Clinical trial NCT02654132: An Investigational Immuno-therapy Trial of Pomalidomide and Low-dose Dexamethasone With or Without Elotuzumab to Treat Refractory and Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)
Official title: An Open Label, Randomized Phase 2 Trial of Pomalidomide/Dexamethasone With or Without Elotuzumab in Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Celgene
name: AbbVie
First posted: 2016-01-13
Enrollment: 117
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 this study is to determine if adding Elotuzumab to Pomalidomide and low-dose dexamethasone is a more effective treatment of relapsed and refractory multiple myeloma compared to pomalidomide and low-dose dexamethasone by itself.


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* ≥ 2 prior lines of therapy which must have included at least 2 consecutive cycles of lenalidomide and a proteosome inhibitor alone or in combination
* Documented refractory or relapsed and refractory multiple myeloma
* Refractory to proteosome inhibitor and lenalidomide, and to last treatment
* Relapsed and refractory patients must have achieved at least a partial response to previous treatment with proteosome inhibitor or lenalidomide, or both, but progressed within 6 months, and were refractory to their last treatment
* Measurable disease at screening
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

* Active plasma cell leukemia
* Prior treatment with pomalidomide
* Unable to tolerate thromboembolic prophylaxis while on the study
* Prior autologous stem cell transplant within 12 weeks
* 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 progression or death (up to approximately 21 months)
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From first dose to disease progression (up to approximately 21 months)
measure: Overall Survival (OS)
timeFrame: From randomization to death (up to approximately 52 months)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Winship Cancer Institute
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Investigative Clinical Research Of Indiana, Llc
state: Indiana
city: Boston
country: United States
facility: Beth Israel Comprehensive Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute.
state: Massachusetts
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Charlotte
country: United States
facility: Carolinas Healthcare System
state: North Carolina
city: Pittsburgh
country: United States
facility: Va Pittsburgh Healthcare System
state: Pennsylvania
city: Greenville
country: United States
facility: St Francis Hospital
state: South Carolina
city: Knoxville
country: United States
facility: Tennessee Cancer Specialists
state: Tennessee
city: Ogden
country: United States
facility: Northern Utah Associates
state: Utah
city: Seattle
country: United States
facility: University Of Washington
state: Washington
city: South Brisbane
country: Australia
facility: Local Institution
state: Queensland
city: London
country: Canada
facility: Local Institution
state: Ontario
city: Gatineau
country: Canada
facility: CISSS de l'Outaouais
state: Quebec
city: Montreal
country: Canada
facility: Local Institution - 0048
state: Quebec
city: Nantes Cedex 1
country: France
facility: Local Institution - 0022
city: Paris Cedex 12
country: France
facility: Local Institution - 0021
city: Pessac
country: France
facility: Local Institution - 0020
city: Poitiers Cedex
country: France
facility: Local Institution - 0019
city: Saint Pierre Cedex
country: France
facility: Local Institution
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg
city: Hamm
country: Germany
facility: St. Barbara-Klinik
city: Heidelberg
country: Germany
facility: Local Institution - 0041
city: Kiel
country: Germany
facility: Local Institution - 0056
city: Mainz
country: Germany
facility: Klinikum Der Johannes Gutenberg Universitaet Mainz
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Athens
country: Greece
facility: Laiko University Hospital
city: Athens
country: Greece
facility: Alexandra General Hospital Of Athens
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Di Ancona
city: Bologna
country: Italy
facility: A. O. U. Di Bologna, Policlinico S. Orsola Malpighi
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Roma
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Universita' La Sapienza
city: Torino
country: Italy
facility: Azienda Ospedaliera Citta' Della Salute E Della Scienza Di Torino
city: Nagoya-shi
country: Japan
facility: Local Institution - 0030
state: Aichi
city: Morioka-shi
country: Japan
facility: Local Institution - 0069
state: Iwate
city: Kyoto-shi
country: Japan
facility: Local Institution - 0031
state: Kyoto
city: Niigata-shi
country: Japan
facility: Local Institution - 0029
state: Niigata
city: Shibuya-ku
country: Japan
facility: Local Institution - 0027
state: Tokyo
city: Tachikawa-shi
country: Japan
facility: Local Institution - 0028
state: Tokyo
city: Kasama-shi
country: Japan
facility: Local Institution - 0067
city: Okayama
country: Japan
facility: Local Institution - 0032
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Groningen
country: Netherlands
facility: Local Institution
city: Maastrict
country: Netherlands
facility: Local Institution
city: Utrecht
country: Netherlands
facility: Local Institution
city: Chorzow
country: Poland
facility: Oddzial Kliniczny Hematologii i Profilaktyki Chorob Nowotworowych
city: Lublin
country: Poland
facility: Local Institution
city: Poznan
country: Poland
facility: Oddzial Hematologii i Transplantacji Szpiku
city: Pamplona
country: Spain
facility: Local Institution
state: Navarra
city: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution - 0024
city: Valencia
country: Spain
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Dimopoulos MA, Dytfeld D, Grosicki S, Moreau P, Takezako N, Hori M, Leleu X, LeBlanc R, Suzuki K, Raab MS, Richardson PG, Popa McKiver M, Jou YM, Yao D, Das P, San-Miguel J. Elotuzumab Plus Pomalidomide and Dexamethasone for Relapsed/Refractory Multiple Myeloma: Final Overall Survival Analysis From the Randomized Phase II ELOQUENT-3 Trial. J Clin Oncol. 2023 Jan 20;41(3):568-578. doi: 10.1200/JCO.21.02815. Epub 2022 Aug 12.
citation: Dimopoulos MA, Dytfeld D, Grosicki S, Moreau P, Takezako N, Hori M, Leleu X, LeBlanc R, Suzuki K, Raab MS, Richardson PG, Popa McKiver M, Jou YM, Shelat SG, Robbins M, Rafferty B, San-Miguel J. Elotuzumab plus Pomalidomide and Dexamethasone for Multiple Myeloma. N Engl J Med. 2018 Nov 8;379(19):1811-1822. doi: 10.1056/NEJMoa1805762.