Multiple Myeloma Clinical Trial

Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma

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).

View Eligibility Criteria

Eligibility Criteria

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

Inclusion Criteria:

Documented progression from most recent line of therapy
1-3 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

Exclusion Criteria:

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

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

646

Study ID:

NCT01239797

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 211 Locations for this study

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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
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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
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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
Washington University School Of Medicine
Saint Louis Missouri, 63110, United States
Local Institution
Springfield Missouri, 65807, United States
Local Institution
Las Vegas Nevada, 89106, United States
NYU Clinical Cancer Center
New York New York, 10016, United States
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New York New York, 10019, United States
Weill Cornell Medical College
New York New York, 10065, United States
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Stony Brook New York, 11794, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
Gaston Hematology & Oncology
Gastonia North Carolina, 28054, United States
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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, 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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Wels , 4600, Austria
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Wien , 1220, Austria
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Antwerpen , 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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Liege , 4000, Belgium
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Yvoir , 5530, Belgium
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Calgary Alberta, T2N 4, Canada
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Edmonton Alberta, T6G 1, Canada
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Halifax Nova Scotia, B3H 2, Canada
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London Ontario, N6A 4, Canada
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Toronto Ontario, M5G 2, Canada
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Montreal Quebec, H4J 1, Canada
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Saskatoon Saskatchewan, S7N 4, Canada
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Barrie , L4M 6, Canada
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Montreal , H4A 3, Canada
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Brno , 625 0, Czechia
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Hradec Kralove , 500 0, Czechia
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Praha 10 , 100 3, Czechia
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Praha 2 , 128 0, 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 Cedex , 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 12 , 75012, France
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Pierre Benita , 69495, France
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Toulouse , 31059, France
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Tours Cedex , 37044, France
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Vandoeuvre , 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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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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Koln , 50937, Germany
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Marburg , 35037, Germany
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Munchen , 81377, Germany
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Munchen , 81675, Germany
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Munster , 48149, Germany
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Ravensburg , 88212, Germany
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Tuebingen , 72076, Germany
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Ulm , 89081, Germany
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Wurzburg , 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-403, Hungary
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Gyor , 9024, Hungary
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Szeged , H-672, 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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Zerifin , 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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Firenze , 50134, Italy
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Genova , 16132, Italy
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Meldola , 47014, Italy
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Milano , 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-shi Aichi, 46000, Japan
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Nagoya-shi Aichi, 46786, Japan
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Maebashi-shi Gunma, 371-8, Japan
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Shibukawa-shi Gunma, 37702, Japan
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Sapporo-city Hokkaido, 06085, Japan
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Sendai-shi Miyagi, 980-8, Japan
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Osaka-shi Osaka, 54385, Japan
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Bunkyo-Ku Tokyo, 11386, Japan
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Koto-ku Tokyo, 13585, Japan
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Shibuya-ku Tokyo, 15089, Japan
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Shinjuuku-ku Tokyo, 16085, Japan
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Kamogawa Toyko, 296-8, Japan
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Chiba-shi , 260-8, Japan
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Fukuoka , 812-8, Japan
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Kyoto , 602-8, Japan
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Niigata , 95185, Japan
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Okayama , 70111, Japan
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Toyohashi-shi , 44185, Japan
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Bialystok , 15-27, Poland
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Chorzow , 41-50, Poland
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Lublin , 20-08, Poland
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Poznan , 60-56, Poland
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Warszawa , 02-10, Poland
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Warszawa , 02-50, Poland
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Warszawa , 02-77, Poland
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Wroclaw , 50-36, Poland
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Ponce , 00716, Puerto Rico
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San Juan , 00918, Puerto Rico
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Brasov , 50015, Romania
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Brasov , 70010, Romania
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Bucaresti , 03017, Romania
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Bucuresti , 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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Geneve 14 , 1211, Switzerland
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Izmir Bornova, 35100, Turkey
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Istanbul Capa, 34390, Turkey
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Ankara , 06620, Turkey
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Izmir , 35330, Turkey
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Leicester , LE1 5, United Arab Emirates
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London Greater London, EC1A , United Kingdom
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Manchester Greater Manchester, M20 4, United Kingdom
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Airdrie Lancashire, ML6 O, United Kingdom
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Edinburgh Midlothian, EH4 2, United Kingdom
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Nottingham Nottinghamshire, NG5 1, United Kingdom
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Sutton Surrey, SM2 5, United Kingdom
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Leeds , LS9 7, United Kingdom
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London , NW1 2, United Kingdom
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Newcastle Upon Tyne , NE7 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

646

Study ID:

NCT01239797

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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