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)

NCT ID: NCT02654132

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-18
• Study Completion Date: 2021-10-21

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Elotuzumab

Intervention Type: DRUG

Pomalidomide

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

Pomalidomide

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

Interventions

Elotuzumab

Intervention Type: DRUG

Pomalidomide

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

Other Intervention Names

Pomalyst; Decadron, Dexamethasone, Intensol, Dexpak, Taperpak

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: collaborator

AbbVie

INDUSTRY

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Winship Cancer Institute

Atlanta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Investigative Clinical Research Of Indiana, Llc

Indianapolis, Indiana, United States

Beth Israel Comprehensive Cancer Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute.

Boston, Massachusetts, United States

Rochester General Hospital

Rochester, New York, United States

Carolinas Healthcare System

Charlotte, North Carolina, United States

Va Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, United States

St Francis Hospital

Greenville, South Carolina, United States

Tennessee Cancer Specialists

Knoxville, Tennessee, United States

Northern Utah Associates

Ogden, Utah, United States

University Of Washington

Seattle, Washington, United States

Local Institution

South Brisbane, Queensland, Australia

Local Institution

London, Ontario, Canada

CISSS de l'Outaouais

Gatineau, Quebec, Canada

Local Institution - 0048

Montreal, Quebec, Canada

Local Institution - 0022

Nantes, , France

Local Institution - 0021

Paris, , France

Local Institution - 0020

Pessac, , France

Local Institution - 0019

Poitiers, , France

Local Institution

Saint-Pierre, , France

Universitaetsklinikum Carl Gustav Carus

Dresden, , Germany

Universitaetsklinikum Freiburg

Freiburg im Breisgau, , Germany

St. Barbara-Klinik

Hamm, , Germany

Local Institution - 0041

Heidelberg, , Germany

Local Institution - 0056

Kiel, , Germany

Klinikum Der Johannes Gutenberg Universitaet Mainz

Mainz, , Germany

Universitaetsklinikum Tuebingen

Tübingen, , Germany

Laiko University Hospital

Athens, , Greece

Alexandra General Hospital Of Athens

Athens, , Greece

Azienda Ospedaliero Universitaria Ospedali Riuniti Di Ancona

Ancona, , Italy

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

Bologna, , Italy

Azienda Ospedaliera Universitaria Careggi

Florence, , Italy

Local Institution

Roma, , Italy

Universita' La Sapienza

Roma, , Italy

Azienda Ospedaliera Citta' Della Salute E Della Scienza Di Torino

Torino, , Italy

Local Institution - 0030

Nagoya, Aichi-ken, Japan

Local Institution - 0069

Morioka, Iwate, Japan

Local Institution - 0031

Kyoto, Kyoto, Japan

Local Institution - 0029

Niigata, Niigata, Japan

Local Institution - 0027

Shibuya-ku, Tokyo, Japan

Local Institution - 0028

Tachikawa-shi, Tokyo, Japan

Local Institution - 0067

Kasama-shi, , Japan

Local Institution - 0032

Okayama, , Japan

Local Institution

Amsterdam, , Netherlands

Local Institution

Groningen, , Netherlands

Local Institution

Maastrict, , Netherlands

Local Institution

Utrecht, , Netherlands

Oddzial Kliniczny Hematologii i Profilaktyki Chorob Nowotworowych

Chorzów, , Poland

Local Institution

Lublin, , Poland

Oddzial Hematologii i Transplantacji Szpiku

Poznan, , Poland

Local Institution

Pamplona, Navarre, Spain

Local Institution

Barcelona, , Spain

Local Institution - 0024

Madrid, , Spain

Local Institution

Valencia, , Spain

Countries

United States; Australia; Canada; France; Germany; Greece; Italy; Japan; Netherlands; Poland; Spain

References

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.

Reference Type: DERIVED

PMID: 35960908 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30403938 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

http://www.BMSStudyConnect.com

BMS Clinical Trial Patient Recruiting

Other Identifiers

2014-003282-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA204-125

Identifier Type: -

Identifier Source: org_study_id