Clinical trial NCT01239797: Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma
Official title: Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma (MM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lymphoma
Multiple Myeloma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2010-11-11
Enrollment: 646
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:

* 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

Primary outcomes:
measure: Median Progression Free Survival (PFS)
timeFrame: From randomization up to 326 events (up to approximately 38 months)
measure: Objective Response Rate (ORR)
timeFrame: From randomization up to approximately 38 months
Secondary outcomes:
measure: Median Overall Survival (OS)
timeFrame: Randomization to the date of death from any cause (up to approximately 9 years)
measure: Change From Baseline of Mean Score Pain Severity (BPI-SF)
timeFrame: From baseline up to approximately 38 months
measure: Change From Baseline of Mean Score Pain Interference (BPI-SF)
timeFrame: From baseline up to approximately 38 months
Other outcomes:
Locations:
city: Muscle Shoals
country: United States
facility: Northwest Alabama Cancer Center, Pc
state: Alabama
city: Tucson
country: United States
facility: Acrc/Arizona Clinical Research Center, Inc.
state: Arizona
city: Berkeley
country: United States
facility: Local Institution
state: California
city: Burbank
country: United States
facility: Local Institution
state: California
city: Corona
country: United States
facility: Compassionate Cancer Res Grp
state: California
city: Corona
country: United States
facility: Local Institution
state: California
city: Encinitas
country: United States
facility: San Diego Pacific Oncology& Hematology Associates, Inc
state: California
city: Greenbrae
country: United States
facility: Local Institution
state: California
city: Los Angeles
country: United States
facility: Ucla-Division Of Hematology/Oncology
state: California
city: Orange
country: United States
facility: Medical Oncology Care Associates
state: California
city: San Diego
country: United States
facility: Sharp Clinical Oncology Research
state: California
city: Vallejo
country: United States
facility: Local Institution
state: California
city: Boca Raton
country: United States
facility: Local Institution
state: Florida
city: Brooksville
country: United States
facility: Cancer Care Centers Of Florida
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: New Port Richey
country: United States
facility: Local Institution
state: Florida
city: Orlando
country: United States
facility: Cancer Institute Of Florida
state: Florida
city: Titusville
country: United States
facility: Local Institution
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute.
state: Georgia
city: Augusta
country: United States
facility: Georgia Health Science University
state: Georgia
city: Skokie
country: United States
facility: Orchard Healthcare Research Inc.
state: Illinois
city: Indianapolis
country: United States
facility: Local Institution
state: Indiana
city: Mishawaka
country: United States
facility: Local Institution
state: Indiana
city: Iowa City
country: United States
facility: Local Institution
state: Iowa
city: Lexington
country: United States
facility: Local Institution
state: Kentucky
city: Louisville
country: United States
facility: Local Institution
state: Kentucky
city: Pikeville
country: United States
facility: Pikeville Medical Center
state: Kentucky
city: Lafayette
country: United States
facility: Cancer Center Of Acadiana At Lafayette General
state: Louisiana
city: Shreveport
country: United States
facility: Local Institution
state: Louisiana
city: Shreveport
country: United States
facility: Local Institution
state: Louisiana
city: Shreveport
country: United States
facility: Willis Knighton Cancer Center
state: Louisiana
city: Boston
country: United States
facility: Dana Farber Cancer Inst
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Jefferson City
country: United States
facility: Capitol Comprehensive Cancer Care Center
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School Of Medicine
state: Missouri
city: Springfield
country: United States
facility: Local Institution
state: Missouri
city: Las Vegas
country: United States
facility: Local Institution
state: Nevada
city: New York
country: United States
facility: NYU Clinical Cancer Center
state: New York
city: New York
country: United States
facility: Local Institution
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Stony Brook
country: United States
facility: Local Institution
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Gastonia
country: United States
facility: Gaston Hematology & Oncology
state: North Carolina
city: Bismarck
country: United States
facility: Local Institution
state: North Dakota
city: Oklahoma City
country: United States
facility: University Of Oklahoma Health Sciences Center
state: Oklahoma
city: Tulsa
country: United States
facility: Local Institution
state: Oklahoma
city: Bethlehem
country: United States
facility: Local Institution
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Western Pennsylvania Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Local Institution
state: South Carolina
city: Greenville
country: United States
facility: Local Institution
state: South Carolina
city: Knoxville
country: United States
facility: Local Institution
state: Tennessee
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Corpus Christi
country: United States
facility: Cancer Specialists Of South Texas, Pa
state: Texas
city: Dallas
country: United States
facility: Ut Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: University Of Texas Md Anderson Cancer Ctr
state: Texas
city: Houston
country: United States
facility: Northwest Cancer Center
state: Texas
city: Fredericksburg
country: United States
facility: Hematology-Oncology Associates Of Fredricksburg, Inc
state: Virginia
city: Seattle
country: United States
facility: Va Puget Sound Health Care System
state: Washington
city: La Crosse
country: United States
facility: Gundersen Clinic, Ltd
state: Wisconsin
city: Madison
country: United States
facility: University Of Wisconsin Hospital And Clinics
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Albury
country: Australia
facility: Local Institution
state: New South Wales
city: Canberra
country: Australia
facility: Local Institution
state: New South Wales
city: South Brisbane
country: Australia
facility: Local Institution
state: Queensland
city: Adelaide
country: Australia
facility: Local Institution
state: South Australia
city: Malvern
country: Australia
facility: Local Institution
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution
state: Victoria
city: Nedlands
country: Australia
facility: Local Institution
state: Western Australia
city: Murdoch
country: Australia
facility: Local Institution
city: Rankweil
country: Austria
facility: Local Institution
city: Steyr
country: Austria
facility: Local Institution
city: Wels
country: Austria
facility: Local Institution
city: Wien
country: Austria
facility: Local Institution
city: Antwerpen
country: Belgium
facility: Local Institution
city: Brussels
country: Belgium
facility: Local Institution
city: Brussels
country: Belgium
facility: Local Institution
city: Brussels
country: Belgium
facility: Local Institution
city: Brussles
country: Belgium
facility: Local Institution
city: Edegem-antwerp
country: Belgium
facility: Local Institution
city: Liege
country: Belgium
facility: Local Institution
city: Yvoir
country: Belgium
facility: Local Institution
city: Calgary
country: Canada
facility: Local Institution
state: Alberta
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Halifax
country: Canada
facility: Local Institution
state: Nova Scotia
city: London
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Saskatoon
country: Canada
facility: Local Institution
state: Saskatchewan
city: Barrie
country: Canada
facility: Local Institution
city: Montreal
country: Canada
facility: Local Institution
city: Brno
country: Czechia
facility: Local Institution
city: Hradec Kralove
country: Czechia
facility: Local Institution
city: Praha 10
country: Czechia
facility: Local Institution
city: Praha 2
country: Czechia
facility: Local Institution
city: Copenhagen
country: Denmark
facility: Local Institution
city: Odense C
country: Denmark
facility: Local Institution
city: Vejle
country: Denmark
facility: Local Institution
city: Blois
country: France
facility: Local Institution
city: Bordeaux
country: France
facility: Local Institution
city: Caen
country: France
facility: Local Institution
city: Clamart Cedex
country: France
facility: Local Institution
city: La Roche Sur Yon
country: France
facility: Local Institution
city: La Tronche
country: France
facility: Local Institution
city: Lille
country: France
facility: Local Institution
city: Limoges
country: France
facility: Local Institution
city: Nantes
country: France
facility: Local Institution
city: Paris 12
country: France
facility: Local Institution
city: Pierre Benita
country: France
facility: Local Institution
city: Toulouse
country: France
facility: Local Institution
city: Tours Cedex
country: France
facility: Local Institution
city: Vandoeuvre
country: France
facility: Local Institution
city: Aschaffenburg
country: Germany
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Chemnitz
country: Germany
facility: Local Institution
city: Dresden
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Hamm
country: Germany
facility: Local Institution
city: Heidelberg
country: Germany
facility: Local Institution
city: Jena
country: Germany
facility: Local Institution
city: Kiel
country: Germany
facility: Local Institution
city: Koln
country: Germany
facility: Local Institution
city: Marburg
country: Germany
facility: Local Institution
city: Munchen
country: Germany
facility: Local Institution
city: Munchen
country: Germany
facility: Local Institution
city: Munster
country: Germany
facility: Local Institution
city: Ravensburg
country: Germany
facility: Local Institution
city: Tuebingen
country: Germany
facility: Local Institution
city: Ulm
country: Germany
facility: Local Institution
city: Wurzburg
country: Germany
facility: Local Institution
city: Athens
country: Greece
facility: Local Institution
city: Ioannina
country: Greece
facility: Local Institution
city: Larissa
country: Greece
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Debrecen
country: Hungary
facility: Local Institution
city: Gyor
country: Hungary
facility: Local Institution
city: Szeged
country: Hungary
facility: Local Institution
city: Dublin
country: Ireland
facility: Local Institution
city: Tullamore
country: Ireland
facility: Local Institution
city: Afula
country: Israel
facility: Local Institution
city: Jerusalem
country: Israel
facility: Local Institution
city: Petah Tikva
country: Israel
facility: Local Institution
city: Rehovot
country: Israel
facility: Local Institution
city: Zerifin
country: Israel
facility: Local Institution
city: Ancona
country: Italy
facility: Local Institution
city: Bergamo
country: Italy
facility: Local Institution
city: Bologna
country: Italy
facility: Local Institution
city: Firenze
country: Italy
facility: Local Institution
city: Genova
country: Italy
facility: Local Institution
city: Meldola
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Palermo
country: Italy
facility: Local Institution
city: Ravenna
country: Italy
facility: Local Institution
city: Rimini
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Torino
country: Italy
facility: Local Institution
city: Nagoya-shi
country: Japan
facility: Local Institution
state: Aichi
city: Nagoya-shi
country: Japan
facility: Local Institution
state: Aichi
city: Maebashi-shi
country: Japan
facility: Local Institution
state: Gunma
city: Shibukawa-shi
country: Japan
facility: Local Institution
state: Gunma
city: Sapporo-city
country: Japan
facility: Local Institution
state: Hokkaido
city: Sendai-shi
country: Japan
facility: Local Institution
state: Miyagi
city: Osaka-shi
country: Japan
facility: Local Institution
state: Osaka
city: Bunkyo-Ku
country: Japan
facility: Local Institution
state: Tokyo
city: Koto-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Shinjuuku-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Kamogawa
country: Japan
facility: Local Institution
state: Toyko
city: Chiba-shi
country: Japan
facility: Local Institution
city: Fukuoka
country: Japan
facility: Local Institution
city: Kyoto
country: Japan
facility: Local Institution
city: Niigata
country: Japan
facility: Local Institution
city: Okayama
country: Japan
facility: Local Institution
city: Toyohashi-shi
country: Japan
facility: Local Institution
city: Bialystok
country: Poland
facility: Local Institution
city: Chorzow
country: Poland
facility: Local Institution
city: Lublin
country: Poland
facility: Local Institution
city: Poznan
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Wroclaw
country: Poland
facility: Local Institution
city: Ponce
country: Puerto Rico
facility: Local Institution
city: San Juan
country: Puerto Rico
facility: Local Institution
city: Brasov
country: Romania
facility: Local Institution
city: Brasov
country: Romania
facility: Local Institution
city: Bucaresti
country: Romania
facility: Local Institution
city: Bucuresti
country: Romania
facility: Local Institution
city: Badalona-Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Murcia
country: Spain
facility: Local Institution
city: Salamanca
country: Spain
facility: Local Institution
city: Santiago De Comp-coruna
country: Spain
facility: Local Institution
city: Toledo
country: Spain
facility: Local Institution
city: Bern
country: Switzerland
facility: Local Institution
city: Geneve 14
country: Switzerland
facility: Local Institution
city: Izmir
country: Turkey
facility: Local Institution
state: Bornova
city: Istanbul
country: Turkey
facility: Local Institution
state: Capa
city: Ankara
country: Turkey
facility: Local Institution
city: Izmir
country: Turkey
facility: Local Institution
city: Leicester
country: United Arab Emirates
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: Manchester
country: United Kingdom
facility: Local Institution
state: Greater Manchester
city: Airdrie
country: United Kingdom
facility: Local Institution
state: Lancashire
city: Edinburgh
country: United Kingdom
facility: Local Institution
state: Midlothian
city: Nottingham
country: United Kingdom
facility: Local Institution
state: Nottinghamshire
city: Sutton
country: United Kingdom
facility: Local Institution
state: Surrey
city: Leeds
country: United Kingdom
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
city: Newcastle Upon Tyne
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.