Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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)
Query!
Scientific title
An Open Label, Randomized Phase 2 Trial of Pomalidomide/Dexamethasone With or Without Elotuzumab in Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)
Query!
Secondary ID [1]
0
0
2014-003282-19
Query!
Secondary ID [2]
0
0
CA204-125
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Other cancer types
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression Free Survival (PFS)
Query!
Assessment method [1]
0
0
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
Query!
Timepoint [1]
0
0
From randomization to date of progression or death (up to approximately 21 months)
Query!
Secondary outcome [1]
0
0
Objective Response Rate (ORR)
Query!
Assessment method [1]
0
0
ORR is defined as the percentage of participants who achieved a best overall response (BOR) 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.
Query!
Timepoint [1]
0
0
From first dose to disease progression (up to approximately 21 months)
Query!
Secondary outcome [2]
0
0
Overall Survival (OS)
Query!
Assessment method [2]
0
0
OS is the time from randomization to the date of death from any cause. The survival time for participants 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.
Query!
Timepoint [2]
0
0
From randomization to death (up to approximately 52 months)
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
18/03/2016
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
21/10/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
117
Query!
Recruitment in Australia
Recruitment state(s)
QLD
Query!
Recruitment hospital [1]
0
0
Local Institution - South Brisbane
Query!
Recruitment postcode(s) [1]
0
0
4101 - South Brisbane
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Georgia
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Illinois
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Indiana
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Massachusetts
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
New York
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
North Carolina
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Pennsylvania
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
South Carolina
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Tennessee
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Utah
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Washington
Query!
Country [12]
0
0
Canada
Query!
State/province [12]
0
0
Ontario
Query!
Country [13]
0
0
Canada
Query!
State/province [13]
0
0
Quebec
Query!
Country [14]
0
0
France
Query!
State/province [14]
0
0
Nantes Cedex 1
Query!
Country [15]
0
0
France
Query!
State/province [15]
0
0
Paris Cedex 12
Query!
Country [16]
0
0
France
Query!
State/province [16]
0
0
Pessac
Query!
Country [17]
0
0
France
Query!
State/province [17]
0
0
Poitiers Cedex
Query!
Country [18]
0
0
France
Query!
State/province [18]
0
0
Saint Pierre Cedex
Query!
Country [19]
0
0
Germany
Query!
State/province [19]
0
0
Dresden
Query!
Country [20]
0
0
Germany
Query!
State/province [20]
0
0
Freiburg
Query!
Country [21]
0
0
Germany
Query!
State/province [21]
0
0
Hamm
Query!
Country [22]
0
0
Germany
Query!
State/province [22]
0
0
Heidelberg
Query!
Country [23]
0
0
Germany
Query!
State/province [23]
0
0
Kiel
Query!
Country [24]
0
0
Germany
Query!
State/province [24]
0
0
Mainz
Query!
Country [25]
0
0
Germany
Query!
State/province [25]
0
0
Tuebingen
Query!
Country [26]
0
0
Greece
Query!
State/province [26]
0
0
Athens
Query!
Country [27]
0
0
Italy
Query!
State/province [27]
0
0
Ancona
Query!
Country [28]
0
0
Italy
Query!
State/province [28]
0
0
Bologna
Query!
Country [29]
0
0
Italy
Query!
State/province [29]
0
0
Firenze
Query!
Country [30]
0
0
Italy
Query!
State/province [30]
0
0
Roma
Query!
Country [31]
0
0
Italy
Query!
State/province [31]
0
0
Torino
Query!
Country [32]
0
0
Japan
Query!
State/province [32]
0
0
Aichi
Query!
Country [33]
0
0
Japan
Query!
State/province [33]
0
0
Iwate
Query!
Country [34]
0
0
Japan
Query!
State/province [34]
0
0
Kyoto
Query!
Country [35]
0
0
Japan
Query!
State/province [35]
0
0
Niigata
Query!
Country [36]
0
0
Japan
Query!
State/province [36]
0
0
Tokyo
Query!
Country [37]
0
0
Japan
Query!
State/province [37]
0
0
Kasama-shi
Query!
Country [38]
0
0
Japan
Query!
State/province [38]
0
0
Okayama
Query!
Country [39]
0
0
Netherlands
Query!
State/province [39]
0
0
Amsterdam
Query!
Country [40]
0
0
Netherlands
Query!
State/province [40]
0
0
Groningen
Query!
Country [41]
0
0
Netherlands
Query!
State/province [41]
0
0
Maastrict
Query!
Country [42]
0
0
Netherlands
Query!
State/province [42]
0
0
Utrecht
Query!
Country [43]
0
0
Poland
Query!
State/province [43]
0
0
Chorzow
Query!
Country [44]
0
0
Poland
Query!
State/province [44]
0
0
Lublin
Query!
Country [45]
0
0
Poland
Query!
State/province [45]
0
0
Poznan
Query!
Country [46]
0
0
Spain
Query!
State/province [46]
0
0
Navarra
Query!
Country [47]
0
0
Spain
Query!
State/province [47]
0
0
Barcelona
Query!
Country [48]
0
0
Spain
Query!
State/province [48]
0
0
Madrid
Query!
Country [49]
0
0
Spain
Query!
State/province [49]
0
0
Valencia
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Bristol-Myers Squibb
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Celgene
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Commercial sector/Industry
Query!
Name [2]
0
0
AbbVie
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02654132
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bristol-Myers Squibb
Query!
Address
0
0
Bristol-Myers Squibb
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02654132
Download to PDF