Clinical trial NCT01335399: Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma
Official title: A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: Newly Diagnosed
Previously Untreated
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2011-04-14
Enrollment: 748
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)


Eligibility 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

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: From randomization to date of first documented tumor progression or death due to any cause (up to 8 years)
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From randomization to primary completion date (approximately 8 years)
measure: Overall Survival (OS)
timeFrame: From randomization to the date of death (up to 8 years)
measure: Mean Change From Baseline of Pain Severity Score and Pain Interference Score
timeFrame: From Baseline to End of Treatment (approximately 8 years)
measure: Progression Free Survival (PFS) Rate at Specific Time-points
timeFrame: From randomization to the specified time-point (up to 5 years)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 1628
state: Alabama
city: Mobile
country: United States
facility: Local Institution - 7619
state: Alabama
city: Mobile
country: United States
facility: Local Institution - 7618
state: Alabama
city: Chandler
country: United States
facility: Local Institution - 7617
state: Arizona
city: Tucson
country: United States
facility: Local Institution - 1644
state: Arizona
city: Bakersfield
country: United States
facility: Local Institution - 1618
state: California
city: Berkeley
country: United States
facility: Local Institution - 1602
state: California
city: Corona
country: United States
facility: Local Institution - 1636
state: California
city: Corona
country: United States
facility: Local Institution - 1668
state: California
city: Greenbrae
country: United States
facility: Local Institution - 1616
state: California
city: Long Beach
country: United States
facility: Local Institution - 7609
state: California
city: Los Angeles
country: United States
facility: Local Institution - 1660
state: California
city: Orange
country: United States
facility: Local Institution - 1673
state: California
city: San Diego
country: United States
facility: Local Institution - 1613
state: California
city: New Haven
country: United States
facility: Local Institution - 1621
state: Connecticut
city: Washington
country: United States
facility: Local Institution - 1612
state: District of Columbia
city: Boca Raton
country: United States
facility: Local Institution - 1682
state: Florida
city: Brooksville
country: United States
facility: Local Institution - 1617
state: Florida
city: Fort Myers
country: United States
facility: Local Institution - 1648
state: Florida
city: Hollywood
country: United States
facility: Local Institution - 7613
state: Florida
city: Jacksonville
country: United States
facility: Local Institution - 1623
state: Florida
city: New Port Richey
country: United States
facility: Local Institution - 1625
state: Florida
city: Saint Petersburg
country: United States
facility: Local Institution - 1649
state: Florida
city: West Palm Beach
country: United States
facility: Local Institution - 1611
state: Florida
city: Atlanta
country: United States
facility: Local Institution - 1630
state: Georgia
city: Honolulu
country: United States
facility: Local Institution - 1684
state: Hawaii
city: Chicago
country: United States
facility: Local Institution - 1607
state: Illinois
city: Chicago
country: United States
facility: Local Institution - 1635
state: Illinois
city: Maywood
country: United States
facility: Local Institution - 1632
state: Illinois
city: Peoria
country: United States
facility: Local Institution - 7606
state: Illinois
city: Skokie
country: United States
facility: Local Institution - 7610
state: Illinois
city: Urbana
country: United States
facility: Local Institution - 1603
state: Illinois
city: Bloomington
country: United States
facility: Local Institution - 7616
state: Indiana
city: Indianapolis
country: United States
facility: Local Institution - 7620
state: Indiana
city: Indianapolis
country: United States
facility: Local Institution - 1669
state: Indiana
city: Mishawaka
country: United States
facility: Local Institution - 1656
state: Indiana
city: Iowa City
country: United States
facility: Local Institution - 1633
state: Iowa
city: Lexington
country: United States
facility: Local Institution - 1674
state: Kentucky
city: Louisville
country: United States
facility: Local Institution - 1683
state: Kentucky
city: Lafayette
country: United States
facility: Local Institution - 1646
state: Louisiana
city: Marrero
country: United States
facility: Local Institution - 7614
state: Louisiana
city: New Orleans
country: United States
facility: Local Institution - 1626
state: Louisiana
city: Shreveport
country: United States
facility: Local Institution - 1652
state: Louisiana
city: Baltimore
country: United States
facility: Local Institution - 1676
state: Maryland
city: Baltimore
country: United States
facility: Local Institution - 1650
state: Maryland
city: Boston
country: United States
facility: Local Institution - 1619
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 1699
state: Massachusetts
city: Detroit
country: United States
facility: Local Institution - 1604
state: Michigan
city: Jefferson City
country: United States
facility: Local Institution - 1667
state: Missouri
city: Saint Louis
country: United States
facility: Local Institution - 1645
state: Missouri
city: Springfield
country: United States
facility: Local Institution - 1651
state: Missouri
city: Omaha
country: United States
facility: Local Institution - 1637
state: Nebraska
city: Mineola
country: United States
facility: Local Institution - 7621
state: New York
city: New York
country: United States
facility: Local Institution - 1615
state: New York
city: Stony Brook
country: United States
facility: Local Institution - 1671
state: New York
city: Goldsboro
country: United States
facility: Local Institution - 7604
state: North Carolina
city: Winston-Salem
country: United States
facility: Local Institution - 1610
state: North Carolina
city: Cleveland
country: United States
facility: Local Institution - 1608
state: Ohio
city: Cleveland
country: United States
facility: Local Institution - 1693
state: Ohio
city: Columbus
country: United States
facility: Local Institution - 1638
state: Ohio
city: Columbus
country: United States
facility: Local Institution - 1664
state: Ohio
city: Middletown
country: United States
facility: Local Institution - 1690
state: Ohio
city: Tulsa
country: United States
facility: Local Institution - 1655
state: Oklahoma
city: Langhorne
country: United States
facility: Local Institution - 7611
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution - 1647
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution - 1679
state: Pennsylvania
city: Sayre
country: United States
facility: Local Institution - 1677
state: Pennsylvania
city: Charleston
country: United States
facility: Local Institution - 1629
state: South Carolina
city: Charleston
country: United States
facility: Local Institution - 7615
state: South Carolina
city: Greenville
country: United States
facility: Local Institution - 1624
state: South Carolina
city: Sioux Falls
country: United States
facility: Local Institution - 7607
state: South Dakota
city: Knoxville
country: United States
facility: Local Institution - 1600
state: Tennessee
city: Memphis
country: United States
facility: Local Institution - 7628
state: Tennessee
city: Nashville
country: United States
facility: Local Institution - 1627
state: Tennessee
city: Nashville
country: United States
facility: Local Institution - 1670
state: Tennessee
city: Corpus Christi
country: United States
facility: Local Institution - 1634
state: Texas
city: Dallas
country: United States
facility: Local Institution - 7612
state: Texas
city: Houston
country: United States
facility: Local Institution - 1643
state: Texas
city: Houston
country: United States
facility: Local Institution - 1686
state: Texas
city: Houston
country: United States
facility: Local Institution - 1642
state: Texas
city: Ogden
country: United States
facility: Local Institution - 7623
state: Utah
city: Fredericksburg
country: United States
facility: Local Institution - 1657
state: Virginia
city: Seattle
country: United States
facility: Local Institution - 1640
state: Washington
city: Seattle
country: United States
facility: Local Institution - 1631
state: Washington
city: Huntington
country: United States
facility: Local Institution - 1601
state: West Virginia
city: La Crosse
country: United States
facility: Gundersen Clinic, Ltd
state: Wisconsin
city: Madison
country: United States
facility: Local Institution - 1663
state: Wisconsin
city: Madison
country: United States
facility: Local Institution - 1609
state: Wisconsin
city: Garran
country: Australia
facility: Local Institution - 3600
state: Australian Capital Territory
city: Waratah
country: Australia
facility: Local Institution - 3607
state: New South Wales
city: Westmead
country: Australia
facility: Local Institution - 3610
state: New South Wales
city: Herston
country: Australia
facility: Local Institution - 3609
state: Queensland
city: Milton
country: Australia
facility: Local Institution - 3608
state: Queensland
city: Adelaide
country: Australia
facility: Local Institution - 3612
state: South Australia
city: Woodville South
country: Australia
facility: Local Institution - 3606
state: South Australia
city: Fitzroy
country: Australia
facility: Local Institution - 3601
state: Victoria
city: Frankston
country: Australia
facility: Local Institution - 3602
state: Victoria
city: Heidelberg Melbourne
country: Australia
facility: Local Institution - 3603
state: Victoria
city: Wodonga
country: Australia
facility: Local Institution - 3604
state: Victoria
city: Murdoch
country: Australia
facility: Local Institution - 3605
city: Nedlands
country: Australia
facility: Local Institution - 3611
city: Fadingerstraße 1
country: Austria
facility: Local Institution - 4052
city: Innsbruck
country: Austria
facility: Local Institution - 4051
city: Rankweil
country: Austria
facility: Local Institution - 4054
city: Wels
country: Austria
facility: Local Institution - 4053
city: Brussels
country: Belgium
facility: Local Institution - 4160
city: Brussels
country: Belgium
facility: Local Institution - 4156
city: Brussles
country: Belgium
facility: Local Institution - 4157
city: Charleroi
country: Belgium
facility: Local Institution - 4154
city: Haine St Paul
country: Belgium
facility: Local Institution - 4159
city: Leuven
country: Belgium
facility: Local Institution - 4158
city: Liege
country: Belgium
facility: Local Institution - 4150
city: Roeselare
country: Belgium
facility: Local Institution - 4153
city: Yvoir
country: Belgium
facility: Local Institution - 4151
city: Calgary
country: Canada
facility: Local Institution - 2601
state: Alberta
city: Edmonton
country: Canada
facility: Local Institution - 2600
state: Alberta
city: Winnipeg
country: Canada
facility: Local Institution - 2602
state: Manitoba
city: Saint John
country: Canada
facility: Local Institution - 2611
state: New Brunswick
city: Halifax
country: Canada
facility: Local Institution - 2610
state: Nova Scotia
city: London
country: Canada
facility: Local Institution - 2606
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 2612
state: Ontario
city: Greenfield Park
country: Canada
facility: Local Institution - 2603
state: Quebec
city: Montreal
country: Canada
facility: Local Institution - 2605
state: Quebec
city: Montreal
country: Canada
facility: Local Institution - 2607
state: Quebec
city: Hradec Kralove
country: Czechia
facility: Local Institution - 4252
city: Praha 10
country: Czechia
facility: Local Institution - 4250
city: Praha 2
country: Czechia
facility: Local Institution - 4251
city: Aschaffenburg
country: Germany
facility: Local Institution - 4565
city: Berlin
country: Germany
facility: Local Institution - 4550
city: Chemnitz
country: Germany
facility: Local Institution - 4555
city: Dresden
country: Germany
facility: Local Institution - 4562
city: Hamm
country: Germany
facility: Local Institution - 4552
city: Heidelberg
country: Germany
facility: Local Institution - 4553
city: Jena
country: Germany
facility: Local Institution - 4560
city: Koln
country: Germany
facility: Local Institution - 4563
city: Mainz
country: Germany
facility: Local Institution - 4554
city: Munchen
country: Germany
facility: Local Institution - 4561
city: Munster
country: Germany
facility: Local Institution - 4558
city: Offenbach
country: Germany
facility: Local Institution - 4551
city: Stuttgart
country: Germany
facility: Local Institution - 4556
city: Tuebingen
country: Germany
facility: Local Institution - 4564
city: Ulm
country: Germany
facility: Local Institution - 4559
city: Athens
country: Greece
facility: Local Institution - 4653
city: Athens
country: Greece
facility: Local Institution - 4651
city: Ioannina
country: Greece
facility: Local Institution - 4650
city: Larissa
country: Greece
facility: Local Institution - 4652
city: Patras
country: Greece
facility: Local Institution - 4654
city: Budapest
country: Hungary
facility: Local Institution - 4751
city: Budapest
country: Hungary
facility: Local Institution - 4754
city: Debrecen
country: Hungary
facility: Local Institution - 4750
city: Gyor
country: Hungary
facility: Local Institution - 4753
city: Szeged
country: Hungary
facility: Local Institution - 4752
city: Dublin
country: Ireland
facility: Local Institution - 4852
city: Dublin
country: Ireland
facility: Local Institution - 4850
city: Galway
country: Ireland
facility: Local Institution - 4851
city: Afula
country: Israel
facility: Local Institution - 4950
city: Ashkelon
country: Israel
facility: Local Institution - 4956
city: Haifa
country: Israel
facility: Local Institution - 4960
city: Jerusalem
country: Israel
facility: Local Institution - 4958
city: Jerusalem
country: Israel
facility: Local Institution - 4951
city: Kfar Saba
country: Israel
facility: Local Institution - 4959
city: Nahariya
country: Israel
facility: Local Institution - 4954
city: Petah Tikva
country: Israel
facility: Local Institution - 4952
city: Tel Aviv
country: Israel
facility: Local Institution - 4957
city: Zerifin
country: Israel
facility: Local Institution - 4955
city: Ancona
country: Italy
facility: Local Institution - 5067
city: Bari
country: Italy
facility: Local Institution - 5065
city: Bergamo
country: Italy
facility: Local Institution - 5053
city: Bologna
country: Italy
facility: Local Institution - 5070
city: Firenze
country: Italy
facility: Local Institution - 5066
city: Genova
country: Italy
facility: Local Institution - 5050
city: Meldola
country: Italy
facility: Local Institution - 5057
city: Milano
country: Italy
facility: Local Institution - 5075
city: Milan
country: Italy
facility: Local Institution - 5069
city: Monza
country: Italy
facility: Local Institution - 5052
city: Napoli
country: Italy
facility: Local Institution - 5062
city: Napoli
country: Italy
facility: Local Institution - 5068
city: Palermo
country: Italy
facility: Local Institution - 5055
city: Ravenna
country: Italy
facility: Local Institution - 5063
city: Reggio Nell Emilia (RE)
country: Italy
facility: Local Institution - 5073
city: Rimini
country: Italy
facility: Local Institution - 5064
city: Roma
country: Italy
facility: Local Institution - 5058
city: Roma
country: Italy
facility: Local Institution - 5054
city: Rome
country: Italy
facility: Local Institution - 5056
city: Terni
country: Italy
facility: Local Institution - 5072
city: Torino
country: Italy
facility: Local Institution - 5051
city: Bialystok
country: Poland
facility: Local Institution - 5250
city: Chorzow
country: Poland
facility: Local Institution - 5252
city: Gdansk
country: Poland
facility: Local Institution - 5254
city: Krakow
country: Poland
facility: Local Institution - 7626
city: Lodz
country: Poland
facility: Local Institution - 5258
city: Lublin
country: Poland
facility: Local Institution - 5257
city: Poznan
country: Poland
facility: Local Institution - 5259
city: Szczecin
country: Poland
facility: Local Institution - 5255
city: Warszawa
country: Poland
facility: Local Institution - 5256
city: Warszawa
country: Poland
facility: Local Institution - 5253
city: Warszawa
country: Poland
facility: Local Institution - 5260
city: Wroclaw
country: Poland
facility: Local Institution - 5251
city: Ponce
country: Puerto Rico
facility: Local Institution - 7600
city: San Juan
country: Puerto Rico
facility: Local Institution - 7602
city: Brasov
country: Romania
facility: Local Institution - 5356
city: Bucaresti
country: Romania
facility: Local Institution - 5350
city: Bucuresti
country: Romania
facility: Local Institution - 5355
city: Bucuresti
country: Romania
facility: Local Institution - 5353
city: Bucuresti
country: Romania
facility: Local Institution - 5352
city: Lasi
country: Romania
facility: Local Institution - 5351
city: Samara
country: Russian Federation
facility: Local Institution - 5453
city: St. Petersburg
country: Russian Federation
facility: Local Institution - 5450
city: St. Petersburg
country: Russian Federation
facility: Local Institution - 5452
city: Badalona-barcelona
country: Spain
facility: Local Institution - 5552
city: Barcelona
country: Spain
facility: Local Institution - 5559
city: Barcelona
country: Spain
facility: Local Institution - 5555
city: La Laguna- Tenerife
country: Spain
facility: Local Institution - 5561
city: Madrid
country: Spain
facility: Local Institution - 5553
city: Madrid
country: Spain
facility: Local Institution - 5551
city: Madrid
country: Spain
facility: Local Institution - 5560
city: Madrid
country: Spain
facility: Local Institution - 5554
city: Pamplona
country: Spain
facility: Local Institution - 5558
city: Salamanca
country: Spain
facility: Local Institution - 5550
city: San Sebastian
country: Spain
facility: Local Institution - 5557
city: Toledo
country: Spain
facility: Local Institution - 5556
city: Bern
country: Switzerland
facility: Local Institution - 5751
city: St Gallen
country: Switzerland
facility: Local Institution - 5750
city: Zurich
country: Switzerland
facility: Local Institution - 5753
city: Zurich
country: Switzerland
facility: Local Institution - 5752
city: Izmir
country: Turkey
facility: Local Institution - 5853
state: Bornova
city: Ankara
country: Turkey
facility: Local Institution - 5851
state: Dikimevi
city: Izmir
country: Turkey
facility: Local Institution - 5854
state: Inciralti
city: Gaziantep
country: Turkey
facility: Local Institution - 5856
city: Belfast
country: United Kingdom
facility: Local Institution - 5951
state: Antrim
city: London
country: United Kingdom
facility: Local Institution - 5953
state: Greater London
city: London
country: United Kingdom
facility: Local Institution - 5950
city: London
country: United Kingdom
facility: Local Institution - 5954
city: London
country: United Kingdom
facility: Local Institution - 5952
city: London
country: United Kingdom
facility: Local Institution - 5955
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.