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Brief Title: Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma
Official Title: Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma (MM)
Study ID: NCT01239797
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).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Local Institution, Mishawaka, Indiana, United States
Local Institution, Iowa City, Iowa, United States
Local Institution, Lexington, Kentucky, United States
Local Institution, 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
Washington University School Of Medicine, Saint Louis, Missouri, United States
Local Institution, Springfield, 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
Local Institution, Tulsa, Oklahoma, United States
Local Institution, Bethlehem, Pennsylvania, United States
Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States
Local Institution, Charleston, South Carolina, United States
Local Institution, Greenville, South Carolina, United States
Local Institution, 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
Local Institution, Albury, New South Wales, Australia
Local Institution, Canberra, New South Wales, Australia
Local Institution, South Brisbane, Queensland, Australia
Local Institution, Adelaide, South Australia, Australia
Local Institution, Malvern, Victoria, Australia
Local Institution, Melbourne, Victoria, Australia
Local Institution, Nedlands, Western Australia, Australia
Local Institution, Murdoch, , Australia
Local Institution, Rankweil, , Austria
Local Institution, Steyr, , Austria
Local Institution, Wels, , Austria
Local Institution, Wien, , Austria
Local Institution, Antwerpen, , Belgium
Local Institution, Brussels, , Belgium
Local Institution, Brussels, , Belgium
Local Institution, Brussels, , Belgium
Local Institution, Brussles, , Belgium
Local Institution, Edegem-antwerp, , Belgium
Local Institution, Liege, , Belgium
Local Institution, Yvoir, , Belgium
Local Institution, Calgary, Alberta, Canada
Local Institution, Edmonton, Alberta, Canada
Local Institution, Halifax, Nova Scotia, Canada
Local Institution, London, Ontario, Canada
Local Institution, Toronto, Ontario, Canada
Local Institution, Montreal, Quebec, Canada
Local Institution, Saskatoon, Saskatchewan, Canada
Local Institution, Barrie, , Canada
Local Institution, Montreal, , Canada
Local Institution, Brno, , Czechia
Local Institution, Hradec Kralove, , Czechia
Local Institution, Praha 10, , Czechia
Local Institution, Praha 2, , Czechia
Local Institution, Copenhagen, , Denmark
Local Institution, Odense C, , Denmark
Local Institution, Vejle, , Denmark
Local Institution, Blois, , France
Local Institution, Bordeaux, , France
Local Institution, Caen, , France
Local Institution, Clamart Cedex, , France
Local Institution, La Roche Sur Yon, , France
Local Institution, La Tronche, , France
Local Institution, Lille, , France
Local Institution, Limoges, , France
Local Institution, Nantes, , France
Local Institution, Paris 12, , France
Local Institution, Pierre Benita, , France
Local Institution, Toulouse, , France
Local Institution, Tours Cedex, , France
Local Institution, Vandoeuvre, , France
Local Institution, Aschaffenburg, , Germany
Local Institution, Berlin, , Germany
Local Institution, Berlin, , Germany
Local Institution, Chemnitz, , Germany
Local Institution, Dresden, , Germany
Local Institution, Hamburg, , Germany
Local Institution, Hamburg, , Germany
Local Institution, Hamburg, , Germany
Local Institution, Hamm, , Germany
Local Institution, Heidelberg, , Germany
Local Institution, Jena, , Germany
Local Institution, Kiel, , Germany
Local Institution, Koln, , Germany
Local Institution, Marburg, , Germany
Local Institution, Munchen, , Germany
Local Institution, Munchen, , Germany
Local Institution, Munster, , Germany
Local Institution, Ravensburg, , Germany
Local Institution, Tuebingen, , Germany
Local Institution, Ulm, , Germany
Local Institution, Wurzburg, , Germany
Local Institution, Athens, , Greece
Local Institution, Ioannina, , Greece
Local Institution, Larissa, , Greece
Local Institution, Budapest, , Hungary
Local Institution, Debrecen, , Hungary
Local Institution, Gyor, , Hungary
Local Institution, Szeged, , Hungary
Local Institution, Dublin, , Ireland
Local Institution, Tullamore, , Ireland
Local Institution, Afula, , Israel
Local Institution, Jerusalem, , Israel
Local Institution, Petah Tikva, , Israel
Local Institution, Rehovot, , Israel
Local Institution, Zerifin, , Israel
Local Institution, Ancona, , Italy
Local Institution, Bergamo, , Italy
Local Institution, Bologna, , Italy
Local Institution, Firenze, , Italy
Local Institution, Genova, , Italy
Local Institution, Meldola, , Italy
Local Institution, Milano, , Italy
Local Institution, Palermo, , Italy
Local Institution, Ravenna, , Italy
Local Institution, Rimini, , Italy
Local Institution, Roma, , Italy
Local Institution, Roma, , Italy
Local Institution, Torino, , Italy
Local Institution, Nagoya-shi, Aichi, Japan
Local Institution, Nagoya-shi, Aichi, Japan
Local Institution, Maebashi-shi, Gunma, Japan
Local Institution, Shibukawa-shi, Gunma, Japan
Local Institution, Sapporo-city, Hokkaido, Japan
Local Institution, Sendai-shi, Miyagi, Japan
Local Institution, Osaka-shi, Osaka, Japan
Local Institution, Bunkyo-Ku, Tokyo, Japan
Local Institution, Koto-ku, Tokyo, Japan
Local Institution, Shibuya-ku, Tokyo, Japan
Local Institution, Shinjuuku-ku, Tokyo, Japan
Local Institution, Kamogawa, Toyko, Japan
Local Institution, Chiba-shi, , Japan
Local Institution, Fukuoka, , Japan
Local Institution, Kyoto, , Japan
Local Institution, Niigata, , Japan
Local Institution, Okayama, , Japan
Local Institution, Toyohashi-shi, , Japan
Local Institution, Bialystok, , Poland
Local Institution, Chorzow, , Poland
Local Institution, Lublin, , Poland
Local Institution, Poznan, , Poland
Local Institution, Warszawa, , Poland
Local Institution, Warszawa, , Poland
Local Institution, Warszawa, , Poland
Local Institution, Wroclaw, , Poland
Local Institution, Ponce, , Puerto Rico
Local Institution, San Juan, , Puerto Rico
Local Institution, Brasov, , Romania
Local Institution, Brasov, , Romania
Local Institution, Bucaresti, , Romania
Local Institution, Bucuresti, , Romania
Local Institution, Badalona-Barcelona, , Spain
Local Institution, Madrid, , Spain
Local Institution, Madrid, , Spain
Local Institution, Murcia, , Spain
Local Institution, Salamanca, , Spain
Local Institution, Santiago De Comp-coruna, , Spain
Local Institution, Toledo, , Spain
Local Institution, Bern, , Switzerland
Local Institution, Geneve 14, , Switzerland
Local Institution, Izmir, Bornova, Turkey
Local Institution, Istanbul, Capa, Turkey
Local Institution, Ankara, , Turkey
Local Institution, Izmir, , Turkey
Local Institution, Leicester, , United Arab Emirates
Local Institution, London, Greater London, United Kingdom
Local Institution, Manchester, Greater Manchester, United Kingdom
Local Institution, Airdrie, Lancashire, United Kingdom
Local Institution, Edinburgh, Midlothian, United Kingdom
Local Institution, Nottingham, Nottinghamshire, United Kingdom
Local Institution, Sutton, Surrey, United Kingdom
Local Institution, Leeds, , United Kingdom
Local Institution, London, , United Kingdom
Local Institution, Newcastle Upon Tyne, , United Kingdom
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR