Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma (ELOQUENT - 1)

This study is currently recruiting participants.
Verified January 2014 by Bristol-Myers Squibb
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01335399
First received: April 13, 2011
Last updated: January 23, 2014
Last verified: January 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
Multiple Myeloma
Drug: Lenalidomide
Drug: Dexamethasone
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: A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma

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: Every 4 weeks (-1/+3 days) relative to the first dose of study medication. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective Response Rate - The percentage of patients who have a partial or complete response to study therapy. [ Time Frame: All response endpoints assessed every 4 weeks (-1/+3 days). ] [ Designated as safety issue: No ]
  • 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 16 weeks in the Follow Up Phase of the trial. ] [ Designated as safety issue: No ]

Estimated Enrollment: 750
Study Start Date: August 2011
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: May 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
Tablets, Oral, 28 mg, once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Other Names:
  • Decadron®
  • Dexamethasone Intensol®
  • Dexpak®
  • Taperpak®
Drug: Dexamethasone
Tablets, Oral, 40 mg, once daily, on Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Other Names:
  • Decadron®
  • Dexamethasone Intensol®
  • Dexpak®
  • Taperpak®
Drug: Dexamethasone
Solution, Intravenous (IV), 8 mg, Once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), 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, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Biological: Elotuzumab (BMS-901608; HuLuc63)
Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 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:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01335399

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

  Hide Study Locations
Locations
United States, Alabama
Birmingham Hematology & Oncology Associates Llc Recruiting
Birmingham, Alabama, United States, 35213
Contact: Kevin S Windsor, Site 1628    205-939-7181      
University Of South Alabama / Mitchell Cancer Institute Recruiting
Mobile, Alabama, United States, 36604
Contact: David Clarkson, Site 7619    251-445-9815      
Southern Cancer Center Recruiting
Mobile, Alabama, United States, 36608
Contact: Sherri Arledge, Site 7618    251-607-5280      
United States, Arizona
Ironwood Physicians PC Recruiting
Chandler, Arizona, United States, 85224
Contact: Mikhail Shtivelband, Site 7617         
Acrc/Arizona Clinical Research Center, Inc. Recruiting
Tucson, Arizona, United States, 85715
Contact: Manuel R Modiano, Site 1644    520-290-8830      
United States, California
Comprehensive Blood And Cancer Center Recruiting
Bakersfield, California, United States, 93309
Contact: Ravindranath Patel, Site 1618    661-322-2206      
Alta Bates Summit Comprehensive Cancer Center Recruiting
Berkeley, California, United States, 94704
Contact: Rajesh Behl, Site 1602    510-204-3428      
Compassionate Cancer Care Medical Group, Inc. Recruiting
Corona, California, United States, 92879
Contact: Haresh S Jhangiani, Site 1668    951-371-2411      
Compassionate Cancer Care Medical Group Inc Recruiting
Corona, California, United States, 92879
Contact: Haresh S Jhangiani, Site 1636    951-276-2760      
Local Institution Not yet recruiting
Greenbrae, California, United States, 94904-2011
Contact: Site 1616         
Pacific Shores Medical Group Recruiting
Long Beach, California, United States, 90813
Contact: Kiem Liem, Site 7609    562-590-0345      
Local Institution Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Site 1660         
Medical Oncology Care Associates Recruiting
Orange, California, United States, 92868
Contact: Birbal Bhaskar, Site 1673    714-541-6622      
Local Institution Not yet recruiting
Pittsburgh, California, United States, 15232
Contact: Site 7625         
Sharp Clinical Oncology Research Recruiting
San Diego, California, United States, 92123
Contact: Rajesh Belani, Site 1613    858-939-5062      
Pacific Hematology Oncology Associates Recruiting
San Francisco, California, United States, 94115
Contact: Caroline Behler, Site 7624    415-923-3012      
Local Institution Not yet recruiting
West Hollywood, California, United States, 90069
Contact: Site 7627         
United States, Connecticut
Yale University School Of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Contact: Madhav V Dhodapkar, Site 1621    203-785-4796      
United States, District of Columbia
Washington Cancer Institute At Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Joseph P Catlett, Site 1612    202-877-7858      
United States, Florida
Pasco Hernando Oncology Associates, Pa Completed
Brooksville, Florida, United States, 34613
Florida Cancer Specialists Recruiting
Fort Myers, Florida, United States, 33916
Contact: James Andrew Jr Reeves, Site 1648    239-275-6400      
Memorial Cancer Institute Recruiting
Hollywood, Florida, United States, 33021
Contact: Alvaro Alencar, Site 7613    954-265-6363      
Cancer Specialists Of North Florida Beaches Recruiting
Jacksonville, Florida, United States, 32256
Contact: Mehdi M Moezi, Site 1623    904-739-7779      
Pasco Hernando Oncology Associates, Pa Completed
New Port Richey, Florida, United States, 34652
Florida Cancer Specialists Recruiting
St. Petersburg, Florida, United States, 33705
Contact: Peter Acs, Site 1649    727-895-6586      
Palm Beach Cancer Institute Recruiting
West Palm Beach, Florida, United States, 33401
Contact: Shachar Peles, Site 1611    561-366-4140      
United States, Georgia
Winship Cancer Center Recruiting
Atlanta, Georgia, United States, 30322
Contact: Jonathan Kaufman, Site 1630    404-778-1900      
United States, Illinois
The University Of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Cara Rosenbaum, Site 1607    773-834-9126      
Cardinal Bernardin Cancer Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Kevin Barton, Site 1632         
Local Institution Not yet recruiting
Peoria, Illinois, United States, 61615
Contact: Site 7606         
Orchard Healthcare Research Inc. Recruiting
Skokie, Illinois, United States, 60077
Contact: Ira Anton Oliff, Site 7610         
Local Institution Not yet recruiting
Urbana, Illinois, United States, 61801
Contact: Site 1603         
United States, Indiana
Premier Healthcare, Llc Recruiting
Bloomington, Indiana, United States, 47403
Contact: David Joyce, Site 7616    812-355-6586      
Investigative Clinical Research Of Indiana, Llc Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Robert F Manges, Site 1669    317-297-2208      
Franciscan St. Francis Health Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Stephen Rubenstein, Site 7620    317-782-7353      
Local Institution Not yet recruiting
Mishawaka, Indiana, United States, 46545
Contact: Site 1656         
United States, Iowa
University Of Iowa Hospitals And Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Raymond Hohl, Site 1633    319-356-8242      
United States, Kentucky
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40207
Contact: Don Stevens, Site 1683    502-899-3366      
United States, Louisiana
Cancer Center Of Acadiana At Lafayette General Recruiting
Lafayette, Louisiana, United States, 70503
Contact: Victoria Panelli, Site 1646    337-289-8400      
Crescent City Research Consortium, LLC Recruiting
Marrero, Louisiana, United States, 70072
Contact: Thomas Cosgriff, Site 7614         
Willis Knighton Cancer Center Recruiting
Shreveport, Louisiana, United States, 71103
Contact: Michael Moore, Site 1652    501-221-5012      
United States, Maryland
Greater Baltimore Medical Center Recruiting
Baltimore, Maryland, United States, 21204
Contact: Gary I Cohen, Site 1676    443-849-2000      
Harry & Jeanette Weinberg Cancer Institute Recruiting
Baltimore, Maryland, United States, 21237
Contact: Stephen Noga, Site 1650    443-777-7452      
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jacob Laubach, Site 1619    617-632-3786      
United States, Michigan
Local Institution Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Site 1681         
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Philip Kuriakose, Site 1604    313-876-2972      
United States, Missouri
Columbia Comprehensive Cancer Care Clinic Recruiting
Jefferson City, Missouri, United States, 65109
Contact: Ali Khojasteh, Site 1667         
Mercy Medical Research Institute Recruiting
Springfield, Missouri, United States, 65807
Contact: Viran Roger Holden, Site 1651    417-820-9742      
Washington University School Of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Keith Stockerl-Goldstein, Site 1645    314-747-1217      
United States, Nebraska
Local Institution Not yet recruiting
Lincoln, Nebraska, United States, 68506
Contact: Site 7605         
Hematology/Oncology Recruiting
Omaha, Nebraska, United States, 68198-7680
Contact: Edward Jr. Faber, Site 1637         
United States, New York
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Harry Staszewski, Site 7621    516-663-0333      
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: Ruben Niesvizky, Site 1689    212-746-4495      
Beth Israel Medical Center Recruiting
New York, New York, United States, 10003
Contact: Jacob Laubach, Site 1699    617-732-3000      
St. Luke'S-Roosevelt Hospital Center Completed
New York, New York, United States, 10019
United States, North Carolina
Mecklenburg Medical Group Recruiting
Charlotte, North Carolina, United States, 28204
Contact: David W Miller, Site 1605    704-367-8238      
Southeastern Medical Oncology Center Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: Samer Kasbari, Site 7604    919-587-0000      
Piedmont Hematology Oncology Associates, Pa Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Franklin L Chen, Site 1610         
United States, Ohio
Local Institution Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Site 1693         
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Christy Samaras, Site 1608    216-444-9567      
Benson, Md, Don Recruiting
Columbus, Ohio, United States, 43210
Contact: Don Benson, Site 1638    740-296-8508      
Mid Ohio Oncology/Hematology, Inc,Dba Recruiting
Columbus, Ohio, United States, 43219
Contact: Tarek A Chidiac, Site 1664         
United States, Oklahoma
Tulsa Cancer Institute, Pllc Recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Charles M Strnad, Site 1655    918-292-8574      
United States, Pennsylvania
Cancer Care Associates Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Yacoub Faroun, Site 1665         
St. Mary Medical Center Recruiting
Longhorne, Pennsylvania, United States, 19047
Contact: Robert E Reilly, Site 7611    215-750-5050      
Western Pennsylvania Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Entezam A Sahovic, Site 1647    412-578-5675      
Guthrie Clinic Ltd. Recruiting
Sayre, Pennsylvania, United States, 18840
Contact: Bradley Lash, Site 1677    570-887-2151      
United States, South Carolina
Charleston Hematology Oncology Associates, Pa Recruiting
Charleston, South Carolina, United States, 29414
Contact: George F Geils Jr, Site 1629    843-577-6957      
Musc Hollings Cancer Center Recruiting
Charleston, South Carolina, United States, 29425
Contact: Luciano Costa, Site 7615    843-792-9007      
Cancer Center Of The Carolinas Recruiting
Greenville, South Carolina, United States, 29615
Contact: Suzanne Fanning, Site 1624    864-241-6251      
United States, South Dakota
Avera Cancer Institute Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Ahmed Galal, Site 7607    605-322-3055      
United States, Tennessee
Tennessee Cancer Specialists Recruiting
Knoxville, Tennessee, United States, 37909
Contact: Tracy W Dobbs, Site 1600    865-934-5818      
Baptist Cancer Center Recruiting
Memphis, Tennessee, United States, 38120
Contact: William K Walsh, Site 7628    901-226-1472      
Tennessee Oncology, Pllc Recruiting
Nashville, Tennessee, United States, 37203
Contact: Jesus Berdeja, Site 1627    615-342-1741      
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Madan Jagasia, Site 1670    615-327-7045      
United States, Texas
Cancer Specialists Of South Texas, Pa Recruiting
Corpus Christi, Texas, United States, 78412
Contact: Aftab Mahmood, Site 1634    361-993-3456      
Local Institution Not yet recruiting
Dallas, Texas, United States, 75246
Contact: Site 7612         
Local Institution Not yet recruiting
Houston, Texas, United States, 77030
Contact: Site 1614         
Northwest Cancer Center Recruiting
Houston, Texas, United States, 77090
Contact: Laurent Gressot, Site 1642    520-742-4183      
Baylor College Of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Sarvari Yellapragada, Site 1686    713-798-0180      
Baylor College Of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Martha Mims, Site 1643    832-355-8966      
United States, Utah
Northern Utah Associates Recruiting
Ogden, Utah, United States, 84403
Contact: Vincent L Hansen, Site 7623    801-387-7150      
United States, Virginia
Hematology-Oncology Associates Of Fredricksburg, Inc Recruiting
Fredricksburg, Virginia, United States, 22408
Contact: Christopher Vaughn, Site 1657    540-371-0079      
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109
Contact: William Bensinger, Site 1631    206-667-4402      
Va Puget Sound Health Care System Recruiting
Seattle, Washington, United States, 98108
Contact: Robert Richard, Site 1640    253-589-4176      
United States, West Virginia
Edwards Comprehensive Cancer Center Recruiting
Huntington, West Virginia, United States, 25701
Contact: Mohamad Khasawneh, Site 1601    304-399-6663      
United States, Wisconsin
Local Institution Not yet recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Site 1653         
Australia, Australian Capital Territory
Local Institution Recruiting
Canberra, Australian Capital Territory, Australia, 2605
Contact: Site 3600         
Australia, New South Wales
Local Institution Recruiting
Waratah, New South Wales, Australia, 2298
Contact: Site 3607         
Local Institution Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Site 3610         
Australia, Queensland
Local Institution Not yet recruiting
Herston, Queensland, Australia, 4029
Contact: Site 3609         
Local Institution Not yet recruiting
South Brisbane, Queensland, Australia, 4101
Contact: Site 3608         
Australia, South Australia
Local Institution Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Site 3612         
Local Institution Recruiting
Adelaide, South Australia, Australia, 5011
Contact: Site 3606         
Australia, Victoria
Local Institution Recruiting
Fitzroy, Victoria, Australia, 3065
Contact: Site 3601         
Local Institution Recruiting
Frankston, Victoria, Australia, 3199
Contact: Site 3602         
Local Institution Recruiting
Heidelberg Melbourne, Victoria, Australia, 3084
Contact: Site 3603         
Local Institution Recruiting
Wodonga, Victoria, Australia, 3690
Contact: Site 3604         
Australia, Western Australia
Local Institution Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Site 3611         
Local Institution Recruiting
Perth, Western Australia, Australia, 6000
Contact: Site 3605         
Austria
Local Institution Recruiting
Linz, Austria, 4020
Contact: Site 4052         
Local Institution Recruiting
Wels, Austria, 4600
Contact: Site 4053         
Belgium
Local Institution Recruiting
Brussels, Belgium, 1090
Contact: Site 4156         
Local Institution Recruiting
Brussels, Belgium, 1020
Contact: Site 4160         
Local Institution Recruiting
Brussles, Belgium, 1200
Contact: Site 4157         
Local Institution Recruiting
Charleroi, Belgium, 6000
Contact: Site 4154         
Local Institution Recruiting
Gent, Belgium, 9000
Contact: Site 7608         
Local Institution Recruiting
La Louviere, Belgium, 7100
Contact: Site 4159         
Local Institution Recruiting
Leuven, Belgium, 3000
Contact: Site 4158         
Local Institution Recruiting
Liege, Belgium, 4000
Contact: Site 4150         
Local Institution Recruiting
Roeselare, Belgium, 8800
Contact: Site 4153         
Local Institution Recruiting
Yvoir, Belgium, 5530
Contact: Site 4151         
Canada, Alberta
Local Institution Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Site 2601         
Local Institution Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Site 2600         
Canada, Manitoba
Local Institution Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Site 2602         
Canada, New Brunswick
Local Institution Recruiting
Saint John, New Brunswick, Canada, E2L 4L2
Contact: Site 2611         
Canada, Nova Scotia
Local Institution Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Contact: Site 2610         
Canada, Ontario
Local Institution Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Site 2606         
Local Institution Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Site 2612         
Canada, Quebec
Local Institution Recruiting
Greenfield Park, Quebec, Canada, J4V 2H1
Contact: Site 2603         
Local Institution Recruiting
Montral, Quebec, Canada, H3A 1A1
Contact: Site 2607         
Local Institution Recruiting
Montreal, Quebec, Canada, H1T 2M4
Contact: Site 2605         
Canada, Saskatchewan
Local Institution Not yet recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
Contact: Site 2604         
Czech Republic
Local Institution Recruiting
Hradec Kralove, Czech Republic, 500 05
Contact: Site 4252         
Local Institution Recruiting
Praha 10, Czech Republic, 100 34
Contact: Site 4250         
Local Institution Recruiting
Praha 2, Czech Republic, 128 08
Contact: Site 4251         
Germany
Local Institution Recruiting
Aschaffenburg, Germany, 63739
Contact: Site 4565         
Local Institution Recruiting
Berlin, Germany, 12200
Contact: Site 4550         
Local Institution Not yet recruiting
Chemnitz, Germany, 09113
Contact: Site 4555         
Local Institution Recruiting
Dresden, Germany, 01307
Contact: Site 4562         
Local Institution Recruiting
Hamm, Germany, 59071
Contact: Site 4552         
Local Institution Recruiting
Heidelberg, Germany, 69120
Contact: Site 4553         
Local Institution Recruiting
Jena, Germany, 07747
Contact: Site 4560         
Local Institution Recruiting
Koln, Germany, 50937
Contact: Site 4563         
Local Institution Recruiting
Mainz, Germany, 55131
Contact: Site 4554         
Local Institution Not yet recruiting
Munchen, Germany, 81377
Contact: Site 4561         
Local Institution Recruiting
Munster, Germany, 48149
Contact: Site 4558         
Local Institution Recruiting
Offenbach, Germany, 63069
Contact: Site 4551         
Local Institution Not yet recruiting
Stuttgart, Germany, 70376
Contact: Site 4556         
Local Institution Recruiting
Tuebingen, Germany, 72076
Contact: Site 4564         
Local Institution Recruiting
Ulm, Germany, 89081
Contact: Site 4559         
Greece
Local Institution Recruiting
Athens, Greece, 11527
Contact: Site 4653         
Local Institution Recruiting
Athens, Greece, 11528
Contact: Site 4651         
Local Institution Recruiting
Ioannina, Greece, 45500
Contact: Site 4650         
Local Institution Recruiting
Larissa, Greece, 41110
Contact: Site 4652         
Local Institution Recruiting
Patras, Greece, 26504
Contact: Site 4654         
Hungary
Local Institution Recruiting
Budapest, Hungary, 1122
Contact: Site 4754         
Local Institution Recruiting
Budapest, Hungary, 1097
Contact: Site 4751         
Local Institution Recruiting
Debrecen, Hungary, 4032
Contact: Site 4750         
Local Institution Recruiting
Gyor, Hungary, 9024
Contact: Site 4753         
Local Institution Recruiting
Szeged, Hungary, 6720
Contact: Site 4752         
Ireland
Local Institution Recruiting
Dublin, Ireland, 7
Contact: Site 4852         
Local Institution Recruiting
Dublin, Ireland, 8
Contact: Site 4850         
Local Institution Recruiting
Galway, Ireland
Contact: Site 4851         
Israel
Local Institution Recruiting
Afula, Israel, 18101
Contact: Site 4950         
Local Institution Recruiting
Ashkelon, Israel, 78278
Contact: Site 4956         
Local Institution Recruiting
Haifa, Israel, 31096
Contact: Site 4960         
Local Institution Recruiting
Jerusalem, Israel, 91031
Contact: Site 4958         
Local Institution Recruiting
Jerusalem, Israel, 91120
Contact: Site 4951         
Local Institution Recruiting
Kfar-saba, Israel, 44281
Contact: Site 4959         
Local Institution Recruiting
Nahariya, Israel, 22100
Contact: Site 4954         
Local Institution Recruiting
Petah Tikva, Israel, 49100
Contact: Site 4952         
Local Institution Recruiting
Rehovot, Israel, 76100
Contact: Site 4953         
Local Institution Recruiting
Tel Aviv, Israel, 64239
Contact: Site 4957         
Local Institution Recruiting
Zerifin, Israel, 70300
Contact: Site 4955         
Italy
Local Institution Recruiting
Ancona, Italy, 60126
Contact: Site 5067         
Local Institution Not yet recruiting
Bari, Italy, 70124
Contact: Site 5065         
Local Institution Not yet recruiting
Bergamo, Italy, 24127
Contact: Site 5053         
Local Institution Recruiting
Bologna, Italy, 40138
Contact: Site 5070         
Local Institution Recruiting
Firenze, Italy, 50134
Contact: Site 5066         
Local Institution Recruiting
Genova, Italy, 16132
Contact: Site 5050         
Local Institution Recruiting
Meldola, Italy, 47014
Contact: Site 5057         
Local Institution Recruiting
Milano, Italy, 20132
Contact: Site 5069         
Local Institution Recruiting
Milano, Italy, 20122
Contact: Site 5075         
Local Institution Recruiting
Monza, Italy, 20052
Contact: Site 5052         
Local Institution Recruiting
Napoli, Italy, 80131
Contact: Site 5062         
Local Institution Not yet recruiting
Napoli, Italy, 80131
Contact: Site 5068         
Local Institution Recruiting
Palermo, Italy, 90146
Contact: Site 5055         
Local Institution Recruiting
Ravenna, Italy, 47923
Contact: Site 5063         
Local Institution Not yet recruiting
Reggio Emilia, Italy, 42123
Contact: Site 5073         
Local Institution Recruiting
Rimini, Italy, 47923
Contact: Site 5064         
Local Institution Recruiting
Roma, Italy, 00161
Contact: Site 5056         
Local Institution Recruiting
Roma, Italy, 00144
Contact: Site 5058         
Local Institution Not yet recruiting
Roma, Italy, 00168
Contact: Site 5054         
Local Institution Recruiting
Terni, Italy, 05100
Contact: Site 5072         
Local Institution Recruiting
Torino, Italy, 10126
Contact: Site 5051         
Poland
Local Institution Recruiting
Bialystok, Poland, 15-276
Contact: Site 5250         
Local Institution Recruiting
Chorzow, Poland, 41-500
Contact: Site 5252         
Local Institution Recruiting
Gdansk, Poland, 80-211
Contact: Site 5254         
Local Institution Recruiting
Krakow, Poland, 31-531
Contact: Site 7626         
Local Institution Recruiting
Lodz, Poland, 93-510
Contact: Site 5258         
Local Institution Recruiting
Lublin, Poland, 20-081
Contact: Site 5257         
Local Institution Recruiting
Poznan, Poland, 60-569
Contact: Site 5259         
Local Institution Recruiting
Warsaw, Poland, 02-106
Contact: Site 5256         
Local Institution Recruiting
Warsaw, Poland, 02-776
Contact: Site 5260         
Local Institution Recruiting
Warszawa, Poland, 02-507
Contact: Site 5253         
Local Institution Recruiting
Wroclaw, Poland, 50-367
Contact: Site 5251         
Puerto Rico
Local Institution Recruiting
Ponce, Puerto Rico, 00716
Contact: Site 7600         
Local Institution Recruiting
San Juan, Puerto Rico, 00927
Contact: Site 7602         
Romania
Local Institution Recruiting
Brasov, Romania, 500326
Contact: Site 5356         
Local Institution Recruiting
Bucaresti, Romania, 030171
Contact: Site 5350         
Local Institution Recruiting
Bucuresti, Romania, 050098
Contact: Site 5353         
Local Institution Recruiting
Bucuresti, Romania, 22328
Contact: Site 5352         
Local Institution Recruiting
Lasi, Romania, 700106
Contact: Site 5351         
Russian Federation
Local Institution Recruiting
Samara, Russian Federation, 443095
Contact: Site 5453         
Local Institution Not yet recruiting
St Petersburg, Russian Federation, 197089
Contact: Site 5452         
Local Institution Not yet recruiting
St. Petersburg, Russian Federation, 197022
Contact: Site 5450         
Spain
Local Institution Recruiting
Badalona-Barcelona, Spain, 08916
Contact: Site 5552         
Local Institution Recruiting
Barcelona, Spain, 08041
Contact: Site 5555         
Local Institution Recruiting
Barcelona, Spain, 08036
Contact: Site 5559         
Local Institution Recruiting
LaLaguna-S. Cruz Tener, Spain, 38320
Contact: Site 5561         
Local Institution Recruiting
Madrid, Spain, 28006
Contact: Site 5553         
Local Institution Recruiting
Madrid, Spain, 28041
Contact: Site 5554         
Local Institution Not yet recruiting
Madrid, Spain, 28007
Contact: Site 5551         
Local Institution Recruiting
Madrid, Spain, 28034
Contact: Site 5560         
Local Institution Recruiting
Pamplona, Spain, 31008
Contact: Site 5558         
Local Institution Recruiting
Salamanca, Spain, 37007
Contact: Site 5550         
Local Institution Recruiting
San Sebastian, Spain, 20014
Contact: Site 5557         
Local Institution Recruiting
Toledo, Spain, 45004
Contact: Site 5556         
Switzerland
Local Institution Recruiting
Bern, Switzerland, 3010
Contact: Site 5751         
Local Institution Recruiting
St Gallen, Switzerland, 9007
Contact: Site 5750         
Local Institution Recruiting
Zurich, Switzerland, 8028
Contact: Site 5753         
Local Institution Not yet recruiting
Zurich, Switzerland, 8091
Contact: Site 5752         
Turkey
Local Institution Recruiting
Ankara, Dikimevi, Turkey, 06620
Contact: Site 5851         
United Kingdom
Local Institution Recruiting
London, Greater London, United Kingdom, NW1 2PG
Contact: Site 5952         
Local Institution Recruiting
London, Greater London, United Kingdom, EC1A 7BE
Contact: Site 5950         
Local Institution Recruiting
London, Greater London, United Kingdom, NW3 2QG
Contact: Site 5955         
Local Institution Recruiting
London, United Kingdom, HA1 3UJ
Contact: Site 5954         
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: NCT01335399     History of Changes
Other Study ID Numbers: CA204-006, 2010-022445-20
Study First Received: April 13, 2011
Last Updated: January 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
Czech Republic: State Institute for Drug Control
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
Ireland: Irish Medicines Board
Israel: Israeli Health Ministry Pharmaceutical Administration
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
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
Romania: National Medicines Agency
Romania: Ministry of Public Health
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Russia: FSI Scientific Center of Expertise of Medical Application
Spain: Spanish Agency of Medicines
Switzerland: Federal Office of Public Health
Switzerland: Swissmedic
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Newly Diagnosed
Previously Untreated

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
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
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on April 15, 2014