Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

729

Participants

Timeline

Start Date

October 31, 2010

Primary Completion Date

December 31, 2021

Study Completion Date

December 31, 2026

Conditions
Multiple Myeloma
Interventions
DRUG

Lenalidomide

oral administration

DRUG

Bortezomib

intravenous or, following protocol amendment, subcutaneous administration

DRUG

Dexamethasone

"oral administration~Dose of 20 mg/day for first 3 cycles. Dose of 10 mg/day for remaining cycles."

PROCEDURE

Autologous Stem Cell Transplant

Autologous refers to stem cells that are harvested from the participant to be a source of new blood cells after high-dose chemotherapy with melphalan.

Trial Locations (46)

10021

Memorial Sloan Kettering Cancer Center, New York

10029

Mount Sinai Medical Center, New York

10032

Columbia University, New York

11042

North Shore Long Island Jewish Health System, Lake Success

14263

Roswell Park Cancer Institute, Buffalo

14642

University of Rochester Medical Center, Rochester

15232

University of Pittsburgh Medical Center, Pittsburgh

19104

University of Pennsylvania Medical Center, Philadelphia

19111

Fox Chase Cancer Center, Philadelphia

27157

Wake Forest University, Winston-Salem

27599

UNC Lineberger Comprehensive Cancer Center, Chapel Hill

27710

Duke University, Durham

30322

Emory University, Atlanta

32608

University of Florida, Gainesville

33612

H. Lee Moffitt Cancer Center, Tampa

35294

University of Alabama at Birmingham, Birmingham

37203

Vanderbilt University, Nashville

39216

University of Mississippi Medical Center, Jackson

43210

Ohio State University Medical Center, Columbus

48109

University of Michigan, Ann Arbor

48201

Barbara Ann Karmanos Cancer Institute, Detroit

60637

University of Chicago, Chicago

70121

Ochsner Foundation Clinic, New Orleans

75390

University of Texas Southwestern Medical Center, Dallas

77030

Baylor College of Medicine, Houston

MD Anderson Cancer Center, Houston

80218

Colorado Blood Cancer Institute, Denver

83712

Mountain States Tumor Institute at St. Luke's Regional Medical Center, Boise

85724

Arizona Comprehensive Cancer Center, Tucson

91010

City of Hope, Duarte

94143

University of California, San Francisco, San Francisco

94305

Stanford University, Stanford

98109

Fred Hutchinson Cancer Research Center, Seattle

Unknown

University of California at San Diego, La Jolla

Newton-Wellesley Hospital, Newton

New Hampshire Oncology and Hematology, Concord

New Hampshire Oncology and Hematology, Hooksett

New Hampshire Oncology and Hematology, Laconia

State University of New York Downstate Medical Center, Brooklyn

Oregon Health and Sciences, Portland

Huntsman Cancer Institute, Salt Lake City

04412

Eastern Maine Medical Center, Brewer

02114

Massachusetts General Hospital, Boston

02115

Dana-Farber Cancer Institute, Boston

02215

Beth Israel Deaconess Medical Center, Boston

02601

Cape Cod Healthcare, Hyannis

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

collaborator

Millennium Pharmaceuticals, Inc.

INDUSTRY

collaborator

Massachusetts General Hospital

OTHER

collaborator

Cape Cod Hospital

OTHER

collaborator

Beth Israel Deaconess Medical Center

OTHER

collaborator

Emory University

OTHER

collaborator

University of Michigan

OTHER

collaborator

Fox Chase Cancer Center

OTHER

collaborator

Memorial Sloan Kettering Cancer Center

OTHER

collaborator

Fred Hutchinson Cancer Center

OTHER

collaborator

Barbara Ann Karmanos Cancer Institute

OTHER

collaborator

Duke University

OTHER

collaborator

University of California, San Francisco

OTHER

collaborator

University of Chicago

OTHER

collaborator

M.D. Anderson Cancer Center

OTHER

collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

collaborator

Roswell Park Cancer Institute

OTHER

collaborator

Stanford University

OTHER

collaborator

University of Mississippi Medical Center

OTHER

collaborator

Icahn School of Medicine at Mount Sinai

OTHER

collaborator

Wake Forest University Health Sciences

OTHER

collaborator

University of Arizona

OTHER

collaborator

OHSU Knight Cancer Institute

OTHER

collaborator

Eastern Maine Medical Center

OTHER

collaborator

University of California, San Diego

OTHER

collaborator

University of Alabama at Birmingham

OTHER

collaborator

University of Pittsburgh Medical Center

OTHER

collaborator

Ochsner Health System

OTHER

collaborator

University of Texas Southwestern Medical Center

OTHER

collaborator

State University of New York - Downstate Medical Center

OTHER

collaborator

Newton-Wellesley Hospital

OTHER

collaborator

Baylor College of Medicine

OTHER

collaborator

City of Hope Medical Center

OTHER

collaborator

University of Florida

OTHER

collaborator

Northwell Health

OTHER

collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

collaborator

Vanderbilt University Medical Center

OTHER

collaborator

Ohio State University

OTHER

collaborator

Huntsman Cancer Institute

OTHER

collaborator

Columbia University

OTHER

lead

Paul Richardson, MD

OTHER