AzTrials
AzTrials

Multiple MyelomaPhase 2NCT02654132

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)

A Phase 2 study testing Elotuzumab, Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by Bristol-Myers Squibb at 55 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Elotuzumab, Pomalidomide and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
117 participants
Where
55 sitesin 11 countries
Study dates
18 Mar 2016to 21 Oct 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 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

Who cannot join

  • 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

Trial locations and contacts

55 sites in 11 countries.

55 sites in 11 countries

United States12 sites

  • Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Beth Israel Comprehensive Cancer Center

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute.

    Boston, Massachusetts, 02215

  • Carolinas Healthcare System

    Charlotte, North Carolina, 28204

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • St Francis Hospital

    Greenville, South Carolina, 29607

  • Investigative Clinical Research Of Indiana, Llc

    Indianapolis, Indiana, 46260

  • Tennessee Cancer Specialists

    Knoxville, Tennessee, 37909

  • Northern Utah Associates

    Ogden, Utah, 84403

  • Va Pittsburgh Healthcare System

    Pittsburgh, Pennsylvania, 15240

  • Rochester General Hospital

    Rochester, New York, 14621

  • University Of Washington

    Seattle, Washington, 98109

Other trials in United States

Japan8 sites

  • Local Institution - 0067

    Kasama-shi, 3091793

  • Local Institution - 0031

    Kyoto, Kyoto, 6028566

  • Local Institution - 0069

    Morioka, Iwate, 0208505

  • Local Institution - 0030

    Nagoya, Aichi-ken, 4678602

  • Local Institution - 0029

    Niigata, Niigata, 951-8566

  • Local Institution - 0032

    Okayama, 701-1154

  • Local Institution - 0027

    Shibuya-ku, Tokyo, 1508935

  • Local Institution - 0028

    Tachikawa-shi, Tokyo, 1900014

Other trials in Japan

Germany7 sites

  • Universitaetsklinikum Carl Gustav Carus

    Dresden, 01307

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • St. Barbara-Klinik

    Hamm, 59075

  • Local Institution - 0041

    Heidelberg, 69120

  • Local Institution - 0056

    Kiel, 24105

  • Klinikum Der Johannes Gutenberg Universitaet Mainz

    Mainz, 55101

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076

Other trials in Germany

Italy6 sites

  • Azienda Ospedaliero Universitaria Ospedali Riuniti Di Ancona

    Ancona, 60126

  • A. O. U. Di Bologna, Policlinico S. Orsola Malpighi

    Bologna, 40138

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134

  • Local Institution

    Roma, 00144

  • Universita' La Sapienza

    Roma, 00161

  • Azienda Ospedaliera Citta' Della Salute E Della Scienza Di Torino

    Torino, 10126

Other trials in Italy

France5 sites

  • Local Institution - 0022

    Nantes, 44000

  • Local Institution - 0021

    Paris, 75571

  • Local Institution - 0020

    Pessac, 33604

  • Local Institution - 0019

    Poitiers, 86021

  • Local Institution

    Saint-Pierre, 97448

Other trials in France

Netherlands4 sites

  • Local Institution

    Amsterdam, 1081 HV

  • Local Institution

    Groningen, 9713 GZ

  • Local Institution

    Maastrict, 6229 HX

  • Local Institution

    Utrecht, 3584 CX

Other trials in Netherlands

Spain4 sites

  • Local Institution

    Barcelona, 08025

  • Local Institution - 0024

    Madrid, 28041

  • Local Institution

    Pamplona, Navarre, 31008

  • Local Institution

    Valencia, 46017

Other trials in Spain

Canada3 sites

  • CISSS de l'Outaouais

    Gatineau, Quebec, J8P 7H2

  • Local Institution

    London, Ontario, N6A 4G5

  • Local Institution - 0048

    Montreal, Quebec, H1T 2M4

Other trials in Canada

Poland3 sites

  • Oddzial Kliniczny Hematologii i Profilaktyki Chorob Nowotworowych

    Chorzów, 41-500

  • Local Institution

    Lublin, 20-090

  • Oddzial Hematologii i Transplantacji Szpiku

    Poznan, 60-569

Other trials in Poland

Greece2 sites

  • Laiko University Hospital

    Athens, 11527

  • Alexandra General Hospital Of Athens

    Athens, 11528

Other trials in Greece

Australia1 site

  • Local Institution

    South Brisbane, Queensland, 4101

Other trials in Australia

About this study

Official title: 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.

Being tested
Elotuzumab, Pomalidomide, Dexamethasone
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElotuzumabDrug

  • PomalidomideDrug

    Also called Pomalyst

  • DexamethasoneDrug

    Also called Decadron, Dexamethasone, Intensol, Dexpak, Taperpak

Study groups in NCT02654132
Study groupRoleWhat they receive
Elotuzumab ArmExperimentalBiological: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
Receives: Drug: Elotuzumab; Drug: Pomalidomide; Drug: Dexamethasone
Control ArmActive 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
Receives: Drug: Pomalidomide; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From randomization to date of progression or death (up to approximately 21 months)

Secondary outcomes (2)

  1. Objective Response Rate (ORR)

    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.

    Measured: From first dose to disease progression (up to approximately 21 months)

  2. Overall Survival (OS)

    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.

    Measured: From randomization to death (up to approximately 52 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2016 (estimated)
  2. Study start18 Mar 2016
  3. Primary completion17 Jan 2018
  4. Study completion21 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02654132
Sponsor's protocol ID
CA204-125
Other IDs
2014-003282-19, 2014
Status last verified
Oct 2022
First submitted
31 Dec 2015
Last updated
1 Nov 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

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.

    PubMed 35960908

  • 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.

    PubMed 30403938

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Elotuzumab, Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by Bristol-Myers Squibb at 55 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States, Japan, Germany, Italy, France and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: From randomization to date of progression or death (up to approximately 21 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02654132, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in