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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01335399
First received: April 13, 2011
Last updated: August 7, 2014
Last verified: August 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: May 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
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: NCT01335399

  Hide Study Locations
Locations
United States, Alabama
Alabama Oncology
Birmingham, Alabama, United States, 35213
University Of South Alabama / Mitchell Cancer Institute
Mobile, Alabama, United States, 36604
Southern Cancer Center
Mobile, Alabama, United States, 36608
United States, Arizona
Ironwood Physicians Pc
Chandler, Arizona, United States, 85224
Acrc/Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States, 85715
United States, California
Comprehensive Blood And Cancer Center
Bakersfield, California, United States, 93309
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States, 94704
Compassionate Cancer Care Medical Group Inc
Corona, California, United States, 92879
Compassionate Cancer Care Medical Group, Inc.
Corona, California, United States, 92879
Marin Cancer Care, Inc
Greenbrae, California, United States, 94904
Pacific Shores Medical Group
Long Beach, California, United States, 90813
Local Institution
Los Angeles, California, United States, 90095
Medical Oncology Care Associates
Orange, California, United States, 92868
Sharp Clinical Oncology Research
San Diego, California, United States, 92123
Pacific Hematology Oncology Associates
San Francisco, California, United States, 94115
United States, Connecticut
Yale University School Of Medicine
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Washington Cancer Inst At Medstar Washington Hospital Ctr
Washington, District of Columbia, United States, 20010
United States, Florida
Local Institution
Boca Raton, Florida, United States, 33486
Local Institution
Brooksville, Florida, United States, 34613
Florida Cancer Specialists
Fort Myers, Florida, United States, 33916
Memorial Cancer Institute
Hollywood, Florida, United States, 33021
Cancer Specialists Of North Florida Beaches
Jacksonville, Florida, United States, 32256
Local Institution
New Port Richey, Florida, United States, 34652
Florida Cancer Specialists
Saint Petersburg, Florida, United States, 33705
Palm Beach Cancer Institute
West Palm Beach, Florida, United States, 33401
United States, Georgia
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
United States, Hawaii
Kaiser Permanente Hawaii
Honolulu, Hawaii, United States, 96819
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
The University Of Chicago
Chicago, Illinois, United States, 60637
Cardinal Bernardin Cancer Center
Maywood, Illinois, United States, 60153
Illinois Cancercare, Pc
Peoria, Illinois, United States, 61615
Orchard Healthcare Research Inc.
Skokie, Illinois, United States, 60077
Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Premier Healthcare, Llc
Bloomington, Indiana, United States, 47403
Investigative Clinical Research Of Indiana, Llc
Indianapolis, Indiana, United States, 46260
Franciscan St. Francis Health
Indianapolis, Indiana, United States, 46237
Local Institution
Mishawaka, Indiana, United States, 46545
United States, Iowa
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
Local Institution
Lexington, Kentucky, United States, 40503
Norton Cancer Institute
Louisville, Kentucky, United States, 40207
United States, Louisiana
Cancer Center Of Acadiana At Lafayette General
Lafayette, Louisiana, United States, 70503
Crescent City Research Consortium, Llc
Marrero, Louisiana, United States, 70072
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Willis Knighton Cancer Center
Shreveport, Louisiana, United States, 71103
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
Harry & Jeanette Weinberg Cancer Institute
Baltimore, Maryland, United States, 21237
United States, Massachusetts
Dana Faber Cancer Institute
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
University Of Michigan
Ann Arbor, Michigan, United States, 48109
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Missouri
Columbia Comprehensive Cancer Care Clinic
Jefferson City, Missouri, United States, 65101
Washington University School Of Medicine
Saint Louis, Missouri, United States, 63110
Mercy Medical Research Institute
Springfield, Missouri, United States, 65807
United States, Nebraska
Local Institution
Lincoln, Nebraska, United States, 68506
University Of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
St. Luke'S Roosevelt Hospital Center
New York, New York, United States, 10019
St. Luke'S-Roosevelt Hosp. Ctr.
New York, New York, United States, 10019
Weill Cornell Medical College
New York, New York, United States, 10021
Local Institution
New York, New York, United States, 10019
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, North Carolina
Mecklenburg Medical Group
Charlotte, North Carolina, United States, 28204
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States, 27534
Piedmont Hematology Oncology Associates, Pa
Winston-salem, North Carolina, United States, 27103
United States, Ohio
Local Institution
Cleveland, Ohio, United States, 44195
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Benson, Md, Don
Columbus, Ohio, United States, 43210
Mid Ohio Oncology/Hematology, Inc,Dba
Columbus, Ohio, United States, 43219
Signal Point Clinical Research Center, Llc
Middletown, Ohio, United States, 45042
United States, Oklahoma
Tulsa Cancer Institute
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Local Institution
Bethlehem, Pennsylvania, United States, 18015
St. Mary Medical Center
Longhorne, Pennsylvania, United States, 19047
Local Institution
Pittsburgh, Pennsylvania, United States, 15240
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
Guthrie Clinic Ltd.
Sayre, Pennsylvania, United States, 18840
United States, South Carolina
Musc Hollings Cancer Center
Charleston, South Carolina, United States, 29425
Charleston Hematology Oncology Associates, Pa
Charleston, South Carolina, United States, 29414
Ghs Cancer Institute
Greenville, South Carolina, United States, 29615
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Tennessee Cancer Specialists
Knoxville, Tennessee, United States, 37909
Baptist Cancer Center
Memphis, Tennessee, United States, 38120
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Tennessee Oncology, Pllc
Nashville, Tennessee, United States, 37203
United States, Texas
Cancer Specialists Of South Texas, Pa
Corpus Christi, Texas, United States, 78412
Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Northwest Cancer Center
Houston, Texas, United States, 77090
The University Of Texas Md Anderson Cancer Center
Houston, Texas, United States, 77030
Baylor College Of Medicine
Houston, Texas, United States, 77030
United States, Utah
Northern Utah Associates
Ogden, Utah, United States, 84403
United States, Virginia
Hematology-Oncology Associates Of Fredricksburg, Inc
Fredricksburg, Virginia, United States, 22408
United States, Washington
Va Puget Sound Health Care System
Seattle, Washington, United States, 98108
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
United States, West Virginia
Edwards Comprehensive Cancer Center
Huntington, West Virginia, United States, 25701
United States, Wisconsin
Gundersen Clinic, Ltd
La Crosse, Wisconsin, United States, 54601
Dean Clinic-Hematology And Oncology
Madison, Wisconsin, United States, 53717
University Of Wisconsin Hospital And Clinics
Madison, Wisconsin, United States, 53792
Australia, Australian Capital Territory
Local Institution
Canberra, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Local Institution
Waratah, New South Wales, Australia, 2298
Local Institution
Westmead, New South Wales, Australia, 2145
Australia, Queensland
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Herston, Queensland, Australia, 4029
Local Institution
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
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Adelaide, South Australia, Australia, 5011
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Adelaide, South Australia, Australia, 5000
Australia, Victoria
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Fitzroy, Victoria, Australia, 3065
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Frankston, Victoria, Australia, 3199
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Heidelberg Melbourne, Victoria, Australia, 3084
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Wodonga, Victoria, Australia, 3690
Australia, Western Australia
Local Institution
Nedlands, Western Australia, Australia, 6009
Local Institution
Perth, Western Australia, Australia, 6000
Austria
Local Institution
Innsbruck, Austria, 6020
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Linz, Austria, 4020
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Rankweil, Austria, 6830
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Wels, Austria, 4600
Belgium
Local Institution
Brussels, Belgium, 1020
Local Institution
Brussels, Belgium, 1000
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Brussels, Belgium, 1090
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Brussles, Belgium, 1200
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Charleroi, Belgium, 6000
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Gent, Belgium, 9000
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La Louviere, Belgium, 7100
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Leuven, Belgium, 3000
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Liege, Belgium, 4000
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Roeselare, Belgium, 8800
Local Institution
Yvoir, Belgium, 5530
Canada, Alberta
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Calgary, Alberta, Canada, T2N 2T9
Local Institution
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Manitoba
Local Institution
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
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Saint John, New Brunswick, Canada, E2L 4L2
Canada, Nova Scotia
Local Institution
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
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London, Ontario, Canada, N6A 5W9
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Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Local Institution
Greenfield Park, Quebec, Canada, J4V 2H1
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Montral, Quebec, Canada, H3A 1A1
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Montreal, Quebec, Canada, H1T 2M4
Canada, Saskatchewan
Local Institution
Saskatoon, Saskatchewan, Canada, S7N 4H4
Czech Republic
Local Institution
Hradec Kralove, Czech Republic, 500 05
Local Institution
Praha 10, Czech Republic, 100 34
Local Institution
Praha 2, Czech Republic, 128 08
Germany
Local Institution
Aschaffenburg, Germany, 63739
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Berlin, Germany, 12200
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Chemnitz, Germany, 09113
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Dresden, Germany, 01307
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Hamm, Germany, 59071
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Heidelberg, Germany, 69120
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Jena, Germany, 07747
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Koln, Germany, 50937
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Mainz, Germany, 55131
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Munchen, Germany, 81377
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Munster, Germany, 48149
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Offenbach, Germany, 63069
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Stuttgart, Germany, 70376
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Tuebingen, Germany, 72076
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Ulm, Germany, 89081
Greece
Local Institution
Athens, Greece, 11528
Local Institution
Athens, Greece, 11527
Local Institution
Ioannina, Greece, 45500
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Larissa, Greece, 41110
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Patras, Greece, 26504
Hungary
Local Institution
Budapest, Hungary, 1122
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Budapest, Hungary, 1097
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Debrecen, Hungary, 4032
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Gyor, Hungary, 9024
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Szeged, Hungary, 6720
Ireland
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Dublin, Ireland, 7
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Dublin, Ireland, 8
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Galway, Ireland
Israel
Local Institution
Afula, Israel, 18101
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Ashkelon, Israel, 78278
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Haifa, Israel, 31096
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Jerusalem, Israel, 91031
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Jerusalem, Israel, 91120
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Kfar-saba, Israel, 44281
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Nahariya, Israel, 22100
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Petah Tikva, Israel, 49100
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Rehovot, Israel, 76100
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Tel Aviv, Israel, 64239
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Zerifin, Israel, 70300
Italy
Local Institution
Ancona, Italy, 60126
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Bari, Italy, 70124
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Bergamo, Italy, 24127
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Bologna, Italy, 40138
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Firenze, Italy, 50134
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Genova, Italy, 16132
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Meldola, Italy, 47014
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Milano, Italy, 20132
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Milano, Italy, 20122
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Monza, Italy, 20052
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Napoli, Italy, 80131
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Palermo, Italy, 90146
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Ravenna, Italy, 47923
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Reggio Emilia, Italy, 42123
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Rimini, Italy, 47923
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Roma, Italy, 00168
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Roma, Italy, 00144
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Roma, Italy, 00161
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Terni, Italy, 05100
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Torino, Italy, 10126
Poland
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Bialystok, Poland, 15-276
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Chorzow, Poland, 41-500
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Gdansk, Poland, 80-211
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Krakow, Poland, 31-501
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Lodz, Poland, 93-510
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Lublin, Poland, 20-081
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Poznan, Poland, 60-569
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Warsaw, Poland, 02-106
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Warsaw, Poland, 02-776
Local Institution
Warszawa, Poland, 02-507
Local Institution
Wroclaw, Poland, 50-367
Puerto Rico
Ponce School Of Medicine
Ponce, Puerto Rico, 00716
Auxilio Mutuo Cancer Center
San Juan, Puerto Rico, 00918
Romania
Local Institution
Brasov, Romania, 500326
Local Institution
Bucaresti, Romania, 030171
Local Institution
Bucuresti, Romania, 050098
Local Institution
Bucuresti, Romania, 22328
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Lasi, Romania, 700106
Russian Federation
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Samara, Russian Federation, 443095
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St Petersburg, Russian Federation, 197089
Local Institution
St. Petersburg, Russian Federation, 197022
Spain
Local Institution
Badalona-barcelona, Spain, 08916
Local Institution
Barcelona, Spain, 08036
Local Institution
Barcelona, Spain, 08041
Local Institution
LaLaguna-S. Cruz Tener, Spain, 38320
Local Institution
Madrid, Spain, 28006
Local Institution
Madrid, Spain, 28007
Local Institution
Madrid, Spain, 28041
Local Institution
Madrid, Spain, 28034
Local Institution
Pamplona, Spain, 31008
Local Institution
Salamanca, Spain, 37007
Local Institution
San Sebastian, Spain, 20014
Local Institution
Toledo, Spain, 45004
Switzerland
Local Institution
Bern, Switzerland, 3010
Local Institution
St Gallen, Switzerland, 9007
Local Institution
Zurich, Switzerland, 8028
Local Institution
Zurich, Switzerland, 8091
Turkey
Local Institution
Izmir, Bornova, Turkey, 35100
Local Institution
Ankara, Dikimevi, Turkey, 06620
Local Institution
Izmir, Inciralti, Turkey, 35340
Local Institution
Gaziantep, Turkey, 27310
United Kingdom
Local Institution
Belfast, Antrim, United Kingdom, BT9 7AB
Local Institution
London, Greater London, United Kingdom, SE5 9RS
Local Institution
London, Greater London, United Kingdom, NW3 2QG
Local Institution
London, Greater London, United Kingdom, EC1A 7BE
Local Institution
London, Greater London, United Kingdom, NW1 2PG
Local Institution
London, United Kingdom, HA1 3UJ
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: August 7, 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 August 20, 2014