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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01239797
First received: November 8, 2010
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
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: Approximately up to 6.75 years ] [ 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: March 2018
Estimated Primary Completion Date: August 2017 (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

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Locations
United States, Alabama
Northwest Alabama Cancer Center, Pc
Muscle Shoals, Alabama, United States, 35661
United States, Arizona
Acrc/Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States, 85715
United States, California
Local Institution
Berkeley, California, United States, 94704
Local Institution
Burbank, California, United States, 91505
Compassionate Cancer Care Medical Group Inc
Corona, California, United States, 92879
Local Institution
Corona, California, United States, 92879
San Diego Pacific Oncology& Hematology Associates, Inc
Encinitas, California, United States, 92024
Local Institution
Greenbrae, California, United States, 94904
Ucla-Division Of Hematology/Oncology
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
Local Institution
Vallejo, California, United States, 94589
United States, Florida
Local Institution
Boca Raton, Florida, United States, 33486
Cancer Care Centers Of Florida
Brooksville, Florida, United States, 34613
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
Local Institution
New Port Richey, Florida, United States, 34652
Cancer Institute Of Florida
Orlando, Florida, United States, 32804
Local Institution
Titusville, Florida, United States, 32796
Palm Beach Cancer Institute
West Palm Beach, Florida, United States, 33401
United States, Georgia
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
Georgia Health Science University
Augusta, Georgia, United States, 30912
United States, Illinois
Orchard Healthcare Research Inc.
Skokie, Illinois, United States, 60077
United States, Indiana
Local Institution
Indianapolis, Indiana, United States, 46260
Local Institution
Mishawaka, Indiana, United States, 46545
United States, Iowa
Local Institution
Iowa City, Iowa, United States, 52242
United States, Kentucky
Local Institution
Lexington, Kentucky, United States, 40503
Local Institution
Louisville, Kentucky, United States, 40207
Pikeville Medical Center Leonard Lawson Cancer Center
Pikeville, Kentucky, United States, 41501
United States, Louisiana
Cancer Center Of Acadiana At Lafayette General
Lafayette, Louisiana, United States, 70503
Local Institution
Shreveport, Louisiana, United States, 71103
Willis Knighton Cancer Center
Shreveport, Louisiana, United States, 71103
Local Institution
Shreveport, Louisiana, United States, 71101
United States, Massachusetts
Dana Farber Cancer Inst
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
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
Local Institution
Springfield, Missouri, United States, 65807
United States, Nevada
Local Institution
Las Vegas, Nevada, United States, 89106
United States, New York
Local Institution
New York, New York, United States, 10019
Nyu Clinical Cancer Center
New York, New York, United States, 10016
Weill Cornell Medical College
New York, New York, United States, 10065
Local Institution
Stony Brook, New York, United States, 11794
United States, North Carolina
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Gaston Hematology & Oncology
Gastonia, North Carolina, United States, 28054
United States, North Dakota
Local Institution
Bismarck, North Dakota, United States, 58501
United States, Oklahoma
University Of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
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Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Local Institution
Bethlehem, Pennsylvania, United States, 18015
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
Local Institution
Charleston, South Carolina, United States, 29414
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Greenville, South Carolina, United States, 29615
United States, Tennessee
Local Institution
Knoxville, Tennessee, United States, 37909
The West Clinic
Memphis, Tennessee, United States, 38120
United States, Texas
Cancer Specialists Of South Texas, Pa
Corpus Christi, Texas, United States, 78412
University Of Texas Southwestern
Dallas, Texas, United States, 75390
University Of Texas Md Anderson Cancer Ctr
Houston, Texas, United States, 77030
Northwest Cancer Center
Houston, Texas, United States, 77090
United States, Virginia
Hematology-Oncology Associates Of Fredricksburg, Inc
Fredricksburg, Virginia, United States, 22408
United States, Washington
The Canberra Hospital
Seattle, Washington, United States, 98108VA
Va Puget Sound Health Care System
Seattle, Washington, United States, 98108
United States, Wisconsin
Gundersen Clinic, Ltd
La Crosse, Wisconsin, United States, 54601
University Of Wisconsin Hospital And Clinics
Madison, Wisconsin, United States, 53792
Medical College Of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
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Westmead, New South Wales, Australia, 2145
Australia, Queensland
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Herston, Queensland, Australia, 4029
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South Brisbane, Queensland, Australia, 4101
Australia, South Australia
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Adelaide, South Australia, Australia, 5000
Australia, Victoria
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Frankston, Victoria, Australia, 3199
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Malvern, Victoria, Australia, 3144
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Melbourne, Victoria, Australia, 3004
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Wodonga, Victoria, Australia, 3690
Australia, Western Australia
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Nedlands, Western Australia, Australia, 6009
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Perth, Western Australia, Australia, 6001
Austria
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Rankweil, Austria, 6830
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Steyr, Austria, 4400
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Wels, Austria, 4600
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Wien, Austria, 1220
Belgium
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Antwerpen, Belgium, 2060
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Brugge, Belgium, 8000
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Brussels, Belgium, 1000
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Brussels, Belgium, 1090
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Brussels, Belgium, 1020
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Brussles, Belgium, 1200
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Edegem-antwerp, Belgium, 2650
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La Louviere, Belgium, 7100
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Liege, Belgium, 4000
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Yvoir, Belgium, 5530
Canada, Alberta
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Calgary, Alberta, Canada, T2N 2T9
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Edmonton, Alberta, Canada, T6G 1Z2
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
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Barrie, Ontario, Canada, L4M 6M2
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London, Ontario, Canada, N6A 5W9
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Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
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Montral, Quebec, Canada, H3A 1A1
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Montreal, Quebec, Canada, H4J 1C5
Canada, Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 4H4
Czech Republic
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Brno, Czech Republic, 625 00
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Hradec Kralove, Czech Republic, 500 05
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Praha 10, Czech Republic, 100 34
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Praha 2, Czech Republic, 128 08
Denmark
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Copenhagen, Denmark, 2100
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Odense C, Denmark, 5000
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Vejle, Denmark, 7100
France
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Blois, France, 41016
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Bordeaux, France, 33076
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Caen, France, 14000
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Clamart Cedex, France, 92140
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La Roche Sur Yon, France, 85925
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La Tronche, France, 38700
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Lille, France, 59037
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Limoges, France, 87042
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Nantes, France, 44093
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Paris 12, France, 75012
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Pierre Benita, France, 69495
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Toulouse, France, 31059
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Tours Cedex, France, 37044
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Vandoeuvre, France, 54511
Germany
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Aschaffenburg, Germany, 63739
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Berlin, Germany, 12200
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Berlin, Germany, 13125
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Chemnitz, Germany, 09113
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Dresden, Germany, 01307
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Hamburg, Germany, 66421
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Hamburg, Germany, 22763
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Hamburg, Germany, 20246
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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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Kiel, Germany, 24105
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Koln, Germany, 50937
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Marburg, Germany, 35037
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Munchen, Germany, 81377
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Munchen, Germany, 81675
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Munster, Germany, 48149
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Ravensburg, Germany, 88212
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Tuebingen, Germany, 72076
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Ulm, Germany, 89081
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Wurzburg, Germany, 97080
Greece
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Athens, Greece, 11528
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Ioannina, Greece, 45500
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Larissa, Greece, 41110
Hungary
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Budapest, Hungary, 1125
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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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Tullamore, Ireland
Israel
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Afula, Israel, 18101
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Ashkelon, Israel, 78278
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Jerusalem, Israel, 91120
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Petah Tikva, Israel, 49100
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Rehovot, Israel, 76100
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Zerifin, Israel, 70300
Italy
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Ancona, Italy, 60126
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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, 20133
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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, 48100
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Rimini, Italy, 47923
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Roma, Italy, 00168
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Roma, Italy, 00161
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Torino, Italy, 10126
Japan
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Nagoya-shi, Aichi, Japan, 4600001
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Maebashi-shi, Gunma, Japan, 371-8511
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Shibukawa, Gunma, Japan, 377-8511
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Sendai-shi, Miyagi, Japan, 9808574
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Osaka-shi, Osaka, Japan, 5438555
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Bunkyo-ku, Tokyo, Japan, 1138677
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Shibuya-ku, Tokyo, Japan, 1508935
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Shinjuuku-ku, Tokyo, Japan, 1608582
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Kamogawa, Toyko, Japan, 296-8602
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Chiba-shi, Japan, 260-8677
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Fukuoka, Japan, 812-8582
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Kyoto, Japan, 602-8566
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Nagoya-shi, Japan, 467-8602
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Niigata, Japan, 9518566
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Okayama, Japan, 7011192
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Sapporo, Japan, 0608543
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Tokyo, Japan, 1358550
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Toyohashi-shi, Japan, 441-8570
Poland
Local Institution
Bialystok, Poland, 15-276
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Chorzow, Poland, 41-500
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Lublin, Poland, 20-081
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Poznan, Poland, 60-569
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Warsaw, Poland, 02-776
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Warsaw, Poland, 02-106
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Warszawa, Poland, 02-507
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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
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Bucaresti, Romania, 030171
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Bucuresti, Romania, 22328
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Lasi, Romania, 700483
Spain
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Badalona-barcelona, Spain, 08916
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Madrid, Spain, 28006
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Madrid, Spain, 28007
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Murcia, Spain, 30008
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Salamanca, Spain, 37007
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Santiago De Comp-coruna, Spain, 15706
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Toledo, Spain, 45004
Switzerland
Local Institution
Bern, Switzerland, 3010
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Geneve 14, Switzerland, 1211
Turkey
Local Institution
Izmir, Bornova, Turkey, 35100
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Istanbul, Capa, Turkey, 34340
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Izmir, Inciralti, Turkey, 35340
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Ankara, Turkey, 06620
United Kingdom
Local Institution
London, Greater London, United Kingdom, EC1A 7BE
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London, Greater London, United Kingdom, NW1 2PG
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Manchester, Greater Manchester, United Kingdom, M20 4BX
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Airdrie, Lancashire, United Kingdom, ML6 OJS
Local Institution
Edinburgh, Midlothian, United Kingdom, EH4 2XU
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Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
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Sutton, Surrey, United Kingdom, SM2 5PT
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Leeds, United Kingdom, LS9 7FT
Local Institution
Leicester, United Kingdom, LE1 5WW
Local Institution
Newcastle Upon Tyne, United Kingdom, NE7 7DN
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: 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
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:
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 October 01, 2014