Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant

Last updated: May 9, 2025
Sponsor: National Cancer Institute (NCI)
Overall Status: Active - Not Recruiting

Phase

3

Condition

Multiple Myeloma

Platelet Disorders

Leukemia

Treatment

Laboratory Biomarker Analysis

Peripheral Blood Stem Cell Transplantation

Placebo Administration

Clinical Study ID

NCT00114101
NCI-2009-00439
NCI-2009-00439
U10CA180821
CDR0000434845
CALGB 100104/ECOG 100104
U10CA031946
CALGB-100104
  • Ages 18-70
  • All Genders

Study Summary

This randomized phase III trial studies lenalidomide to see how well it works compared to a placebo in treating patients with multiple myeloma who are undergoing autologous stem cell transplant. Giving chemotherapy before a peripheral blood stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Giving lenalidomide after autologous stem cell transplant may be an effective treatment for multiple myeloma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients must have active multiple myeloma requiring treatment (Durie-Salmon stage >= 1) and have stable disease or be responsive to at least 2 months of any induction therapy; patients with smoldering myeloma are not eligible unless the disease has progressed to >= stage 1

  • No more than 12 months of any prior therapy, including CC-5013 and thalidomide

  • Within 12 months of initiation of induction therapy

  • No prior progression after initial therapy; in addition, no more than two regimens will be allowed excluding dexamethasone alone

  • No prior peripheral blood, bone marrow, or solid organ transplant

  • Patients must have peripheral blood stem cell collection of >= 2 x 10^6 cluster of differentiation (CD)34+ cells/kg (patient body weight) and preferably 5 x 10^6 cells/kg (patient body weight); stem cells may be collected at any time prior to transplant; peripheral blood stem cell collection may occur before or after registration

  • Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

  • Patients must have diffusing capacity of the lung for carbon monoxide (DLCO) > 50% predicted with no symptomatic pulmonary disease

  • Patients must have left ventricular ejection fraction (LVEF) >= 40% by multi gated acquisition scan (MUGA) or echocardiogram

  • Patients must not have uncontrolled diabetes mellitus

  • Patients must not have an active serious infection

  • Patients must not be human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSag), or hepatitis (Hep) C positive

  • Patients must be non-pregnant and non-nursing; women of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL 10-14 days prior to registration and repeated within 24 hours prior to the first dose of lenalidomide; in addition, women of childbearing potential taking lenalidomide must have a pregnancy test performed by the doctor weekly during the first 4 weeks of treatment, and then every 4 weeks if menses are regular and every 2 weeks if menses are irregular, and then 30 days following the last dose of lenalidomide; women of childbearing potential must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control - one highly effective method (intrauterine device [IUD], hormonal, tubal ligation, or partner's vasectomy), and one additional effective method (latex condom, diaphragm, or cervical cap) - at the same time, at least 4 weeks before she begins lenalidomide therapy; "women of childbearing" potential is defined as a sexually mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months; men must agree not to father a child and must use a latex condom during any sexual contact with women of childbearing potential while taking lenalidomide and for 4 weeks after therapy is stopped, even if they have undergone a successful vasectomy

  • Absolute neutrophil count (ANC) >= 1000/uL

  • Platelets >= 100,000/uL

  • Creatinine clearance* >= 40 cc/min

  • To be calculated by method of Cockcroft-Gault or after 24-hour urine collection

  • Creatinine =< 2 mg/dL

  • Total bilirubin =< 2 mg/dL

  • Aspartate aminotransferase (AST) =< 3 x upper limits of normal

  • Alkaline phosphatase =< 3 x upper limits of normal

  • Urine (U)-human chorionic gonadotropin (HCG) or serum HCG negative (if patient of childbearing potential)

Study Design

Total Participants: 460
Treatment Group(s): 6
Primary Treatment: Laboratory Biomarker Analysis
Phase: 3
Study Start date:
December 15, 2004
Estimated Completion Date:
February 22, 2026

Study Description

PRIMARY OBJECTIVE:

I. To determine the efficacy of CC-5013 (lenalidomide) in prolonging time to disease progression in patients with multiple myeloma after autologous stem cell transplant (ASCT).

SECONDARY OBJECTIVES:

I. To determine if CC-5013 will increase the complete response (CR) rate in patients with multiple myeloma following ASCT.

II. To compare the progression-free survival (PFS) and overall survival (OS) in patients with multiple myeloma who have undergone ASCT and who then are randomized to either CC-5013 or placebo.

III. To determine the feasibility of long-term administration of CC-5013 to multiple myeloma patients who have undergone ASCT.

OUTLINE:

PERIPHERAL BLOOD STEM CELL (PBSC) MOBILIZATION: Mobilization of autologous PBSC will be performed according to institutional guidelines.

AUTOLOGOUS PBSC TRANSPLANTATION (PBSCT): Patients receive melphalan intravenously (IV) over 30-60 minutes on day -2 or -1 or over 2 days on days -3 and -2 or -2 and -1. Patients undergo autologous PBSCT on day 0.

Patients are then randomized to 1 of 2 maintenance treatment arms. (Note: As of 12/17/09, no more patients will be randomized between lenalidomide and placebo. Patients who have not been randomized as of 12/17/09 will be assigned to lenalidomide.)

ARM I: Beginning between day 100-110, patients receive lenalidomide orally (PO) once daily.

ARM II: Beginning between day 100-110, patients receive placebo (PO) once daily.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months thereafter.

Connect with a study center

  • Mayo Clinic in Arizona

    Scottsdale, Arizona 85259
    United States

    Site Not Available

  • City of Hope Comprehensive Cancer Center

    Duarte, California 91010
    United States

    Site Not Available

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California 92093-0658
    United States

    Site Not Available

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California 95817
    United States

    Site Not Available

  • UC San Diego Medical Center - Hillcrest

    San Diego, California 92103
    United States

    Site Not Available

  • UCSF Medical Center-Mount Zion

    San Francisco, California 94115
    United States

    Site Not Available

  • The Medical Center of Aurora

    Aurora, Colorado 80012
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  • Boulder Community Hospital

    Boulder, Colorado 80301
    United States

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  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado 80907
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  • AdventHealth Porter

    Denver, Colorado 80210
    United States

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  • Porter Adventist Hospital

    Denver, Colorado 80210
    United States

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  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado 80218
    United States

    Site Not Available

  • Rose Medical Center

    Denver, Colorado 80220
    United States

    Site Not Available

  • SCL Health Saint Joseph Hospital

    Denver, Colorado 80218
    United States

    Site Not Available

  • Saint Joseph Hospital - Cancer Centers of Colorado

    Denver, Colorado 80218
    United States

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  • Western States Cancer Research NCORP

    Denver, Colorado 80222
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  • Swedish Medical Center

    Englewood, Colorado 80113
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  • Saint Mary's Hospital and Regional Medical Center

    Grand Junction, Colorado 81501
    United States

    Site Not Available

  • Banner North Colorado Medical Center

    Greeley, Colorado 80631
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  • North Colorado Medical Center

    Greeley, Colorado 80631
    United States

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  • Saint Anthony Hospital

    Lakewood, Colorado 80228
    United States

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  • Sky Ridge Medical Center

    Lone Tree, Colorado 80124
    United States

    Site Not Available

  • Longmont United Hospital

    Longmont, Colorado 80501
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  • Banner McKee Medical Center

    Loveland, Colorado 80539
    United States

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  • McKee Medical Center

    Loveland, Colorado 80539
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    Pueblo, Colorado 81004
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  • North Suburban Medical Center

    Thornton, Colorado 80229
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    Wheat Ridge, Colorado 80401
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  • SCL Health Lutheran Medical Center

    Wheat Ridge, Colorado 80033
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  • Beebe Medical Center

    Lewes, Delaware 19958
    United States

    Site Not Available

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware 19718
    United States

    Site Not Available

  • Saint Francis Hospital - Wilmington

    Wilmington, Delaware 19805
    United States

    Site Not Available

  • George Washington University Medical Center

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • George Washington University Medical Center

    Washington, D.C., District of Columbia 20037
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    Site Not Available

  • University of Florida Health Science Center - Gainesville

    Gainesville, Florida 32610
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    Site Not Available

  • Mayo Clinic in Florida

    Jacksonville, Florida 32224-9980
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    Site Not Available

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida 33136
    United States

    Site Not Available

  • Northside Hospital

    Atlanta, Georgia 30342
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  • Augusta University Medical Center

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho 83712
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    Site Not Available

  • OSF Saint Joseph Medical Center

    Bloomington, Illinois 61701
    United States

    Site Not Available

  • Saint Joseph Medical Center

    Bloomington, Illinois 61701
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  • Graham Hospital Association

    Canton, Illinois 61520
    United States

    Site Not Available

  • Memorial Hospital

    Carthage, Illinois 62321
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  • Jesse Brown Veterans Affairs Medical Center

    Chicago, Illinois 60612
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    Site Not Available

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • University of Illinois

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Heartland Cancer Research NCORP

    Decatur, Illinois 62526
    United States

    Site Not Available

  • Eureka Hospital

    Eureka, Illinois 61530
    United States

    Site Not Available

  • Galesburg Cottage Hospital

    Galesburg, Illinois 61401
    United States

    Site Not Available

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois 61401
    United States

    Site Not Available

  • Mason District Hospital

    Havana, Illinois 62644
    United States

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  • Hopedale Medical Complex - Hospital

    Hopedale, Illinois 61747
    United States

    Site Not Available

  • Kewanee Hospital

    Kewanee, Illinois 61443
    United States

    Site Not Available

  • Mcdonough District Hospital

    Macomb, Illinois 61455
    United States

    Site Not Available

  • Bromenn Regional Medical Center

    Normal, Illinois 61761
    United States

    Site Not Available

  • Carle BroMenn Medical Center

    Normal, Illinois 61761
    United States

    Site Not Available

  • Carle Cancer Institute Normal

    Normal, Illinois 61761
    United States

    Site Not Available

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois 61350
    United States

    Site Not Available

  • Ottawa Regional Hospital and Healthcare Center

    Ottawa, Illinois 61350
    United States

    Site Not Available

  • OSF Saint Francis Radiation Oncology at Pekin

    Pekin, Illinois 61554
    United States

    Site Not Available

  • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

    Pekin, Illinois 61554
    United States

    Site Not Available

  • Pekin Hospital

    Pekin, Illinois 61554
    United States

    Site Not Available

  • Illinois CancerCare-Peoria

    Peoria, Illinois 61615
    United States

    Site Not Available

  • Methodist Medical Center of Illinois

    Peoria, Illinois 61636
    United States

    Site Not Available

  • OSF Saint Francis Medical Center

    Peoria, Illinois 61637
    United States

    Site Not Available

  • Proctor Hospital

    Peoria, Illinois 61614
    United States

    Site Not Available

  • Illinois Valley Hospital

    Peru, Illinois 61354
    United States

    Site Not Available

  • Perry Memorial Hospital

    Princeton, Illinois 61356
    United States

    Site Not Available

  • Saint Margaret's Hospital

    Spring Valley, Illinois 61362
    United States

    Site Not Available

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana 46202
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    Site Not Available

  • Providence Medical Center

    Kansas City, Kansas 66112
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    Site Not Available

  • Lawrence Memorial Hospital

    Lawrence, Kansas 66044
    United States

    Site Not Available

  • Menorah Medical Center

    Overland Park, Kansas 66209
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    Site Not Available

  • Radiation Oncology Practice Corporation Southwest

    Overland Park, Kansas 66210
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    Site Not Available

  • Advent Health - Shawnee Mission Medical Center

    Shawnee Mission, Kansas 66204
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    Site Not Available

  • AdventHealth Shawnee Mission

    Shawnee Mission, Kansas 66204
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    Site Not Available

  • Walter Reed National Military Medical Center

    Bethesda, Maryland 20889-5600
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    Site Not Available

  • Christiana Care - Union Hospital

    Elkton, Maryland 21921
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    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
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    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
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    Site Not Available

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts 01805
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    Site Not Available

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    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
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    Site Not Available

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Centerpoint Medical Center LLC

    Independence, Missouri 64057
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    Site Not Available

  • North Kansas City Hospital

    Kansas City, Missouri 64116
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    Site Not Available

  • Radiation Oncology Practice Corporation - North

    Kansas City, Missouri 64154
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    Site Not Available

  • Radiation Oncology Practice Corporation South

    Kansas City, Missouri 64114
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    Site Not Available

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    Kansas City, Missouri 64132
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  • Saint Joseph Health Center

    Kansas City, Missouri 64114
    United States

    Site Not Available

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Truman Medical Centers

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • University Health Truman Medical Center

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • Saint Luke's East - Lee's Summit

    Lee's Summit, Missouri 64086
    United States

    Site Not Available

  • Liberty Hospital

    Liberty, Missouri 64068
    United States

    Site Not Available

  • Liberty Radiation Oncology Center

    Liberty, Missouri 64068
    United States

    Site Not Available

  • Heartland Regional Medical Center

    Saint Joseph, Missouri 64506
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • Cooper Hospital University Medical Center

    Camden, New Jersey 08103
    United States

    Site Not Available

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08903
    United States

    Site Not Available

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico 87106
    United States

    Site Not Available

  • Montefiore Medical Center - Moses Campus

    Bronx, New York 10467
    United States

    Site Not Available

  • Montefiore Medical Center-Wakefield Campus

    Bronx, New York 10466
    United States

    Site Not Available

  • Montefiore Medical Center-Weiler Hospital

    Bronx, New York 10461
    United States

    Site Not Available

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Site Not Available

  • Northwell Health NCORP

    Lake Success, New York 11042
    United States

    Site Not Available

  • North Shore University Hospital

    Manhasset, New York 11030
    United States

    Site Not Available

  • Long Island Jewish Medical Center

    New Hyde Park, New York 11040
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Mount Sinai Hospital

    New York, New York 10029
    United States

    Site Not Available

  • NYP/Weill Cornell Medical Center

    New York, New York 10065
    United States

    Site Not Available

  • University of Rochester

    Rochester, New York 14642
    United States

    Site Not Available

  • State University of New York Upstate Medical University

    Syracuse, New York 13210
    United States

    Site Not Available

  • Montefiore Medical Center-Weiler Hospital

    The Bronx, New York 10461
    United States

    Site Not Available

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • The Jewish Hospital

    Cincinnati, Ohio 45236
    United States

    Site Not Available

  • Case Western Reserve University

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • MetroHealth Medical Center

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Legacy Good Samaritan Hospital and Medical Center

    Portland, Oregon 97210
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Providence Portland Medical Center

    Portland, Oregon 97213
    United States

    Site Not Available

  • Geisinger Medical Center

    Danville, Pennsylvania 17822
    United States

    Site Not Available

  • Geisinger Medical Center-Cancer Center Hazleton

    Hazleton, Pennsylvania 18201
    United States

    Site Not Available

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pittsburgh Cancer Institute (UPCI)

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • West Penn Hospital

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Geisinger Medical Group

    State College, Pennsylvania 16801
    United States

    Site Not Available

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania 18711
    United States

    Site Not Available

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • Saint Francis Hospital

    Greenville, South Carolina 29601
    United States

    Site Not Available

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • LDS Hospital

    Salt Lake City, Utah 84143
    United States

    Site Not Available

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin, Vermont 05602
    United States

    Site Not Available

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont 05602
    United States

    Site Not Available

  • University of Vermont and State Agricultural College

    Burlington, Vermont 05405
    United States

    Site Not Available

  • Virginia Oncology Associates-Hampton

    Hampton, Virginia 23666
    United States

    Site Not Available

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia 23298
    United States

    Site Not Available

  • University of Washington Medical Center - Montlake

    Seattle, Washington 98195
    United States

    Site Not Available

  • Saint Mary's Medical Center

    Huntington, West Virginia 25702
    United States

    Site Not Available

  • Aurora Cancer Care-Glendale

    Glendale, Wisconsin 53212
    United States

    Site Not Available

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin 54449
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Ascension Saint Mary's Hospital

    Rhinelander, Wisconsin 54501
    United States

    Site Not Available

  • Aspirus Cancer Care - James Beck Cancer Center

    Rhinelander, Wisconsin 54501
    United States

    Site Not Available

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin 54868
    United States

    Site Not Available

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