Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma
NCT ID: NCT01335399
Last Updated: 2022-09-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
748 participants
INTERVENTIONAL
2011-08-04
2021-09-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lenalidomide + Dexamethasone
Lenalidomide
Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study 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
Lenalidomide + Dexamethasone + Elotuzumab
Lenalidomide
Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study 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
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
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
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
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
Interventions
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Lenalidomide
Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study 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
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
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
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
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 1628
Birmingham, Alabama, United States
Local Institution - 7619
Mobile, Alabama, United States
Local Institution - 7618
Mobile, Alabama, United States
Local Institution - 7617
Chandler, Arizona, United States
Local Institution - 1644
Tucson, Arizona, United States
Local Institution - 1618
Bakersfield, California, United States
Local Institution - 1602
Berkeley, California, United States
Local Institution - 1636
Corona, California, United States
Local Institution - 1668
Corona, California, United States
Local Institution - 1616
Greenbrae, California, United States
Local Institution - 7609
Long Beach, California, United States
Local Institution - 1660
Los Angeles, California, United States
Local Institution - 1673
Orange, California, United States
Local Institution - 1613
San Diego, California, United States
Local Institution - 1621
New Haven, Connecticut, United States
Local Institution - 1612
Washington D.C., District of Columbia, United States
Local Institution - 1682
Boca Raton, Florida, United States
Local Institution - 1617
Brooksville, Florida, United States
Local Institution - 1648
Fort Myers, Florida, United States
Local Institution - 7613
Hollywood, Florida, United States
Local Institution - 1623
Jacksonville, Florida, United States
Local Institution - 1625
New Port Richey, Florida, United States
Local Institution - 1649
St. Petersburg, Florida, United States
Local Institution - 1611
West Palm Beach, Florida, United States
Local Institution - 1630
Atlanta, Georgia, United States
Local Institution - 1684
Honolulu, Hawaii, United States
Local Institution - 1607
Chicago, Illinois, United States
Local Institution - 1635
Chicago, Illinois, United States
Local Institution - 1632
Maywood, Illinois, United States
Local Institution - 7606
Peoria, Illinois, United States
Local Institution - 7610
Skokie, Illinois, United States
Local Institution - 1603
Urbana, Illinois, United States
Local Institution - 7616
Bloomington, Indiana, United States
Local Institution - 7620
Indianapolis, Indiana, United States
Local Institution - 1669
Indianapolis, Indiana, United States
Local Institution - 1656
Mishawaka, Indiana, United States
Local Institution - 1633
Iowa City, Iowa, United States
Local Institution - 1674
Lexington, Kentucky, United States
Local Institution - 1683
Louisville, Kentucky, United States
Local Institution - 1646
Lafayette, Louisiana, United States
Local Institution - 7614
Marrero, Louisiana, United States
Local Institution - 1626
New Orleans, Louisiana, United States
Local Institution - 1652
Shreveport, Louisiana, United States
Local Institution - 1676
Baltimore, Maryland, United States
Local Institution - 1650
Baltimore, Maryland, United States
Local Institution - 1619
Boston, Massachusetts, United States
Local Institution - 1699
Boston, Massachusetts, United States
Local Institution - 1604
Detroit, Michigan, United States
Local Institution - 1667
Jefferson City, Missouri, United States
Local Institution - 1651
Springfield, Missouri, United States
Local Institution - 1645
St Louis, Missouri, United States
Local Institution - 1637
Omaha, Nebraska, United States
Local Institution - 7621
Mineola, New York, United States
Local Institution - 1615
New York, New York, United States
Local Institution - 1671
Stony Brook, New York, United States
Local Institution - 7604
Goldsboro, North Carolina, United States
Local Institution - 1610
Winston-Salem, North Carolina, United States
Local Institution - 1608
Cleveland, Ohio, United States
Local Institution - 1693
Cleveland, Ohio, United States
Local Institution - 1638
Columbus, Ohio, United States
Local Institution - 1664
Columbus, Ohio, United States
Local Institution - 1690
Middletown, Ohio, United States
Local Institution - 1655
Tulsa, Oklahoma, United States
Local Institution - 7611
Langhorne, Pennsylvania, United States
Local Institution - 1647
Pittsburgh, Pennsylvania, United States
Local Institution - 1679
Pittsburgh, Pennsylvania, United States
Local Institution - 1677
Sayre, Pennsylvania, United States
Local Institution - 1629
Charleston, South Carolina, United States
Local Institution - 7615
Charleston, South Carolina, United States
Local Institution - 1624
Greenville, South Carolina, United States
Local Institution - 7607
Sioux Falls, South Dakota, United States
Local Institution - 1600
Knoxville, Tennessee, United States
Local Institution - 7628
Memphis, Tennessee, United States
Local Institution - 1627
Nashville, Tennessee, United States
Local Institution - 1670
Nashville, Tennessee, United States
Local Institution - 1634
Corpus Christi, Texas, United States
Local Institution - 7612
Dallas, Texas, United States
Local Institution - 1643
Houston, Texas, United States
Local Institution - 1686
Houston, Texas, United States
Local Institution - 1642
Houston, Texas, United States
Local Institution - 7623
Ogden, Utah, United States
Local Institution - 1657
Fredericksburg, Virginia, United States
Local Institution - 1640
Seattle, Washington, United States
Local Institution - 1631
Seattle, Washington, United States
Local Institution - 1601
Huntington, West Virginia, United States
Gundersen Clinic, Ltd
La Crosse, Wisconsin, United States
Local Institution - 1663
Madison, Wisconsin, United States
Local Institution - 1609
Madison, Wisconsin, United States
Local Institution - 3600
Garran, Australian Capital Territory, Australia
Local Institution - 3607
Waratah, New South Wales, Australia
Local Institution - 3610
Westmead, New South Wales, Australia
Local Institution - 3609
Herston, Queensland, Australia
Local Institution - 3608
Milton, Queensland, Australia
Local Institution - 3612
Adelaide, South Australia, Australia
Local Institution - 3606
Woodville South, South Australia, Australia
Local Institution - 3601
Fitzroy, Victoria, Australia
Local Institution - 3602
Frankston, Victoria, Australia
Local Institution - 3603
Heidelberg Melbourne, Victoria, Australia
Local Institution - 3604
Wodonga, Victoria, Australia
Local Institution - 3605
Murdoch, , Australia
Local Institution - 3611
Nedlands, , Australia
Local Institution - 4052
Fadingerstraße 1, , Austria
Local Institution - 4051
Innsbruck, , Austria
Local Institution - 4054
Rankweil, , Austria
Local Institution - 4053
Wels, , Austria
Local Institution - 4160
Brussels, , Belgium
Local Institution - 4156
Brussels, , Belgium
Local Institution - 4157
Brussles, , Belgium
Local Institution - 4154
Charleroi, , Belgium
Local Institution - 4159
Haine-Saint-Paul, , Belgium
Local Institution - 4158
Leuven, , Belgium
Local Institution - 4150
Liège, , Belgium
Local Institution - 4153
Roeselare, , Belgium
Local Institution - 4151
Yvoir, , Belgium
Local Institution - 2601
Calgary, Alberta, Canada
Local Institution - 2600
Edmonton, Alberta, Canada
Local Institution - 2602
Winnipeg, Manitoba, Canada
Local Institution - 2611
Saint John, New Brunswick, Canada
Local Institution - 2610
Halifax, Nova Scotia, Canada
Local Institution - 2606
London, Ontario, Canada
Local Institution - 2612
Toronto, Ontario, Canada
Local Institution - 2603
Greenfield Park, Quebec, Canada
Local Institution - 2605
Montreal, Quebec, Canada
Local Institution - 2607
Montreal, Quebec, Canada
Local Institution - 4252
Hradec Králové, , Czechia
Local Institution - 4250
Prague, , Czechia
Local Institution - 4251
Prague, , Czechia
Local Institution - 4565
Aschaffenburg, , Germany
Local Institution - 4550
Berlin, , Germany
Local Institution - 4555
Chemnitz, , Germany
Local Institution - 4563
Cologne, , Germany
Local Institution - 4562
Dresden, , Germany
Local Institution - 4552
Hamm, , Germany
Local Institution - 4553
Heidelberg, , Germany
Local Institution - 4560
Jena, , Germany
Local Institution - 4554
Mainz, , Germany
Local Institution - 4561
München, , Germany
Local Institution - 4558
Münster, , Germany
Local Institution - 4551
Offenbach, , Germany
Local Institution - 4556
Stuttgart, , Germany
Local Institution - 4564
Tübingen, , Germany
Local Institution - 4559
Ulm, , Germany
Local Institution - 4653
Athens, , Greece
Local Institution - 4651
Athens, , Greece
Local Institution - 4650
Ioannina, , Greece
Local Institution - 4652
Larissa, , Greece
Local Institution - 4654
Pátrai, , Greece
Local Institution - 4751
Budapest, , Hungary
Local Institution - 4754
Budapest, , Hungary
Local Institution - 4750
Debrecen, , Hungary
Local Institution - 4753
Győr, , Hungary
Local Institution - 4752
Szeged, , Hungary
Local Institution - 4852
Dublin, , Ireland
Local Institution - 4850
Dublin, , Ireland
Local Institution - 4851
Galway, , Ireland
Local Institution - 4950
Afula, , Israel
Local Institution - 4956
Ashkelon, , Israel
Local Institution - 4960
Haifa, , Israel
Local Institution - 4958
Jerusalem, , Israel
Local Institution - 4951
Jerusalem, , Israel
Local Institution - 4959
Kfar Saba, , Israel
Local Institution - 4954
Nahariya, , Israel
Local Institution - 4952
Petah Tikva, , Israel
Local Institution - 4957
Tel Aviv, , Israel
Local Institution - 4955
Ẕerifin, , Israel
Local Institution - 5067
Ancona, , Italy
Local Institution - 5065
Bari, , Italy
Local Institution - 5053
Bergamo, , Italy
Local Institution - 5070
Bologna, , Italy
Local Institution - 5066
Florence, , Italy
Local Institution - 5050
Genova, , Italy
Local Institution - 5057
Meldola, , Italy
Local Institution - 5069
Milan, , Italy
Local Institution - 5075
Milan, , Italy
Local Institution - 5052
Monza, , Italy
Local Institution - 5062
Napoli, , Italy
Local Institution - 5068
Napoli, , Italy
Local Institution - 5055
Palermo, , Italy
Local Institution - 5063
Ravenna, , Italy
Local Institution - 5073
Reggio Nell Emilia (RE), , Italy
Local Institution - 5064
Rimini, , Italy
Local Institution - 5058
Roma, , Italy
Local Institution - 5054
Roma, , Italy
Local Institution - 5056
Rome, , Italy
Local Institution - 5072
Terni, , Italy
Local Institution - 5051
Torino, , Italy
Local Institution - 5250
Bialystok, , Poland
Local Institution - 5252
Chorzów, , Poland
Local Institution - 5254
Gdansk, , Poland
Local Institution - 7626
Krakow, , Poland
Local Institution - 5258
Lodz, , Poland
Local Institution - 5257
Lublin, , Poland
Local Institution - 5259
Poznan, , Poland
Local Institution - 5255
Szczecin, , Poland
Local Institution - 5256
Warsaw, , Poland
Local Institution - 5253
Warsaw, , Poland
Local Institution - 5260
Warsaw, , Poland
Local Institution - 5251
Wroclaw, , Poland
Local Institution - 7600
Ponce, , Puerto Rico
Local Institution - 7602
San Juan, , Puerto Rico
Local Institution - 5356
Brasov, , Romania
Local Institution - 5350
Bucaresti, , Romania
Local Institution - 5355
Bucharest, , Romania
Local Institution - 5353
Bucharest, , Romania
Local Institution - 5352
Bucharest, , Romania
Local Institution - 5351
Lasi, , Romania
Local Institution - 5450
Saint Petersburg, , Russia
Local Institution - 5452
Saint Petersburg, , Russia
Local Institution - 5453
Samara, , Russia
Local Institution - 5552
Badalona-barcelona, , Spain
Local Institution - 5559
Barcelona, , Spain
Local Institution - 5555
Barcelona, , Spain
Local Institution - 5557
Donostia / San Sebastian, , Spain
Local Institution - 5561
La Laguna- Tenerife, , Spain
Local Institution - 5553
Madrid, , Spain
Local Institution - 5551
Madrid, , Spain
Local Institution - 5560
Madrid, , Spain
Local Institution - 5554
Madrid, , Spain
Local Institution - 5558
Pamplona, , Spain
Local Institution - 5550
Salamanca, , Spain
Local Institution - 5556
Toledo, , Spain
Local Institution - 5751
Bern, , Switzerland
Local Institution - 5750
Sankt Gallen, , Switzerland
Local Institution - 5753
Zurich, , Switzerland
Local Institution - 5752
Zurich, , Switzerland
Local Institution - 5853
Izmir, Bornova, Turkey (Türkiye)
Local Institution - 5851
Ankara, Dikimevi, Turkey (Türkiye)
Local Institution - 5854
Izmir, Inciralti, Turkey (Türkiye)
Local Institution - 5856
Gaziantep, , Turkey (Türkiye)
Local Institution - 5951
Belfast, Antrim, United Kingdom
Local Institution - 5953
London, Greater London, United Kingdom
Local Institution - 5950
London, , United Kingdom
Local Institution - 5954
London, , United Kingdom
Local Institution - 5952
London, , United Kingdom
Local Institution - 5955
London, , United Kingdom
Countries
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References
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Dimopoulos MA, Richardson PG, Bahlis NJ, Grosicki S, Cavo M, Beksac M, Legiec W, Liberati AM, Goldschmidt H, Belch A, Magen H, Larocca A, Laubach JP, Petrucci MT, Reece D, White D, Mateos MV, Spicka I, Lazaroiu M, Berdeja J, Kaufman JL, Jou YM, Ganetsky A, Popa McKiver M, Lonial S, Weisel K; ELOQUENT-1 investigators. Addition of elotuzumab to lenalidomide and dexamethasone for patients with newly diagnosed, transplantation ineligible multiple myeloma (ELOQUENT-1): an open-label, multicentre, randomised, phase 3 trial. Lancet Haematol. 2022 Jun;9(6):e403-e414. doi: 10.1016/S2352-3026(22)00103-X. Epub 2022 May 9.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
FDA Safety Alerts and Recalls
Other Identifiers
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2010-022445-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA204-006
Identifier Type: -
Identifier Source: org_study_id
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