator
Study Sites (216)
Northwest Alabama Cancer Center, Pc
Muscle Shoals, Alabama, 35661, United States
Acrc/Arizona Clinical Research Center, Inc.
Tucson, Arizona, 85715, United States
Local Institution
Berkeley, California, 94704, United States
Local Institution
Burbank, California, 91505, United States
Compassionate Cancer Res Grp
Corona, California, 92879, United States
Local Institution
Corona, California, 92879, United States
San Diego Pacific Oncology& Hematology Associates, Inc
Encinitas, California, 92024, United States
Local Institution
Greenbrae, California, 94904, United States
Ucla-Division Of Hematology/Oncology
Los Angeles, California, 90095, United States
Medical Oncology Care Associates
Orange, California, 92868, United States
Sharp Clinical Oncology Research
San Diego, California, 92123, United States
Local Institution
Vallejo, California, 94589, United States
Local Institution
Boca Raton, Florida, 33486, United States
Cancer Care Centers Of Florida
Brooksville, Florida, 34613, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140, United States
Local Institution
New Port Richey, Florida, 34652, United States
Cancer Institute Of Florida
Orlando, Florida, 32804, United States
Local Institution
Titusville, Florida, 32796, United States
Florida Cancer Specialists
West Palm Beach, Florida, 33401, United States
Winship Cancer Institute.
Atlanta, Georgia, 30322, United States
Georgia Health Science University
Augusta, Georgia, 30912, United States
Orchard Healthcare Research Inc.
Skokie, Illinois, 60077, United States
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Indianapolis, Indiana, 46260, United States
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Mishawaka, Indiana, 46545, United States
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Iowa City, Iowa, 52242, United States
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Lexington, Kentucky, 40503, United States
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Louisville, Kentucky, 40207, United States
Pikeville Medical Center
Pikeville, Kentucky, 41501, United States
Cancer Center Of Acadiana At Lafayette General
Lafayette, Louisiana, 70503, United States
Local Institution
Shreveport, Louisiana, 71101, United States
Local Institution
Shreveport, Louisiana, 71103, United States
Willis Knighton Cancer Center
Shreveport, Louisiana, 71103, United States
Dana Farber Cancer Inst
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Capitol Comprehensive Cancer Care Center
Jefferson City, Missouri, 65101, United States
Local Institution
Springfield, Missouri, 65807, United States
Washington University School Of Medicine
St Louis, Missouri, 63110, United States
Local Institution
Las Vegas, Nevada, 89106, United States
NYU Clinical Cancer Center
New York, New York, 10016, United States
Local Institution
New York, New York, 10019, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Local Institution
Stony Brook, New York, 11794-8151, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Gaston Hematology & Oncology
Gastonia, North Carolina, 28054, United States
Local Institution
Bismarck, North Dakota, 58501, United States
University Of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
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Tulsa, Oklahoma, 74136, United States
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Bethlehem, Pennsylvania, 18015, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224, United States
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Charleston, South Carolina, 29414, United States
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Greenville, South Carolina, 29615, United States
Local Institution
Knoxville, Tennessee, 37909, United States
The West Clinic
Memphis, Tennessee, 38120, United States
Cancer Specialists Of South Texas, Pa
Corpus Christi, Texas, 78412, United States
Ut Southwestern Medical Center
Dallas, Texas, 75390-8565, United States
University Of Texas Md Anderson Cancer Ctr
Houston, Texas, 77030, United States
Northwest Cancer Center
Houston, Texas, 77090, United States
Hematology-Oncology Associates Of Fredricksburg, Inc
Fredericksburg, Virginia, 22408, United States
Va Puget Sound Health Care System
Seattle, Washington, 98108, United States
Gundersen Clinic, Ltd
La Crosse, Wisconsin, 54601, United States
University Of Wisconsin Hospital And Clinics
Madison, Wisconsin, 53792, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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Albury, New South Wales, 2640, Australia
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Canberra, New South Wales, 2605, Australia
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South Brisbane, Queensland, 4101, Australia
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Adelaide, South Australia, 5000, Australia
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Malvern, Victoria, 3144, Australia
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Melbourne, Victoria, 3004, Australia
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Nedlands, Western Australia, 6009, Australia
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Murdoch, 6150, Australia
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Rankweil, 6830, Austria
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Steyr, 4400, Austria
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Vienna, 1220, Austria
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Wels, 4600, Austria
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Antwerp, 2060, Belgium
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Brussels, 1000, Belgium
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Brussels, 1020, Belgium
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Brussels, 1090, Belgium
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Brussles, 1200, Belgium
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Edegem-antwerp, 2650, Belgium
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Liège, 4000, Belgium
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Yvoir, 5530, Belgium
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Calgary, Alberta, T2N 4N2, Canada
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Edmonton, Alberta, T6G 1Z2, Canada
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Halifax, Nova Scotia, B3H 2Y9, Canada
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London, Ontario, N6A 4G5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H4J 1C5, Canada
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Saskatoon, Saskatchewan, S7N 4H4, Canada
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Barrie, L4M 6M2, Canada
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Montreal, H4A 3J1, Canada
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Brno, 625 00, Czechia
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Hradec Králové, 500 05, Czechia
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Prague, 100 34, Czechia
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Prague, 128 08, Czechia
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Copenhagen, 2100, Denmark
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Odense C, 5000, Denmark
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Vejle, 7100, Denmark
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Blois, 41016, France
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Bordeaux, 33076, France
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Caen, 14000, France
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Clamart, 92140, France
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La Roche-sur-Yon, 85925, France
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La Tronche, 38700, France
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Lille, 59037, France
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Limoges, 87042, France
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Nantes, 44093, France
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Paris, 75012, France
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Pierre Benita, 69495, France
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Toulouse, 31059, France
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Tours, 37044, France
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Vandœuvre-lès-Nancy, 54511, France
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Aschaffenburg, 63739, Germany
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Berlin, 12200, Germany
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Berlin, 13125, Germany
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Chemnitz, 09113, Germany
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Cologne, 50937, Germany
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Dresden, 01307, Germany
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Hamburg, 20246, Germany
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Hamburg, 22763, Germany
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Hamburg, 66421, Germany
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Hamm, 59071, Germany
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Heidelberg, 69120, Germany
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Jena, 07747, Germany
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Kiel, 24105, Germany
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Marburg, 35037, Germany
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München, 81377, Germany
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München, 81675, Germany
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Münster, 48149, Germany
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Ravensburg, 88212, Germany
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Tübingen, 72076, Germany
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Ulm, 89081, Germany
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Würzburg, 97080, Germany
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Athens, 11528, Greece
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Ioannina, 45500, Greece
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Larissa, 41110, Greece
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Budapest, 1125, Hungary
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Debrecen, H-4032, Hungary
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Győr, 9024, Hungary
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Szeged, H-6725, Hungary
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Dublin, 7, Ireland
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Tullamore, Ireland
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Afula, 18101, Israel
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Jerusalem, 91120, Israel
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Petah Tikva, 49100, Israel
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Rehovot, 76100, Israel
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Ẕerifin, 70300, Israel
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Ancona, 60126, Italy
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Bergamo, 24127, Italy
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Bologna, 40138, Italy
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Florence, 50134, Italy
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Genova, 16132, Italy
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Meldola, 47014, Italy
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Milan, 20133, Italy
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Palermo, 90146, Italy
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Ravenna, 48100, Italy
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Rimini, 47923, Italy
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Roma, 00161, Italy
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Roma, 00168, Italy
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Torino, 10126, Italy
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Nagoya, Aichi-ken, 4600001, Japan
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Nagoya, Aichi-ken, 4678602, Japan
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Maebashi, Gunma, 371-8511, Japan
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Shibukawa-shi, Gunma, 3770280, Japan
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Sapporo, Hokkaido, 0608543, Japan
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Sendai, Miyagi, 980-8754, Japan
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Osaka, Osaka, 5438555, Japan
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Bunkyo-Ku, Tokyo, 1138677, Japan
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Koto-ku, Tokyo, 1358550, Japan
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Shibuya-ku, Tokyo, 1508935, Japan
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Shinjuuku-ku, Tokyo, 1608582, Japan
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Kamogawa, Toyko, 296-8602, Japan
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Chiba, 260-8677, Japan
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Fukuoka, 812-8582, Japan
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Kyoto, 602-8566, Japan
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Niigata, 9518566, Japan
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Okayama, 7011192, Japan
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Toyohashi, 4418570, Japan
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Bialystok, 15-276, Poland
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Chorzów, 41-500, Poland
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Lublin, 20-081, Poland
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Poznan, 60-569, Poland
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Warsaw, 02-106, Poland
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Warsaw, 02-507, Poland
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Warsaw, 02-776, Poland
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Wroclaw, 50-367, Poland
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Ponce, 00716, Puerto Rico
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San Juan, 00918, Puerto Rico
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Brasov, 500152, Romania
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Brasov, 700106, Romania
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Bucaresti, 030171, Romania
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Bucharest, 22328, Romania
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Badalona-Barcelona, 08916, Spain
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Madrid, 28006, Spain
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Madrid, 28007, Spain
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Murcia, 30008, Spain
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Salamanca, 37007, Spain
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Santiago de Comp-coruna, 15706, Spain
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Toledo, 45004, Spain
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Bern, 3010, Switzerland
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Geneva, 1211, Switzerland
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Izmir, Bornova, 35100, Turkey (Türkiye)
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Istanbul, CAPA, 34390, Turkey (Türkiye)
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Ankara, 06620, Turkey (Türkiye)
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Izmir, 35330, Turkey (Türkiye)
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Leicester, LE1 5WW, United Arab Emirates
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London, Greater London, EC1A 7BE, United Kingdom
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Manchester, Greater Manchester, M20 4BX, United Kingdom
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Airdrie, Lancashire, ML6 OJS, United Kingdom
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Edinburgh, Midlothian, EH4 2XU, United Kingdom
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Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
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Sutton, Surrey, SM2 5PT, United Kingdom
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Leeds, LS9 7FT, United Kingdom
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London, NW1 2PG, United Kingdom
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Newcastle upon Tyne, NE7 7DN, United Kingdom
Related Publications (3)
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.
PMID: 30204239DERIVEDPassey 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.
PMID: 28070715DERIVEDLonial 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.
PMID: 26035255DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2010
First Posted
November 11, 2010
Study Start
June 20, 2011
Primary Completion
September 2, 2014
Study Completion
April 21, 2021
Last Updated
June 1, 2022
Results First Posted
January 5, 2017
Record last verified: 2022-05