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NCT00114101Active, not recruitingPhase 3

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

A Phase III Randomized, Double-Blind Study of Maintenance Therapy With CC-5013 (NSC # 703813) or Placebo Following Autologous Stem Cell Transplantation for Multiple Myeloma

Source: ClinicalTrials.gov · Last updated 26 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
460 (actual)
First submitted
13 Jun 2005
Start date
15 Dec 2004
Primary completion date
31 Dec 2012
Lead sponsor
National Cancer Institute (NCI)
NCT number
NCT00114101

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 460
  • From 15 Dec 2004 to the primary completion date, 31 Dec 2012
  • 140 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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)

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (140)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of New Mexico Cancer Center
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AlbuquerqueUnited StatesUnknown status
Northside Hospital
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AtlantaUnited StatesUnknown status
Augusta University Medical Center
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AugustaUnited StatesUnknown status
The Medical Center of Aurora
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AuroraUnited StatesUnknown status
Central Vermont Medical Center/National Life Cancer Treatment
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Berlin CornersUnited StatesUnknown status
Walter Reed National Military Medical Center
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BethesdaUnited StatesUnknown status
OSF Saint Joseph Medical Center
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BloomingtonUnited StatesUnknown status
Saint Luke's Cancer Institute - Boise
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BoiseUnited StatesUnknown status
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
Brigham and Women's Hospital
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BostonUnited StatesUnknown status
Boulder Community Foothills Hospital
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BoulderUnited StatesUnknown status
Roswell Park Cancer Institute
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BuffaloUnited StatesUnknown status
University of Vermont and State Agricultural College
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BurlingtonUnited StatesUnknown status
Lahey Clinic
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BurlingtonUnited StatesUnknown status
Cooper Hospital University Medical Center
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CamdenUnited StatesUnknown status
Graham Hospital Association
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CantonUnited StatesUnknown status
Memorial Hospital
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CarthageUnited StatesUnknown status
UNC Lineberger Comprehensive Cancer Center
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Chapel HillUnited StatesUnknown status
Carolinas Medical Center/Levine Cancer Institute
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CharlotteUnited StatesUnknown status
University of Chicago Comprehensive Cancer Center
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ChicagoUnited StatesUnknown status
University of Illinois
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ChicagoUnited StatesUnknown status
Jesse Brown Veterans Affairs Medical Center
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ChicagoUnited StatesUnknown status
The Jewish Hospital
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CincinnatiUnited StatesUnknown status
MetroHealth Medical Center
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ClevelandUnited StatesUnknown status
Case Western Reserve University
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ClevelandUnited StatesUnknown status
Penrose-Saint Francis Healthcare
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Colorado SpringsUnited StatesUnknown status
Ohio State University Comprehensive Cancer Center
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ColumbusUnited StatesUnknown status
Geisinger Medical Center
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DanvilleUnited StatesUnknown status
Heartland Cancer Research NCORP
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DecaturUnited StatesUnknown status
Rose Medical Center
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DenverUnited StatesUnknown status
AdventHealth Porter
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DenverUnited StatesUnknown status
Western States Cancer Research NCORP
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DenverUnited StatesUnknown status
Saint Joseph Hospital - Cancer Centers of Colorado
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DenverUnited StatesUnknown status
Presbyterian - Saint Lukes Medical Center - Health One
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DenverUnited StatesUnknown status
City of Hope Comprehensive Cancer Center
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DuarteUnited StatesUnknown status
Christiana Care - Union Hospital
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ElktonUnited StatesUnknown status
Swedish Medical Center
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EnglewoodUnited StatesUnknown status
Eureka Hospital
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EurekaUnited StatesUnknown status
UF Health Cancer Institute - Gainesville
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GainesvilleUnited StatesUnknown status
Illinois CancerCare-Galesburg
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GalesburgUnited StatesUnknown status
Galesburg Cottage Hospital
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GalesburgUnited StatesUnknown status
Aurora Cancer Care-Glendale
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GlendaleUnited StatesUnknown status
Saint Mary's Hospital and Regional Medical Center
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Grand JunctionUnited StatesUnknown status
Banner North Colorado Medical Center
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GreeleyUnited StatesUnknown status
Saint Francis Hospital
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GreenvilleUnited StatesUnknown status
Prisma Health Greenville Memorial Hospital
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GreenvilleUnited StatesUnknown status
Prisma Health Cancer Institute - Eastside
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GreenvilleUnited StatesUnknown status
Virginia Oncology Associates-Hampton
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HamptonUnited StatesUnknown status
Mason District Hospital
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HavanaUnited StatesUnknown status
Geisinger Medical Center-Cancer Center Hazleton
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HazletonUnited StatesUnknown status
Hopedale Medical Complex - Hospital
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HopedaleUnited StatesUnknown status
Houston Methodist Hospital
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HoustonUnited StatesUnknown status
UT MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
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HoustonUnited StatesUnknown status
Saint Mary's Medical Center
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HuntingtonUnited StatesUnknown status
Centerpoint Medical Center LLC
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IndependenceUnited StatesUnknown status
Indiana University/Melvin and Bren Simon Cancer Center
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IndianapolisUnited StatesUnknown status
University of Mississippi Medical Center
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JacksonUnited StatesUnknown status
Mayo Clinic in Florida
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JacksonvilleUnited StatesUnknown status
Radiation Oncology Practice Corporation South
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Kansas CityUnited StatesUnknown status
Saint Joseph Health Center
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Kansas CityUnited StatesUnknown status
Saint Luke's Hospital of Kansas City
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Kansas CityUnited StatesUnknown status
Providence Medical Center
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Kansas CityUnited StatesUnknown status
Research Medical Center
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Kansas CityUnited StatesUnknown status
University Health Truman Medical Center
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Kansas CityUnited StatesUnknown status
North Kansas City Hospital
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Kansas CityUnited StatesUnknown status
Radiation Oncology Practice Corporation - North
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Kansas CityUnited StatesUnknown status
Kewanee Hospital
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KewaneeUnited StatesUnknown status
Northwell Health NCORP
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Lake SuccessUnited StatesUnknown status
CommonSpirit Saint Anthony Hospital Cancer Center
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LakewoodUnited StatesUnknown status
Lawrence Memorial Hospital
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LawrenceUnited StatesUnknown status
Saint Luke's East - Lee's Summit
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Lee's SummitUnited StatesUnknown status
Beebe Medical Center
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LewesUnited StatesUnknown status
Liberty Hospital
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LibertyUnited StatesUnknown status
Sky Ridge Medical Center
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Lone TreeUnited StatesUnknown status
Longmont United Hospital
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LongmontUnited StatesUnknown status
Banner North Colorado Medical Center - Loveland Campus
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LovelandUnited StatesUnknown status
Mcdonough District Hospital
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MacombUnited StatesUnknown status
University of Wisconsin Carbone Cancer Center - University Hospital
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MadisonUnited StatesUnknown status
North Shore University Hospital
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ManhassetUnited StatesUnknown status
Marshfield Medical Center-Marshfield
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MarshfieldUnited StatesUnknown status
University of Miami Miller School of Medicine-Sylvester Cancer Center
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MiamiUnited StatesUnknown status
Medical College of Wisconsin
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MilwaukeeUnited StatesUnknown status
University of Minnesota/Masonic Cancer Center
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MinneapolisUnited StatesUnknown status
Vanderbilt University/Ingram Cancer Center
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NashvilleUnited StatesUnknown status
Christiana Care Health System-Christiana Hospital
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NewarkUnited StatesUnknown status
Rutgers Cancer Institute of New Jersey
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New BrunswickUnited StatesUnknown status
Long Island Jewish Medical Center
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New Hyde ParkUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
NYP/Weill Cornell Medical Center
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New YorkUnited StatesUnknown status
Mount Sinai Hospital
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New YorkUnited StatesUnknown status
Carle BroMenn Medical Center
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NormalUnited StatesUnknown status
Carle Cancer Institute Normal
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NormalUnited StatesUnknown status
University of Nebraska Medical Center
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OmahaUnited StatesUnknown status
Ottawa Regional Hospital and Healthcare Center
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OttawaUnited StatesUnknown status
Illinois CancerCare-Ottawa Clinic
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OttawaUnited StatesUnknown status
Menorah Medical Center
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Overland ParkUnited StatesUnknown status
Radiation Oncology Practice Corporation Southwest
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Overland ParkUnited StatesUnknown status
OSF Saint Francis Radiation Oncology at Pekin
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PekinUnited StatesUnknown status
Pekin Hospital
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PekinUnited StatesUnknown status
Proctor Hospital
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PeoriaUnited StatesUnknown status
Methodist Medical Center of Illinois
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PeoriaUnited StatesUnknown status
Illinois CancerCare-Peoria
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PeoriaUnited StatesUnknown status
OSF Saint Francis Medical Center
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PeoriaUnited StatesUnknown status
Illinois Valley Hospital
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PeruUnited StatesUnknown status
Fox Chase Cancer Center
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PhiladelphiaUnited StatesUnknown status
University of Pennsylvania/Abramson Cancer Center
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PhiladelphiaUnited StatesUnknown status
West Penn Hospital
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PittsburghUnited StatesUnknown status
UPMC Hillman Cancer Center
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PittsburghUnited StatesUnknown status
Legacy Good Samaritan Hospital and Medical Center
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PortlandUnited StatesUnknown status
Oregon Health and Science University
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PortlandUnited StatesUnknown status
Providence Portland Medical Center
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PortlandUnited StatesUnknown status
Perry Memorial Hospital
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PrincetonUnited StatesUnknown status
Saint Mary Corwin Medical Center
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PuebloUnited StatesUnknown status
Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
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RhinelanderUnited StatesUnknown status
Marshfield Medical Center-Rice Lake
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Rice LakeUnited StatesUnknown status
VCU Massey Comprehensive Cancer Center
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RichmondUnited StatesUnknown status
Mayo Clinic in Rochester
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RochesterUnited StatesUnknown status
University of Rochester
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RochesterUnited StatesUnknown status
University of California Davis Comprehensive Cancer Center
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SacramentoUnited StatesUnknown status
Heartland Regional Medical Center
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Saint JosephUnited StatesUnknown status
LDS Hospital
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Salt Lake CityUnited StatesUnknown status
UC San Diego Medical Center - Hillcrest
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San DiegoUnited StatesUnknown status
UCSF Medical Center-Mount Zion
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San FranciscoUnited StatesUnknown status
Mayo Clinic in Arizona
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ScottsdaleUnited StatesUnknown status
University of Washington Medical Center - Montlake
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SeattleUnited StatesUnknown status
AdventHealth Shawnee Mission
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Shawnee MissionUnited StatesUnknown status
Saint Margaret's Hospital
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Spring ValleyUnited StatesUnknown status
Geisinger Medical Group
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State CollegeUnited StatesUnknown status
Washington University School of Medicine
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St LouisUnited StatesUnknown status
State University of New York Upstate Medical University
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SyracuseUnited StatesUnknown status
Montefiore Medical Center - Moses Campus
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The BronxUnited StatesUnknown status
Montefiore Medical Center-Wakefield Campus
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The BronxUnited StatesUnknown status
Montefiore Medical Center-Weiler Hospital
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The BronxUnited StatesUnknown status
North Suburban Medical Center
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ThorntonUnited StatesUnknown status
George Washington University Medical Center
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Washington D.C.United StatesUnknown status
Intermountain Health Lutheran Hospital
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Wheat RidgeUnited StatesUnknown status
Geisinger Wyoming Valley/Henry Cancer Center
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Wilkes-BarreUnited StatesUnknown status
Saint Francis Hospital - Wilmington
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WilmingtonUnited StatesUnknown status
Wake Forest University Health Sciences
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Winston-SalemUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.