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)
An Open Label, Randomized Phase 2 Trial of Pomalidomide/Dexamethasone With or Without Elotuzumab in Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)
2 other identifiers
interventional
117
11 countries
55
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 multiple-myeloma
Started Mar 2016
Typical duration for phase_2 multiple-myeloma
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 31, 2015
CompletedFirst Posted
Study publicly available on registry
January 13, 2016
CompletedStudy Start
First participant enrolled
March 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2018
CompletedResults Posted
Study results publicly available
June 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 21, 2021
CompletedNovember 1, 2022
October 1, 2022
1.8 years
December 31, 2015
January 17, 2019
October 5, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
PFS is defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Progressive disease response criteria were defined as an increase of 25% from lowest response value in any one or more of the following: 1\. Serum M-component and/or 2. Urine M-component and/or 3. Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels 4. Bone marrow plasma cell percentage; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder
From randomization to date of progression or death (up to approximately 21 months)
Secondary Outcomes (2)
Objective Response Rate (ORR)
From first dose to disease progression (up to approximately 21 months)
Overall Survival (OS)
From randomization to death (up to approximately 52 months)
Study Arms (2)
Elotuzumab Arm
EXPERIMENTALBiological:Elotuzumab (BMS-901608; HuLuc63) * Solution, Intravenous(IV),10 mg/kg(Cycles 1 and 2 weekly, on Days 1,8,15,22) * Solution, Intravenous(IV),20 mg/kg(Cycle 3 and Beyond: Day 1) Drug: Pomalidomide •Capsules,Oral,4 mg,once daily, on Days 1-21 Other Name: Pomalyst Drug: Dexamethasone * Subjects ≤ 75 years old: •Tablets, Oral,28 mg, once daily on: Days 1,8,15,22(Cycles 1\&2) Day 1(Cycle 3 and Beyond) •Solution, Intravenous(IV), 8 mg, once daily on: Days 1,8,15,22(Cycles 1\&2) Day 1(Cycle 3 and Beyond) •Tablets, Oral,40 mg, once daily on: Days 8,15,22(Cycle 3 and Beyond) * Subjects \> 75 years old: •Tablets, Oral,8 mg, once daily on: Days 1,8,15,22(Cycles 1\&2) Day 1(Cycle 3 and Beyond) •Solution, Intravenous(IV), 8 mg, once daily on: Days 1,8,15,22(Cycles 1\&2) Day 1(Cycle 3 and Beyond) •Tablets, Oral, 20 mg, once daily on: Days 8,15,22(Cycle 3 and Beyond) Other Names: Decadron,Dexamethasone ,Intensol,Dexpak,Taperpak
Control Arm
ACTIVE COMPARATORDrug: Pomalidomide • Capsules, Oral, 4 mg, once daily, on Days 1-21 Other Name: Pomalyst Drug: Dexamethasone Subjects ≤ 75 years old: • Tablets, Oral, 40 mg, weekly on Days 1, 8, 15 and 22 Subjects \> 75 years old: • Tablets, Oral, 20 mg, weekly on Days 1, 8, 15 and 22, Other Names: * Decadron * Dexamethasone Intensol * Dexpak * Taperpak
Interventions
Eligibility Criteria
You may qualify if:
- ≥ 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Celgenecollaborator
- AbbViecollaborator
Study Sites (55)
Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Investigative Clinical Research Of Indiana, Llc
Indianapolis, Indiana, 46260, United States
Beth Israel Comprehensive Cancer Center
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute.
Boston, Massachusetts, 02215, United States
Rochester General Hospital
Rochester, New York, 14621, United States
Carolinas Healthcare System
Charlotte, North Carolina, 28204, United States
Va Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240, United States
St Francis Hospital
Greenville, South Carolina, 29607, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909, United States
Northern Utah Associates
Ogden, Utah, 84403, United States
University Of Washington
Seattle, Washington, 98109, United States
Local Institution
South Brisbane, Queensland, 4101, Australia
Local Institution
London, Ontario, N6A 4G5, Canada
CISSS de l'Outaouais
Gatineau, Quebec, J8P 7H2, Canada
Local Institution - 0048
Montreal, Quebec, H1T 2M4, Canada
Local Institution - 0022
Nantes, 44000, France
Local Institution - 0021
Paris, 75571, France
Local Institution - 0020
Pessac, 33604, France
Local Institution - 0019
Poitiers, 86021, France
Local Institution
Saint-Pierre, 97448, France
Universitaetsklinikum Carl Gustav Carus
Dresden, 01307, Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
St. Barbara-Klinik
Hamm, 59075, Germany
Local Institution - 0041
Heidelberg, 69120, Germany
Local Institution - 0056
Kiel, 24105, Germany
Klinikum Der Johannes Gutenberg Universitaet Mainz
Mainz, 55101, Germany
Universitaetsklinikum Tuebingen
Tübingen, 72076, Germany
Laiko University Hospital
Athens, 11527, Greece
Alexandra General Hospital Of Athens
Athens, 11528, Greece
Azienda Ospedaliero Universitaria Ospedali Riuniti Di Ancona
Ancona, 60126, Italy
A. O. U. Di Bologna, Policlinico S. Orsola Malpighi
Bologna, 40138, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, 50134, Italy
Local Institution
Roma, 00144, Italy
Universita' La Sapienza
Roma, 00161, Italy
Azienda Ospedaliera Citta' Della Salute E Della Scienza Di Torino
Torino, 10126, Italy
Local Institution - 0030
Nagoya, Aichi-ken, 4678602, Japan
Local Institution - 0069
Morioka, Iwate, 0208505, Japan
Local Institution - 0031
Kyoto, Kyoto, 6028566, Japan
Local Institution - 0029
Niigata, Niigata, 951-8566, Japan
Local Institution - 0027
Shibuya-ku, Tokyo, 1508935, Japan
Local Institution - 0028
Tachikawa-shi, Tokyo, 1900014, Japan
Local Institution - 0067
Kasama-shi, 3091793, Japan
Local Institution - 0032
Okayama, 701-1154, Japan
Local Institution
Amsterdam, 1081 HV, Netherlands
Local Institution
Groningen, 9713 GZ, Netherlands
Local Institution
Maastrict, 6229 HX, Netherlands
Local Institution
Utrecht, 3584 CX, Netherlands
Oddzial Kliniczny Hematologii i Profilaktyki Chorob Nowotworowych
Chorzów, 41-500, Poland
Local Institution
Lublin, 20-090, Poland
Oddzial Hematologii i Transplantacji Szpiku
Poznan, 60-569, Poland
Local Institution
Pamplona, Navarre, 31008, Spain
Local Institution
Barcelona, 08025, Spain
Local Institution - 0024
Madrid, 28041, Spain
Local Institution
Valencia, 46017, Spain
Related Publications (2)
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.
PMID: 35960908DERIVEDDimopoulos 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.
PMID: 30403938DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol Myers-Squibb Study Director
- Organization
- Bristol Myers-Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 31, 2015
First Posted
January 13, 2016
Study Start
March 18, 2016
Primary Completion
January 17, 2018
Study Completion
October 21, 2021
Last Updated
November 1, 2022
Results First Posted
June 3, 2019
Record last verified: 2022-10