Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma

July 7, 2026 updated by: National Cancer Institute (NCI)

A Randomized Phase III Trial of CC-5013 (Lenalidomide, NSC-703813) and Low Dose Dexamethasone (LLD) Versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients With Previously Untreated Multiple Myeloma Without an Intent for Immediate Autologous Stem Cell Transplant

This randomized phase III trial studies lenalidomide, dexamethasone, and bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the cancer. It is not yet known whether lenalidomide and dexamethasone is more effective with or without bortezomib in treating multiple myeloma.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To compare progression-free survival (PFS) in patients with newly diagnosed myeloma treated with lenalidomide plus low dose dexamethasone versus bortezomib plus lenalidomide and low dose dexamethasone.

SECONDARY OBJECTIVES:

I. Assess response using the new international response criteria. II. To bank specimens for future translational medicine research. III. Follow patients to assess overall survival and other long-term outcomes stratified by intent to transplant at progression.

TERTIARY OBJECTIVES:

I. To evaluate custom and genome-wide single nucleotide polymorphisms in correlation with biology, prognosis and outcome for both treatment regimens combined; to verify the findings recently obtained with the custom Bank on a Cure program (BOAC) single nucleotide polymorphism (SNP) chip on Total Therapy 2 (TT2) data with respect to bone disease in the cooperative group setting.

II. To use baseline gene expression profiling as a tool to evaluate the biology, prognostic and risk factors, and response to therapy for both treatment regimens combined. To validate John Shaughnessy's 70 gene risk model developed for Total Therapy 2 (TT2) in the cooperative group setting.

OUTLINE:

INDUCTION THERAPY: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive dexamethasone orally (PO) once daily (QD) on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.

In both arms, patients who intend to undergo transplantation at relapse undergo peripheral blood stem cell collection, preferably after course 2.

MAINTENANCE THERAPY: After the completion of at least 4 courses (Arm I) or at least 6 courses (Arm II) of induction therapy, patients receive maintenance therapy comprising dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically for up to 6 years.

Study Type

Interventional

Enrollment (Actual)

525

Phase

  • Phase 3

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

  • Puerto Rico
      • San Juan, Puerto Rico, 00936
        • San Juan City Hospital
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11211
        • King Faisal Specialist Hospital and Research Centre
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Providence Alaska Medical Center
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona
      • Tucson, Arizona, United States, 85704
        • University of Arizona Cancer Center-Orange Grove Campus
      • Tucson, Arizona, United States, 85719
        • Banner University Medical Center - Tucson
      • Tucson, Arizona, United States, 85719
        • University of Arizona Cancer Center-North Campus
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Antioch, California, United States, 94531
        • Kaiser Permanente-Deer Valley Medical Center
      • Arroyo Grande, California, United States, 93420
        • PCR Oncology
      • Berkeley, California, United States, 94704
        • Alta Bates Summit Medical Center-Herrick Campus
      • Burbank, California, United States, 91505
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • Burlingame, California, United States, 94010
        • Mills-Peninsula Medical Center
      • Fremont, California, United States, 94538
        • Kaiser Permanente-Fremont
      • Fresno, California, United States, 93720
        • Kaiser Permanente-Fresno
      • Fullerton, California, United States, 92835
        • Saint Jude Medical Center
      • Greenbrae, California, United States, 94904
        • Marin General Hospital
      • Marysville, California, United States, 95901
        • Fremont - Rideout Cancer Center
      • Mission Hills, California, United States, 91346-9600
        • Providence Holy Cross Medical Center
      • Mountain View, California, United States, 94040
        • Palo Alto Medical Foundation-Camino Division
      • Novato, California, United States, 94945
        • Sutter Cancer Research Consortium
      • Oakland, California, United States, 94611
        • Kaiser Permanente-Oakland
      • Orange, California, United States, 92868
        • Saint Joseph Hospital - Orange
      • Palm Springs, California, United States, 92262
        • Desert Regional Medical Center
      • Palo Alto, California, United States, 94301
        • Palo Alto Medical Foundation Health Care
      • Pleasanton, California, United States, 94588
        • Valley Medical Oncology Consultants
      • Rancho Mirage, California, United States, 92270
        • Eisenhower Medical Center
      • Redwood City, California, United States, 94063
        • Kaiser Permanente-Redwood City
      • Richmond, California, United States, 94801
        • Kaiser Permanente-Richmond
      • Roseville, California, United States, 95661
        • Kaiser Permanente-Roseville
      • Sacramento, California, United States, 95817
        • University of California Davis Comprehensive Cancer Center
      • Sacramento, California, United States, 95823
        • Kaiser Permanente-South Sacramento
      • Sacramento, California, United States, 95825
        • Kaiser Permanente Sacramento Medical Center
      • San Francisco, California, United States, 94115
        • Kaiser Permanente-San Francisco
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center-Pacific Campus
      • San Jose, California, United States, 95119
        • Kaiser Permanente-Santa Teresa-San Jose
      • San Leandro, California, United States, 94577
        • Kaiser Permanente San Leandro
      • San Rafael, California, United States, 94903
        • Kaiser Permanente-San Rafael
      • Santa Clara, California, United States, 95051
        • Kaiser Permanente Medical Center - Santa Clara
      • Santa Rosa, California, United States, 95403
        • Kaiser Permanente-Santa Rosa
      • South San Francisco, California, United States, 94080
        • Kaiser Permanente-South San Francisco
      • Stockton, California, United States, 95210
        • Kaiser Permanente-Stockton
      • Truckee, California, United States, 96161
        • Gene Upshaw Memorial Tahoe Forest Cancer Center
      • Vacaville, California, United States, 95688
        • Kaiser Permanente Medical Center-Vacaville
      • Vallejo, California, United States, 94589
        • Kaiser Permanente-Vallejo
      • Vallejo, California, United States, 94589
        • Sutter Solano Medical Center/Cancer Center
      • Walnut Creek, California, United States, 94596
        • Kaiser Permanente-Walnut Creek
    • Colorado
      • Aurora, Colorado, United States, 80012
        • The Medical Center of Aurora
      • Aurora, Colorado, United States, 80045
        • UCHealth University of Colorado Hospital
      • Boulder, Colorado, United States, 80303
        • Boulder Community Foothills Hospital
      • Colorado Springs, Colorado, United States, 80907
        • Penrose-Saint Francis Healthcare
      • Denver, Colorado, United States, 80205
        • Kaiser Permanente-Franklin
      • Denver, Colorado, United States, 80218
        • Presbyterian - Saint Lukes Medical Center - Health One
      • Denver, Colorado, United States, 80220
        • Rose Medical Center
      • Denver, Colorado, United States, 80204
        • Denver Health Medical Center
      • Denver, Colorado, United States, 80222
        • Western States Cancer Research NCORP
      • Denver, Colorado, United States, 80218
        • Saint Joseph Hospital - Cancer Centers of Colorado
      • Denver, Colorado, United States, 80210
        • AdventHealth Porter
      • Englewood, Colorado, United States, 80113
        • Swedish Medical Center
      • Fort Collins, Colorado, United States, 80524
        • Poudre Valley Hospital
      • Grand Junction, Colorado, United States, 81501
        • Saint Mary's Hospital and Regional Medical Center
      • Greeley, Colorado, United States, 80631
        • Banner North Colorado Medical Center
      • Lafayette, Colorado, United States, 80026
        • Kaiser Permanente-Rock Creek
      • Lakewood, Colorado, United States, 80228
        • CommonSpirit Saint Anthony Hospital Cancer Center
      • Lone Tree, Colorado, United States, 80124
        • Sky Ridge Medical Center
      • Longmont, Colorado, United States, 80501
        • Longmont United Hospital
      • Loveland, Colorado, United States, 80539
        • Banner North Colorado Medical Center - Loveland Campus
      • Parker, Colorado, United States, 80138
        • AdventHealth Parker
      • Pueblo, Colorado, United States, 81004
        • Saint Mary Corwin Medical Center
      • Thornton, Colorado, United States, 80229
        • North Suburban Medical Center
      • Wheat Ridge, Colorado, United States, 80401
        • Intermountain Health Lutheran Hospital
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Danbury Hospital
      • Hartford, Connecticut, United States, 06105
        • Smilow Cancer Hospital Care Center at Saint Francis
      • New Britain, Connecticut, United States, 06050
        • The Hospital of Central Connecticut
      • Norwalk, Connecticut, United States, 06856
        • Norwalk Hospital
    • Delaware
      • Lewes, Delaware, United States, 19958
        • Beebe Medical Center
      • Newark, Delaware, United States, 19718
        • Christiana Care Health System-Christiana Hospital
    • Florida
      • Jacksonville, Florida, United States, 32224-9980
        • Mayo Clinic in Florida
      • Orlando, Florida, United States, 32806
        • Orlando Health Cancer Institute
      • Orlando, Florida, United States, 32803
        • AdventHealth Orlando
      • Stuart, Florida, United States, 34994
        • Martin Medical Center
      • Stuart, Florida, United States, 34994
        • Robert and Carol Weissman Cancer Center at Martin Health
      • Stuart, Florida, United States, 34997
        • Martin Hospital South
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Emory Saint Joseph's Hospital
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital
      • Atlanta, Georgia, United States, 30342
        • Atlanta Regional CCOP
      • Austell, Georgia, United States, 30106
        • WellStar Cobb Hospital
      • Columbus, Georgia, United States, 31904
        • John B Amos Cancer Center
      • Decatur, Georgia, United States, 30033
        • Emory Decatur Hospital
      • Fayetteville, Georgia, United States, 30214
        • Piedmont Fayette Hospital
      • Lawrenceville, Georgia, United States, 30046
        • Northside Hospital - Gwinnett
      • Marietta, Georgia, United States, 30060
        • Wellstar Kennestone Hospital
      • Riverdale, Georgia, United States, 30274
        • Southern Regional Medical Center
      • Rome, Georgia, United States, 30165
        • Harbin Clinic Medical Oncology and Clinical Research
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Queen's Medical Center
      • Honolulu, Hawaii, United States, 96817
        • The Cancer Center of Hawaii-Liliha
      • Honolulu, Hawaii, United States, 96813
        • Hawaii Cancer Care Inc - Waterfront Plaza
      • Honolulu, Hawaii, United States, 96813
        • Straub Clinic and Hospital
      • Honolulu, Hawaii, United States, 96813
        • University of Hawaii Cancer Center
      • Honolulu, Hawaii, United States, 96817
        • Queen's Cancer Center - Kuakini
      • Honolulu, Hawaii, United States, 96826
        • Kapiolani Medical Center for Women and Children
      • Honolulu, Hawaii, United States, 96819
        • Kaiser Permanente Moanalua Medical Center
      • Kailua, Hawaii, United States, 96734
        • Castle Medical Center
      • Lihue, Hawaii, United States, 96766
        • Wilcox Memorial Hospital and Kauai Medical Clinic
      • Wailuku, Hawaii, United States, 96793
        • Maui Memorial Medical Center
      • Wailuku, Hawaii, United States, 96793
        • Pacific Cancer Institute of Maui
      • ‘Aiea, Hawaii, United States, 96701
        • Pali Momi Medical Center
    • Illinois
      • Alton, Illinois, United States, 62002
        • OSF Saint Anthony's Health Center
      • Aurora, Illinois, United States, 60504
        • Rush-Copley Medical Center
      • Berwyn, Illinois, United States, 60402
        • MacNeal Hospital and Cancer Center
      • Bloomington, Illinois, United States, 61704
        • Illinois CancerCare-Bloomington
      • Bloomington, Illinois, United States, 61701
        • OSF Saint Joseph Medical Center
      • Canton, Illinois, United States, 61520
        • Illinois CancerCare-Canton
      • Canton, Illinois, United States, 61520
        • Graham Hospital Association
      • Carthage, Illinois, United States, 62321
        • Illinois CancerCare-Carthage
      • Carthage, Illinois, United States, 62321
        • Memorial Hospital
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60612
        • University of Illinois
      • Chicago, Illinois, United States, 60611
        • Hematology and Oncology Associates
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, United States, 62526
        • Heartland Cancer Research NCORP
      • Downers Grove, Illinois, United States, 60515
        • Advocate Good Samaritan Hospital
      • Eureka, Illinois, United States, 61530
        • Illinois CancerCare-Eureka
      • Eureka, Illinois, United States, 61530
        • Eureka Hospital
      • Evanston, Illinois, United States, 60201
        • NorthShore University HealthSystem-Evanston Hospital
      • Galesburg, Illinois, United States, 61401
        • Illinois CancerCare-Galesburg
      • Galesburg, Illinois, United States, 61401
        • Galesburg Cottage Hospital
      • Havana, Illinois, United States, 62644
        • Mason District Hospital
      • Havana, Illinois, United States, 62644
        • Illinois CancerCare-Havana
      • Highland Park, Illinois, United States, 60035
        • Hematology Oncology Associates of Illinois-Highland Park
      • Hopedale, Illinois, United States, 61747
        • Hopedale Medical Complex - Hospital
      • Joliet, Illinois, United States, 60435
        • Duly Health and Care Joliet
      • Joliet, Illinois, United States, 60432
        • Midwest Center for Hematology Oncology
      • Kankakee, Illinois, United States, 60901
        • Presence Saint Mary's Hospital
      • Kewanee, Illinois, United States, 61443
        • Illinois CancerCare-Kewanee Clinic
      • Libertyville, Illinois, United States, 60048
        • AMG Libertyville - Oncology
      • Macomb, Illinois, United States, 61455
        • Illinois CancerCare-Macomb
      • Macomb, Illinois, United States, 61455
        • Mcdonough District Hospital
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
      • Monmouth, Illinois, United States, 61462
        • Illinois CancerCare-Monmouth
      • Monmouth, Illinois, United States, 61462
        • Holy Family Medical Center
      • Mount Vernon, Illinois, United States, 62864
        • SSM Health Good Samaritan
      • Naperville, Illinois, United States, 60563
        • DuPage Medical Group-Ogden
      • Niles, Illinois, United States, 60714
        • Illinois Cancer Specialists-Niles
      • Normal, Illinois, United States, 61761
        • Carle Cancer Institute Normal
      • Normal, Illinois, United States, 61761
        • Illinois CancerCare-Community Cancer Center
      • Normal, Illinois, United States, 61761
        • Carle BroMenn Medical Center
      • Ottawa, Illinois, United States, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Ottawa, Illinois, United States, 61350
        • Ottawa Regional Hospital and Healthcare Center
      • Pekin, Illinois, United States, 61554
        • Illinois CancerCare-Pekin
      • Pekin, Illinois, United States, 61554
        • Pekin Hospital
      • Pekin, Illinois, United States, 61554
        • OSF Saint Francis Radiation Oncology at Pekin
      • Peoria, Illinois, United States, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, United States, 61637
        • OSF Saint Francis Medical Center
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare-Peoria
      • Peoria, Illinois, United States, 61614
        • Proctor Hospital
      • Peru, Illinois, United States, 61354
        • Illinois CancerCare-Peru
      • Peru, Illinois, United States, 61354
        • Illinois Valley Hospital
      • Princeton, Illinois, United States, 61356
        • Illinois CancerCare-Princeton
      • Princeton, Illinois, United States, 61356
        • Perry Memorial Hospital
      • Skokie, Illinois, United States, 60076
        • Hematology Oncology Associates of Illinois - Skokie
      • Spring Valley, Illinois, United States, 61362
        • Saint Margaret's Hospital
      • Spring Valley, Illinois, United States, 61362
        • Illinois CancerCare-Spring Valley
      • Springfield, Illinois, United States, 62781
        • Springfield Memorial Hospital
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
      • Warrenville, Illinois, United States, 60555
        • Northwestern Medicine Cancer Center Warrenville
      • Winfield, Illinois, United States, 60190
        • Northwestern Medicine Central DuPage Hospital
    • Indiana
      • Beech Grove, Indiana, United States, 46107
        • Franciscan Saint Francis Health-Beech Grove
      • Elkhart, Indiana, United States, 46515
        • Elkhart General Hospital
      • Elkhart, Indiana, United States, 46514
        • Michiana Hematology Oncology PC-Elkhart
      • Elkhart, Indiana, United States, 46514-2098
        • Elkhart Clinic
      • Fort Wayne, Indiana, United States, 46845
        • Fort Wayne Medical Oncology and Hematology Inc-Parkview
      • Goshen, Indiana, United States, 46526
        • Goshen Center for Cancer Care
      • Kokomo, Indiana, United States, 46904
        • Community Howard Regional Health
      • La Porte, Indiana, United States, 46350
        • IU Health La Porte Hospital
      • Michigan City, Indiana, United States, 46360
        • Franciscan Saint Anthony Health-Michigan City
      • Mishawaka, Indiana, United States, 46545
        • Michiana Hematology Oncology PC-Mishawaka
      • Mishawaka, Indiana, United States, 46545
        • Saint Joseph Regional Medical Center-Mishawaka
      • Munster, Indiana, United States, 46321
        • The Community Hospital
      • Plymouth, Indiana, United States, 46563
        • Michiana Hematology Oncology PC-Plymouth
      • Richmond, Indiana, United States, 47374
        • Reid Health
      • South Bend, Indiana, United States, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, United States, 46628
        • Northern Indiana Cancer Research Consortium
      • Westville, Indiana, United States, 46391
        • Michiana Hematology Oncology PC-Westville
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403
        • Mercy Hospital
      • Cedar Rapids, Iowa, United States, 52403
        • Oncology Associates at Mercy Medical Center
      • Des Moines, Iowa, United States, 50309
        • Iowa-Wide Oncology Research Coalition NCORP
      • Mason City, Iowa, United States, 50401
        • Mercy Medical Center - North Iowa
      • Ottumwa, Iowa, United States, 52501
        • Ottumwa Regional Health Center
      • Sioux City, Iowa, United States, 51101
        • Siouxland Regional Cancer Center
      • Sioux City, Iowa, United States, 51102
        • Mercy Medical Center-Sioux City
      • Sioux City, Iowa, United States, 51104
        • Saint Luke's Regional Medical Center
    • Kansas
      • Lawrence, Kansas, United States, 66044
        • Lawrence Memorial Hospital
      • Overland Park, Kansas, United States, 66209
        • Menorah Medical Center
      • Overland Park, Kansas, United States, 66213
        • Saint Luke's South Hospital
      • Prairie Village, Kansas, United States, 66208
        • Kansas City NCI Community Oncology Research Program
      • Salina, Kansas, United States, 67401
        • Salina Regional Health Center
      • Shawnee Mission, Kansas, United States, 66204
        • AdventHealth Shawnee Mission
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Cancer Center / Stormont Vail Health
      • Wichita, Kansas, United States, 67214
        • Wichita NCI Community Oncology Research Program
      • Wichita, Kansas, United States, 67214
        • Wesley Medical Center
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Mary Bird Perkins Cancer Center
      • New Orleans, Louisiana, United States, 70112
        • University Medical Center New Orleans
      • New Orleans, Louisiana, United States, 70112
        • Louisiana State University Health Science Center
    • Maine
      • Augusta, Maine, United States, 04330
        • Harold Alfond Center for Cancer Care
      • Bangor, Maine, United States, 04401
        • Eastern Maine Medical Center
      • York Village, Maine, United States, 03909
        • York Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Sinai Hospital of Baltimore
      • Baltimore, Maryland, United States, 21204
        • Greater Baltimore Medical Center
      • Elkton, Maryland, United States, 21921
        • Christiana Care - Union Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Concord, Massachusetts, United States, 01742
        • Commonwealth Hematology Oncology PC-Concord
      • Haverhill, Massachusetts, United States, 01830
        • Dana Farber Community Cancer Care-Haverhill
      • Methuen, Massachusetts, United States, 01844
        • Dana Farber-Merrimack Valley
      • Quincy, Massachusetts, United States, 02169
        • Dana Farber Community Cancer Care-Quincy
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center
      • Stoneham, Massachusetts, United States, 02180
        • Dana Farber Community Cancer Care-Stoneham
      • Weymouth, Massachusetts, United States, 02189
        • Dana Farber Community Cancer Care-Weymouth
      • Worcester, Massachusetts, United States, 01605
        • Commonwealth Hematology Oncology PC-Worcester
    • Michigan
      • Adrian, Michigan, United States, 49221
        • Bixby Medical Center
      • Adrian, Michigan, United States, 49221
        • Hickman Cancer Center
      • Ann Arbor, Michigan, United States, 48106
        • Michigan Cancer Research Consortium NCORP
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Rogel Cancer Center
      • Ann Arbor, Michigan, United States, 48106
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
      • Battle Creek, Michigan, United States, 49017
        • Bronson Battle Creek
      • Big Rapids, Michigan, United States, 49307
        • Spectrum Health Big Rapids Hospital
      • Dearborn, Michigan, United States, 48124
        • Corewell Health Dearborn Hospital
      • Detroit, Michigan, United States, 48201
        • Wayne State University/Karmanos Cancer Institute
      • Detroit, Michigan, United States, 48236
        • Henry Ford Health Saint John Hospital
      • Escanaba, Michigan, United States, 49829
        • OSF Saint Francis Hospital and Medical Group
      • Flint, Michigan, United States, 48532
        • Genesys Regional Medical Center-West Flint Campus
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center
      • Grand Rapids, Michigan, United States, 49503
        • Cancer Research Consortium of West Michigan NCORP
      • Grand Rapids, Michigan, United States, 49503
        • Trinity Health Grand Rapids Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
      • Holland, Michigan, United States, 49423
        • Holland Community Hospital
      • Jackson, Michigan, United States, 49201
        • Allegiance Health
      • Kalamazoo, Michigan, United States, 49007
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, United States, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, United States, 49048
        • Beacon Kalamazoo
      • Lansing, Michigan, United States, 48912
        • University of Michigan Health - Sparrow Lansing
      • Livonia, Michigan, United States, 48154
        • Trinity Health Saint Mary Mercy Livonia Hospital
      • Marquette, Michigan, United States, 49855
        • UP Health System Marquette
      • Monroe, Michigan, United States, 48162
        • Mercy Memorial Hospital
      • Monroe, Michigan, United States, 48162
        • Toledo Clinic Cancer Centers-Monroe
      • Mount Clemens, Michigan, United States, 48043
        • McLaren Cancer Institute-Macomb
      • Muskegon, Michigan, United States, 49442
        • Mercy Health Partners-Hackley Campus
      • Muskegon, Michigan, United States, 49444
        • Trinity Health Muskegon Hospital
      • Niles, Michigan, United States, 49120
        • Corewell Health Lakeland Hospitals - Niles Hospital
      • Pontiac, Michigan, United States, 48341
        • Trinity Health Saint Joseph Mercy Oakland Hospital
      • Port Huron, Michigan, United States, 48060
        • Lake Huron Medical Center
      • Royal Oak, Michigan, United States, 48073
        • Corewell Health William Beaumont University Hospital
      • Saginaw, Michigan, United States, 48601
        • MyMichigan Medical Center Saginaw
      • Saint Joseph, Michigan, United States, 49085
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
      • Saint Joseph, Michigan, United States, 49085
        • Corewell Health Lakeland Hospitals - Saint Joseph Hospital
      • Southfield, Michigan, United States, 48075
        • Henry Ford Health Providence Southfield Hospital
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
      • Warren, Michigan, United States, 48093
        • Henry Ford Health Warren Hospital
      • Wyoming, Michigan, United States, 49519
        • University of Michigan Health - West
    • Minnesota
      • Alexandria, Minnesota, United States, 56308
        • Medini, Eitan MD (UIA Investigator)
      • Brainerd, Minnesota, United States, 56401
        • Essentia Health Saint Joseph's Medical Center
      • Burnsville, Minnesota, United States, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Duluth, Minnesota, United States, 55805
        • Essentia Health Cancer Center
      • Duluth, Minnesota, United States, 55805
        • Essentia Health Saint Mary's Medical Center
      • Duluth, Minnesota, United States, 55805
        • Miller-Dwan Hospital
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Hospital
      • Fergus Falls, Minnesota, United States, 56537
        • Etzell, Paul S MD (UIA Investigator)
      • Fergus Falls, Minnesota, United States, 56537
        • Swenson, Wade II, MD (UIA Investigator)
      • Fridley, Minnesota, United States, 55432
        • Unity Hospital
      • Hutchinson, Minnesota, United States, 55350
        • Hutchinson Area Health Care
      • Litchfield, Minnesota, United States, 55355
        • Meeker County Memorial Hospital
      • Maplewood, Minnesota, United States, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55407
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, United States, 55407
        • Virginia Piper Cancer Institute
      • Robbinsdale, Minnesota, United States, 55422
        • North Memorial Medical Health Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester
      • Saint Cloud, Minnesota, United States, 56303
        • Coborn Cancer Center at Saint Cloud Hospital
      • Saint Cloud, Minnesota, United States, 56303
        • Saint Cloud Hospital
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Louis Park, Minnesota, United States, 55416
        • Metro Minnesota Community Oncology Research Consortium
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, United States, 55102
        • United Hospital
      • Saint Paul, Minnesota, United States, 55102
        • Saint Joseph's Hospital - Healtheast
      • Shakopee, Minnesota, United States, 55379
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, United States, 55082
        • Lakeview Hospital
      • Waconia, Minnesota, United States, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, United States, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology Hematology PA-Woodbury
      • Woodbury, Minnesota, United States, 55125
        • Fairview Cancer Center - Woodbury
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
      • Keesler Air Force Base, Mississippi, United States, 39534
        • Keesler Medical Center
      • Pascagoula, Mississippi, United States, 39581
        • Singing River Hospital
    • Missouri
      • Cape Girardeau, Missouri, United States, 63703
        • Saint Francis Medical Center
      • Cape Girardeau, Missouri, United States, 63701
        • Southeast Missouri Hospital
      • Joplin, Missouri, United States, 64804
        • Freeman Health System
      • Kansas City, Missouri, United States, 64116
        • North Kansas City Hospital
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital of Kansas City
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center
      • Kansas City, Missouri, United States, 64118
        • Heartland Hematology and Oncology Associates Incorporated
      • Kansas City, Missouri, United States, 64114
        • Saint Joseph Health Center
      • Kansas City, Missouri, United States, 64108
        • University Health Truman Medical Center
      • Lee's Summit, Missouri, United States, 64086
        • Saint Luke's East - Lee's Summit
      • Liberty, Missouri, United States, 64068
        • Liberty Hospital
      • Saint Joseph, Missouri, United States, 64506
        • Heartland Regional Medical Center
      • St Louis, Missouri, United States, 63109
        • Mercy Infusion Center - Chippewa
      • St Louis, Missouri, United States, 63141
        • Mercy Hospital Saint Louis
      • St Louis, Missouri, United States, 63141
        • Saint Louis-Cape Girardeau CCOP
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic Cancer Center
      • Billings, Montana, United States, 59101
        • Saint Vincent Healthcare
      • Billings, Montana, United States, 59102
        • Montana Cancer Consortium NCORP
      • Billings, Montana, United States, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, United States, 59102
        • Saint Vincent Frontier Cancer Center
      • Bozeman, Montana, United States, 59715
        • Bozeman Health Deaconess Hospital
      • Butte, Montana, United States, 59701
        • Saint James Community Hospital and Cancer Treatment Center
      • Great Falls, Montana, United States, 59405
        • Great Falls Clinic
      • Great Falls, Montana, United States, 59405
        • Berdeaux, Donald MD (UIA Investigator)
      • Great Falls, Montana, United States, 59405
        • Benefis Sletten Cancer Institute
      • Havre, Montana, United States, 59501
        • Northern Montana Hospital
      • Helena, Montana, United States, 59601
        • Saint Peter's Community Hospital
      • Kalispell, Montana, United States, 59901
        • Glacier Oncology PLLC
      • Kalispell, Montana, United States, 59901
        • Kalispell Medical Oncology
      • Kalispell, Montana, United States, 59901
        • Logan Health Medical Center
      • Missoula, Montana, United States, 59802
        • Saint Patrick Hospital - Community Hospital
      • Missoula, Montana, United States, 59804
        • Guardian Oncology and Center for Wellness
      • Missoula, Montana, United States, 59802
        • Montana Cancer Specialists
      • Missoula, Montana, United States, 59804
        • Community Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, United States, 89120
        • Nevada Cancer Research Foundation NCORP
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper Hospital University Medical Center
      • Freehold, New Jersey, United States, 07728
        • CentraState Medical Center
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
      • Newark, New Jersey, United States, 07101
        • Rutgers New Jersey Medical School
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Lovelace Medical Center-Saint Joseph Square
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico Cancer Center
      • Las Cruces, New Mexico, United States, 88011
        • Memorial Medical Center-Las Cruces
      • San Juan, New Mexico, United States, 87401
        • San Juan Regional Medical Center
    • New York
      • Glens Falls, New York, United States, 12801
        • Adirondack Cancer Center
      • Middletown, New York, United States, 10940
        • Garnet Health Medical Center
      • Mineola, New York, United States, 11501
        • NYU Langone Hospital - Long Island
      • New York, New York, United States, 10019
        • Mount Sinai West
      • New York, New York, United States, 10003
        • Mount Sinai Union Square
      • Rochester, New York, United States, 14642
        • University of Rochester
      • Rochester, New York, United States, 14620
        • Highland Hospital
      • The Bronx, New York, United States, 10466
        • Montefiore Medical Center-Wakefield Campus
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Mission Hospital
      • Charlotte, North Carolina, United States, 28204
        • Novant Health Presbyterian Medical Center
      • Goldsboro, North Carolina, United States, 27534
        • Wayne Memorial Hospital
      • Hendersonville, North Carolina, United States, 28791
        • Margaret R Pardee Memorial Hospital
      • Kinston, North Carolina, United States, 28501
        • ECU Health Oncology Kinston
      • Rutherfordton, North Carolina, United States, 28139
        • Rutherford Hospital
      • Winston-Salem, North Carolina, United States, 27104
        • Southeast Clinical Oncology Research Consortium NCORP
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Sanford Bismarck Medical Center
      • Bismarck, North Dakota, United States, 58501
        • Mid Dakota Clinic
      • Bismarck, North Dakota, United States, 58501
        • Saint Alexius Medical Center
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Cleveland Clinic Cancer Center Beachwood
      • Bowling Green, Ohio, United States, 43402
        • Toledo Clinic Cancer Centers-Bowling Green
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44111
        • Cleveland Clinic Cancer Center/Fairview Hospital
      • Clyde, Ohio, United States, 43410
        • North Coast Cancer Care-Clyde
      • Dayton, Ohio, United States, 45406
        • Good Samaritan Hospital - Dayton
      • Dayton, Ohio, United States, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, United States, 45415
        • Miami Valley Hospital North
      • Dayton, Ohio, United States, 45405
        • Grandview Hospital
      • Dayton, Ohio, United States, 45459
        • Dayton NCI Community Oncology Research Program
      • Dayton, Ohio, United States, 45428
        • Dayton Veterans Affairs Medical Center
      • Elyria, Ohio, United States, 44035
        • Mercy Cancer Center-Elyria
      • Elyria, Ohio, United States, 44035
        • Hematology Oncology Center Incorporated
      • Findlay, Ohio, United States, 45840
        • Blanchard Valley Hospital
      • Franklin, Ohio, United States, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Greenville, Ohio, United States, 45331
        • Wayne Hospital
      • Independence, Ohio, United States, 44131
        • Cleveland Clinic Cancer Center Independence
      • Kettering, Ohio, United States, 45429
        • Kettering Medical Center
      • Lima, Ohio, United States, 45801
        • Saint Rita's Medical Center
      • Lima, Ohio, United States, 45804
        • Lima Memorial Hospital
      • Maumee, Ohio, United States, 43537
        • Toledo Clinic Cancer Centers-Maumee
      • Maumee, Ohio, United States, 43537
        • Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
      • Maumee, Ohio, United States, 43537
        • Saint Luke's Hospital
      • Mayfield Heights, Ohio, United States, 44124
        • Hillcrest Hospital Cancer Center
      • Norwalk, Ohio, United States, 44857
        • Fisher-Titus Medical Center
      • Oregon, Ohio, United States, 43616
        • Saint Charles Hospital
      • Oregon, Ohio, United States, 43616
        • Toledo Clinic Cancer Centers-Oregon
      • Parma, Ohio, United States, 44129
        • University Hospitals Parma Medical Center
      • Sandusky, Ohio, United States, 44870
        • North Coast Cancer Care
      • Sylvania, Ohio, United States, 43560
        • ProMedica Flower Hospital
      • Tiffin, Ohio, United States, 44883
        • Mercy Hospital of Tiffin
      • Toledo, Ohio, United States, 43606
        • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
      • Toledo, Ohio, United States, 43623
        • Mercy Health - Saint Anne Hospital
      • Toledo, Ohio, United States, 43623
        • Toledo Clinic Cancer Centers-Toledo
      • Toledo, Ohio, United States, 43614
        • University of Toledo
      • Toledo, Ohio, United States, 43617
        • Toledo Community Hospital Oncology Program CCOP
      • Toledo, Ohio, United States, 43608
        • Mercy Health - Saint Vincent Hospital
      • Troy, Ohio, United States, 45373
        • Upper Valley Medical Center
      • Wauseon, Ohio, United States, 43567
        • Fulton County Health Center
      • Wilmington, Ohio, United States, 45177
        • Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center
      • Wooster, Ohio, United States, 44691
        • Cleveland Clinic Wooster Family Health and Surgery Center
      • Xenia, Ohio, United States, 45385
        • Greene Memorial Hospital
    • Oregon
      • Clackamas, Oregon, United States, 97015
        • Clackamas Radiation Oncology Center
      • Gresham, Oregon, United States, 97030
        • Legacy Mount Hood Medical Center
      • Milwaukie, Oregon, United States, 97222
        • Providence Milwaukie Hospital
      • Newberg, Oregon, United States, 97132
        • Providence Newberg Medical Center
      • Oregon City, Oregon, United States, 97045
        • Providence Willamette Falls Medical Center
      • Portland, Oregon, United States, 97210
        • Legacy Good Samaritan Hospital and Medical Center
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97225
        • Providence Saint Vincent Medical Center
      • Portland, Oregon, United States, 97227
        • Legacy Emanuel Hospital and Health Center
      • Portland, Oregon, United States, 97216
        • Adventist Medical Center
      • Portland, Oregon, United States, 97227
        • Compass Oncology Rose Quarter
      • Tualatin, Oregon, United States, 97062
        • Legacy Meridian Park Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital-Cedar Crest
      • Butler, Pennsylvania, United States, 16001
        • Butler Memorial Hospital
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • DuBois, Pennsylvania, United States, 15801
        • Oncology Hematology Associates of Northern Pennsylvania
      • Hazleton, Pennsylvania, United States, 18201
        • Geisinger Medical Center-Cancer Center Hazleton
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Milton S Hershey Medical Center
      • Lancaster, Pennsylvania, United States, 17602
        • Lancaster General Hospital
      • Philadelphia, Pennsylvania, United States, 19107
        • Pennsylvania Hospital
      • State College, Pennsylvania, United States, 16801
        • Geisinger Medical Group
      • State College, Pennsylvania, United States, 16803
        • Mount Nittany Medical Center
      • Upland, Pennsylvania, United States, 19013
        • Associates In Hematology Oncology PC-Upland
      • West Grove, Pennsylvania, United States, 19390
        • Jennersville Regional Hospital
      • West Reading, Pennsylvania, United States, 19611
        • Reading Hospital
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Geisinger Wyoming Valley/Henry Cancer Center
      • Wilkes-Barre, Pennsylvania, United States, 18765
        • Geisinger South Wilkes-Barre
    • Rhode Island
      • Cranston, Rhode Island, United States, 02920
        • Hematology and Oncology Associates of Rhode Island Inc
      • Pawtucket, Rhode Island, United States, 02860
        • Memorial Hospital of Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Kent Hospital
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Health Hospital
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Center
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, United States, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Cancer Center Oncology Clinic
      • Sioux Falls, South Dakota, United States, 57105
        • Medical X-Ray Center
      • Sioux Falls, South Dakota, United States, 57117-5045
        • Avera McKennan Hospital and University Health Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Erlanger Medical Center
      • Jackson, Tennessee, United States, 38301
        • Jackson-Madison County General Hospital
      • Jackson, Tennessee, United States, 38301
        • The Jackson Clinic PA
      • Kingsport, Tennessee, United States, 37660
        • Wellmont Holston Valley Hospital and Medical Center
      • Memphis, Tennessee, United States, 38163
        • University of Tennessee Health Science Center
    • Texas
      • Amarillo, Texas, United States, 79106
        • The Don and Sybil Harrington Cancer Center
      • Fort Sam Houston, Texas, United States, 78234
        • Brooke Army Medical Center
      • Houston, Texas, United States, 77030
        • UT MD Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
      • Houston, Texas, United States, 77030
        • Michael E DeBakey VA Medical Center
      • Houston, Texas, United States, 77030
        • Ben Taub General Hospital
      • Houston, Texas, United States, 77030
        • Baylor Saint Luke's Medical Center
      • Lackland Air Force Base, Texas, United States, 78236
        • Wilford Hall Medical Center
    • Virginia
      • Danville, Virginia, United States, 24541
        • Danville Regional Medical Center
      • Fredericksburg, Virginia, United States, 22401
        • Fredericksburg Oncology Inc
      • Martinsville, Virginia, United States, 24112
        • Sovah Health Martinsville
      • Norton, Virginia, United States, 24273
        • Ballad Health Cancer Care - Norton
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
      • Vancouver, Washington, United States, 98686
        • Legacy Salmon Creek Hospital
      • Vancouver, Washington, United States, 98664
        • PeaceHealth Southwest Medical Center
      • Vancouver, Washington, United States, 98684
        • Compass Oncology Vancouver
    • West Virginia
      • Wheeling, West Virginia, United States, 26003
        • Wheeling Hospital/Schiffler Cancer Center
    • Wisconsin
      • Burlington, Wisconsin, United States, 53105
        • Aurora Cancer Care-Southern Lakes VLCC
      • Chippewa Falls, Wisconsin, United States, 54729
        • Marshfield Clinic-Chippewa Center
      • Eau Claire, Wisconsin, United States, 54701
        • HSHS Sacred Heart Hospital
      • Eau Claire, Wisconsin, United States, 54701
        • Marshfield Clinic Cancer Center at Sacred Heart
      • Green Bay, Wisconsin, United States, 54311
        • Aurora BayCare Medical Center
      • Green Bay, Wisconsin, United States, 54301
        • Saint Vincent Hospital Cancer Center Green Bay
      • Green Bay, Wisconsin, United States, 54303
        • Saint Vincent Hospital Cancer Center at Saint Mary's
      • Green Bay, Wisconsin, United States, 54301-3526
        • Green Bay Oncology at Saint Vincent Hospital
      • Johnson Creek, Wisconsin, United States, 53038
        • University of Wisconsin Carbone Cancer Center - Johnson Creek
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Medical Center
      • La Crosse, Wisconsin, United States, 54601
        • Mayo Clinic Health System-Franciscan Healthcare
      • Ladysmith, Wisconsin, United States, 54848
        • Marshfield Medical Center - Ladysmith
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Carbone Cancer Center - University Hospital
      • Manitowoc, Wisconsin, United States, 54221
        • Holy Family Memorial Hospital
      • Marinette, Wisconsin, United States, 54143
        • Aurora Bay Area Medical Group-Marinette
      • Marinette, Wisconsin, United States, 54143
        • Bay Area Medical Center
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Medical Center-Marshfield
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Medical Center
      • Milwaukee, Wisconsin, United States, 53210
        • Ascension Southeast Wisconsin Hospital-Saint Joseph-Milwaukee
      • Minocqua, Wisconsin, United States, 54548
        • Marshfield Medical Center - Minocqua
      • Oconto Falls, Wisconsin, United States, 54154
        • Saint Vincent Hospital Cancer Center at Oconto Falls
      • Rhinelander, Wisconsin, United States, 54501
        • Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
      • Rice Lake, Wisconsin, United States, 54868
        • Marshfield Medical Center-Rice Lake
      • Sheboygan, Wisconsin, United States, 53081
        • Vince Lombardi Cancer Clinic-Sheboygan
      • Sheboygan, Wisconsin, United States, 53081
        • HSHS Saint Nicholas Hospital
      • Stevens Point, Wisconsin, United States, 54481
        • Aspirus Cancer Care - Stevens Point
      • Sturgeon Bay, Wisconsin, United States, 54235-1495
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
      • Summit, Wisconsin, United States, 53066
        • Aurora Medical Center in Summit
      • Two Rivers, Wisconsin, United States, 54241
        • Vince Lombardi Cancer Clinic-Two Rivers
      • Weston, Wisconsin, United States, 54476
        • Marshfield Medical Center - Weston
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Marshfield Clinic - Wisconsin Rapids Center
    • Wyoming
      • Casper, Wyoming, United States, 82609
        • Rocky Mountain Oncology
      • Sheridan, Wyoming, United States, 82801
        • Welch Cancer Center

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

Description

Inclusion Criteria:

  • Patients must have newly diagnosed multiple myeloma with measurable disease; patients with non-secretory multiple myeloma (MM) based upon standard M-component criteria (i.e., measurable serum/urine M-component) are not eligible for this study; exception: patients with non-secretory MM will be eligible only if the baseline serum Freelite is elevated (Note that serum Freelite must be drawn; serum light chains are not acceptable); all tests for establishing baseline disease status must be completed within 28 days prior to registration and documented on the baseline and follow-up tumor assessment form for multiple myeloma
  • Patients must have received no prior chemotherapy for this disease; patients must have received no prior radiotherapy to a large area of the pelvis (more than half of the pelvis); prior steroid treatment is allowed provided treatment was not more than 2 weeks in duration; patients must not have received any prior treatment with bortezomib or lenalidomide
  • Patients must have a Zubrod performance status (PS) of 0 - 3; NOTE: patients with PS 3 are eligible only if it is documented by the treating physician that the patient's multiple myeloma is the central cause of his/her disability; patients who have a PS of 3 due to other concurrent medical conditions are not eligible for this trial
  • Platelet count >= 80 x 10^3/mcL; must be obtained within 28 days prior to registration; exception: patients with biopsy-proven heavy-marrow involvement, as defined by having at least 30% marrow cellularity, with > 50% of the cells being malignant plasma cells (documented marrow results required); in this case, although there are no required lower limits of normal for the blood counts, the treating physician must use his/her medical judgment as to the appropriateness of this study therapy for these patients
  • Absolute neutrophil count (ANC) >= 1 x 10^3/mcL; must be obtained within 28 days prior to registration; exception: patients with biopsy-proven heavy-marrow involvement, as defined by having at least 30% marrow cellularity, with > 50% of the cells being malignant plasma cells (documented marrow results required); in this case, although there are no required lower limits of normal for the blood counts, the treating physician must use his/her medical judgment as to the appropriateness of this study therapy for these patients
  • Hemoglobin (including patients who have been either transfused or treated with erythropoietin [EPO]) >= 9 g/dL; must be obtained within 28 days prior to registration; exception: patients with biopsy-proven heavy-marrow involvement, as defined by having at least 30% marrow cellularity, with > 50% of the cells being malignant plasma cells (documented marrow results required); in this case, although there are no required lower limits of normal for the blood counts, the treating physician must use his/her medical judgment as to the appropriateness of this study therapy for these patients
  • Patients must be offered participation in the Myeloma Specimen Repository for banking and future research; with the patient's consent, bone marrow aspirates and serum specimens will be submitted to the Myeloma Specimen Repository for additional testing and banking (including SNP testing); patient consent must be obtained before specimens may be submitted
  • Patients must have baseline skeletal survey to include lateral skull, anterior-posterior (AP) pelvis and posterior-anterior (PA) chest within 28 days prior to registration
  • Institutions must submit a local cytogenetics report and fluorescence in situ hybridization (FISH) analysis report obtained prior to enrollment to S0777; for FISH analysis two probes will be utilized: LSI 13 (RBI) 13q14 SpectrumOrange Probe for detection of chromosome 13 deletion and LSI p53 (17p13.1) SpectrumOrange probe for detection of tumor protein (p)53 locus on chromosome 17; if these exact probes are not available locally, it is acceptable to submit results using local protocol; this must be noted on the prestudy form; NOTE: it is not required that the results of the FISH analysis be known prior to registration, only that pre-registration specimens be drawn and sent for analysis prior to registration, and the FISH analysis report be submitted
  • Patients with pathologic fractures, pneumonia at diagnosis or symptomatic hyperviscosity must have these conditions attended to prior to registration (i.e., intramedullary rod, I.V. antibiotics, plasmapheresis)
  • Patients must have a calculated or measured creatinine clearance > 30 cc/min; measured creatinine clearance or serum creatinine used in calculation must be obtained within 28 days prior to registration
  • Patients must not have uncontrolled, active infection requiring intravenous antibiotics, New York Heart Association (NYHA) class III or class IV heart failure, myocardial infarction within the last 6 months, history of treatment for clinically significant ventricular cardiac arrhythmias, poorly controlled hypertension, or poorly controlled diabetes mellitus; patients must have undergone an electrocardiogram (EKG) within 28 days prior to registration
  • Patients must not have any psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
  • Patients must not be hepatitis B, hepatitis C or human immunodeficiency virus (HIV) positive; patients must have a negative hepatitis B and HIV test performed within 28 days prior to registration; exception: treatment-sensitive HIV infection patients will be eligible provided that immunological and virologic indices are indicative of favorable long-term survival prospects on the basis of HIV infection, but whose life expectancy is limited predominantly by multiple myeloma rather than HIV infection in the judgment of the treating physician
  • Patients must not have a history of cerebral vascular accident with persistent neurologic deficits
  • Patients must be able to take aspirin 325 mg daily (or enoxaparin 40 mg subcutaneously [SQ] daily if patient is unable to take aspirin) as prophylactic anticoagulation; exception: patients receiving anticoagulation therapy such as Coumadin or heparin will NOT receive aspirin, and therefore need not be able to take it
  • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days and again within 24 hours prior to starting cycle 1 of lenalidomide; further, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy; a FCBP is a sexually mature woman who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months); all patients must be counseled by a trained counselor every 28 days about pregnancy precautions and risks of fetal exposure
  • No prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for five years
  • Patients must be offered participation in gene expression profiling (GEP) molecular studies for the evaluation of genetic polymorphisms
  • All patients must be informed of the investigational nature of this study and must sign and give written consent in accordance with institutional federal guidelines
  • At the time of patient registration, the treating institution's name and identification (ID) number must be provided to the statistical center in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base

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
Active Comparator: Arm I (dexamethasone and lenalidomide)
Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: Lenalidomide
Given PO
Other Names:
  • CC-5013
  • Revlimid
  • CC5013
  • CDC 501
  • CC 5013
Drug: Dexamethasone
Given PO
Other Names:
  • Decadron
  • Hemady
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron DP
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethasone Intensol
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Dxevo
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • TaperDex
  • Visumetazone
  • ZoDex
  • LenaDex
Other: Laboratory Biomarker Analysis
Optional correlative studies
Experimental: Arm II (dexamethasone, lenalidomide, bortezomib)
Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Drug: Lenalidomide
Given PO
Other Names:
  • CC-5013
  • Revlimid
  • CC5013
  • CDC 501
  • CC 5013
Drug: Dexamethasone
Given PO
Other Names:
  • Decadron
  • Hemady
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron DP
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethasone Intensol
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Dxevo
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • TaperDex
  • Visumetazone
  • ZoDex
  • LenaDex
Other: Laboratory Biomarker Analysis
Optional correlative studies
Drug: Bortezomib
Given IV
Other Names:
  • Velcade
  • MLN341
  • PS-341
  • LDP 341
  • [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid
  • PS341
  • LDP-341
  • MLN-341
  • LDP341
  • MLN 341
  • PS 341
  • Boruzu

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival
Time Frame: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 6 years
Unstratified median progression-free survival in months.
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Up to 6 years
Unstratified median overall survival in months.
Up to 6 years
Response Rates ()
Time Frame: Up to 6 years
The response rate was calculated as the number of patients with documented confirmed partial response (PR) or better, which includes confirmed/unconfirmed stringent complete response (sCR), confirmed/unconfirmed complete response (CR), confirmed/unconfirmed very good partial response (VGPR), or confirmed partial response (PR), as best response divided by the total number of evaluable patients, in each arm. Patients with measurable disease, as defined in the protocol, are evaluable. Response rates were compared between the two treatment arms using a stratified Cochran-Mantel-Haenszel test. Response designations were based on the International Uniform Response Criteria for Multiple Myeloma. Due to the complexity of these criteria, the details of these criteria have been omitted.
Up to 6 years

Collaborators and Investigators

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

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Brian M Durie, SWOG Cancer Research Network

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)

July 28, 2008

Primary Completion (Actual)

November 5, 2015

Study Completion (Estimated)

June 10, 2027

Study Registration Dates

First Submitted

March 22, 2008

First Submitted That Met QC Criteria

March 22, 2008

First Posted (Estimated)

March 26, 2008

Study Record Updates

Last Update Posted (Actual)

July 29, 2026

Last Update Submitted That Met QC Criteria

July 7, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2009-00798 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U10CA032102 (U.S. NIH Grant/Contract)
  • U10CA180888 (U.S. NIH Grant/Contract)
  • SWOG-S0777
  • S0777 (Other Identifier: CTEP)
  • CDR0000590321

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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