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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02654132
Ethics application status
Date submitted
31/12/2015
Date registered
13/01/2016
Date last updated
18/06/2020

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
Treatment: Drugs - Elotuzumab
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Dexamethasone

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


Treatment: Drugs: Elotuzumab


Treatment: Drugs: Pomalidomide


Treatment: Drugs: Dexamethasone


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS) - PFS will be defined as the time, in months, 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
Timepoint [1] 0 0
Approximately 14 months
Secondary outcome [1] 0 0
Objective Response Rate (ORR) - ORR is the proportion of randomized subjects who achieve a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) using the modified International Myeloma Working Group (IMWG) criteria described as follows, as per investigator's assessment CR: Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow; sCR: CR, as defined above, plus the following: Normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >= 90% reduction in serum M-protein level plus urine M-protein level < 100 mg per 24 hour; PR: >= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90% or to < 200 mg per 24 hour.
Timepoint [1] 0 0
Approximately 14 months
Secondary outcome [2] 0 0
Overall Survival (OS) - OS is the time from randomization to the date of death from any cause. The survival time for subjects who had not died was censored at the last known alive date. OS was censored at the date of randomization for subjects who were randomized but had no follow-up. NOTE: This data is immature and will be analyzed again at time of LPLV final.
Timepoint [2] 0 0
Approximately 32 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
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Okayama
Country [37] 0 0
Japan
State/province [37] 0 0
Tokyo
Country [38] 0 0
Japan
State/province [38] 0 0
Kasama-shi
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/show/NCT02654132
Trial related presentations / publications
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
Other publications