Bortezomib or Carfilzomib With Lenalidomide and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:8/24/2018
Start Date:December 2, 2013

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Randomized Phase III Trial of Bortezomib, Lenalidomide, and Dexamethasone (VRd) Versus Carfilzomib, Lenalidomide, and Dexamethasone (CRd) Followed by Limited or Indefinite Duration Lenalidomide Maintenance in Patients With Newly Diagnosed Symptomatic Multiple Myeloma (ENDURANCE)

This randomized phase III trial studies bortezomib, lenalidomide, and dexamethasone to see
how well they work compared to carfilzomib, lenalidomide, and dexamethasone in treating
patients with newly diagnosed multiple myeloma. Bortezomib and carfilzomib may stop the
growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide
may help the immune system kill abnormal blood cells or cancer cells. 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. It is not yet known whether bortezomib, lenalidomide, and dexamethasone are more
or less effective than carfilzomib, lenalidomide, and dexamethasone in treating patients with
multiple myeloma

PRIMARY OBJECTIVES:

I. To compare the overall survival between two strategies of lenalidomide maintenance
following induction with a proteasome inhibitor? immunomodulatory drug (IMiD) combination:
limited duration of maintenance (24 months) versus indefinite maintenance therapy until
disease progression.

II. To compare progression-free survival between bortezomib, lenalidomide, and dexamethasone
(VRd) and carfilzomib, lenalidomide, and dexamethasone (CRd) induction followed by
lenalidomide maintenance in patients with newly diagnosed symptomatic multiple myeloma.

SECONDARY OBJECTIVES:

I. To compare the progression-free survival between two strategies of lenalidomide
maintenance following induction with a proteasome inhibitor?IMiD combination: limited
duration of maintenance (24 months) or indefinite maintenance therapy until disease
progression.

II. To compare induction rates of response between VRd and CRd arms. III. To evaluate time to
progression, duration of response and overall survival between VRd and CRd induction therapy.

IV. To compare induction rates of toxicity between VRd and CRd arms. V. To evaluate toxicity
during lenalidomide maintenance. VI. To compare minimal residual disease (MRD) negative rates
between VRd and CRd arms at end of induction therapy.

TERTIARY OBJECTIVES:

I. To compare the short and long-term health-related quality of life impact between the two
strategies of lenalidomide maintenance.

II. To compare the impact on health-related quality of life between VRd and CRd induction
therapy.

III. To evaluate the association between early induction response and change in
health-related quality of life.

IV. To describe changes in health-related quality of life during the induction, active
maintenance and observation phases.

V. To evaluate correlation between treatment adherence during maintenance and health-related
quality of life.

VI. To compare MRD negative rates between the two strategies of lenalidomide maintenance.

VII. To compare MRD negative rates between VRd and CRd arms during induction therapy.

VIII. To examine patterns of change in MRD levels over time and examine conversion from
detectable to MRD negative status.

IX. To evaluate agreement and association between International Myeloma Working Group (IMWG)
and MRD based disease-free status.

X. To describe the mutational profile of newly diagnosed multiple myeloma. XI. To identify
mutations associated with resistance to VRd and CRd induction therapy.

XI. To identify expression profiles associated with MRD negative status with each induction
therapy.

XII. To determine the ability of MRD status at induction end to predict short-term and
long-term overall and progression-free survival.

XIII. To determine the effects of tobacco, operationalized as combustible tobacco (1a), other
forms of tobacco (1b), and environmental tobacco exposure (ETS) (1c) on provider-reported
cancer-treatment toxicity (adverse events [both clinical and hematologic] and dose
modifications).

XIV. To determine the effects of tobacco on patient-reported physical symptoms and
psychological symptoms.

XV. To examine quitting behaviors and behavioral counseling/support and cessation medication
utilization.

XVI. To explore the effect of tobacco use and exposure on treatment duration, relative dose
intensity, and therapeutic benefit.

OUTLINE:

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

ARM A: Patients receive bortezomib subcutaneously (SC) or intravenously (IV) on days 1, 4, 8,
and 11 of courses 1-8 and days 1 and 8 of courses 9-12; lenalidomide orally (PO) daily on
days 1-14; and dexamethasone PO daily on days 1, 2, 4, 5, 8, 9, 11, and 12 of courses 1-8 and
days 1, 2, 8, and 9 of courses 9-12. Treatment repeats every 3 weeks for 12 courses in the
absence of disease progression or unacceptable toxicity.

ARM B: Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16;
lenalidomide PO daily on days 1-21; and dexamethasone PO on days 1, 8, 15, and 22. Treatment
repeats every 4 weeks for 9 courses in the absence of disease progression or unacceptable
toxicity.

MAINTENANCE: After completion of induction therapy (or completion of at least 6 courses in
Arm A but stopped early due to unacceptable toxicity, or at least 4 courses in Arm B but
stopped early due to unacceptable toxicity), patients are then randomized to 1 of 2
maintenance treatment arms.

ARM C: Patients receive lenalidomide PO daily on days 1-21. Treatment repeats every 4 weeks
for 24 courses in the absences of disease progression or unacceptable toxicity.

ARM D: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 4 weeks in
the absence of disease progression or unacceptable toxicity.

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 10 years.

Inclusion Criteria:

- STEP I: Patients must be diagnosed with symptomatic standard-risk multiple myeloma
(SR-MM) as defined by all of the following (except gene expression profile [GEP]70
status if unknown):

- No evidence of t(14;16) by fluorescence in situ hybridization (FISH) testing on
bone marrow or not available

- No evidence of t(14:20) by FISH testing on bone marrow or not available

- No evidence of deletion 17p by FISH testing on bone marrow

- FISH should be from within 90 days of registration

- NOTE: If the FISH result states that no immunoglobulin heavy chain (IgH)
abnormality is present, both t(14;16) and t(14;20) can be considered
negative; in addition, if the patient has a t(11;14) or t(4;14)
translocation present, they can be considered negative for t(14;16) and
t(14;20); if testing for t(14;16) or t(14;20) could not be performed for
lack of sufficient material or non-availability of the probe in the test
panel, patients can be enrolled on the study

- Standard Risk GEP70 signature within the past 90 days (only if GEP has been done
and results are available)

- NOTE: GEP testing is NOT a requirement for the study; if the test has been
done, patients found to have a GEP70 status of high-risk will not be
eligible

- Serum lactate dehydrogenase (LDH) =< 2 x upper limit of normal (ULN) within the
past 28 days

- No more than 20% circulating plasma cells on peripheral blood smear differential
or 2,000 plasma cells/microliter on white blood cell (WBC) differential of
peripheral blood within the past 90 days

- NOTE: This is NOT the plasma cell % from the marrow aspirate

- STEP I: Patients must have measurable or evaluable disease as defined by having one or
more of the following, obtained within 28 days prior to randomization:

- >= 1 g/dL monoclonal protein (M-protein) on serum protein electrophoresis

- >= 200 mg/24 hours (hrs) of monoclonal protein on a 24 hour urine protein
electrophoresis

- Involved free light chain >= 10 mg/dL or >= 100 mg/L AND abnormal serum
immunoglobulin kappa to lambda free light chain ratio (< 0.26 or > 1.65)

- Monoclonal bone marrow plasmacytosis >= 30% (evaluable disease)

- Serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), and
serum free light chain (FLC) assay are required to be performed within 28 days
prior to randomization; a bone marrow biopsy and/or aspirate is required within
28 days if bone marrow is being followed for response

- NOTE: UPEP (on a 24-hour collection) is required, no substitute method is
acceptable; urine must be followed monthly if the baseline urine M-spike is
>= 200 mg/24 hr; please note that if both serum and urine M-components are
present, both must be followed in order to evaluate response

- NOTE: The serum free light chain test is required to be done if the patient
does not have measurable disease in the serum or urine; measurable disease
in the serum is defined as having a serum M-spike >= 1 g/dL; measurable
disease in the urine is defined as having a urine M-spike >= 200 mg/24 hr

- STEP I: Hemoglobin >= 8 g/dL (obtained within 28 days prior to randomization)

- STEP I: Untransfused platelet count >= 75,000 cells/mm^3 (obtained within 28 days
prior to randomization)

- STEP I: Absolute neutrophil count >= 1000 cells/mm^3 (obtained within 28 days prior to
randomization)

- STEP I: Calculated creatinine clearance >= 30 mL/min (obtained within 28 days prior to
randomization)

- STEP I: Bilirubin =< 1.5 mg/dL (obtained within 28 days prior to randomization)

- STEP I: 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 (obtained within 28 days prior to randomization)

- STEP I: Patients must have received no more than one cycle (4 weeks or less) of prior
chemotherapy and no more than 160 mg of prior dexamethasone (or equivalent dose of
prednisone) for treatment of symptomatic myeloma; they should not have been exposed to
lenalidomide, bortezomib or carfilzomib for treatment of symptomatic myeloma; prior
radiation therapy to symptomatic lesions is allowed provided there are no residual
toxicity related to radiation and blood counts that meet the study requirements

- STEP I: Prior systemic glucocorticoid use for the treatment of non-malignant disorders
is permitted; prior or concurrent topical or localized glucocorticoid therapy to treat
non-malignant comorbid disorders is permitted

- STEP I: Patients must not have active, uncontrolled seizure disorder; patients must
have had no seizures in the last 6 months

- STEP I: 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

- STEP I: Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
(performance status [PS] 3 allowed if secondary to pain)

- STEP I: Patients with monoclonal gammopathy of undetermined significance or
asymptomatic multiple myeloma are not eligible

- STEP I: Patients must not have grade 2 or higher peripheral neuropathy by Common
Terminology Criteria for Adverse Events (CTCAE) 4.0

- STEP I: Patients must not have active, uncontrolled infection

- STEP I: Patients may have a history of current or previous deep vein thrombosis or
pulmonary embolism but must be willing to take some form of anti-coagulation as
prophylaxis if they are not currently on full-dose anticoagulation

- STEP I: Patients should not have New York Heart Association classification III or IV
heart failure or myocardial infarction within the previous 6 months

- STEP I: Patients with a history of prior malignancy are eligible provided they were
treated with curative intent and do not require active therapy (currently treated
basal cell, squamous cell carcinoma of the skin, or carcinoma ?in situ? of the cervix
or breast are not excluded)

- STEP I: Females of childbearing potential (FCBP)* must have a negative serum or urine
pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to and
again within 24 hours of starting lenalidomide and 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 she starts taking lenalidomide throughout the entire
duration of study treatment, and for 28 days after the last dose of lenalidomide; FCBP
must also agree to ongoing pregnancy testing; all patients must be counseled at a
minimum of every 28 days about pregnancy precautions and risks of fetal exposure;
female subjects must agree to use contraception or abstinence for 30 days after last
dose of carfilzomib

- A female of childbearing potential is any woman, regardless of sexual orientation
or whether they have undergone tubal ligation, who meets the following criteria:
1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) 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

- STEP I: Sexually active males must be willing to use a condom (even if they have
undergone a prior vasectomy) while having intercourse, while taking lenalidomide and
for 28 days after stopping lenalidomide; male subjects must also agree to abstain from
donating blood, semen, or sperm during study participation and for at least 28 days
after discontinuation from lenalidomide; male subjects must be willing to use condoms
for 90 days after discontinuation of carfilzomib

- STEP I: The following patients will be excluded:

- Pregnant women

- Nursing women

- STEP I: Human immunodeficiency virus (HIV) infection is not excluded; known HIV
positive patients must meet the following criteria:

- Cluster of differentiation (CD)4 cell count >= 350/mm^3

- No history of acquired immune deficiency syndrome (AIDS)-related illness

- Not currently prescribed zidovudine or stavudine

- STEP I: Patient enrolling to this study must agree to register to the mandatory
RevAssist program, and be willing and able to comply with the requirements of
RevAssist

- STEP II: Patients must have complete induction without experiencing progression or
patients must have received at least 6 cycles on Arm A and 4 cycles on Arm B but
stopped induction therapy due to adverse events

- STEP II: Step 2 registration must be within 6 weeks of completing step 1 therapy

- STEP II: Patients must not have received any non-protocol therapy outside of the
assigned induction therapy including stem cell transplant

- STEP II: ECOG performance status 0, 1, or 2 (PS 3 allowed if secondary to pain)

- STEP II: Any adverse event related to step 1 therapy must have resolved to grade 2 or
less

- STEP II: Hemoglobin >= 8 g/dL (within 28 days prior to randomization to Step II)

- STEP II: Platelet count >= 75,000 cells/mm^3 (within 28 days prior to randomization to
Step II)

- STEP II: Absolute neutrophil count >= 1000 cells/mm^3 (within 28 days prior to
randomization to Step II)

- STEP II: Calculated creatinine clearance >= 30 mL/min (within 28 days prior to
randomization to Step II)

- STEP II: Bilirubin =< 1.5 mg/dL (within 28 days prior to randomization to Step II)

- STEP II: SGPT (ALT) and SGOT (AST) < 2.5 times the upper limit of normal (within 28
days prior to randomization to Step II)

- STEP II: Females of childbearing potential (FCBP)* must have a negative serum or urine
pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to and
again within 24 hours of starting lenalidomide and 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 she starts taking lenalidomide throughout the entire
duration of study treatment, and for 28 days after the last dose of lenalidomide; FCBP
must also agree to ongoing pregnancy testing; all patients must be counseled at a
minimum of every 28 days about pregnancy precautions and risks of fetal exposure

- A female of childbearing potential is any woman, regardless of sexual orientation
or whether they have undergone tubal ligation, who meets the following criteria:
1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) 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

- STEP II: Sexually active males must be willing to use a condom (even if they have
undergone a prior vasectomy) while having intercourse, while taking lenalidomide and
for 28 days after stopping lenalidomide; male subjects must also agree to abstain from
donating blood, semen, or sperm during study participation and for at least 28 days
after discontinuation from lenalidomide; males must agree to use contraception and
agree to not donate sperm for at least 90 days after the last day of carfilzomib

- STEP II: The following patients will be excluded:

- Pregnant women

- Nursing women

- STEP II: Patient enrolling to this study must agree to register to the mandatory
RevAssist program and be willing and able to comply with the requirements of RevAssist
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Principal Investigator: Jorge A. Garcia-Young
Phone: 415-209-2686
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Aurora, Colorado 80012
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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1501 S Potomac St
Aurora, Colorado 80012
(303) 695-2600
Principal Investigator: Keren Sturtz
Phone: 303-777-2642
Medical Center of Aurora At The Medical Center of Aurora and Centennial Medical Plaza patients...
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2000 Ogden Ave
Aurora, Illinois 60504
(630) 978-6200
Principal Investigator: Vamsi K. Vasireddy
Phone: 630-978-6212
Rush - Copley Medical Center Rush-Copley is proud to be the leading provider of health...
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3325 Pocahontas Road
Baker City, Oregon 97814
Principal Investigator: Christopher M. Reynolds
Phone: 734-712-3671
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Baltimore, Maryland 21218
Principal Investigator: David H. Vesole
Phone: 410-261-8151
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Baltimore, Maryland 21237
Principal Investigator: David H. Vesole
Phone: 443-777-7364
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489 State St
Bangor, Maine 04401
(207) 973-7000
Principal Investigator: Thomas H. Openshaw
Phone: 207-973-4274
Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
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4305 New Shepherdsville Road
Bardstown, Kentucky 40004
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
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Baton Rouge, Louisiana 70806
Principal Investigator: Augusto C. Ochoa
Phone: 504-210-2970
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Baton Rouge, Louisiana 70809
Principal Investigator: David S. Hanson
Phone: 225-215-1353
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Baton Rouge, Louisiana 70809
Principal Investigator: David S. Hanson
Phone: 225-215-1353
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Baton Rouge, Louisiana 70805
Principal Investigator: David S. Hanson
Phone: 225-215-1353
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4950 Essen Lane
Baton Rouge, Louisiana 70809
Principal Investigator: David S. Hanson
Phone: 225-215-1353
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265 Fremont St
Battle Creek, Michigan 49017
(269) 245-8166
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
Bronson Battle Creek As a proud member of the Battle Creek community, we believe everyone...
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Bay City, Michigan 48706
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3535 Pentagon Boulevard
Beavercreek, Ohio 45431
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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2500 Bellevue Medical Center Drive
Bellevue, Nebraska 68123
Principal Investigator: Muhamed Baljevic
Phone: 402-559-6941
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Bellingham, Washington 98225
Principal Investigator: Alison K. Conlin
Phone: 360-715-4133
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800 Farson Street
Belpre, Ohio 45714
(740) 401-0417
Principal Investigator: Timothy D. Moore
Phone: 800-523-3977
Strecker Cancer Center-Belpre The Memorial Health System's Strecker Cancer Center, Belpre combines the clinical expertise...
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1300 Anne Street NW
Bemidji, Minnesota 56601
(218) 751-5430
Principal Investigator: Preston D. Steen
Phone: 218-333-5000
Sanford Clinic North-Bemidgi Sanford Health is a voluntary, not-for-profit health care organization. Through its entities,...
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Bend, Oregon 97701
Principal Investigator: Alison K. Conlin
Phone: 541-706-2909
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Berkeley, California 94704
Principal Investigator: Jorge A. Garcia-Young
Phone: 415-209-2686
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Berlin, Vermont 05602
Principal Investigator: Julian R. Sprague
Phone: 802-225-5400
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8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Principal Investigator: Mary L. Kwok
Phone: 301-319-2100
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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Bettendorf, Iowa 52722
Principal Investigator: David M. Spector
Phone: 309-779-4221
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Billings, Montana 59101
Principal Investigator: Benjamin T. Marchello
Phone: 800-996-2663
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1233 North 30th Street
Billings, Montana 59101
406-237-7000
Principal Investigator: Keren Sturtz
Phone: 406-969-6060
Saint Vincent Healthcare The Sisters of Charity of Leavenworth, Kansas, founded St. Vincent Healthcare in...
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Billings, Montana 59102
Principal Investigator: Keren Sturtz
Phone: 800-648-6274
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Billings, Montana 59101
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300 N. Seventh St.
Bismarck, North Dakota 58501
(701) 323-6000
Principal Investigator: Preston D. Steen
Phone: 701-323-5760
Sanford Bismarck Medical Center Whether your stay in our hospital is one day for same...
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1505 Eastland Drive
Bloomington, Illinois 61701
309-662-2102
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
Illinois CancerCare-Bloomington Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
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Bloomington, Illinois 61701
Principal Investigator: James L. Wade
Phone: 217-876-6606
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963 East 7th Street
Bloomington, Indiana 47402
Principal Investigator: Jeffrey P. Allerton
Phone: 812-676-4445
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100 E Idaho St
Boise, Idaho 83712
(208) 381-2711
Principal Investigator: Alison K. Conlin
Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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Boise, Idaho 83706
Principal Investigator: Christopher M. Reynolds
Phone: 734-712-3671
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Bolivar, Missouri 65613
Principal Investigator: Rakesh Gaur
Phone: 913-948-5588
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Bonne Terre, Missouri 63628
Principal Investigator: Bryan A. Faller
Phone: 314-996-5569
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Boone, Iowa 50036
Principal Investigator: Joseph J. Merchant
Phone: 515-239-2621
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1100 Balsam Ave
Boulder, Colorado 80304
(303) 440-2273
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
Boulder Community Hospital Founded in 1922 as a community-owned and operated not-for-profit hospital, Boulder Community...
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Boulder, Colorado 80303
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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960 W Wooster St
Bowling Green, Ohio 43402
419-353-5419
Toledo Clinic Cancer Centers-Bowling Green Our doctors evaluate and make recommendations regarding cancer treatment for...
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915 Highland Blvd
Bozeman, Montana 59715
(406) 414-5000
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
Bozeman Deaconess Hospital Bozeman Deaconess Hospital is a Joint Commission certified, licensed Level III trauma...
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Brainerd, Minnesota 56401
Principal Investigator: Bret E. Friday
Phone: 888-203-7267
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Branson, Missouri 65616
Principal Investigator: Jay W. Carlson
Phone: 417-269-4520
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Bremerton, Washington 98310
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
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Brewer, Maine 04412
Principal Investigator: Thomas H. Openshaw
Phone: 800-987-3005
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Bridgeport, West Virginia 26330
Principal Investigator: Abraham S. Kanate
Phone: 304-293-7374
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7575 Grand River Avenue
Brighton, Michigan 48114
Principal Investigator: Christopher M. Reynolds
Phone: 734-712-3671
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