Multiple Myeloma Clinical Trial

Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated 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:

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

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

748

Study ID:

NCT01335399

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 229 Locations for this study

See Locations Near You

Local Institution - 1628
Birmingham Alabama, 35243, United States
Local Institution - 7619
Mobile Alabama, 36604, United States
Local Institution - 7618
Mobile Alabama, 36608, United States
Local Institution - 7617
Chandler Arizona, 85224, United States
Local Institution - 1644
Tucson Arizona, 85715, United States
Local Institution - 1618
Bakersfield California, 93309, United States
Local Institution - 1602
Berkeley California, 94704, United States
Local Institution - 1636
Corona California, 92879, United States
Local Institution - 1668
Corona California, 92879, United States
Local Institution - 1616
Greenbrae California, 94904, United States
Local Institution - 7609
Long Beach California, 90813, United States
Local Institution - 1660
Los Angeles California, 90095, United States
Local Institution - 1673
Orange California, 92868, United States
Local Institution - 1613
San Diego California, 92123, United States
Local Institution - 1621
New Haven Connecticut, 06520, United States
Local Institution - 1612
Washington District of Columbia, 20010, United States
Local Institution - 1682
Boca Raton Florida, 33486, United States
Local Institution - 1617
Brooksville Florida, 34613, United States
Local Institution - 1648
Fort Myers Florida, 33916, United States
Local Institution - 7613
Hollywood Florida, 33021, United States
Local Institution - 1623
Jacksonville Florida, 32256, United States
Local Institution - 1625
New Port Richey Florida, 34652, United States
Local Institution - 1649
Saint Petersburg Florida, 33705, United States
Local Institution - 1611
West Palm Beach Florida, 33401, United States
Local Institution - 1630
Atlanta Georgia, 30322, United States
Local Institution - 1684
Honolulu Hawaii, 96819, United States
Local Institution - 1607
Chicago Illinois, 19123, United States
Local Institution - 1635
Chicago Illinois, 60612, United States
Local Institution - 1632
Maywood Illinois, 60153, United States
Local Institution - 7606
Peoria Illinois, 61615, United States
Local Institution - 7610
Skokie Illinois, 60077, United States
Local Institution - 1603
Urbana Illinois, 61801, United States
Local Institution - 7616
Bloomington Indiana, 47403, United States
Local Institution - 7620
Indianapolis Indiana, 46237, United States
Local Institution - 1669
Indianapolis Indiana, 46260, United States
Local Institution - 1656
Mishawaka Indiana, 46545, United States
Local Institution - 1633
Iowa City Iowa, 52242, United States
Local Institution - 1674
Lexington Kentucky, 40503, United States
Local Institution - 1683
Louisville Kentucky, 40207, United States
Local Institution - 1646
Lafayette Louisiana, 70503, United States
Local Institution - 7614
Marrero Louisiana, 70072, United States
Local Institution - 1626
New Orleans Louisiana, 70121, United States
Local Institution - 1652
Shreveport Louisiana, 71103, United States
Local Institution - 1676
Baltimore Maryland, 21204, United States
Local Institution - 1650
Baltimore Maryland, 21237, United States
Local Institution - 1619
Boston Massachusetts, 02215, United States
Local Institution - 1699
Boston Massachusetts, 02215, United States
Local Institution - 1604
Detroit Michigan, 48202, United States
Local Institution - 1667
Jefferson City Missouri, 65101, United States
Local Institution - 1645
Saint Louis Missouri, 63110, United States
Local Institution - 1651
Springfield Missouri, 65804, United States
Local Institution - 1637
Omaha Nebraska, 68198, United States
Local Institution - 7621
Mineola New York, 11501, United States
Local Institution - 1615
New York New York, 10019, United States
Local Institution - 1671
Stony Brook New York, 11794, United States
Local Institution - 7604
Goldsboro North Carolina, 27534, United States
Local Institution - 1610
Winston-Salem North Carolina, 27103, United States
Local Institution - 1608
Cleveland Ohio, 44195, United States
Local Institution - 1693
Cleveland Ohio, 44195, United States
Local Institution - 1638
Columbus Ohio, 43210, United States
Local Institution - 1664
Columbus Ohio, 43219, United States
Local Institution - 1690
Middletown Ohio, 45042, United States
Local Institution - 1655
Tulsa Oklahoma, 74146, United States
Local Institution - 7611
Langhorne Pennsylvania, 19047, United States
Local Institution - 1647
Pittsburgh Pennsylvania, 15224, United States
Local Institution - 1679
Pittsburgh Pennsylvania, 15240, United States
Local Institution - 1677
Sayre Pennsylvania, 18840, United States
Local Institution - 1629
Charleston South Carolina, 29414, United States
Local Institution - 7615
Charleston South Carolina, 29425, United States
Local Institution - 1624
Greenville South Carolina, 29615, United States
Local Institution - 7607
Sioux Falls South Dakota, 57105, United States
Local Institution - 1600
Knoxville Tennessee, 37909, United States
Local Institution - 7628
Memphis Tennessee, 38120, United States
Local Institution - 1627
Nashville Tennessee, 37203, United States
Local Institution - 1670
Nashville Tennessee, 37232, United States
Local Institution - 1634
Corpus Christi Texas, 78412, United States
Local Institution - 7612
Dallas Texas, 75246, United States
Local Institution - 1643
Houston Texas, 77030, United States
Local Institution - 1686
Houston Texas, 77030, United States
Local Institution - 1642
Houston Texas, 77090, United States
Local Institution - 7623
Ogden Utah, 84405, United States
Local Institution - 1657
Fredericksburg Virginia, 22408, United States
Local Institution - 1640
Seattle Washington, 98108, United States
Local Institution - 1631
Seattle Washington, 98109, United States
Local Institution - 1601
Huntington West Virginia, 25701, United States
Gundersen Clinic, Ltd
La Crosse Wisconsin, 54601, United States
Local Institution - 1663
Madison Wisconsin, 53717, United States
Local Institution - 1609
Madison Wisconsin, 53792, United States
Local Institution - 3600
Garran Australian Capital Territory, 2605, Australia
Local Institution - 3607
Waratah New South Wales, 2298, Australia
Local Institution - 3610
Westmead New South Wales, 2145, Australia
Local Institution - 3609
Herston Queensland, 4029, Australia
Local Institution - 3608
Milton Queensland, 4064, Australia
Local Institution - 3612
Adelaide South Australia, 5000, Australia
Local Institution - 3606
Woodville South South Australia, 5001, Australia
Local Institution - 3601
Fitzroy Victoria, 3065, Australia
Local Institution - 3602
Frankston Victoria, 3199, Australia
Local Institution - 3603
Heidelberg Melbourne Victoria, 3084, Australia
Local Institution - 3604
Wodonga Victoria, 3690, Australia
Local Institution - 3605
Murdoch , 6150, Australia
Local Institution - 3611
Nedlands , 6009, Australia
Local Institution - 4052
Fadingerstraße 1 , 4020, Austria
Local Institution - 4051
Innsbruck , 6020, Austria
Local Institution - 4054
Rankweil , 6830, Austria
Local Institution - 4053
Wels , 4600, Austria
Local Institution - 4160
Brussels , 1020, Belgium
Local Institution - 4156
Brussels , 1090, Belgium
Local Institution - 4157
Brussles , 1200, Belgium
Local Institution - 4154
Charleroi , 6000, Belgium
Local Institution - 4159
Haine St Paul , 7100, Belgium
Local Institution - 4158
Leuven , 3000, Belgium
Local Institution - 4150
Liege , 4000, Belgium
Local Institution - 4153
Roeselare , 8800, Belgium
Local Institution - 4151
Yvoir , 5530, Belgium
Local Institution - 2601
Calgary Alberta, T2N 4, Canada
Local Institution - 2600
Edmonton Alberta, T6G 1, Canada
Local Institution - 2602
Winnipeg Manitoba, R3E 0, Canada
Local Institution - 2611
Saint John New Brunswick, E2L 4, Canada
Local Institution - 2610
Halifax Nova Scotia, B3H 2, Canada
Local Institution - 2606
London Ontario, N6A 5, Canada
Local Institution - 2612
Toronto Ontario, M5G 2, Canada
Local Institution - 2603
Greenfield Park Quebec, J4V 2, Canada
Local Institution - 2605
Montreal Quebec, H1T 2, Canada
Local Institution - 2607
Montreal Quebec, H3A 1, Canada
Local Institution - 4252
Hradec Kralove , 500 0, Czechia
Local Institution - 4250
Praha 10 , 100 3, Czechia
Local Institution - 4251
Praha 2 , 128 0, Czechia
Local Institution - 4565
Aschaffenburg , 63739, Germany
Local Institution - 4550
Berlin , 12200, Germany
Local Institution - 4555
Chemnitz , 09113, Germany
Local Institution - 4562
Dresden , 01307, Germany
Local Institution - 4552
Hamm , 59063, Germany
Local Institution - 4553
Heidelberg , 69120, Germany
Local Institution - 4560
Jena , 07747, Germany
Local Institution - 4563
Koln , 50937, Germany
Local Institution - 4554
Mainz , 55101, Germany
Local Institution - 4561
Munchen , 81377, Germany
Local Institution - 4558
Munster , 48149, Germany
Local Institution - 4551
Offenbach , 63069, Germany
Local Institution - 4556
Stuttgart , 70376, Germany
Local Institution - 4564
Tuebingen , 72076, Germany
Local Institution - 4559
Ulm , 89081, Germany
Local Institution - 4653
Athens , 11527, Greece
Local Institution - 4651
Athens , 11528, Greece
Local Institution - 4650
Ioannina , 45500, Greece
Local Institution - 4652
Larissa , 41110, Greece
Local Institution - 4654
Patras , 26504, Greece
Local Institution - 4751
Budapest , 1097, Hungary
Local Institution - 4754
Budapest , 1122, Hungary
Local Institution - 4750
Debrecen , 4012, Hungary
Local Institution - 4753
Gyor , 9024, Hungary
Local Institution - 4752
Szeged , 6720, Hungary
Local Institution - 4852
Dublin , 7, Ireland
Local Institution - 4850
Dublin , 8, Ireland
Local Institution - 4851
Galway , 0, Ireland
Local Institution - 4950
Afula , 18341, Israel
Local Institution - 4956
Ashkelon , 78306, Israel
Local Institution - 4960
Haifa , 31096, Israel
Local Institution - 4958
Jerusalem , 91031, Israel
Local Institution - 4951
Jerusalem , 91120, Israel
Local Institution - 4959
Kfar Saba , 44281, Israel
Local Institution - 4954
Nahariya , 22100, Israel
Local Institution - 4952
Petah Tikva , 49414, Israel
Local Institution - 4957
Tel Aviv , 64239, Israel
Local Institution - 4955
Zerifin , 70300, Israel
Local Institution - 5067
Ancona , 60126, Italy
Local Institution - 5065
Bari , 70124, Italy
Local Institution - 5053
Bergamo , 24127, Italy
Local Institution - 5070
Bologna , 40138, Italy
Local Institution - 5066
Firenze , 50134, Italy
Local Institution - 5050
Genova , 16132, Italy
Local Institution - 5057
Meldola , 47014, Italy
Local Institution - 5075
Milano , 20122, Italy
Local Institution - 5069
Milan , 20132, Italy
Local Institution - 5052
Monza , 20052, Italy
Local Institution - 5062
Napoli , 80131, Italy
Local Institution - 5068
Napoli , 80131, Italy
Local Institution - 5055
Palermo , 90146, Italy
Local Institution - 5063
Ravenna , 48100, Italy
Local Institution - 5073
Reggio Nell Emilia (RE) , 42100, Italy
Local Institution - 5064
Rimini , 47923, Italy
Local Institution - 5058
Roma , 00144, Italy
Local Institution - 5054
Roma , 00168, Italy
Local Institution - 5056
Rome , 00161, Italy
Local Institution - 5072
Terni , 05100, Italy
Local Institution - 5051
Torino , 10126, Italy
Local Institution - 5250
Bialystok , 15-27, Poland
Local Institution - 5252
Chorzow , 41-50, Poland
Local Institution - 5254
Gdansk , 80-95, Poland
Local Institution - 7626
Krakow , 31-53, Poland
Local Institution - 5258
Lodz , 93-51, Poland
Local Institution - 5257
Lublin , 20-08, Poland
Local Institution - 5259
Poznan , 60-56, Poland
Local Institution - 5255
Szczecin , 70-11, Poland
Local Institution - 5256
Warszawa , 02-10, Poland
Local Institution - 5253
Warszawa , 02-50, Poland
Local Institution - 5260
Warszawa , 02-77, Poland
Local Institution - 5251
Wroclaw , 50-36, Poland
Local Institution - 7600
Ponce , 00716, Puerto Rico
Local Institution - 7602
San Juan , 00918, Puerto Rico
Local Institution - 5356
Brasov , 50015, Romania
Local Institution - 5350
Bucaresti , 03017, Romania
Local Institution - 5355
Bucuresti , 02012, Romania
Local Institution - 5353
Bucuresti , 05009, Romania
Local Institution - 5352
Bucuresti , 22328, Romania
Local Institution - 5351
Lasi , 70048, Romania
Local Institution - 5453
Samara , 44309, Russian Federation
Local Institution - 5450
St. Petersburg , 19702, Russian Federation
Local Institution - 5452
St. Petersburg , 19702, Russian Federation
Local Institution - 5552
Badalona-barcelona , 08916, Spain
Local Institution - 5559
Barcelona , 08036, Spain
Local Institution - 5555
Barcelona , 08041, Spain
Local Institution - 5561
La Laguna- Tenerife , 38320, Spain
Local Institution - 5553
Madrid , 28006, Spain
Local Institution - 5551
Madrid , 28007, Spain
Local Institution - 5560
Madrid , 28034, Spain
Local Institution - 5554
Madrid , 28041, Spain
Local Institution - 5558
Pamplona , 31008, Spain
Local Institution - 5550
Salamanca , 37007, Spain
Local Institution - 5557
San Sebastian , 20014, Spain
Local Institution - 5556
Toledo , 45004, Spain
Local Institution - 5751
Bern , 3010, Switzerland
Local Institution - 5750
St Gallen , 9007, Switzerland
Local Institution - 5753
Zurich , 8028, Switzerland
Local Institution - 5752
Zurich , 8091, Switzerland
Local Institution - 5853
Izmir Bornova, 35100, Turkey
Local Institution - 5851
Ankara Dikimevi, 06620, Turkey
Local Institution - 5854
Izmir Inciralti, 35340, Turkey
Local Institution - 5856
Gaziantep , 27310, Turkey
Local Institution - 5951
Belfast Antrim, BT9 7, United Kingdom
Local Institution - 5953
London Greater London, SE5 9, United Kingdom
Local Institution - 5950
London , EC1A , United Kingdom
Local Institution - 5954
London , HA1 3, United Kingdom
Local Institution - 5952
London , NW1 2, United Kingdom
Local Institution - 5955
London , NW3 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

748

Study ID:

NCT01335399

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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