Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma
NCT ID: NCT01239797
Last Updated: 2022-06-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
646 participants
INTERVENTIONAL
2011-06-20
2021-04-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lenalidomide + Dexamethasone
Lenalidomide
Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study 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
Lenalidomide + Dexamethasone +Elotuzumab
Lenalidomide
Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug
Dexamethasone (Oral)
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
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 subject meets 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 subject meets criteria for discontinuation of study drug
Interventions
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Lenalidomide
Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study 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
Dexamethasone (Oral)
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
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 subject meets 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 subject meets criteria for discontinuation of study drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 1-3 prior lines of therapy
* Measurable disease
* Life expectancy ≥3 months
* Prior treatment with Lenalidomide permitted if:
1. Best response achieved was ≥Partial Response (PR)
2. Patient was not refractory
3. Patient did not discontinue due to a Grade ≥3 related adverse event
4. Subject did not receive more than 9 cycles of Lenalidomide and had at least 9 months between the last dose of Lenalidomide and progression
Exclusion Criteria
* Active plasma cell leukemia
* Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Northwest Alabama Cancer Center, Pc
Muscle Shoals, Alabama, United States
Acrc/Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States
Local Institution
Berkeley, California, United States
Local Institution
Burbank, California, United States
Compassionate Cancer Res Grp
Corona, California, United States
Local Institution
Corona, California, United States
San Diego Pacific Oncology& Hematology Associates, Inc
Encinitas, California, United States
Local Institution
Greenbrae, California, United States
Ucla-Division Of Hematology/Oncology
Los Angeles, California, United States
Medical Oncology Care Associates
Orange, California, United States
Sharp Clinical Oncology Research
San Diego, California, United States
Local Institution
Vallejo, California, United States
Local Institution
Boca Raton, Florida, United States
Cancer Care Centers Of Florida
Brooksville, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Local Institution
New Port Richey, Florida, United States
Cancer Institute Of Florida
Orlando, Florida, United States
Local Institution
Titusville, Florida, United States
Florida Cancer Specialists
West Palm Beach, Florida, United States
Winship Cancer Institute.
Atlanta, Georgia, United States
Georgia Health Science University
Augusta, Georgia, United States
Orchard Healthcare Research Inc.
Skokie, Illinois, United States
Local Institution
Indianapolis, Indiana, United States
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Mishawaka, Indiana, United States
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Iowa City, Iowa, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
Pikeville Medical Center
Pikeville, Kentucky, United States
Cancer Center Of Acadiana At Lafayette General
Lafayette, Louisiana, United States
Local Institution
Shreveport, Louisiana, United States
Local Institution
Shreveport, Louisiana, United States
Willis Knighton Cancer Center
Shreveport, Louisiana, United States
Dana Farber Cancer Inst
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Capitol Comprehensive Cancer Care Center
Jefferson City, Missouri, United States
Local Institution
Springfield, Missouri, United States
Washington University School Of Medicine
St Louis, Missouri, United States
Local Institution
Las Vegas, Nevada, United States
NYU Clinical Cancer Center
New York, New York, United States
Local Institution
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Local Institution
Stony Brook, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Gaston Hematology & Oncology
Gastonia, North Carolina, United States
Local Institution
Bismarck, North Dakota, United States
University Of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Bethlehem, Pennsylvania, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Greenville, South Carolina, United States
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Knoxville, Tennessee, United States
The West Clinic
Memphis, Tennessee, United States
Cancer Specialists Of South Texas, Pa
Corpus Christi, Texas, United States
Ut Southwestern Medical Center
Dallas, Texas, United States
University Of Texas Md Anderson Cancer Ctr
Houston, Texas, United States
Northwest Cancer Center
Houston, Texas, United States
Hematology-Oncology Associates Of Fredricksburg, Inc
Fredericksburg, Virginia, United States
Va Puget Sound Health Care System
Seattle, Washington, United States
Gundersen Clinic, Ltd
La Crosse, Wisconsin, United States
University Of Wisconsin Hospital And Clinics
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
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Albury, New South Wales, Australia
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Canberra, New South Wales, Australia
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South Brisbane, Queensland, Australia
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Adelaide, South Australia, Australia
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Malvern, Victoria, Australia
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Melbourne, Victoria, Australia
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Nedlands, Western Australia, Australia
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Murdoch, , Australia
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Rankweil, , Austria
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Steyr, , Austria
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Vienna, , Austria
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Wels, , Austria
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Antwerp, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Brussles, , Belgium
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Edegem-antwerp, , Belgium
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Liège, , Belgium
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Yvoir, , Belgium
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Halifax, Nova Scotia, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Barrie, , Canada
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Montreal, , Canada
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Brno, , Czechia
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Hradec Králové, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Copenhagen, , Denmark
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Odense C, , Denmark
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Vejle, , Denmark
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Blois, , France
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Bordeaux, , France
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Caen, , France
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Clamart, , France
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La Roche-sur-Yon, , France
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La Tronche, , France
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Lille, , France
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Limoges, , France
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Nantes, , France
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Paris, , France
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Pierre Benita, , France
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Toulouse, , France
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Tours, , France
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Vandœuvre-lès-Nancy, , France
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Aschaffenburg, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Chemnitz, , Germany
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Cologne, , Germany
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Dresden, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamm, , Germany
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Heidelberg, , Germany
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Jena, , Germany
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Kiel, , Germany
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Marburg, , Germany
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München, , Germany
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München, , Germany
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Münster, , Germany
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Ravensburg, , Germany
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Tübingen, , Germany
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Ulm, , Germany
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Würzburg, , Germany
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Athens, , Greece
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Ioannina, , Greece
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Larissa, , Greece
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Budapest, , Hungary
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Debrecen, , Hungary
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Győr, , Hungary
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Szeged, , Hungary
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Dublin, , Ireland
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Tullamore, , Ireland
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Afula, , Israel
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Jerusalem, , Israel
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Petah Tikva, , Israel
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Rehovot, , Israel
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Ẕerifin, , Israel
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Ancona, , Italy
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Bergamo, , Italy
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Bologna, , Italy
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Florence, , Italy
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Genova, , Italy
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Meldola, , Italy
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Milan, , Italy
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Palermo, , Italy
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Ravenna, , Italy
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Rimini, , Italy
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Roma, , Italy
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Roma, , Italy
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Torino, , Italy
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Nagoya, Aichi-ken, Japan
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Nagoya, Aichi-ken, Japan
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Maebashi, Gunma, Japan
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Shibukawa-shi, Gunma, Japan
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Sapporo, Hokkaido, Japan
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Sendai, Miyagi, Japan
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Osaka, Osaka, Japan
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Bunkyo-Ku, Tokyo, Japan
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Koto-ku, Tokyo, Japan
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Shibuya-ku, Tokyo, Japan
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Shinjuuku-ku, Tokyo, Japan
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Kamogawa, Toyko, Japan
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Chiba, , Japan
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Fukuoka, , Japan
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Kyoto, , Japan
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Niigata, , Japan
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Okayama, , Japan
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Toyohashi, , Japan
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Bialystok, , Poland
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Chorzów, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Ponce, , Puerto Rico
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San Juan, , Puerto Rico
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Brasov, , Romania
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Brasov, , Romania
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Bucaresti, , Romania
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Bucharest, , Romania
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Badalona-Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Murcia, , Spain
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Salamanca, , Spain
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Santiago de Comp-coruna, , Spain
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Toledo, , Spain
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Bern, , Switzerland
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Geneva, , Switzerland
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Izmir, Bornova, Turkey (Türkiye)
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Istanbul, CAPA, Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Leicester, , United Arab Emirates
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London, Greater London, United Kingdom
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Manchester, Greater Manchester, United Kingdom
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Airdrie, Lancashire, United Kingdom
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Edinburgh, Midlothian, United Kingdom
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Nottingham, Nottinghamshire, United Kingdom
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Sutton, Surrey, United Kingdom
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Leeds, , United Kingdom
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London, , United Kingdom
Local Institution
Newcastle upon Tyne, , United Kingdom
Countries
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References
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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.
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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2010-020347-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA204-004
Identifier Type: -
Identifier Source: org_study_id
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