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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02654132




Registration number
NCT02654132
Ethics application status
Date submitted
31/12/2015
Date registered
13/01/2016
Date last updated
1/11/2022

Titles & IDs
Public title
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)
Scientific title
An Open Label, Randomized Phase 2 Trial of Pomalidomide/Dexamethasone With or Without Elotuzumab in Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)
Secondary ID [1] 0 0
2014-003282-19
Secondary ID [2] 0 0
CA204-125
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Elotuzumab Arm - Biological: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

Active comparator: Control Arm - Drug: 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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
From randomization to date of progression or death (up to approximately 21 months)
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
From first dose to disease progression (up to approximately 21 months)
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
From randomization to death (up to approximately 52 months)

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



* = 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/10/2021
Sample size
Target
Accrual to date
Final
117
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Local Institution - South Brisbane
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Utah
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
France
State/province [14] 0 0
Nantes Cedex 1
Country [15] 0 0
France
State/province [15] 0 0
Paris Cedex 12
Country [16] 0 0
France
State/province [16] 0 0
Pessac
Country [17] 0 0
France
State/province [17] 0 0
Poitiers Cedex
Country [18] 0 0
France
State/province [18] 0 0
Saint Pierre Cedex
Country [19] 0 0
Germany
State/province [19] 0 0
Dresden
Country [20] 0 0
Germany
State/province [20] 0 0
Freiburg
Country [21] 0 0
Germany
State/province [21] 0 0
Hamm
Country [22] 0 0
Germany
State/province [22] 0 0
Heidelberg
Country [23] 0 0
Germany
State/province [23] 0 0
Kiel
Country [24] 0 0
Germany
State/province [24] 0 0
Mainz
Country [25] 0 0
Germany
State/province [25] 0 0
Tuebingen
Country [26] 0 0
Greece
State/province [26] 0 0
Athens
Country [27] 0 0
Italy
State/province [27] 0 0
Ancona
Country [28] 0 0
Italy
State/province [28] 0 0
Bologna
Country [29] 0 0
Italy
State/province [29] 0 0
Firenze
Country [30] 0 0
Italy
State/province [30] 0 0
Roma
Country [31] 0 0
Italy
State/province [31] 0 0
Torino
Country [32] 0 0
Japan
State/province [32] 0 0
Aichi
Country [33] 0 0
Japan
State/province [33] 0 0
Iwate
Country [34] 0 0
Japan
State/province [34] 0 0
Kyoto
Country [35] 0 0
Japan
State/province [35] 0 0
Niigata
Country [36] 0 0
Japan
State/province [36] 0 0
Tokyo
Country [37] 0 0
Japan
State/province [37] 0 0
Kasama-shi
Country [38] 0 0
Japan
State/province [38] 0 0
Okayama
Country [39] 0 0
Netherlands
State/province [39] 0 0
Amsterdam
Country [40] 0 0
Netherlands
State/province [40] 0 0
Groningen
Country [41] 0 0
Netherlands
State/province [41] 0 0
Maastrict
Country [42] 0 0
Netherlands
State/province [42] 0 0
Utrecht
Country [43] 0 0
Poland
State/province [43] 0 0
Chorzow
Country [44] 0 0
Poland
State/province [44] 0 0
Lublin
Country [45] 0 0
Poland
State/province [45] 0 0
Poznan
Country [46] 0 0
Spain
State/province [46] 0 0
Navarra
Country [47] 0 0
Spain
State/province [47] 0 0
Barcelona
Country [48] 0 0
Spain
State/province [48] 0 0
Madrid
Country [49] 0 0
Spain
State/province [49] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Celgene
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
AbbVie
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT02654132
Trial related presentations / publications
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02654132