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)

October 5, 2022 updated by: Bristol-Myers Squibb

An Open Label, Randomized Phase 2 Trial of Pomalidomide/Dexamethasone With or Without Elotuzumab in Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Local Institution
  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4G5
        • Local Institution
    • Quebec
      • Gatineau, Quebec, Canada, J8P 7H2
        • CISSS de l'Outaouais
      • Montreal, Quebec, Canada, H1T 2M4
        • Local Institution - 0048
  • France
      • Nantes Cedex 1, France, 44000
        • Local Institution - 0022
      • Paris Cedex 12, France, 75571
        • Local Institution - 0021
      • Pessac, France, 33604
        • Local Institution - 0020
      • Poitiers Cedex, France, 86021
        • Local Institution - 0019
      • Saint Pierre Cedex, France, 97448
        • Local Institution
  • Germany
      • Dresden, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus
      • Freiburg, Germany, 79106
        • Universitaetsklinikum Freiburg
      • Hamm, Germany, 59075
        • St. Barbara-Klinik
      • Heidelberg, Germany, 69120
        • Local Institution - 0041
      • Kiel, Germany, 24105
        • Local Institution - 0056
      • Mainz, Germany, 55101
        • Klinikum Der Johannes Gutenberg Universitaet Mainz
      • Tuebingen, Germany, 72076
        • Universitaetsklinikum Tuebingen
  • Greece
      • Athens, Greece, 11528
        • Alexandra General Hospital of Athens
      • Athens, Greece, 11527
        • Laiko University Hospital
  • Italy
      • Ancona, Italy, 60126
        • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
      • Bologna, Italy, 40138
        • A. O. U. Di Bologna, Policlinico S. Orsola Malpighi
      • Firenze, Italy, 50134
        • Azienda Ospedaliera Universitaria Careggi
      • Roma, Italy, 00144
        • Local Institution
      • Roma, Italy, 00161
        • Universita' La Sapienza
      • Torino, Italy, 10126
        • Azienda Ospedaliera Citta' Della Salute E Della Scienza Di Torino
  • Japan
      • Kasama-shi, Japan, 3091793
        • Local Institution - 0067
      • Okayama, Japan, 701-1154
        • Local Institution - 0032
    • Aichi
      • Nagoya-shi, Aichi, Japan, 4678602
        • Local Institution - 0030
    • Iwate
      • Morioka-shi, Iwate, Japan, 0208505
        • Local Institution - 0069
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 6028566
        • Local Institution - 0031
    • Niigata
      • Niigata-shi, Niigata, Japan, 951-8566
        • Local Institution - 0029
    • Tokyo
      • Shibuya-ku, Tokyo, Japan, 1508935
        • Local Institution - 0027
      • Tachikawa-shi, Tokyo, Japan, 1900014
        • Local Institution - 0028
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Local Institution
      • Groningen, Netherlands, 9713 GZ
        • Local Institution
      • Maastrict, Netherlands, 6229 HX
        • Local Institution
      • Utrecht, Netherlands, 3584 CX
        • Local Institution
  • Poland
      • Chorzow, Poland, 41-500
        • Oddzial Kliniczny Hematologii i Profilaktyki Chorob Nowotworowych
      • Lublin, Poland, 20-090
        • Local Institution
      • Poznan, Poland, 60-569
        • Oddzial Hematologii i Transplantacji Szpiku
  • Spain
      • Barcelona, Spain, 08025
        • Local Institution
      • Madrid, Spain, 28041
        • Local Institution - 0024
      • Valencia, Spain, 46017
        • Local Institution
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Local Institution
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Investigative Clinical Research of Indiana, LLC
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute.
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Comprehensive Cancer Center
    • New York
      • Rochester, New York, United States, 14621
        • Rochester General Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Carolinas Healthcare System
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15240
        • VA Pittsburgh Healthcare System
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • St Francis Hospital
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Tennessee Cancer Specialists
    • Utah
      • Ogden, Utah, United States, 84403
        • Northern Utah Associates
    • Washington
      • Seattle, Washington, United States, 98109
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: Dexamethasone
Other Names:
  • Decadron, Dexamethasone, Intensol, Dexpak, Taperpak
Drug: Elotuzumab
Drug: Pomalidomide
Other Names:
  • Pomalyst
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
Drug: Dexamethasone
Other Names:
  • Decadron, Dexamethasone, Intensol, Dexpak, Taperpak
Drug: Pomalidomide
Other Names:
  • Pomalyst

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: From randomization to date of progression or death (up to approximately 21 months)

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: From first dose to disease progression (up to approximately 21 months)

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.
From first dose to disease progression (up to approximately 21 months)
Overall Survival (OS)
Time Frame: From randomization to death (up to approximately 52 months)
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.
From randomization to death (up to approximately 52 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

AbbVie
Celgene

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2016

Primary Completion (Actual)

January 17, 2018

Study Completion (Actual)

October 21, 2021

Study Registration Dates

First Submitted

December 31, 2015

First Submitted That Met QC Criteria

January 12, 2016

First Posted (Estimate)

January 13, 2016

Study Record Updates

Last Update Posted (Actual)

November 1, 2022

Last Update Submitted That Met QC Criteria

October 5, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA204-125
  • 2014-003282-19 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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