Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma (ELOQUENT - 2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Bristol-Myers Squibb
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01239797
First received: November 8, 2010
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention Phase
Lymphoma (Myeloma)
Multiple Myeloma
Drug: Lenalidomide
Drug: Dexamethasone
Drug: Dexamethasone (Oral)
Drug: Dexamethasone (IV)
Biological: Elotuzumab (BMS-901608; HuLuc63)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma (MM)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Progression-free survival (PFS) - Time from randomization to date of first tumor progression or death due to any cause, provided death is not more than 10 weeks after the last tumor assessment [ Time Frame: Tumor assessments every 4 weeks (±1 week) relative to the first dose of study medication (median length of time for tumor assessments should be approximately 13 months) ] [ Designated as safety issue: No ]
  • Objective response rate (ORR) of Elotuzumab and Lenalidomide / low-dose Dexamethasone [ Time Frame: Up to Day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival - The period of time from study entry until the date of death or last known date alive [ Time Frame: Survival will be assessed every 12 weeks in the Follow Up Phase of the trial (approximate length of the overall survival period is 6.75 years) ] [ Designated as safety issue: No ]
  • Change from baseline of the mean score of pain severity and the change from baseline of the mean score of pain interference using the Brief Pain Inventory-Short Form (BPI-SF) of LdE versus Ld [ Time Frame: Approximately up to 6.75 years ] [ Designated as safety issue: No ]

    Lenalidomide, (low-dose) Dexamethasone, Elotuzumab (LdE)

    Lenalidomide, (low-dose) Dexamethasone (Ld)



Estimated Enrollment: 640
Study Start Date: March 2011
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lenalidomide + Dexamethasone Drug: Lenalidomide
Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug
Other Name: Revlimid®
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
Other Names:
  • Decadron®
  • Dexamethasone Intensol®
  • Dexpak®
  • Taperpak®
Experimental: Lenalidomide + Dexamethasone +Elotuzumab Drug: Lenalidomide
Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug
Other Name: Revlimid®
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

Other Names:
  • Decadron®
  • Dexamethasone Intensol®
  • Dexpak®
  • Taperpak®
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

Other Names:
  • Decadron®
  • Dexamethasone Intensol®
  • Dexpak®
  • Taperpak®
Biological: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

    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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01239797

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Hide Study Locations
Locations
United States, Alabama
Northwest Alabama Cancer Center, Pc Recruiting
Muscle Shoals, Alabama, United States, 35661
Contact: Karl T Hagler, Site 1424    256-381-1001      
United States, Arizona
Acrc/Arizona Clinical Research Center, Inc. Recruiting
Tucson, Arizona, United States, 85715
Contact: Manuel R Modiano, Site 1410         
United States, California
Local Institution Not yet recruiting
Berkeley, California, United States, 94704
Contact: Site 1402         
Local Institution Not yet recruiting
Burbank, California, United States, 91505
Contact: Site 1459         
Compassionate Cancer Care Medical Group Inc Recruiting
Corona, California, United States, 92879
Contact: Haresh S Jhangiani, Site 1443    951-371-2411      
Local Institution Not yet recruiting
Corona, California, United States, 92879
Contact: Site 1454         
San Diego Pacific Oncology& Hematology Associates, Inc Recruiting
Encinitas, California, United States, 92024
Contact: Alberto Bessudo, Site 1460         
Local Institution Not yet recruiting
Greenbrae, California, United States, 94904
Contact: Site 1434         
Ucla-Division Of Hematology/Oncology Recruiting
Los Angeles, California, United States, 90095
Contact: Gary Schiller, Site 1465    310-794-0242      
Medical Oncology Care Associates Recruiting
Orange, California, United States, 92868
Contact: Birbal Bhaskar, Site 1471         
Sharp Clinical Oncology Research Recruiting
San Diego, California, United States, 92123
Contact: Rajesh Belani, Site 1422    760-940-2524      
Local Institution Not yet recruiting
Vallejo, California, United States, 94589
Contact: Site 1435         
United States, Florida
Local Institution Not yet recruiting
Boca Raton, Florida, United States, 33486
Contact: Site 1490         
Cancer Care Centers Of Florida Recruiting
Brooksville, Florida, United States, 34613
Contact: Raju Rao, Site 1420    352-596-1401      
Mount Sinai Comprehensive Cancer Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Jose Lutzky, Site 1407    305-535-3350      
Local Institution Not yet recruiting
New Port Richey, Florida, United States, 34652
Contact: Site 1436         
Cancer Institute Of Florida Recruiting
Orlando, Florida, United States, 32804
Contact: Carlos Alemany, Site 1448    407-303-2091      
Local Institution Not yet recruiting
Titusville, Florida, United States, 32796
Contact: Site 1464         
Palm Beach Cancer Institute Recruiting
West Palm Beach, Florida, United States, 33401
Contact: Shachar Peles, Site 1411    561-366-4128      
United States, Georgia
Winship Cancer Institute, Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Sagar Lonial, Site 1406    404-778-5144      
Georgia Health Science University Recruiting
Augusta, Georgia, United States, 30912
Contact: Anand Jillella, Site 1478    706-721-3424      
United States, Illinois
Orchard Healthcare Research Inc. Active, not recruiting
Skokie, Illinois, United States, 60077
United States, Indiana
Local Institution Not yet recruiting
Indianapolis, Indiana, United States, 46260
Contact: Site 1467         
Local Institution Not yet recruiting
Mishawaka, Indiana, United States, 46545
Contact: Site 1461         
United States, Iowa
Local Institution Not yet recruiting
Iowa City, Iowa, United States, 52242
Contact: Site 1419         
United States, Kentucky
Local Institution Not yet recruiting
Lexington, Kentucky, United States, 40503
Contact: Site 1472         
Local Institution Not yet recruiting
Louisville, Kentucky, United States, 40207
Contact: Site 1441         
Pikeville Medical Center Leonard Lawson Cancer Center Recruiting
Pikeville, Kentucky, United States, 41501
Contact: Bharat Jenigiri, Site 1473    606-218-4843      
United States, Louisiana
Cancer Center Of Acadiana At Lafayette General Recruiting
Lafayette, Louisiana, United States, 70503
Contact: Victoria Panelli, Site 1438    337-289-8659      
Local Institution Not yet recruiting
Shreveport, Louisiana, United States, 71101
Contact: Site 1486         
Willis Knighton Cancer Center Recruiting
Shreveport, Louisiana, United States, 71103
Contact: Michael Moore, Site 1455    318-212-8952      
Local Institution Not yet recruiting
Shreveport, Louisiana, United States, 71103
Contact: Site 1457         
United States, Massachusetts
Dana Farber Cancer Inst Recruiting
Boston, Massachusetts, United States, 02215
Contact: Paul Richardson, Site 1414    617-632-3655      
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Paul Richardson, Site 1452    617-724-5251      
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Philip Kuriakose, Site 1427    313-916-7827      
United States, Missouri
Columbia Comprehensive Cancer Care Clinic Recruiting
Jefferson City, Missouri, United States, 65101
Contact: Ali Khojasteh, Site 1405    573-893-2375      
Washington University School Of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Keith Stockerl-Goldstein, Site 1442    314-454-8302      
Local Institution Not yet recruiting
Springfield, Missouri, United States, 65807
Contact: Site 1463         
United States, Nevada
Local Institution Not yet recruiting
Las Vegas, Nevada, United States, 89106
Contact: Site 1483         
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Contact: Ruben Niesvizky, Site 1428    646-962-9338      
Nyu Clinical Cancer Center Recruiting
New York, New York, United States, 10016
Contact: Amitabha Mazumder, Site 1409    212-263-4406      
Local Institution Not yet recruiting
New York, New York, United States, 10019
Contact: Site 1421         
Local Institution Not yet recruiting
Stony Brook, New York, United States, 11794
Contact: Site 1456         
United States, North Carolina
Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28204
Contact: David W Miller, Site 1416    704-355-5142      
Gaston Hematology & Oncology Active, not recruiting
Gastonia, North Carolina, United States, 28054
United States, North Dakota
Local Institution Not yet recruiting
Bismarck, North Dakota, United States, 58501
Contact: Site 1415         
United States, Oklahoma
University Of Oklahoma Health Sciences Center Active, not recruiting
Oklahoma City, Oklahoma, United States, 73104
Local Institution Not yet recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Site 1470         
United States, Pennsylvania
Local Institution Not yet recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Site 1468         
Western Pennsylvania Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Entezam A Sahovic, Site 1477    412-578-4492      
United States, South Carolina
Local Institution Not yet recruiting
Charleston, South Carolina, United States, 29414
Contact: Site 1437         
Local Institution Not yet recruiting
Greenville, South Carolina, United States, 29615
Contact: Site 1450         
United States, Tennessee
Local Institution Not yet recruiting
Knoxville, Tennessee, United States, 37909
Contact: Site 1400         
The West Clinic Recruiting
Memphis, Tennessee, United States, 38120
Contact: Jason Chandler, Site 1489    901-683-0055      
United States, Texas
Cancer Specialists Of South Texas, Pa Recruiting
Corpus Christi, Texas, United States, 78412
Contact: Aftab Mahmood, Site 1408    361-994-4469      
University Of Texas Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Larry Anderson Jr, Site 1431    214-648-1854      
University Of Texas Md Anderson Cancer Ctr Recruiting
Houston, Texas, United States, 77030
Contact: Donna Weber, Site 1401    713-794-1079      
Northwest Cancer Center Recruiting
Houston, Texas, United States, 77090
Contact: Laurent Gressot, Site 1447    877-870-2640      
United States, Virginia
Hematology-Oncology Associates Of Fredricksburg, Inc Recruiting
Fredricksburg, Virginia, United States, 22408
Contact: Christopher Vaughn, Site 1466    540-371-0079 ext 144      
United States, Washington
The Canberra Hospital Recruiting
Seattle, Washington, United States, 98108VA
Contact: James D'Rozario, Site 3408         
Va Puget Sound Health Care System Recruiting
Seattle, Washington, United States, 98108
Contact: Robert Richard, Site 1413    206-277-3101      
United States, Wisconsin
Gundersen Clinic, Ltd Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: John Farnen, Site 1481    608-775-2837      
University Of Wisconsin Hospital And Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Rachel Cook, Site 1423    608-263-9761      
Medical College Of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Parameswaran N Hari, Site 1403    414-805-6590      
Australia, New South Wales
Local Institution Not yet recruiting
Westmead, New South Wales, Australia, 2145
Contact: Site 3403         
Australia, Queensland
Local Institution Recruiting
Herston, Queensland, Australia, 4029
Contact: Site 3407         
Local Institution Active, not recruiting
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
Local Institution Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Site 3401         
Australia, Victoria
Local Institution Not yet recruiting
Frankston, Victoria, Australia, 3199
Contact: Site 3411         
Local Institution Recruiting
Malvern, Victoria, Australia, 3144
Contact: Site 3409         
Local Institution Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Site 3400         
Local Institution Recruiting
Wodonga, Victoria, Australia, 3690
Contact: Site 3410         
Australia, Western Australia
Local Institution Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Site 3402         
Local Institution Recruiting
Perth, Western Australia, Australia, 6001
Contact: Site 3404         
Austria
Local Institution Recruiting
Rankweil, Austria, 6830
Contact: Site 4004         
Local Institution Not yet recruiting
Steyr, Austria, 4400
Contact: Site 4001         
Local Institution Recruiting
Wels, Austria, 4600
Contact: Site 4003         
Local Institution Not yet recruiting
Wien, Austria, 1220
Contact: Site 4002         
Belgium
Local Institution Recruiting
Antwerpen, Belgium, 2060
Contact: Site 4100         
Local Institution Not yet recruiting
Brugge, Belgium, 8000
Contact: Site 4101         
Local Institution Recruiting
Brussels, Belgium, 1000
Contact: Site 4104         
Local Institution Recruiting
Brussels, Belgium, 1090
Contact: Site 4102         
Local Institution Recruiting
Brussels, Belgium, 1020
Contact: Site 4106         
Local Institution Recruiting
Brussles, Belgium, 1200
Contact: Site 4105         
Local Institution Recruiting
Edegem-antwerp, Belgium, 2650
Contact: Site 4108         
Local Institution Recruiting
La Louviere, Belgium, 7100
Contact: Site 4107         
Local Institution Recruiting
Liege, Belgium, 4000
Contact: Site 4109         
Local Institution Recruiting
Yvoir, Belgium, 5530
Contact: Site 4103         
Canada, Alberta
Local Institution Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Site 2409         
Local Institution Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Site 2400         
Canada, Nova Scotia
Local Institution Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Contact: Site 2407         
Canada, Ontario
Local Institution Not yet recruiting
Barrie, Ontario, Canada, L4M 6M2
Contact: Site 2410         
Local Institution Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Site 2405         
Local Institution Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Site 2403         
Canada, Quebec
Local Institution Recruiting
Montral, Quebec, Canada, H3A 1A1
Contact: Site 2406         
Local Institution Not yet recruiting
Montreal, Quebec, Canada, H4J 1C5
Contact: Site 2402         
Canada, Saskatchewan
Local Institution Recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
Contact: Site 2401         
Czech Republic
Local Institution Recruiting
Brno, Czech Republic, 625 00
Contact: Site 4200         
Local Institution Recruiting
Hradec Kralove, Czech Republic, 500 05
Contact: Site 4202         
Local Institution Recruiting
Praha 10, Czech Republic, 100 34
Contact: Site 4203         
Local Institution Recruiting
Praha 2, Czech Republic, 128 08
Contact: Site 4201         
Denmark
Local Institution Recruiting
Copenhagen, Denmark, 2100
Contact: Site 4301         
Local Institution Recruiting
Odense C, Denmark, 5000
Contact: Site 4302         
Local Institution Recruiting
Vejle, Denmark, 7100
Contact: Site 4300         
France
Local Institution Recruiting
Blois, France, 41016
Contact: Site 4414         
Local Institution Recruiting
Bordeaux, France, 33076
Contact: Site 4413         
Local Institution Recruiting
Caen, France, 14000
Contact: Site 4405         
Local Institution Not yet recruiting
Clamart Cedex, France, 92140
Contact: Site 4408         
Local Institution Recruiting
La Roche Sur Yon, France, 85925
Contact: Site 4411         
Local Institution Recruiting
La Tronche, France, 38700
Contact: Site 4404         
Local Institution Recruiting
Lille, France, 59037
Contact: Site 4402         
Local Institution Recruiting
Limoges, France, 87042
Contact: Site 4403         
Local Institution Recruiting
Nantes, France, 44093
Contact: Site 4401         
Local Institution Recruiting
Paris 12, France, 75012
Contact: Site 4407         
Local Institution Recruiting
Pierre Benita, France, 69495
Contact: Site 4409         
Local Institution Recruiting
Toulouse, France, 31059
Contact: Site 4406         
Local Institution Recruiting
Tours Cedex, France, 37044
Contact: Site 4400         
Local Institution Not yet recruiting
Vandoeuvre, France, 54511
Contact: Site 4412         
Germany
Local Institution Not yet recruiting
Aschaffenburg, Germany, 63739
Contact: Site 4520         
Local Institution Recruiting
Berlin, Germany, 13125
Contact: Site 4517         
Local Institution Recruiting
Berlin, Germany, 12200
Contact: Site 4511         
Local Institution Recruiting
Chemnitz, Germany, 09113
Contact: Site 4508         
Local Institution Recruiting
Dresden, Germany, 01307
Contact: Site 4514         
Local Institution Recruiting
Hamburg, Germany, 22763
Contact: Site 4505         
Local Institution Not yet recruiting
Hamburg, Germany, 20246
Contact: Site 4504         
Local Institution Recruiting
Hamburg, Germany, 66421
Contact: Site 4503         
Local Institution Recruiting
Hamm, Germany, 59071
Contact: Site 4510         
Local Institution Recruiting
Heidelberg, Germany, 69120
Contact: Site 4501         
Local Institution Recruiting
Jena, Germany, 07747
Contact: Site 4515         
Local Institution Recruiting
Kiel, Germany, 24105
Contact: Site 4516         
Local Institution Recruiting
Koln, Germany, 50937
Contact: Site 4507         
Local Institution Not yet recruiting
Marburg, Germany, 35037
Contact: Site 4502         
Local Institution Active, not recruiting
Munchen, Germany, 81377
Local Institution Recruiting
Munchen, Germany, 81675
Contact: Site 4518         
Local Institution Not yet recruiting
Munster, Germany, 48149
Contact: Site 4513         
Local Institution Recruiting
Ravensburg, Germany, 88212
Contact: Site 4519         
Local Institution Recruiting
Tuebingen, Germany, 72076
Contact: Site 4512         
Local Institution Recruiting
Ulm, Germany, 89081
Contact: Site 4509         
Local Institution Recruiting
Wurzburg, Germany, 97080
Contact: Site 4506         
Greece
Local Institution Recruiting
Athens, Greece, 11528
Contact: Site 4600         
Local Institution Recruiting
Ioannina, Greece, 45500
Contact: Site 4602         
Local Institution Recruiting
Larissa, Greece, 41110
Contact: Site 4601         
Hungary
Local Institution Suspended
Budapest, Hungary, 1125
Local Institution Recruiting
Debrecen, Hungary, 4032
Contact: Site 4700         
Local Institution Recruiting
Gyor, Hungary, 9024
Contact: Site 4703         
Local Institution Recruiting
Szeged, Hungary, 6720
Contact: Site 4702         
Ireland
Local Institution Recruiting
Dublin, Ireland, 7
Contact: Site 4802         
Local Institution Recruiting
Tullamore, Ireland
Contact: Site 4800         
Israel
Local Institution Recruiting
Afula, Israel, 18101
Contact: Site 4902         
Local Institution Not yet recruiting
Ashkelon, Israel, 78278
Contact: Site 4904         
Local Institution Recruiting
Jerusalem, Israel, 91120
Contact: Site 4900         
Local Institution Recruiting
Petah Tikva, Israel, 49100
Contact: Site 4901         
Local Institution Recruiting
Rehovot, Israel, 76100
Contact: Site 4905         
Local Institution Recruiting
Zerifin, Israel, 70300
Contact: Site 4903         
Italy
Local Institution Recruiting
Ancona, Italy, 60126
Contact: Site 5010         
Local Institution Recruiting
Bergamo, Italy, 24127
Contact: Site 5005         
Local Institution Recruiting
Bologna, Italy, 40138
Contact: Site 5008         
Local Institution Recruiting
Firenze, Italy, 50134
Contact: Site 5012         
Local Institution Recruiting
Genova, Italy, 16132
Contact: Site 5000         
Local Institution Recruiting
Meldola, Italy, 47014
Contact: Site 5001         
Local Institution Recruiting
Milano, Italy, 20133
Contact: Site 5003         
Local Institution Not yet recruiting
Monza, Italy, 20052
Contact: Site 5004         
Local Institution Not yet recruiting
Napoli, Italy, 80131
Contact: Site 5013         
Local Institution Not yet recruiting
Napoli, Italy, 80131
Contact: Site 5009         
Local Institution Recruiting
Palermo, Italy, 90146
Contact: Site 5007         
Local Institution Recruiting
Ravenna, Italy, 48100
Contact: Site 5015         
Local Institution Recruiting
Rimini, Italy, 47923
Contact: Site 5014         
Local Institution Recruiting
Roma, Italy, 00168
Contact: Site 5006         
Local Institution Recruiting
Roma, Italy, 00161
Contact: Site 5011         
Local Institution Recruiting
Torino, Italy, 10126
Contact: Site 5002         
Japan
Local Institution Recruiting
Nagoya-shi, Aichi, Japan, 4600001
Contact: Site 6012         
Local Institution Recruiting
Maebashi-shi, Gunma, Japan, 371-8511
Contact: Site 6003         
Local Institution Recruiting
Shibukawa, Gunma, Japan, 377-8511
Contact: Site 6004         
Local Institution Recruiting
Sendai-shi, Miyagi, Japan, 9808574
Contact: Site 6001         
Local Institution Recruiting
Osaka-shi, Osaka, Japan, 5438555
Contact: Site 6015         
Local Institution Recruiting
Bunkyo-ku, Tokyo, Japan, 1138677
Contact: Site 6005         
Local Institution Recruiting
Shibuya-ku, Tokyo, Japan, 1508935
Contact: Site 6006         
Local Institution Recruiting
Shinjuuku-ku, Tokyo, Japan, 1608582
Contact: Site 6007         
Local Institution Recruiting
Kamogawa, Toyko, Japan, 296-8602
Contact: Site 6010         
Local Institution Recruiting
Chiba-shi, Japan, 260-8677
Contact: Site 6009         
Local Institution Recruiting
Fukuoka, Japan, 812-8582
Contact: Site 6018         
Local Institution Recruiting
Kyoto, Japan, 602-8566
Contact: Site 6014         
Local Institution Recruiting
Nagoya-shi, Japan, 467-8602
Contact: Site 6011         
Local Institution Recruiting
Niigata, Japan, 9518566
Contact: Site 6002         
Local Institution Recruiting
Okayama, Japan, 7011192
Contact: Site 6016         
Local Institution Recruiting
Sapporo, Japan, 0608543
Contact: Site 6000         
Local Institution Recruiting
Tokyo, Japan, 1358550
Contact: Site 6008         
Local Institution Recruiting
Toyohashi-shi, Japan, 441-8570
Contact: Site 6013         
Poland
Local Institution Recruiting
Bialystok, Poland, 15-276
Contact: Site 5200         
Local Institution Recruiting
Chorzow, Poland, 41-500
Contact: Site 5204         
Local Institution Recruiting
Lublin, Poland, 20-081
Contact: Site 5208         
Local Institution Not yet recruiting
Poznan, Poland, 60-569
Contact: Site 5203         
Local Institution Recruiting
Warsaw, Poland, 02-776
Contact: Site 5205         
Local Institution Recruiting
Warsaw, Poland, 02-106
Contact: Site 5202         
Local Institution Recruiting
Warszawa, Poland, 02-507
Contact: Site 5207         
Local Institution Not yet recruiting
Wroclaw, Poland, 50-367
Contact: Site 5201         
Puerto Rico
Ponce School Of Medicine Recruiting
Ponce, Puerto Rico, 00716
Contact: Hector A Velez Cortes, Site 1418    7878402575      
Auxilio Mutuo Cancer Center Recruiting
San Juan, Puerto Rico, 00918
Contact: Fernando Cabanillas, Site 1451    +78775820003569      
Romania
Local Institution Recruiting
Brasov, Romania, 500326
Contact: Site 5302         
Local Institution Recruiting
Bucaresti, Romania, 030171
Contact: Site 5300         
Local Institution Recruiting
Bucuresti, Romania, 22328
Contact: Site 5303         
Local Institution Recruiting
Lasi, Romania, 700483
Contact: Site 5301         
Spain
Local Institution Recruiting
Badalona-barcelona, Spain, 08916
Contact: Site 5500         
Local Institution Recruiting
Madrid, Spain, 28007
Contact: Site 5502         
Local Institution Recruiting
Madrid, Spain, 28006
Contact: Site 5503         
Local Institution Recruiting
Murcia, Spain, 30008
Contact: Site 5506         
Local Institution Recruiting
Salamanca, Spain, 37007
Contact: Site 5501         
Local Institution Recruiting
Santiago De Comp-coruna, Spain, 15706
Contact: Site 5504         
Local Institution Recruiting
Toledo, Spain, 45004
Contact: Site 5505         
Switzerland
Local Institution Recruiting
Bern, Switzerland, 3010
Contact: Site 5700         
Local Institution Not yet recruiting
Geneve 14, Switzerland, 1211
Contact: Site 5701         
Turkey
Local Institution Recruiting
Izmir, Bornova, Turkey, 35100
Contact: Site 5803         
Local Institution Not yet recruiting
Istanbul, Capa, Turkey, 34340
Contact: Site 5802         
Local Institution Not yet recruiting
Izmir, Inciralti, Turkey, 35340
Contact: Site 5804         
Local Institution Recruiting
Ankara, Turkey, 06620
Contact: Site 5801         
United Kingdom
Local Institution Recruiting
London, Greater London, United Kingdom, EC1A 7BE
Contact: Site 5900         
Local Institution Recruiting
London, Greater London, United Kingdom, NW1 2PG
Contact: Site 5905         
Local Institution Recruiting
Manchester, Greater Manchester, United Kingdom, M20 4BX
Contact: Site 5907         
Local Institution Recruiting
Airdrie, Lancashire, United Kingdom, ML6 OJS
Contact: Site 5901         
Local Institution Recruiting
Edinburgh, Midlothian, United Kingdom, EH4 2XU
Contact: Site 5903         
Local Institution Recruiting
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Contact: Site 5904         
Local Institution Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Site 5910         
Local Institution Recruiting
Leeds, United Kingdom, LS9 7FT
Contact: Site 5909         
Local Institution Recruiting
Leicester, United Kingdom, LE1 5WW
Contact: Site 5906         
Local Institution Not yet recruiting
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Contact: Site 5908         
Sponsors and Collaborators
Bristol-Myers Squibb
AbbVie
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01239797     History of Changes
Other Study ID Numbers: CA204-004, 2010-020347-12
Study First Received: November 8, 2010
Last Updated: July 23, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: National Health and Medical Research Council
Austria: Federal Office for Safety in Health Care
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Canada: Health Canada
Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: The Danish National Committee on Biomedical Research Ethics
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Germany: Paul-Ehrlich-Institut
Germany: Federal Office for Radiation Protection
Germany: Ministry of Health
Greece: Ethics Committee
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency
Poland: National Institute of Medicines
Poland: Ministry of Health
Poland: Ministry of Science and Higher Education
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Russia: Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Lenalidomide
Thalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 23, 2014