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Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma (ELOQUENT - 1)

Primary Purpose

Multiple Myeloma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Lenalidomide

Dexamethasone

Elotuzumab (BMS-901608; HuLuc63)

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Newly Diagnosed, Previously Untreated

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who:
- have not received any prior systemic anti-myeloma therapy AND
- have measurable disease AND
- are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because of age (≥ 65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204006 for a subject < 65 years old. There must be a comorbidity that prevents SCT for a subject < 65 years old

Exclusion Criteria:

Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
Monoclonal Gammopathy of Undetermined Significance (MGUS)
Active plasma cell leukemia
Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Lenalidomide + Dexamethasone

Lenalidomide + Dexamethasone + Elotuzumab

Arm Description

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)

PFS is defined as the time from randomization to the date of the first documented tumor progression (as determined by the Independent Review Committee (IRC)) or death due to any cause. The IRC conducted a blinded, independent review of the tumor assessments based on the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Censoring rules applied: Participants receiving subsequent systemic anti-myeloma therapy prior to documented progression were censored at the date of the last adequate tumor assessment prior to new therapy. Participants who had an event (progression or death) > 10 weeks after their last tumor assessment were censored at their last adequate tumor assessment prior to the event. Participants without progression or death (and not receiving subsequent therapy prior to progression) were censored at their last adequate tumor assessment. Participants without any post-baseline tumor assessments were censored on the date of randomization

Secondary Outcome Measures

Objective Response Rate (ORR)

ORR is defined as the percentage of participants with objective response among all randomized subjects. Participants with an objective response are those participants experiencing a partial response (PR) or better, based on Independent Review Committee (IRC) assessment, as per EBMT criteria.

Overall Survival (OS)

Survival is defined as the time from randomization to the date of death. A participant who did not die had his or her survival duration censored at the date of last contact ('last known date alive").

Mean Change From Baseline of Pain Severity Score and Pain Interference Score

Pain severity (sensory dimension) and pain interference (reactive dimension, assessing the degree to which pain interferes with function) are measured using the Brief Pain Inventory- Short Form (BPI-SF). BPI-SF numeric rating scale goes from 0 (No pain) to 10 (Pain as bad as you can imagine).

Progression Free Survival (PFS) Rate at Specific Time-points

PFS rate is defined as the percentage of participants experiencing PFS at the defined time-points.

Full Information

NCT ID

NCT01335399

First Posted

April 13, 2011

Last Updated

September 2, 2022

Sponsor

Bristol-Myers Squibb

Collaborators

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT01335399

Brief Title

Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma

Acronym

ELOQUENT - 1

Official Title

A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

August 4, 2011 (Actual)

Primary Completion Date

October 1, 2019 (Actual)

Study Completion Date

September 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

Collaborators

AbbVie

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

Keywords

Newly Diagnosed, Previously Untreated

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

748 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lenalidomide + Dexamethasone

Arm Type

Active Comparator

Arm Title

Lenalidomide + Dexamethasone + Elotuzumab

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Lenalidomide

Other Intervention Name(s)

Revlimid®

Intervention Description

Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

Decadron®, Dexamethasone Intensol®, Dexpak®, Taperpak®

Intervention Description

Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

Decadron®, Dexamethasone Intensol®, Dexpak®, Taperpak®

Intervention Description

Tablets, Oral, 28 mg, once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

Decadron®, Dexamethasone Intensol®, Dexpak®, Taperpak®

Intervention Description

Tablets, Oral, 40 mg, once daily, on Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

Decadron®, Dexamethasone Intensol®, Dexpak®, Taperpak®

Intervention Description

Solution, Intravenous (IV), 8 mg, Once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Intervention Type

Biological

Intervention Name(s)

Elotuzumab (BMS-901608; HuLuc63)

Intervention Description

Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Intervention Type

Biological

Intervention Name(s)

Elotuzumab (BMS-901608; HuLuc63)

Intervention Description

Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Primary Outcome Measure Information:

Title

Progression-Free Survival (PFS)

Description

Time Frame

From randomization to date of first documented tumor progression or death due to any cause (up to 8 years)

Secondary Outcome Measure Information:

Title

Objective Response Rate (ORR)

Description

Time Frame

From randomization to primary completion date (approximately 8 years)

Title

Overall Survival (OS)

Description

Survival is defined as the time from randomization to the date of death. A participant who did not die had his or her survival duration censored at the date of last contact ('last known date alive").

Time Frame

From randomization to the date of death (up to 8 years)

Title

Mean Change From Baseline of Pain Severity Score and Pain Interference Score

Description

Time Frame

From Baseline to End of Treatment (approximately 8 years)

Title

Progression Free Survival (PFS) Rate at Specific Time-points

Description

PFS rate is defined as the percentage of participants experiencing PFS at the defined time-points.

Time Frame

From randomization to the specified time-point (up to 5 years)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who: have not received any prior systemic anti-myeloma therapy AND have measurable disease AND are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because of age (≥ 65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204006 for a subject < 65 years old. There must be a comorbidity that prevents SCT for a subject < 65 years old Exclusion Criteria: Subjects with non-secretory or oligo-secretory or free light-chain only myeloma Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions Monoclonal Gammopathy of Undetermined Significance (MGUS) Active plasma cell leukemia Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Local Institution - 1628

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35243

Country

United States

Facility Name

Local Institution - 7619

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36604

Country

United States

Facility Name

Local Institution - 7618

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Local Institution - 7617

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

Local Institution - 1644

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85715

Country

United States

Facility Name

Local Institution - 1618

City

Bakersfield

State/Province

California

ZIP/Postal Code

93309

Country

United States

Facility Name

Local Institution - 1602

City

Berkeley

State/Province

California

ZIP/Postal Code

94704

Country

United States

Facility Name

Local Institution - 1636

City

Corona

State/Province

California

ZIP/Postal Code

92879

Country

United States

Facility Name

Local Institution - 1668

City

Corona

State/Province

California

ZIP/Postal Code

92879

Country

United States

Facility Name

Local Institution - 1616

City

Greenbrae

State/Province

California

ZIP/Postal Code

94904

Country

United States

Facility Name

Local Institution - 7609

City

Long Beach

State/Province

California

ZIP/Postal Code

90813

Country

United States

Facility Name

Local Institution - 1660

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Local Institution - 1673

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Local Institution - 1613

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Local Institution - 1621

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Facility Name

Local Institution - 1612

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

Facility Name

Local Institution - 1682

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33486

Country

United States

Facility Name

Local Institution - 1617

City

Brooksville

State/Province

Florida

ZIP/Postal Code

34613

Country

United States

Facility Name

Local Institution - 1648

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33916

Country

United States

Facility Name

Local Institution - 7613

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Facility Name

Local Institution - 1623

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Local Institution - 1625

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34652

Country

United States

Facility Name

Local Institution - 1649

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33705

Country

United States

Facility Name

Local Institution - 1611

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

Local Institution - 1630

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Local Institution - 1684

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96819

Country

United States

Facility Name

Local Institution - 1607

City

Chicago

State/Province

Illinois

ZIP/Postal Code

19123

Country

United States

Facility Name

Local Institution - 1635

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Local Institution - 1632

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

Facility Name

Local Institution - 7606

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61615

Country

United States

Facility Name

Local Institution - 7610

City

Skokie

State/Province

Illinois

ZIP/Postal Code

60077

Country

United States

Facility Name

Local Institution - 1603

City

Urbana

State/Province

Illinois

ZIP/Postal Code

61801

Country

United States

Facility Name

Local Institution - 7616

City

Bloomington

State/Province

Indiana

ZIP/Postal Code

47403

Country

United States

Facility Name

Local Institution - 7620

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46237

Country

United States

Facility Name

Local Institution - 1669

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

Local Institution - 1656

City

Mishawaka

State/Province

Indiana

ZIP/Postal Code

46545

Country

United States

Facility Name

Local Institution - 1633

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

Local Institution - 1674

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40503

Country

United States

Facility Name

Local Institution - 1683

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40207

Country

United States

Facility Name

Local Institution - 1646

City

Lafayette

State/Province

Louisiana

ZIP/Postal Code

70503

Country

United States

Facility Name

Local Institution - 7614

City

Marrero

State/Province

Louisiana

ZIP/Postal Code

70072

Country

United States

Facility Name

Local Institution - 1626

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70121

Country

United States

Facility Name

Local Institution - 1652

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71103

Country

United States

Facility Name

Local Institution - 1676

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21204

Country

United States

Facility Name

Local Institution - 1650

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21237

Country

United States

Facility Name

Local Institution - 1619

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Local Institution - 1699

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Local Institution - 1604

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Local Institution - 1667

City

Jefferson City

State/Province

Missouri

ZIP/Postal Code

65101

Country

United States

Facility Name

Local Institution - 1645

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Local Institution - 1651

City

Springfield

State/Province

Missouri

ZIP/Postal Code

65804

Country

United States

Facility Name

Local Institution - 1637

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198-7680

Country

United States

Facility Name

Local Institution - 7621

City

Mineola

State/Province

New York

ZIP/Postal Code

11501

Country

United States

Facility Name

Local Institution - 1615

City

New York

State/Province

New York

ZIP/Postal Code

10019

Country

United States

Facility Name

Local Institution - 1671

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11794-8183

Country

United States

Facility Name

Local Institution - 7604

City

Goldsboro

State/Province

North Carolina

ZIP/Postal Code

27534

Country

United States

Facility Name

Local Institution - 1610

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Local Institution - 1608

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Local Institution - 1693

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Local Institution - 1638

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Local Institution - 1664

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43219

Country

United States

Facility Name

Local Institution - 1690

City

Middletown

State/Province

Ohio

ZIP/Postal Code

45042

Country

United States

Facility Name

Local Institution - 1655

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74146

Country

United States

Facility Name

Local Institution - 7611

City

Langhorne

State/Province

Pennsylvania

ZIP/Postal Code

19047

Country

United States

Facility Name

Local Institution - 1647

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15224

Country

United States

Facility Name

Local Institution - 1679

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15240

Country

United States

Facility Name

Local Institution - 1677

City

Sayre

State/Province

Pennsylvania

ZIP/Postal Code

18840

Country

United States

Facility Name

Local Institution - 1629

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29414

Country

United States

Facility Name

Local Institution - 7615

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Local Institution - 1624

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29615

Country

United States

Facility Name

Local Institution - 7607

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57105

Country

United States

Facility Name

Local Institution - 1600

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37909

Country

United States

Facility Name

Local Institution - 7628

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38120

Country

United States

Facility Name

Local Institution - 1627

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Local Institution - 1670

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232-5505

Country

United States

Facility Name

Local Institution - 1634

City

Corpus Christi

State/Province

Texas

ZIP/Postal Code

78412

Country

United States

Facility Name

Local Institution - 7612

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Local Institution - 1643

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Local Institution - 1686

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Local Institution - 1642

City

Houston

State/Province

Texas

ZIP/Postal Code

77090

Country

United States

Facility Name

Local Institution - 7623

City

Ogden

State/Province

Utah

ZIP/Postal Code

84405

Country

United States

Facility Name

Local Institution - 1657

City

Fredericksburg

State/Province

Virginia

ZIP/Postal Code

22408

Country

United States

Facility Name

Local Institution - 1640

City

Seattle

State/Province

Washington

ZIP/Postal Code

98108

Country

United States

Facility Name

Local Institution - 1631

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

Local Institution - 1601

City

Huntington

State/Province

West Virginia

ZIP/Postal Code

25701

Country

United States

Facility Name

Gundersen Clinic, Ltd

City

La Crosse

State/Province

Wisconsin

ZIP/Postal Code

54601

Country

United States

Facility Name

Local Institution - 1663

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53717

Country

United States

Facility Name

Local Institution - 1609

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

Facility Name

Local Institution - 3600

City

Garran

State/Province

Australian Capital Territory

ZIP/Postal Code

2605

Country

Australia

Facility Name

Local Institution - 3607

City

Waratah

State/Province

New South Wales

ZIP/Postal Code

2298

Country

Australia

Facility Name

Local Institution - 3610

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Local Institution - 3609

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

Local Institution - 3608

City

Milton

State/Province

Queensland

ZIP/Postal Code

4064

Country

Australia

Facility Name

Local Institution - 3612

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Local Institution - 3606

City

Woodville South

State/Province

South Australia

ZIP/Postal Code

5001

Country

Australia

Facility Name

Local Institution - 3601

City

Fitzroy

State/Province

Victoria

ZIP/Postal Code

3065

Country

Australia

Facility Name

Local Institution - 3602

City

Frankston

State/Province

Victoria

ZIP/Postal Code

3199

Country

Australia

Facility Name

Local Institution - 3603

City

Heidelberg Melbourne

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

Local Institution - 3604

City

Wodonga

State/Province

Victoria

ZIP/Postal Code

3690

Country

Australia

Facility Name

Local Institution - 3605

City

Murdoch

ZIP/Postal Code

6150

Country

Australia

Facility Name

Local Institution - 3611

City

Nedlands

ZIP/Postal Code

6009

Country

Australia

Facility Name

Local Institution - 4052

City

Fadingerstraße 1

ZIP/Postal Code

4020

Country

Austria

Facility Name

Local Institution - 4051

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

Local Institution - 4054

City

Rankweil

ZIP/Postal Code

6830

Country

Austria

Facility Name

Local Institution - 4053

City

Wels

ZIP/Postal Code

4600

Country

Austria

Facility Name

Local Institution - 4160

City

Brussels

ZIP/Postal Code

1020

Country

Belgium

Facility Name

Local Institution - 4156

City

Brussels

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Local Institution - 4157

City

Brussles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Local Institution - 4154

City

Charleroi

ZIP/Postal Code

6000

Country

Belgium

Facility Name

Local Institution - 4159

City

Haine St Paul

ZIP/Postal Code

7100

Country

Belgium

Facility Name

Local Institution - 4158

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Local Institution - 4150

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Local Institution - 4153

City

Roeselare

ZIP/Postal Code

8800

Country

Belgium

Facility Name

Local Institution - 4151

City

Yvoir

ZIP/Postal Code

5530

Country

Belgium

Facility Name

Local Institution - 2601

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Facility Name

Local Institution - 2600

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

Local Institution - 2602

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3E 0V9

Country

Canada

Facility Name

Local Institution - 2611

City

Saint John

State/Province

New Brunswick

ZIP/Postal Code

E2L 4L2

Country

Canada

Facility Name

Local Institution - 2610

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

Local Institution - 2606

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5W9

Country

Canada

Facility Name

Local Institution - 2612

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Local Institution - 2603

City

Greenfield Park

State/Province

Quebec

ZIP/Postal Code

J4V 2H1

Country

Canada

Facility Name

Local Institution - 2605

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 2M4

Country

Canada

Facility Name

Local Institution - 2607

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 1A1

Country

Canada

Facility Name

Local Institution - 4252

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Local Institution - 4250

City

Praha 10

ZIP/Postal Code

100 34

Country

Czechia

Facility Name

Local Institution - 4251

City

Praha 2

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

Local Institution - 4565

City

Aschaffenburg

ZIP/Postal Code

63739

Country

Germany

Facility Name

Local Institution - 4550

City

Berlin

ZIP/Postal Code

12200

Country

Germany

Facility Name

Local Institution - 4555

City

Chemnitz

ZIP/Postal Code

09113

Country

Germany

Facility Name

Local Institution - 4562

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Local Institution - 4552

City

Hamm

ZIP/Postal Code

59063

Country

Germany

Facility Name

Local Institution - 4553

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Local Institution - 4560

City

Jena

ZIP/Postal Code

07747

Country

Germany

Facility Name

Local Institution - 4563

City

Koln

ZIP/Postal Code

50937

Country

Germany

Facility Name

Local Institution - 4554

City

Mainz

ZIP/Postal Code

55101

Country

Germany

Facility Name

Local Institution - 4561

City

Munchen

ZIP/Postal Code

81377

Country

Germany

Facility Name

Local Institution - 4558

City

Munster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Local Institution - 4551

City

Offenbach

ZIP/Postal Code

63069

Country

Germany

Facility Name

Local Institution - 4556

City

Stuttgart

ZIP/Postal Code

70376

Country

Germany

Facility Name

Local Institution - 4564

City

Tuebingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Local Institution - 4559

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Local Institution - 4653

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

Local Institution - 4651

City

Athens

ZIP/Postal Code

11528

Country

Greece

Facility Name

Local Institution - 4650

City

Ioannina

ZIP/Postal Code

45500

Country

Greece

Facility Name

Local Institution - 4652

City

Larissa

ZIP/Postal Code

41110

Country

Greece

Facility Name

Local Institution - 4654

City

Patras

ZIP/Postal Code

26504

Country

Greece

Facility Name

Local Institution - 4751

City

Budapest

ZIP/Postal Code

1097

Country

Hungary

Facility Name

Local Institution - 4754

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

Local Institution - 4750

City

Debrecen

ZIP/Postal Code

4012

Country

Hungary

Facility Name

Local Institution - 4753

City

Gyor

ZIP/Postal Code

9024

Country

Hungary

Facility Name

Local Institution - 4752

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

Local Institution - 4852

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Local Institution - 4850

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Local Institution - 4851

City

Galway

ZIP/Postal Code

Country

Ireland

Facility Name

Local Institution - 4950

City

Afula

ZIP/Postal Code

1834111

Country

Israel

Facility Name

Local Institution - 4956

City

Ashkelon

ZIP/Postal Code

7830604

Country

Israel

Facility Name

Local Institution - 4960

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Facility Name

Local Institution - 4958

City

Jerusalem

ZIP/Postal Code

91031

Country

Israel

Facility Name

Local Institution - 4951

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Local Institution - 4959

City

Kfar Saba

ZIP/Postal Code

4428164

Country

Israel

Facility Name

Local Institution - 4954

City

Nahariya

ZIP/Postal Code

2210001

Country

Israel

Facility Name

Local Institution - 4952

City

Petah Tikva

ZIP/Postal Code

4941492

Country

Israel

Facility Name

Local Institution - 4957

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Local Institution - 4955

City

Zerifin

ZIP/Postal Code

70300

Country

Israel

Facility Name

Local Institution - 5067

City

Ancona

ZIP/Postal Code

60126

Country

Italy

Facility Name

Local Institution - 5065

City

Bari

ZIP/Postal Code

70124

Country

Italy

Facility Name

Local Institution - 5053

City

Bergamo

ZIP/Postal Code

24127

Country

Italy

Facility Name

Local Institution - 5070

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Local Institution - 5066

City

Firenze

ZIP/Postal Code

50134

Country

Italy

Facility Name

Local Institution - 5050

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

Local Institution - 5057

City

Meldola

ZIP/Postal Code

47014

Country

Italy

Facility Name

Local Institution - 5075

City

Milano

ZIP/Postal Code

20122

Country

Italy

Facility Name

Local Institution - 5069

City

Milan

ZIP/Postal Code

20132

Country

Italy

Facility Name

Local Institution - 5052

City

Monza

ZIP/Postal Code

20052

Country

Italy

Facility Name

Local Institution - 5062

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Local Institution - 5068

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Local Institution - 5055

City

Palermo

ZIP/Postal Code

90146

Country

Italy

Facility Name

Local Institution - 5063

City

Ravenna

ZIP/Postal Code

48100

Country

Italy

Facility Name

Local Institution - 5073

City

Reggio Nell Emilia (RE)

ZIP/Postal Code

42100

Country

Italy

Facility Name

Local Institution - 5064

City

Rimini

ZIP/Postal Code

47923

Country

Italy

Facility Name

Local Institution - 5058

City

Roma

ZIP/Postal Code

00144

Country

Italy

Facility Name

Local Institution - 5054

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

Local Institution - 5056

City

Rome

ZIP/Postal Code

00161

Country

Italy

Facility Name

Local Institution - 5072

City

Terni

ZIP/Postal Code

05100

Country

Italy

Facility Name

Local Institution - 5051

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

Local Institution - 5250

City

Bialystok

ZIP/Postal Code

15-276

Country

Poland

Facility Name

Local Institution - 5252

City

Chorzow

ZIP/Postal Code

41-500

Country

Poland

Facility Name

Local Institution - 5254

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

Local Institution - 7626

City

Krakow

ZIP/Postal Code

31-531

Country

Poland

Facility Name

Local Institution - 5258

City

Lodz

ZIP/Postal Code

93-510

Country

Poland

Facility Name

Local Institution - 5257

City

Lublin

ZIP/Postal Code

20-081

Country

Poland

Facility Name

Local Institution - 5259

City

Poznan

ZIP/Postal Code

60-569

Country

Poland

Facility Name

Local Institution - 5255

City

Szczecin

ZIP/Postal Code

70-111

Country

Poland

Facility Name

Local Institution - 5256

City

Warszawa

ZIP/Postal Code

02-106

Country

Poland

Facility Name

Local Institution - 5253

City

Warszawa

ZIP/Postal Code

02-507

Country

Poland

Facility Name

Local Institution - 5260

City

Warszawa

ZIP/Postal Code

02-776

Country

Poland

Facility Name

Local Institution - 5251

City

Wroclaw

ZIP/Postal Code

50-367

Country

Poland

Facility Name

Local Institution - 7600

City

Ponce

ZIP/Postal Code

00716

Country

Puerto Rico

Facility Name

Local Institution - 7602

City

San Juan

ZIP/Postal Code

00918

Country

Puerto Rico

Facility Name

Local Institution - 5356

City

Brasov

ZIP/Postal Code

500152

Country

Romania

Facility Name

Local Institution - 5350

City

Bucaresti

ZIP/Postal Code

030171

Country

Romania

Facility Name

Local Institution - 5355

City

Bucuresti

ZIP/Postal Code

020125

Country

Romania

Facility Name

Local Institution - 5353

City

Bucuresti

ZIP/Postal Code

050098

Country

Romania

Facility Name

Local Institution - 5352

City

Bucuresti

ZIP/Postal Code

22328

Country

Romania

Facility Name

Local Institution - 5351

City

Lasi

ZIP/Postal Code

700483

Country

Romania

Facility Name

Local Institution - 5453

City

Samara

ZIP/Postal Code

443095

Country

Russian Federation

Facility Name

Local Institution - 5450

City

St. Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Local Institution - 5452

City

St. Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Local Institution - 5552

City

Badalona-barcelona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Local Institution - 5559

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Local Institution - 5555

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Facility Name

Local Institution - 5561

City

La Laguna- Tenerife

ZIP/Postal Code

38320

Country

Spain

Facility Name

Local Institution - 5553

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Local Institution - 5551

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Local Institution - 5560

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Local Institution - 5554

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Local Institution - 5558

City

Pamplona

ZIP/Postal Code

31008

Country

Spain

Facility Name

Local Institution - 5550

City

Salamanca

ZIP/Postal Code

37007

Country

Spain

Facility Name

Local Institution - 5557

City

San Sebastian

ZIP/Postal Code

20014

Country

Spain

Facility Name

Local Institution - 5556

City

Toledo

ZIP/Postal Code

45004

Country

Spain

Facility Name

Local Institution - 5751

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

Facility Name

Local Institution - 5750

City

St Gallen

ZIP/Postal Code

9007

Country

Switzerland

Facility Name

Local Institution - 5753

City

Zurich

ZIP/Postal Code

8028

Country

Switzerland

Facility Name

Local Institution - 5752

City

Zurich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Local Institution - 5853

City

Izmir

State/Province

Bornova

ZIP/Postal Code

35100

Country

Turkey

Facility Name

Local Institution - 5851

City

Ankara

State/Province

Dikimevi

ZIP/Postal Code

06620

Country

Turkey

Facility Name

Local Institution - 5854

City

Izmir

State/Province

Inciralti

ZIP/Postal Code

35340

Country

Turkey

Facility Name

Local Institution - 5856

City

Gaziantep

ZIP/Postal Code

27310

Country

Turkey

Facility Name

Local Institution - 5951

City

Belfast

State/Province

Antrim

ZIP/Postal Code

BT9 7AB

Country

United Kingdom

Facility Name

Local Institution - 5953

City

London

State/Province

Greater London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

Local Institution - 5950

City

London

ZIP/Postal Code

EC1A 7BE

Country

United Kingdom

Facility Name

Local Institution - 5954

City

London

ZIP/Postal Code

HA1 3UJ

Country

United Kingdom

Facility Name

Local Institution - 5952

City

London

ZIP/Postal Code

NW1 2PG

Country

United Kingdom

Facility Name

Local Institution - 5955

City

London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

35550060

Citation

Dimopoulos MA, Richardson PG, Bahlis NJ, Grosicki S, Cavo M, Beksac M, Legiec W, Liberati AM, Goldschmidt H, Belch A, Magen H, Larocca A, Laubach JP, Petrucci MT, Reece D, White D, Mateos MV, Spicka I, Lazaroiu M, Berdeja J, Kaufman JL, Jou YM, Ganetsky A, Popa McKiver M, Lonial S, Weisel K; ELOQUENT-1 investigators. Addition of elotuzumab to lenalidomide and dexamethasone for patients with newly diagnosed, transplantation ineligible multiple myeloma (ELOQUENT-1): an open-label, multicentre, randomised, phase 3 trial. Lancet Haematol. 2022 Jun;9(6):e403-e414. doi: 10.1016/S2352-3026(22)00103-X. Epub 2022 May 9.

Results Reference

derived

Links:

URL

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

Description

BMS Clinical Trial Information

URL

https://www.bmsstudyconnect.com/s/US/English/USenHome

Description

BMS Clinical Trial Patient Recruiting

URL

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

Description

FDA Safety Alerts and Recalls

Learn more about this trial

Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma

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Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma (ELOQUENT - 1)

Multiple Myeloma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial