Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma

Phase 3

Active, not recruiting

Conditions: DS Stage I Multiple Myeloma
DS Stage II Multiple Myeloma
DS Stage III Multiple Myeloma

Interventions: Drug: Dexamethasone
Other: Laboratory Biomarker Analysis
Drug: Lenalidomide
Drug: Thalidomide

Registration Number: NCT00098475

Lead Sponsor: National Cancer Institute (NCI)

Brief Summary: This randomized phase III trial studies lenalidomide and low-dose dexamethasone to see how well it works compared to lenalidomide and standard-dose dexamethasone, given with or without thalidomide, in treating patients with multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide and thalidomide may also stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide, thalidomide, and dexamethasone together may kill more cancer cells.

Detailed Description: PRIMARY OBJECTIVE:

I. To evaluate the response rate and toxicity of lenalidomide (CC-5013) plus dexamethasone (standard dose) versus CC-5013 plus low dose dexamethasone in patients with newly diagnosed myeloma at any time in the first 4 cycles of treatment and to determine if CC-5013 plus low dose dexamethasone will have similar response rate with lower toxicity (First Phase).

SECONDARY OBJECTIVES:

I. To evaluate the response rate of thalidomide plus dexamethasone (Thal/Dex) in patients with newly diagnosed myeloma who do not achieve a complete or partial response at any time in the first 4 cycles with the CC-5013 and dexamethasone combination in either of the two arms (First Phase).

II. To study the effect of CC-5013 on bone marrow microvessel density and angiogenesis grade, on plasma cell labeling index (PCLI), and on the expression of vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF) in the marrow (First Phase).

III. To study the effect of CC-5013 and dexamethasone on bone marrow mesenchymal progenitor cells (MPCs) (First Phase).

IV. To evaluate in a separate expansion phase the efficacy of aspirin (325 mg/day) versus Coumadin (dose adjusted to maintain a target international normalized ratio \[INR\] of 2-3) in preventing deep vein thrombosis (DVT) in patients with newly diagnosed myeloma receiving CC-5013 plus standard dose dexamethasone.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21, and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20.

Arm II: Patients receive lenalidomide as in Arm I and low-dose dexamethasone PO QD on days 1, 8, 15, and 22.

In both arms, cycles repeat every 28 days in the absence of unacceptable toxicity or disease progression. Patients not responding at any point during the first 4 cycles of lenalidomide and dexamethasone are assigned to 1 of 2 salvage therapy arms. Patients who progress during treatment on Arms I or II have the option to register on salvage therapy Arms III or IV respectively.

Arm III (patients with no response after treatment on Arm I): Patients receive thalidomide PO QD on days 1-28 and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20.

Arm IV (patients with no response after treatment on Arm II): Patients receive thalidomide as in Arm III and low-dose dexamethasone PO QD on days 1, 8, 15, and 22.

In both salvage therapy arms, cycles repeat every 28 days in the absence of unacceptable toxicity or disease progression. After completion of 4 cycles of therapy, patients may undergo stem cell harvest (using growth factors only) for cryopreservation.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually for 2 years.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 452

Inclusion Criteria

Patients must be diagnosed with symptomatic multiple myeloma within the past 90 days confirmed by the following:
- Bone marrow plasmacytosis with >= 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma which must be obtained within 4 weeks prior to randomization
- Measurable levels of monoclonal protein (M protein): >= 1.0 g/dL on serum protein electrophoresis or >= 200 mg of monoclonal light chain on a 24 hour urine protein electrophoresis which must be obtained within 4 weeks prior to randomization; both serum protein electrophoresis (SPEP) and urine protein electrophoresis (UPEP) are required to be performed within 28 days prior to randomization; please note that if both serum and urine m-components are present, both must be followed in order to evaluate response
Hemoglobin > 7 g/dL
Platelet count > 75,000 cells/mm^3
Absolute neutrophil count > 1000 cells/mm^3
Creatinine < 2.5 mg/dL and creatinine clearance (measured or calculated) >= 60 mL/min
Bilirubin =< 1.5 mg/dL
Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) and serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 2.5 times the upper limit of normal
Prior palliative and/or localized radiation therapy is permitted provided at least 4 weeks have passed from date of last radiation therapy to date of registration; patients with prior solitary plasmacytoma treated with radiation therapy with curative intent are eligible if the disease has now progressed to active multiple myeloma meeting all the eligibility criteria for this protocol
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
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 (intrauterine device [IUD], birth control pills, tubal ligation or partner's vasectomy) and one additional effective method (condom, diaphragm or cervical cap); 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 starting 4 weeks prior to and while taking CC5013 or thalidomide and for four weeks after discontinuing this therapy; 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
Patients with a history of prior malignancy are eligible provided there is no active malignancy and a low expectation of recurrence within 6 months

Exclusion Criteria

No prior systemic therapy with the exception of bisphosphonates for multiple myeloma
Prior glucocorticosteroid therapy for the treatment of multiple myeloma is not permitted; prior systemic glucocorticosteroid use for the treatment of non-malignant disorders is permitted; concurrent use after registration on the study should be restricted to the equivalent of prednisone 10 mg per day; prior or concurrent topical or localized glucocorticosteroid therapy to treat non-malignant comorbid disorders is permitted
Patients must not have active, uncontrolled seizure disorder; patients must have had no seizures in the last 6 months
Patients must not have uncontrolled intercurrent illness including uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or social situation that would limit compliance with the study, or a prior history of Stevens Johnson syndrome
Patients with smoldering myeloma or monoclonal gammopathy of undetermined significance are not eligible
Patients must not have grade 2 or higher peripheral neuropathy due to other medical conditions at the time of randomization
Patients must not have active, uncontrolled infection
Patients must not have a history of current or previous deep vein thrombosis or pulmonary embolism regardless of whether or not the patient is receiving anticoagulation therapy
- For patients registered prior to activation of Addendum # 6; patients must be willing and able to take prophylaxis with either aspirin at 325 mg/day or alternative prophylaxis with either low molecular weight heparin or Coumadin
- For patients registered after activation of Addendum # 6; patients entering the expansion phase of the protocol, which tests anticoagulant prophylaxis, must be able and willing to be randomized between aspirin at 325 mg/day and Coumadin
Female patients MUST NOT be pregnant or breastfeeding; due to the potential teratogenic properties of CC 5013, and the known teratogenicity associated with thalidomide, the use of these drugs in this patient population is ABSOLUTELY CONTRAINDICATED

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (lenalidomide, low-dose dexamethasone)	Lenalidomide	Patients receive lenalidomide and acetylsalicylic acid as in Arm I and low-dose dexamethasone PO QD on days 1, 8, 15, and 22.
Arm I (lenalidomide, dexamethasone)	Laboratory Biomarker Analysis	Patients receive lenalidomide PO QD on days 1-21 and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20.
Arm II (lenalidomide, low-dose dexamethasone)	Laboratory Biomarker Analysis	Patients receive lenalidomide and acetylsalicylic acid as in Arm I and low-dose dexamethasone PO QD on days 1, 8, 15, and 22.
Arm III (thalidomide, dexamethasone)	Laboratory Biomarker Analysis	Patients with no response after treatment on Arm I: Patients receive thalidomide PO QD on days 1-28 and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20
Arm IV (thalidomide, low-dose dexamethasone)	Laboratory Biomarker Analysis	Patients with no response after treatment on Arm II: Patients receive thalidomide as in arm III and low-dose dexamethasone PO QD on days 1, 8, 15, and 22.
Arm I (lenalidomide, dexamethasone)	Dexamethasone	Patients receive lenalidomide PO QD on days 1-21 and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20.
Arm I (lenalidomide, dexamethasone)	Lenalidomide	Patients receive lenalidomide PO QD on days 1-21 and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20.
Arm II (lenalidomide, low-dose dexamethasone)	Dexamethasone	Patients receive lenalidomide and acetylsalicylic acid as in Arm I and low-dose dexamethasone PO QD on days 1, 8, 15, and 22.
Arm III (thalidomide, dexamethasone)	Dexamethasone	Patients with no response after treatment on Arm I: Patients receive thalidomide PO QD on days 1-28 and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20
Arm IV (thalidomide, low-dose dexamethasone)	Dexamethasone	Patients with no response after treatment on Arm II: Patients receive thalidomide as in arm III and low-dose dexamethasone PO QD on days 1, 8, 15, and 22.
Arm III (thalidomide, dexamethasone)	Thalidomide	Patients with no response after treatment on Arm I: Patients receive thalidomide PO QD on days 1-28 and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20
Arm IV (thalidomide, low-dose dexamethasone)	Thalidomide	Patients with no response after treatment on Arm II: Patients receive thalidomide as in arm III and low-dose dexamethasone PO QD on days 1, 8, 15, and 22.

Primary Outcome Measures

Name	Time	Method
Proportion of Patients With Objective Response (First Phase, Step 1)	Assessed every 4 weeks for 16 weeks during Step 1	Objective response is defined as either complete response (CR) or partial response (PR). Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. PR requires all the following: (1) ≥50% reduction in the level of the serum monoclonal paraprotein. (2) Reduction in 24-hour urinary light chain excretion either by ≥90% or to \<200 mg. (3)For patients with non-secretory (or oligosecretory) myeloma only, a ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy must be documented. (4)50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination). (5) No increase in the number or size of lytic bone lesions (development of a compression fracture does not exclude response). As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only.

Secondary Outcome Measures

Name	Time	Method
Proportion of Patients With Objective Response (First Phase, Step 2)	Assessed every 4 weeks for 16 weeks during Step 2	Objective response is defined as either complete response (CR) or partial response (PR). Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. PR requires all the following: (1) ≥50% reduction in the level of the serum monoclonal paraprotein. (2) Reduction in 24-hour urinary light chain excretion either by ≥90% or to \<200 mg. (3)For patients with non-secretory (or oligosecretory) myeloma only, a ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy must be documented. (4)50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination). (5) No increase in the number or size of lytic bone lesions (development of a compression fracture does not exclude response). As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only.

Trial Locations

Locations (138): Saint Luke's Cancer Institute - Boise
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Boise, Idaho, United States
The Medical Center of Aurora
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Aurora, Colorado, United States
University of Alabama at Birmingham Cancer Center
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Birmingham, Alabama, United States
Huntsville Hospital
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Huntsville, Alabama, United States
Providence Alaska Medical Center
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Anchorage, Alaska, United States
Mayo Clinic in Arizona
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Scottsdale, Arizona, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Burbank, California, United States
Saint Jude Medical Center
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Fullerton, California, United States
El Camino Hospital
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Mountain View, California, United States
Kaiser Permanente-San Diego Mission
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San Diego, California, United States
Penrose-Saint Francis Healthcare
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Colorado Springs, Colorado, United States
Saint Joseph Hospital - Cancer Centers of Colorado
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Denver, Colorado, United States
Swedish Medical Center
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Englewood, Colorado, United States
Poudre Valley Hospital
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Fort Collins, Colorado, United States
Banner McKee Medical Center
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Loveland, Colorado, United States
Danbury Hospital
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Danbury, Connecticut, United States
Eastern Connecticut Hematology and Oncology Associates
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Norwich, Connecticut, United States
Holy Cross Hospital
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Fort Lauderdale, Florida, United States
University of Florida Health Science Center - Gainesville
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Gainesville, Florida, United States
Baptist MD Anderson Cancer Center
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Jacksonville, Florida, United States
Mayo Clinic in Florida
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Jacksonville, Florida, United States
Martin Hospital South
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Stuart, Florida, United States
Phoebe Putney Memorial Hospital
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Albany, Georgia, United States
Emory University Hospital/Winship Cancer Institute
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Atlanta, Georgia, United States
Atlanta Regional CCOP
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Atlanta, Georgia, United States
Augusta Oncology Associates PC-D'Antignac
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Augusta, Georgia, United States
Emory Decatur Hospital
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Decatur, Georgia, United States
Atrium Health Navicent
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Macon, Georgia, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
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Savannah, Georgia, United States
University of Hawaii Cancer Center
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Honolulu, Hawaii, United States
OSF Saint Anthony's Health Center
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Alton, Illinois, United States
Northwestern University
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Chicago, Illinois, United States
John H Stroger Jr Hospital of Cook County
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Chicago, Illinois, United States
Decatur Memorial Hospital
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Decatur, Illinois, United States
Ascension Alexian Brothers - Elk Grove Village
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Elk Grove Village, Illinois, United States
Edward Hines Jr VA Hospital
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Hines, Illinois, United States
Midwest Center for Hematology Oncology
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Joliet, Illinois, United States
Duly Health and Care Joliet
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Joliet, Illinois, United States
Swedish American Hospital
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Rockford, Illinois, United States
UW Health Carbone Cancer Center Rockford
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Rockford, Illinois, United States
Edward H Kaplan MD and Associates
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Skokie, Illinois, United States
Elkhart General Hospital
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Elkhart, Indiana, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview
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Fort Wayne, Indiana, United States
Indiana University/Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, United States
Franciscan Health Indianapolis
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Indianapolis, Indiana, United States
IU Health Arnett Cancer Care
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Lafayette, Indiana, United States
Saint Joseph Regional Medical Center-Mishawaka
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Mishawaka, Indiana, United States
Memorial Hospital of South Bend
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South Bend, Indiana, United States
McFarland Clinic - Ames
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Ames, Iowa, United States
University of Iowa Healthcare Cancer Services Quad Cities
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Bettendorf, Iowa, United States
Iowa Methodist Medical Center
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Des Moines, Iowa, United States
Siouxland Regional Cancer Center
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Sioux City, Iowa, United States
MercyOne Waterloo Cancer Center
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Waterloo, Iowa, United States
Kansas City NCI Community Oncology Research Program
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Prairie Village, Kansas, United States
Harold Alfond Center for Cancer Care
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Augusta, Maine, United States
Greater Baltimore Medical Center
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Baltimore, Maryland, United States
HealthAlliance Hospital - Leominster
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Leominster, Massachusetts, United States
Henry Ford Health Saint John Hospital
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Detroit, Michigan, United States
West Michigan Cancer Center
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Kalamazoo, Michigan, United States
Mercy Hospital
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Coon Rapids, Minnesota, United States
Fairview Southdale Hospital
🇺🇸
Edina, Minnesota, United States
Unity Hospital
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Fridley, Minnesota, United States
Saint John's Hospital - Healtheast
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Maplewood, Minnesota, United States
Mayo Clinic in Rochester
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Rochester, Minnesota, United States
Regions Hospital
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Saint Paul, Minnesota, United States
United Hospital
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Saint Paul, Minnesota, United States
Mercy Hospital Saint Louis
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Saint Louis, Missouri, United States
Saint Louis-Cape Girardeau CCOP
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Saint Louis, Missouri, United States
Montana Cancer Consortium NCORP
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Billings, Montana, United States
Great Falls Clinic
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Great Falls, Montana, United States
Nebraska Cancer Research Center
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Lincoln, Nebraska, United States
Nebraska Methodist Hospital
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Omaha, Nebraska, United States
Alegent Health Immanuel Medical Center
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Omaha, Nebraska, United States
Alegent Health Bergan Mercy Medical Center
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Omaha, Nebraska, United States
Midlands Community Hospital
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Papillion, Nebraska, United States
Hackensack University Medical Center
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Hackensack, New Jersey, United States
The Cancer Institute of New Jersey Hamilton
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Hamilton, New Jersey, United States
Morristown Medical Center
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Morristown, New Jersey, United States
Virtua Memorial
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Mount Holly, New Jersey, United States
Jersey Shore Medical Center
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Neptune, New Jersey, United States
Rutgers Cancer Institute of New Jersey
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New Brunswick, New Jersey, United States
Robert Wood Johnson University Hospital Somerset
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Somerville, New Jersey, United States
Garnet Health Medical Center
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Middletown, New York, United States
NYU Langone Hospital - Long Island
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Mineola, New York, United States
Mount Sinai Union Square
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New York, New York, United States
Stony Brook University Medical Center
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Stony Brook, New York, United States
Mission Hospital
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Asheville, North Carolina, United States
Wayne Memorial Hospital
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Goldsboro, North Carolina, United States
Southeast Clinical Oncology Research Consortium NCORP
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Winston-Salem, North Carolina, United States
Sanford Bismarck Medical Center
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Bismarck, North Dakota, United States
Essentia Health Cancer Center-South University Clinic
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Fargo, North Dakota, United States
Sanford Broadway Medical Center
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Fargo, North Dakota, United States
Summa Health System - Akron Campus
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Akron, Ohio, United States
MetroHealth Medical Center
🇺🇸
Cleveland, Ohio, United States
Miami Valley Hospital
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Dayton, Ohio, United States
Miami Valley Hospital North
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Dayton, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital
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Franklin, Ohio, United States
Kettering Medical Center
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Kettering, Ohio, United States
Saint Charles Hospital
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Oregon, Ohio, United States
Firelands Regional Medical Center
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Sandusky, Ohio, United States
ProMedica Flower Hospital
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Sylvania, Ohio, United States
Mercy Hospital of Tiffin
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Tiffin, Ohio, United States
Toledo Community Hospital Oncology Program CCOP
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Toledo, Ohio, United States
Toledo Clinic Cancer Centers-Toledo
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Toledo, Ohio, United States
Kaiser Permanente Northwest
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Portland, Oregon, United States
Jefferson Abington Hospital
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Abington, Pennsylvania, United States
Penn State Milton S Hershey Medical Center
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Hershey, Pennsylvania, United States
Lancaster General Hospital
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Lancaster, Pennsylvania, United States
Saint Mary Medical and Regional Cancer Center
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Langhorne, Pennsylvania, United States
University of Pennsylvania/Abramson Cancer Center
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Philadelphia, Pennsylvania, United States
Pennsylvania Hospital
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Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
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Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
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Philadelphia, Pennsylvania, United States
Temple Health - Chestnut Hill Hospital
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Philadelphia, Pennsylvania, United States
Einstein Medical Center Philadelphia
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Philadelphia, Pennsylvania, United States
Guthrie Medical Group PC-Robert Packer Hospital
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Sayre, Pennsylvania, United States
Grand View Hospital
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Sellersville, Pennsylvania, United States
Mount Nittany Medical Center
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State College, Pennsylvania, United States
Reading Hospital
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West Reading, Pennsylvania, United States
Lankenau Medical Center
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Wynnewood, Pennsylvania, United States
WellSpan Health-York Hospital
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York, Pennsylvania, United States
McLeod Regional Medical Center
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Florence, South Carolina, United States
Rapid City Regional Hospital
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Rapid City, South Dakota, United States
Sanford Cancer Center Oncology Clinic
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Sioux Falls, South Dakota, United States
Sentara Martha Jefferson Hospital
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Charlottesville, Virginia, United States
University of Virginia Cancer Center
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Charlottesville, Virginia, United States
Centra Alan B Pearson Regional Cancer Center
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Lynchburg, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center
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Richmond, Virginia, United States
Swedish Medical Center-First Hill
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Seattle, Washington, United States
West Virginia University Healthcare
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Morgantown, West Virginia, United States
ThedaCare Regional Cancer Center
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Appleton, Wisconsin, United States
Gundersen Lutheran Medical Center
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La Crosse, Wisconsin, United States
SSM Health Dean Medical Group - South Madison Campus
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Madison, Wisconsin, United States
University of Wisconsin Carbone Cancer Center - University Hospital
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Madison, Wisconsin, United States
Marshfield Medical Center-Marshfield
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Marshfield, Wisconsin, United States
Medical College of Wisconsin
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Milwaukee, Wisconsin, United States
ProHealth Oconomowoc Memorial Hospital
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Oconomowoc, Wisconsin, United States
ProHealth Waukesha Memorial Hospital
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Waukesha, Wisconsin, United States