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

Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma (MM)

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).

Study Overview

• Status: Completed
• Conditions: Lymphoma; Multiple Myeloma
• Intervention / Treatment: Drug: Lenalidomide; Drug: Dexamethasone; Drug: Dexamethasone (Oral); Drug: Dexamethasone (IV); Biological: Elotuzumab (BMS-901608; HuLuc63)

• Study Type: Interventional
• Enrollment (Actual): 646
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Murdoch, Australia, 6150
    • Local Institution
  • New South Wales
    • Albury, New South Wales, Australia, 2640
      • Local Institution
    • Canberra, New South Wales, Australia, 2605
      • Local Institution
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Local Institution
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Local Institution
  • Victoria
    • Malvern, Victoria, Australia, 3144
      • Local Institution
    • Melbourne, Victoria, Australia, 3004
      • Local Institution
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Local Institution
• Austria
  • Rankweil, Austria, 6830
    • Local Institution
  • Steyr, Austria, 4400
    • Local Institution
  • Wels, Austria, 4600
    • Local Institution
  • Wien, Austria, 1220
    • Local Institution
• Belgium
  • Antwerpen, Belgium, 2060
    • Local Institution
  • Brussels, Belgium, 1090
    • Local Institution
  • Brussels, Belgium, 1000
    • Local Institution
  • Brussels, Belgium, 1020
    • Local Institution
  • Brussles, Belgium, 1200
    • Local Institution
  • Edegem-antwerp, Belgium, 2650
    • Local Institution
  • Liege, Belgium, 4000
    • Local Institution
  • Yvoir, Belgium, 5530
    • Local Institution
• Canada
  • Barrie, Canada, L4M 6M2
    • Local Institution
  • Montreal, Canada, H4A 3J1
    • Local Institution
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Local Institution
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Local Institution
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Local Institution
  • Ontario
    • London, Ontario, Canada, N6A 4G5
      • Local Institution
    • Toronto, Ontario, Canada, M5G 2M9
      • Local Institution
  • Quebec
    • Montreal, Quebec, Canada, H4J 1C5
      • Local Institution
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Local Institution
• Czechia
  • Brno, Czechia, 625 00
    • Local Institution
  • Hradec Kralove, Czechia, 500 05
    • Local Institution
  • Praha 10, Czechia, 100 34
    • Local Institution
  • Praha 2, Czechia, 128 08
    • Local Institution
• Denmark
  • Copenhagen, Denmark, 2100
    • Local Institution
  • Odense C, Denmark, 5000
    • Local Institution
  • Vejle, Denmark, 7100
    • Local Institution
• France
  • Blois, France, 41016
    • Local Institution
  • Bordeaux, France, 33076
    • Local Institution
  • Caen, France, 14000
    • Local Institution
  • Clamart Cedex, France, 92140
    • Local Institution
  • La Roche Sur Yon, France, 85925
    • Local Institution
  • La Tronche, France, 38700
    • Local Institution
  • Lille, France, 59037
    • Local Institution
  • Limoges, France, 87042
    • Local Institution
  • Nantes, France, 44093
    • Local Institution
  • Paris 12, France, 75012
    • Local Institution
  • Pierre Benita, France, 69495
    • Local Institution
  • Toulouse, France, 31059
    • Local Institution
  • Tours Cedex, France, 37044
    • Local Institution
  • Vandoeuvre, France, 54511
    • Local Institution
• Germany
  • Aschaffenburg, Germany, 63739
    • Local Institution
  • Berlin, Germany, 13125
    • Local Institution
  • Berlin, Germany, 12200
    • Local Institution
  • Chemnitz, Germany, 09113
    • Local Institution
  • Dresden, Germany, 01307
    • Local Institution
  • Hamburg, Germany, 20246
    • Local Institution
  • Hamburg, Germany, 22763
    • Local Institution
  • Hamburg, Germany, 66421
    • Local Institution
  • Hamm, Germany, 59071
    • Local Institution
  • Heidelberg, Germany, 69120
    • Local Institution
  • Jena, Germany, 07747
    • Local Institution
  • Kiel, Germany, 24105
    • Local Institution
  • Koln, Germany, 50937
    • Local Institution
  • Marburg, Germany, 35037
    • Local Institution
  • Munchen, Germany, 81675
    • Local Institution
  • Munchen, Germany, 81377
    • Local Institution
  • Munster, Germany, 48149
    • Local Institution
  • Ravensburg, Germany, 88212
    • Local Institution
  • Tuebingen, Germany, 72076
    • Local Institution
  • Ulm, Germany, 89081
    • Local Institution
  • Wurzburg, Germany, 97080
    • Local Institution
• Greece
  • Athens, Greece, 11528
    • Local Institution
  • Ioannina, Greece, 45500
    • Local Institution
  • Larissa, Greece, 41110
    • Local Institution
• Hungary
  • Budapest, Hungary, 1125
    • Local Institution
  • Debrecen, Hungary, H-4032
    • Local Institution
  • Gyor, Hungary, 9024
    • Local Institution
  • Szeged, Hungary, H-6725
    • Local Institution
• Ireland
  • Dublin, Ireland, 7
    • Local Institution
  • Tullamore, Ireland
    • Local Institution
• Israel
  • Afula, Israel, 18101
    • Local Institution
  • Jerusalem, Israel, 91120
    • Local Institution
  • Petah Tikva, Israel, 49100
    • Local Institution
  • Rehovot, Israel, 76100
    • Local Institution
  • Zerifin, Israel, 70300
    • Local Institution
• Italy
  • Ancona, Italy, 60126
    • Local Institution
  • Bergamo, Italy, 24127
    • Local Institution
  • Bologna, Italy, 40138
    • Local Institution
  • Firenze, Italy, 50134
    • Local Institution
  • Genova, Italy, 16132
    • Local Institution
  • Meldola, Italy, 47014
    • Local Institution
  • Milano, Italy, 20133
    • Local Institution
  • Palermo, Italy, 90146
    • Local Institution
  • Ravenna, Italy, 48100
    • Local Institution
  • Rimini, Italy, 47923
    • Local Institution
  • Roma, Italy, 00168
    • Local Institution
  • Roma, Italy, 00161
    • Local Institution
  • Torino, Italy, 10126
    • Local Institution
• Japan
  • Chiba-shi, Japan, 260-8677
    • Local Institution
  • Fukuoka, Japan, 812-8582
    • Local Institution
  • Kyoto, Japan, 602-8566
    • Local Institution
  • Niigata, Japan, 9518566
    • Local Institution
  • Okayama, Japan, 7011192
    • Local Institution
  • Toyohashi-shi, Japan, 4418570
    • Local Institution
  • Aichi
    • Nagoya-shi, Aichi, Japan, 4600001
      • Local Institution
    • Nagoya-shi, Aichi, Japan, 4678602
      • Local Institution
  • Gunma
    • Maebashi-shi, Gunma, Japan, 371-8511
      • Local Institution
    • Shibukawa-shi, Gunma, Japan, 3770280
      • Local Institution
  • Hokkaido
    • Sapporo-city, Hokkaido, Japan, 0608543
      • Local Institution
  • Miyagi
    • Sendai-shi, Miyagi, Japan, 980-8754
      • Local Institution
  • Osaka
    • Osaka-shi, Osaka, Japan, 5438555
      • Local Institution
  • Tokyo
    • Bunkyo-Ku, Tokyo, Japan, 1138677
      • Local Institution
    • Koto-ku, Tokyo, Japan, 1358550
      • Local Institution
    • Shibuya-ku, Tokyo, Japan, 1508935
      • Local Institution
    • Shinjuuku-ku, Tokyo, Japan, 1608582
      • Local Institution
  • Toyko
    • Kamogawa, Toyko, Japan, 296-8602
      • Local Institution
• Poland
  • Bialystok, Poland, 15-276
    • Local Institution
  • Chorzow, Poland, 41-500
    • Local Institution
  • Lublin, Poland, 20-081
    • Local Institution
  • Poznan, Poland, 60-569
    • Local Institution
  • Warszawa, Poland, 02-106
    • Local Institution
  • Warszawa, Poland, 02-507
    • Local Institution
  • Warszawa, Poland, 02-776
    • Local Institution
  • Wroclaw, Poland, 50-367
    • Local Institution
• Puerto Rico
  • Ponce, Puerto Rico, 00716
    • Local Institution
  • San Juan, Puerto Rico, 00918
    • Local Institution
• Romania
  • Brasov, Romania, 500152
    • Local Institution
  • Brasov, Romania, 700106
    • Local Institution
  • Bucaresti, Romania, 030171
    • Local Institution
  • Bucuresti, Romania, 22328
    • Local Institution
• Spain
  • Badalona-Barcelona, Spain, 08916
    • Local Institution
  • Madrid, Spain, 28006
    • Local Institution
  • Madrid, Spain, 28007
    • Local Institution
  • Murcia, Spain, 30008
    • Local Institution
  • Salamanca, Spain, 37007
    • Local Institution
  • Santiago De Comp-coruna, Spain, 15706
    • Local Institution
  • Toledo, Spain, 45004
    • Local Institution
• Switzerland
  • Bern, Switzerland, 3010
    • Local Institution
  • Geneve 14, Switzerland, 1211
    • Local Institution
• Turkey
  • Ankara, Turkey, 06620
    • Local Institution
  • Izmir, Turkey, 35330
    • Local Institution
  • Bornova
    • Izmir, Bornova, Turkey, 35100
      • Local Institution
  • Capa
    • Istanbul, Capa, Turkey, 34390
      • Local Institution
• United Arab Emirates
  • Leicester, United Arab Emirates, LE1 5WW
    • Local Institution
• United Kingdom
  • Leeds, United Kingdom, LS9 7FT
    • Local Institution
  • London, United Kingdom, NW1 2PG
    • Local Institution
  • Newcastle Upon Tyne, United Kingdom, NE7 7DN
    • Local Institution
  • Greater London
    • London, Greater London, United Kingdom, EC1A 7BE
      • Local Institution
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M20 4BX
      • Local Institution
  • Lancashire
    • Airdrie, Lancashire, United Kingdom, ML6 OJS
      • Local Institution
  • Midlothian
    • Edinburgh, Midlothian, United Kingdom, EH4 2XU
      • Local Institution
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
      • Local Institution
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • Local Institution
• United States
  • Alabama
    • Muscle Shoals, Alabama, United States, 35661
      • Northwest Alabama Cancer Center, Pc
  • Arizona
    • Tucson, Arizona, United States, 85715
      • Acrc/Arizona Clinical Research Center, Inc.
  • California
    • Berkeley, California, United States, 94704
      • Local Institution
    • Burbank, California, United States, 91505
      • Local Institution
    • Corona, California, United States, 92879
      • Compassionate Cancer Res Grp
    • Corona, California, United States, 92879
      • Local Institution
    • Encinitas, California, United States, 92024
      • San Diego Pacific Oncology& Hematology Associates, Inc
    • Greenbrae, California, United States, 94904
      • Local Institution
    • Los Angeles, California, United States, 90095
      • Ucla-Division Of Hematology/Oncology
    • Orange, California, United States, 92868
      • Medical Oncology Care Associates
    • San Diego, California, United States, 92123
      • Sharp Clinical Oncology Research
    • Vallejo, California, United States, 94589
      • Local Institution
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Local Institution
    • Brooksville, Florida, United States, 34613
      • Cancer Care Centers of Florida
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Comprehensive Cancer Center
    • New Port Richey, Florida, United States, 34652
      • Local Institution
    • Orlando, Florida, United States, 32804
      • Cancer Institute Of Florida
    • Titusville, Florida, United States, 32796
      • Local Institution
    • West Palm Beach, Florida, United States, 33401
      • Florida Cancer Specialists
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute.
    • Augusta, Georgia, United States, 30912
      • Georgia Health Science University
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Orchard Healthcare Research Inc.
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Local Institution
    • Mishawaka, Indiana, United States, 46545
      • Local Institution
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Local Institution
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Local Institution
    • Louisville, Kentucky, United States, 40207
      • Local Institution
    • Pikeville, Kentucky, United States, 41501
      • Pikeville Medical Center
  • Louisiana
    • Lafayette, Louisiana, United States, 70503
      • Cancer Center of Acadiana at Lafayette General
    • Shreveport, Louisiana, United States, 71103
      • Willis Knighton Cancer Center
    • Shreveport, Louisiana, United States, 71101
      • Local Institution
    • Shreveport, Louisiana, United States, 71103
      • Local Institution
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Inst
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Missouri
    • Jefferson City, Missouri, United States, 65101
      • Capitol Comprehensive Cancer Care Center
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • Springfield, Missouri, United States, 65807
      • Local Institution
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Local Institution
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College
    • New York, New York, United States, 10016
      • NYU Clinical Cancer Center
    • New York, New York, United States, 10019
      • Local Institution
    • Stony Brook, New York, United States, 11794-8151
      • Local Institution
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Levine Cancer Institute
    • Gastonia, North Carolina, United States, 28054
      • Gaston Hematology & Oncology
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • Local Institution
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
    • Tulsa, Oklahoma, United States, 74136
      • Local Institution
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • Local Institution
    • Pittsburgh, Pennsylvania, United States, 15224
      • Western Pennsylvania Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Local Institution
    • Greenville, South Carolina, United States, 29615
      • Local Institution
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • Local Institution
    • Memphis, Tennessee, United States, 38120
      • The West Clinic
  • Texas
    • Corpus Christi, Texas, United States, 78412
      • Cancer Specialists Of South Texas, Pa
    • Dallas, Texas, United States, 75390-8565
      • UT southwestern Medical Center
    • Houston, Texas, United States, 77090
      • Northwest Cancer Center
    • Houston, Texas, United States, 77030
      • University Of Texas Md Anderson Cancer Ctr
  • Virginia
    • Fredericksburg, Virginia, United States, 22408
      • Hematology-Oncology Associates Of Fredricksburg, Inc
  • Washington
    • Seattle, Washington, United States, 98108
      • VA Puget Sound Health Care System
  • Wisconsin
    • La Crosse, Wisconsin, United States, 54601
      • Gundersen Clinic, Ltd
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Hospital and Clinics
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Progression Free Survival (PFS)	Primary definition of Progression-free survival (PFS) defined as the time from randomization to the date of first documented tumor progression or death due to any cause. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. The primary analysis of PFS was based on the primary definition using the Independent Review Committee (IRC) tumor assessment using the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Tumor assessments were made every 4 weeks (±1 week) relative to the first dose of study medication.	From randomization up to 326 events (up to approximately 38 months)
Objective Response Rate (ORR)	Objective response rate (ORR) defined as the percentage of participants with a best response on-study of partial response (PR) or better (stringent CR [sCR], complete response [CR], very good partial response [VGPR], and partial response [PR]) based on the Independent Review Committee (IRC) assessment of best response using the European Group for Blood and Bone Marrow Transplant (EBMT) assessment criteria. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. Assessments were made every 4 weeks.	From randomization up to approximately 38 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Overall Survival (OS)	Overall survival is defined as the time from randomization to the date of death from any cause. If a subject has not died, their survival time will be censored at the date of last contact ("last known alive date"). A subject will be censored at the date of randomization if they were randomized but had no follow-up. (Based on Kaplan Meier estimates)	Randomization to the date of death from any cause (up to approximately 9 years)
Change From Baseline of Mean Score Pain Severity (BPI-SF)	The change from baseline of the mean score of pain severity at the end of treatment using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 0 ("No pain", "No interference") to 10 ("Pain as bad as you can imagine", "Highest imaginable interference") numeric rating scale.	From baseline up to approximately 38 months
Change From Baseline of Mean Score Pain Interference (BPI-SF)	The change from baseline of the mean score of pain interference at the end of treatment using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 0 ("No pain", "No interference") to 10 ("Pain as bad as you can imagine", "Highest imaginable interference") numeric rating scale.	From baseline up to approximately 38 months

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: AbbVie

Publications and helpful links

General Publications

• Dimopoulos MA, Lonial S, Betts KA, Chen C, Zichlin ML, Brun A, Signorovitch JE, Makenbaeva D, Mekan S, Sy O, Weisel K, Richardson PG. Elotuzumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: Extended 4-year follow-up and analysis of relative progression-free survival from the randomized ELOQUENT-2 trial. Cancer. 2018 Oct 15;124(20):4032-4043. doi: 10.1002/cncr.31680. Epub 2018 Sep 11.
• Passey C, Mora J, Dodge R, Gibiansky L, Sheng J, Roy A, Bello A, Gupta M. An Integrated Assessment of the Effects of Immunogenicity on the Pharmacokinetics, Safety, and Efficacy of Elotuzumab. AAPS J. 2017 Mar;19(2):557-567. doi: 10.1208/s12248-016-0033-9. Epub 2017 Jan 9.
• Lonial S, Dimopoulos M, Palumbo A, White D, Grosicki S, Spicka I, Walter-Croneck A, Moreau P, Mateos MV, Magen H, Belch A, Reece D, Beksac M, Spencer A, Oakervee H, Orlowski RZ, Taniwaki M, Rollig C, Einsele H, Wu KL, Singhal A, San-Miguel J, Matsumoto M, Katz J, Bleickardt E, Poulart V, Anderson KC, Richardson P; ELOQUENT-2 Investigators. Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2015 Aug 13;373(7):621-31. doi: 10.1056/NEJMoa1505654. Epub 2015 Jun 2.

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 20, 2011
• Primary Completion (ACTUAL): September 2, 2014
• Study Completion (ACTUAL): April 21, 2021

Study Registration Dates

• First Submitted: November 8, 2010
• First Submitted That Met QC Criteria: November 10, 2010
• First Posted (ESTIMATE): November 11, 2010

Study Record Updates

• Last Update Posted (ACTUAL): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Immunologic Factors; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101; Lenalidomide; Elotuzumab
• Other Study ID Numbers: CA204-004; 2010-020347-12 (EUDRACT_NUMBER)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No