Blood Cancer

EAA181 / EQUATE



Testing the Use of Combination Therapy in Adult Patients with Newly Diagnosed Multiple Myeloma, the EQUATE Trial

STATUS: Active


This phase III trial compares the combination of four drugs (daratumumab-hyaluronidase, bortezomib, lenalidomide and dexamethasone) to the use of a three-drug combination (daratumumab-hyaluronidase, lenalidomide and dexamethasone) in patients with newly diagnosed multiple myeloma. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as lenalidomide, 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. Daratumumab-hyaluronidase is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Anti-inflammatory drugs, such as dexamethasone lower the bodyโ€™s immune response and are used with other drugs in the treatment of some types of cancer. Adding bortezomib to daratumumab-hyaluronidase, lenalidomide, and dexamethasone may be more effective in shrinking the cancer or preventing it from returning, compared to continuing on a combination of daratumumab-hyaluronidase, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma.
  • STEP 0: Patient must be >= 18 years of age

  • STEP 0 - Patient must have the ability to understand and the willingness to sign an informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be eligible

  • STEP 0 - Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 (PS 3 allowed if secondary to pain)

  • STEP 0 - Patient must have suspected or confirmed newly diagnosed multiple myeloma (MM) by International Myeloma Working Group (IMWG) criteria and must not have received more than one cycle of treatment. * NOTE: Patient does not need to have bone marrow evaluation prior to Step 0 pre-registration. Bone marrow evaluation may be deferred to after Step 0 pre-registration to confirm presence of > 10% clonal bone marrow plasma cells per IMWG criteria

  • STEP 0 - Patient must be considered ineligible for autologous stem cell transplantation by the treating physician, or willing to delay stem cell transplantation until first relapse or later. * NOTE: Stem cell collection is allowed on study

  • STEP 0 - Patient must agree to register to the mandatory Celgene Revlimid Risk Evaluation and Mitigation Strategy (REMS) program and be willing and able to comply with the requirements of the Revlimid REMS program

  • STEP 0 - Patient must not have any known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to respective package inserts or Investigator's Brochure), or known sensitivity to mammalian-derived products

  • STEP 0 - Patient must be able to undergo diagnostic bone marrow aspirate following preregistration if not performed previously. * NOTE: Bone marrow aspirate specimen, or an acceptable alternative, must be submitted to Adaptive Biotechnologies for clonoSEQ Assay. * NOTE: Adaptive Biotechnologies will release results to the diagnostic portal from the Clonality (ID) test within fourteen (14) days of receipt and reconciliation of fresh bone marrow specimen to the submitting institution * NOTE: If clonoSEQ Assay is performed within 90 days of registration as part of standard of care, results can be used for Step 1 registration

  • STEP 1 - Patient must meet all eligibility criteria in STEP 0 with exception of the last criterion

  • STEP 1 - Institution must have received the Clonality (ID) test results from Adaptive Biotechnologies and dominant sequences must have been identified

  • STEP 1 - Patient must have standard risk MM as defined by the Revised International Staging System (R-ISS) stage I or II * NOTE: R-ISS stage is based on serum beta2 microglobulin, albumin and lactate dehydrogenase (LDH) levels along with presence of chromosomal abnormalities (CA) detected by interphase fluorescent in situ hybridization (iFISH). Presence of del(17p), t(4;14), and/or t(14;16) is considered high risk and absence of these, including any other findings, are standard risk * R-ISS stage ** Stage I: ISS stage I [beta2 macroglobulin < 3.5 mg/L, albumin > 3.5 g/dL] AND standard-risk CA AND normal LDH (=< upper limit of normal) ** Stage II: Not R-ISS stage I or III ** Stage III: ISS stage III [beta2 macroglobulin > 5.5 mg/L] AND high-risk CA OR high LDH (> upper limit of normal) [patients with stage III are ineligible]

  • STEP 1 - Patient must have measurable or evaluable disease as defined by having one or more of the following, obtained within 28 days prior to Step 1 registration: * >= 1 g/dL monoclonal protein (M-protein) on serum protein electrophoresis * >= 200 mg/24 hours 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)

  • STEP 1 - Patient must have a serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), and serum free light chain (FLC) assay performed within 28 days prior to Step 1 registration. In addition, 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 1 - Calculated creatinine clearance > 30 mL/min (obtained =< 14 days prior to Step 1 registration)

  • STEP 1 - Absolute neutrophil count (ANC) >= 1000/mm^3 (obtained =< 14 days prior to Step 1 registration)

  • STEP 1 - Untransfused platelet count >= 75,000/mm^3 (obtained =< 14 days prior to Step 1 registration)

  • STEP 1 - Hemoglobin >= 8.0 g/dL (obtained =< 14 days prior to Step 1 registration)

  • STEP 1 - Total bilirubin =< 1.5 x ULN (institutional upper limit of normal) (obtained =< 14 days prior to Step 1 registration)

  • STEP 1 - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN (obtained =< 14 days prior to Step 1 registration)

  • STEP 1 - Patient must have received no more than one cycle (28 days or less) of prior chemotherapy and no more than 160 mg of prior dexamethasone (or equivalent dose of prednisone) for treatment of symptomatic myeloma. Patient must not have been exposed to daratumumab 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 meet the study requirements. Radiation treatment must be completed at least 14 days prior to Step 1 registration * NOTE: Patients who have received prior treatment for smoldering multiple myeloma (SMM) are eligible, except those who have received prior treatment with lenalidomide in combination with an anti-CD38 monoclonal antibody

  • STEP 1 - Patient must not be pregnant or breast-feeding due to the potential harm and teratogenic effects to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study with a sensitivity of at least 25 mIU/mL within 10-14 days prior to Step 1 registration to rule out pregnancy and again within 24 hours prior to the first dose of lenalidomide. Patients of childbearing potential must also agree to ongoing pregnancy testing while on protocol treatment. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: * Has achieved menarche at some point, * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

  • STEP 1 - Patients of childbearing potential must not expect to conceive children by using accepted and effective method(s) of contraception [for this protocol defined as the use of TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME for 1) at least 28 days before starting protocol treatment; 2) while participating in the study; 3) during dose interruptions; and 4) for at least 3 months after the last dose of protocol treatment] OR by practicing true abstinence from sexual intercourse for the duration of their participation in the study (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception). Patients must not expect to father children by practicing true abstinence from sexual intercourse for the duration of their participation in the study (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception] OR use a latex condom during sexual contact with a partner of child bearing potential while participating in the study and for at least 3 months after the last dose of protocol treatment even if they have had a successful vasectomy. Patients must also agree to abstain from donating sperm, even if they have had a successful vasectomy, or donating eggs while on study treatment and for 3 months after the last dose of protocol treatment. All patients must agree to abstain from donating blood during study participation and for at least 28 days after the last dose of protocol treatment

  • STEP 1 - Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of Step 1 registration are eligible for this trial

  • STEP 1 - For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

  • STEP 1 - Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

  • STEP 1 - Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

  • STEP 1 - Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. Patients must not have evidence of current uncontrolled cardiovascular conditions, including hypertension, cardiac arrhythmias, congestive heart failure, unstable angina, or myocardial infarction within 6 months prior to Step 1 registration

  • STEP 1 - Patient must not have peripheral neuropathy >= grade 2 on clinical examination or grade 1 with pain at time of Step 1 registration

  • STEP 1 - Patient must not have any serious medical or psychiatric illness that could, in the investigatorโ€™s opinion, potentially interfere with the completion of treatment according to this protocol

  • STEP 1 - Patient may have a history of current or previous deep vein thrombosis (DVT) or pulmonary embolism (PE) but must be willing to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation

  • STEP 1 - Patients with a history of chronic obstructive pulmonary disease (COPD) must have FEV1 testing done within 28 days prior to Step 1 registration and the forced expiratory volume in 1 second (FEV1) must be > 50% of predicted normal

  • STEP 1 - Patient must not have moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification * NOTE: Patients who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to register

  • STEP 1 - Patient must not receive any other concurrent chemotherapy, or any ancillary therapy considered investigational while on this protocol * NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment

  • STEP 2 - Institution must have received Tracking (MRD) test results from Adaptive Biotechnologies

  • STEP 2 - Patient must have completed the Step 1 Induction phase of this protocol without experiencing progression

  • STEP 2 - Patient must be registered to Step 2 within 8 weeks of completing Step 1 Induction Treatment, counting from last day of completion of last cycle

  • STEP 2 - Patient must not have received any non-protocol therapy outside of the assigned Step 1 Induction treatment including stem cell transplant

  • STEP 2 - Patient must have an ECOG performance status (PS) of 0-2 (PS 3 allowed if secondary to pain)

  • STEP 2 - Any adverse event(s) related to Step 1 Induction Treatment must have resolved to grade 2 or less

  • STEP 2 - Hemoglobin >= 8 g/dL (obtained within 14 days prior to Step 2 randomization)

  • STEP 2 - Platelet count >= 50,000/mm^3 (obtained within 14 days prior to Step 2 randomization)

  • STEP 2 - Absolute neutrophil count (ANC) >= 1000/mm^3 (obtained within 14 days prior to Step 2 randomization)

  • STEP 2 - Calculated creatinine clearance >= 30 mL/min (obtained within 14 days prior to Step 2 randomization)

  • STEP 2 - Total bilirubin =< 1.5 x ULN (Institutional upper limit of normal) (obtained within 14 days prior to Step 2 randomization)

  • STEP 2 - ALT and AST < 3 x ULN (obtained within 14 days prior to Step 2 randomization)

  • STEP 2 - Patient must not be pregnant or breast-feeding due to the potential harm and teratogenic effects to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study with a sensitivity of at least 25 mIU/mL within 10-14 days prior to Step 2 randomization to rule out pregnancy and again within 24 hours prior to the first dose of lenalidomide. Patients of childbearing potential must also agree to ongoing pregnancy testing while on protocol treatment. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: * Has achieved menarche at some point, * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).

  • STEP 2 - Patients of childbearing potential must not expect to conceive children by using accepted and effective method(s) of contraception [for this protocol defined as the use of TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME for 1) at least 28 days before starting protocol treatment; 2) while participating in the study; 3) during dose interruptions; and 4) for at least 3 months after the last dose of protocol treatment] OR by practicing true abstinence from sexual intercourse for the duration of their participation in the study (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception). Patients must not expect to father children by practicing true abstinence from sexual intercourse for the duration of their participation in the study (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception] OR use a latex condom during sexual contact with a partner of child bearing potential while participating in the study and for at least 3 months after the last dose of protocol treatment even if they have had a successful vasectomy. Patients must also agree to abstain from donating sperm, even if they have had a successful vasectomy, or donating eggs while on study treatment and for 3 months after the last dose of protocol treatment. All patients must agree to abstain from donating blood during study participation and for at least 28 days after the last dose of protocol treatment

United States
AK
Anchorage
Alaska Breast Care and Surgery LLC
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Email: AKPAMC.OncologyResearchSupport@providence.org

Alaska Oncology and Hematology LLC
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Alaska Women's Cancer Care
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Anchorage Associates in Radiation Medicine
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Anchorage Oncology Centre
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Anchorage Radiation Therapy Center
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Katmai Oncology Group
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Email: AKPAMC.OncologyResearchSupport@providence.org

Providence Alaska Medical Center
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Email: AKPAMC.OncologyResearchSupport@providence.org

AR
Ft. Smith
Mercy Hospital Fort Smith
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Hot Springs
CHI Saint Vincent Cancer Center Hot Springs
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Email: ResearchInstituteInquiries@CommonSpirit.org

Little Rock
John L McClellan Memorial Veterans Hospital
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Email: richard.dennis2@va.gov

AZ
Phoenix
Cancer Center at Saint Joseph's
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Email: CancerInstitute@DignityHealth.org

Tucson
Banner University Medical Center - Tucson
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Email: UACC-IIT@uacc.arizona.edu

University of Arizona Cancer Center-North Campus
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University of Arizona Cancer Center-Orange Grove Campus
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CA
Arroyo Grande
Mission Hope Medical Oncology - Arroyo Grande
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Burbank
Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Email: Najee.Boucher@providence.org

Carmichael
Mercy Cancer Center ๏ฟฝ๏ฟฝ Carmichael
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Mercy San Juan Medical Center
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Elk Grove
Mercy Cancer Center - Elk Grove
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Rocklin
Mercy Cancer Center - Rocklin
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Sacramento
Mercy Cancer Center - Sacramento
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Email: OncologyResearch@DignityHealth.org

San Luis Obispo
Pacific Central Coast Health Center-San Luis Obispo
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Santa Maria
Mission Hope Medical Oncology - Santa Maria
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Woodland
Woodland Memorial Hospital
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Email: OncologyResearch@DignityHealth.org

CO
Colorado Springs
Penrose-Saint Francis Healthcare
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Email: ResearchTracking@Centura.Org

Rocky Mountain Cancer Centers-Penrose
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Saint Francis Cancer Center
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Denver
Porter Adventist Hospital
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Durango
Mercy Medical Center
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Southwest Oncology PC
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Lakewood
Saint Anthony Hospital
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Littleton
Littleton Adventist Hospital
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Email: ResearchTracking@Centura.Org

Longmont
Longmont United Hospital
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Rocky Mountain Cancer Centers-Longmont
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Parker
Parker Adventist Hospital
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Pueblo
Saint Mary Corwin Medical Center
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Email: ResearchTracking@Centura.Org

CT
Derby
Smilow Cancer Hospital-Derby Care Center
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Email: canceranswers@yale.edu

Fairfield
Smilow Cancer Hospital Care Center-Fairfield
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Glastonbury
Smilow Cancer Hospital Care Center at Glastonbury
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Email: canceranswers@yale.edu

Greenwich
Smilow Cancer Hospital Care Center at Greenwich
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Email: canceranswers@yale.edu

Guilford
Smilow Cancer Hospital Care Center - Guilford
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Email: canceranswers@yale.edu

Hartford
Hartford Hospital
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Smilow Cancer Hospital Care Center at Saint Francis
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Email: canceranswers@yale.edu

Meriden
Midstate Medical Center
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New Britain
The Hospital of Central Connecticut
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New Haven
Smilow Cancer Center/Yale-New Haven Hospital
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Yale University
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Email: canceranswers@yale.edu

North Haven
Yale-New Haven Hospital North Haven Medical Center
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Email: canceranswers@yale.edu

Orange
Smilow Cancer Hospital-Orange Care Center
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Email: canceranswers@yale.edu

Torrington
Smilow Cancer Hospital-Torrington Care Center
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Email: canceranswers@yale.edu

Trumbull
Smilow Cancer Hospital Care Center-Trumbull
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Waterbury
Smilow Cancer Hospital-Waterbury Care Center
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Waterford
Smilow Cancer Hospital Care Center - Waterford
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DE
Frankford
Beebe South Coastal Health Campus
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Email: research@beebehealthcare.org

Lewes
Beebe Medical Center
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Newark
Christiana Care Health System-Christiana Hospital
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Email: lbarone@christianacare.org

Delaware Clinical and Laboratory Physicians PA
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Email: mhayden@christianacare.org

Helen F Graham Cancer Center
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Medical Oncology Hematology Consultants PA
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Email: lbarone@christianacare.org

Rehoboth Beach
Beebe Health Campus
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Email: research@beebehealthcare.org

Seaford
TidalHealth Nanticoke / Allen Cancer Center
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Email: anna-maria.howard@peninsula.org

Wilmington
Christiana Care Health System-Wilmington Hospital
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FL
Fort Lauderdale
Holy Cross Hospital
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Pensacola
Sacred Heart Hospital
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IA
Ames
Mary Greeley Medical Center
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McFarland Clinic - Ames
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Boone
McFarland Clinic - Boone
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Carroll
Saint Anthony Regional Hospital
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Email: sbenson@iora.org

Cedar Rapids
Mercy Hospital
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Oncology Associates at Mercy Medical Center
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Clive
Medical Oncology and Hematology Associates-West Des Moines
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Mercy Cancer Center-West Lakes
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Council Bluffs
Alegent Health Mercy Hospital
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Creston
Greater Regional Medical Center
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Des Moines
Broadlawns Medical Center
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Iowa Lutheran Hospital
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Iowa Methodist Medical Center
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Medical Oncology and Hematology Associates-Des Moines
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Mercy Medical Center - Des Moines
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Mission Cancer and Blood - Laurel
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Fort Dodge
McFarland Clinic - Trinity Cancer Center
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Trinity Regional Medical Center
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Jefferson
McFarland Clinic - Jefferson
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Marshalltown
McFarland Clinic - Marshalltown
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Sioux City
Siouxland Regional Cancer Center
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Email: HoopingarnerT@jencc.com

West Des Moines
Mercy Medical Center-West Lakes
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Methodist West Hospital
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ID
Boise
Saint Alphonsus Cancer Care Center-Boise
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Email: stephanie.couch@stjoeshealth.org

Saint Luke's Cancer Institute - Boise
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Email: eslinget@slhs.org

Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
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Email: stephanie.couch@stjoeshealth.org

Coeur D'Alene
Kootenai Health - Coeur d'Alene
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Email: mccinfo@mtcancer.org

Emmett
Walter Knox Memorial Hospital
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Fruitland
Saint Luke's Cancer Institute - Fruitland
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Email: eslinget@slhs.org

Meridian
Idaho Urologic Institute-Meridian
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Saint Luke's Cancer Institute - Meridian
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Nampa
Saint Alphonsus Cancer Care Center-Nampa
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Email: mccinfo@mtcancer.org

Saint Luke's Cancer Institute - Nampa
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Post Falls
Kootenai Clinic Cancer Services - Post Falls
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Sandpoint
Kootenai Cancer Clinic
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Twin Falls
Saint Luke's Cancer Institute - Twin Falls
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Email: eslinget@slhs.org

IL
Alton
Saint Anthony's Health
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Aurora
Rush - Copley Medical Center
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Email: Cancer.Research@rushcopley.com

Barrington
Advocate Good Shepherd Hospital
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Bloomington
Illinois CancerCare-Bloomington
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Email: andersonj@illinoiscancercare.com

Burr Ridge
Loyola Center for Health at Burr Ridge
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Canton
Illinois CancerCare-Canton
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Email: andersonj@illinoiscancercare.com

Carbondale
Memorial Hospital of Carbondale
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Email: clinical.research@sih.net

Carterville
SIH Cancer Institute
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Carthage
Illinois CancerCare-Carthage
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Email: andersonj@illinoiscancercare.com

Centralia
Centralia Oncology Clinic
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Saint Mary's Hospital
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Email: ecog.rss@jimmy.harvard.edu

Chicago
Advocate Illinois Masonic Medical Center
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John H Stroger Jr Hospital of Cook County
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University of Illinois
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Crystal Lake
AMG Crystal Lake - Oncology
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Email: advocateresearch@advocate.com

Danville
Carle at The Riverfront
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Email: Research@Carle.com

DeKalb
Northwestern Medicine Cancer Center Kishwaukee
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Email: Donald.Smith3@nm.org

Decatur
Cancer Care Specialists of Illinois - Decatur
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Email: morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
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Dixon
Illinois CancerCare-Dixon
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Downers Grove
Advocate Good Samaritan Hospital
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Email: Barbara.barhamand@advocatehealth.com

Effingham
Carle Physician Group-Effingham
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Email: Research@carle.com

Crossroads Cancer Center
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Email: morganthaler.jodi@mhsil.com

Elgin
Advocate Sherman Hospital
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Eureka
Illinois CancerCare-Eureka
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Email: andersonj@illinoiscancercare.com

Galesburg
Illinois CancerCare-Galesburg
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Email: andersonj@illinoiscancercare.com

Western Illinois Cancer Treatment Center
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Geneva
Northwestern Medicine Cancer Center Delnor
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Email: Donald.Smith3@nm.org

Hazel Crest
Advocate South Suburban Hospital
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Homer Glen
Loyola Medicine Homer Glen
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Kewanee
Illinois CancerCare-Kewanee Clinic
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Email: andersonj@illinoiscancercare.com

Libertyville
AMG Libertyville - Oncology
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Email: advocateresearch@advocatehealth.com

Condell Memorial Hospital
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Email: advocateresearch@advocatehealth.com

Macomb
Illinois CancerCare-Macomb
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Email: andersonj@illinoiscancercare.com

Mattoon
Carle Physician Group-Mattoon/Charleston
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Email: Research@carle.com

Maywood
Loyola University Medical Center
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Melrose Park
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
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Mount Vernon
Good Samaritan Regional Health Center
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O'Fallon
Cancer Care Center of O'Fallon
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Email: morganthaler.jodi@mhsil.com

Oak Lawn
Advocate Christ Medical Center
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Ottawa
Illinois CancerCare-Ottawa Clinic
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Email: andersonj@illinoiscancercare.com

Park Ridge
Advocate Lutheran General Hospital
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Pekin
Illinois CancerCare-Pekin
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peoria
Illinois CancerCare-Peoria
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Methodist Medical Center of Illinois
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peru
Illinois CancerCare-Peru
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Valley Radiation Oncology
Contact: Site Public Contact

Princeton
Illinois CancerCare-Princeton
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Springfield
Memorial Medical Center
Contact: Site Public Contact
Email: pallante.beth@mhsil.com

Southern Illinois University School of Medicine
Contact: Site Public Contact

Springfield Clinic
Contact: Site Public Contact

Urbana
Carle Cancer Center
Contact: Site Public Contact
Email: Research@carle.com

The Carle Foundation Hospital
Contact: Site Public Contact
Email: Research@carle.com

Warrenville
Northwestern Medicine Cancer Center Warrenville
Contact: Site Public Contact
Email: Donald.Smith3@nm.org

Washington
Illinois CancerCare - Washington
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Yorkville
Rush-Copley Healthcare Center
Contact: Site Public Contact
Email: Cancer.Research@rushcopley.com

IN
Carmel
IU Health North Hospital
Contact: Chelsea Young
Email: youngchs@iu.edu

Indianapolis
IU Health Methodist Hospital
Contact: Chelsea Young
Email: youngchs@iu.edu

Indiana University/Melvin and Bren Simon Cancer Center
Contact: Chelsea Young
Email: youngchs@iu.edu

Richmond
Reid Health
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

KS
Chanute
Cancer Center of Kansas - Chanute
Contact: Site Public Contact
Email: research@viachristi.org

Dodge City
Cancer Center of Kansas - Dodge City
Contact: Site Public Contact
Email: research@viachristi.org

El Dorado
Cancer Center of Kansas - El Dorado
Contact: Site Public Contact
Email: research@viachristi.org

Garden City
Central Care Cancer Center - Garden City
Contact: Site Public Contact
Email: aroland@kccop.org

Great Bend
Central Care Cancer Center - Great Bend
Contact: Site Public Contact
Email: aroland@kccop.org

Independence
Cancer Center of Kansas-Independence
Contact: Site Public Contact
Email: research@viachristi.org

Kingman
Cancer Center of Kansas-Kingman
Contact: Site Public Contact
Email: research@viachristi.org

Liberal
Cancer Center of Kansas-Liberal
Contact: Site Public Contact
Email: research@viachristi.org

Manhattan
Cancer Center of Kansas-Manhattan
Contact: Site Public Contact
Email: research@viachristi.org

McPherson
Cancer Center of Kansas - McPherson
Contact: Site Public Contact
Email: research@viachristi.org

Newton
Cancer Center of Kansas - Newton
Contact: Site Public Contact
Email: research@viachristi.org

Parsons
Cancer Center of Kansas - Parsons
Contact: Site Public Contact
Email: research@viachristi.org

Pratt
Cancer Center of Kansas - Pratt
Contact: Site Public Contact
Email: research@viachristi.org

Salina
Cancer Center of Kansas - Salina
Contact: Site Public Contact
Email: research@viachristi.org

Wellington
Cancer Center of Kansas - Wellington
Contact: Site Public Contact
Email: research@viachristi.org

Wichita
Ascension Via Christi Hospitals Wichita
Contact: Site Public Contact
Email: research@viachristi.org

Cancer Center of Kansas - Wichita
Contact: Site Public Contact
Email: research@viachristi.org

Cancer Center of Kansas-Wichita Medical Arts Tower
Contact: Site Public Contact
Email: research@viachristi.org

Winfield
Cancer Center of Kansas - Winfield
Contact: Site Public Contact
Email: research@viachristi.org

KY
Bardstown
Flaget Memorial Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Corbin
Commonwealth Cancer Center-Corbin
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Lexington
Saint Joseph Hospital
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Saint Joseph Hospital East
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Saint Joseph Radiation Oncology Resource Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

London
Saint Joseph London
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Louisville
Jewish Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Saints Mary and Elizabeth Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

UofL Health Medical Center Northeast
Contact: Site Public Contact
Email: ctoinfo@louisville.edu

Mount Sterling
Saint Joseph Mount Sterling
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Shepherdsville
Jewish Hospital Medical Center South
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

LA
Baton Rouge
LSU Health Baton Rouge-North Clinic
Contact: Site Public Contact
Email: research@ololrmc.com

Our Lady of the Lake Physicians Group - Medical Oncology
Contact: Site Public Contact
Email: research@ololrmc.com

Monroe
Ochsner LSU Health Monroe Medical Center
Contact: Site Public Contact
Email: LPost@lsuhsc.edu

Shreveport
LSU Health Sciences Center at Shreveport
Contact: Site Public Contact
Email: LPost@lsuhsc.edu

MA
Boston
Tufts Medical Center
Contact: Site Public Contact
Email: ContactUsCancerCenter@TuftsMedicalCenter.org

MD
Elkton
Christiana Care - Union Hospital
Contact: Site Public Contact
Email: sstewart@uhcc.com

Frederick
FMH James M Stockman Cancer Institute
Contact: Site Public Contact

Frederick Memorial Hospital
Contact: Site Public Contact
Email: clinicaltrials@fmh.org

MI
Adrian
Hickman Cancer Center
Contact: Site Public Contact

Ann Arbor
Saint Joseph Mercy Hospital
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Battle Creek
Bronson Battle Creek
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Brighton
Saint Joseph Mercy Brighton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Brighton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Canton
Saint Joseph Mercy Canton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Canton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Caro
Caro Cancer Center
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Chelsea
Saint Joseph Mercy Chelsea
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Clarkston
Hematology Oncology Consultants-Clarkston
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Newland Medical Associates-Clarkston
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Detroit
Ascension Saint John Hospital
Contact: Site Public Contact
Email: karen.forman@ascension.org

East China
Great Lakes Cancer Management Specialists-Doctors Park
Contact: Site Public Contact
Email: karen.forman@ascension.org

Flint
Genesee Cancer and Blood Disease Treatment Center
Contact: Site Public Contact
Email: wstrong@ghci.org

Genesee Hematology Oncology PC
Contact: Site Public Contact
Email: wstrong@ghci.org

Genesys Hurley Cancer Institute
Contact: Site Public Contact
Email: wstrong@ghci.org

Hurley Medical Center
Contact: Site Public Contact
Email: wstrong@ghci.org

Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Spectrum Health at Butterworth Campus
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Trinity Health Grand Rapids Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Grosse Pointe Woods
Academic Hematology Oncology Specialists
Contact: Site Public Contact
Email: karen.forman@ascension.org

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Contact: Site Public Contact
Email: karen.forman@ascension.org

Michigan Breast Specialists-Grosse Pointe Woods
Contact: Site Public Contact
Email: karen.forman@ascension.org

Kalamazoo
Ascension Borgess Cancer Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Borgess Medical Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Bronson Methodist Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

West Michigan Cancer Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Lansing
Sparrow Hospital
Contact: Site Public Contact

Livonia
Hope Cancer Clinic
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Trinity Health Saint Mary Mercy Livonia Hospital
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Macomb Township
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Contact: Site Public Contact
Email: karen.forman@ascension.org

Michigan Breast Specialists-Macomb Township
Contact: Site Public Contact
Email: karen.forman@ascension.org

Marlette
Saint Mary's Oncology/Hematology Associates of Marlette
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Monroe
Toledo Clinic Cancer Centers-Monroe
Contact: Site Public Contact

Muskegon
Trinity Health Muskegon Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Niles
Lakeland Hospital Niles
Contact: Site Public Contact

Norton Shores
Cancer and Hematology Centers of Western Michigan - Norton Shores
Contact: Site Public Contact
Email: connie.szczepanek@crcwm.org

Novi
Ascension Providence Hospitals - Novi
Contact: Site Public Contact
Email: karen.fife@ascension.org

Pontiac
21st Century Oncology-Pontiac
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Hope Cancer Center
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Newland Medical Associates-Pontiac
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Saint Joseph Mercy Oakland
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Reed City
Spectrum Health Reed City Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Rochester Hills
Great Lakes Cancer Management Specialists-Rochester Hills
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Saginaw
Ascension Saint Mary's Hospital
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Oncology Hematology Associates of Saginaw Valley PC
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Saint Joseph
Lakeland Medical Center Saint Joseph
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Marie Yeager Cancer Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Southfield
Ascension Providence Hospitals - Southfield
Contact: Site Public Contact
Email: karen.fife@ascension.org

Sterling Heights
Bhadresh Nayak MD PC-Sterling Heights
Contact: Site Public Contact
Email: karen.forman@ascension.org

Tawas City
Ascension Saint Joseph Hospital
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Traverse City
Munson Medical Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Warren
Advanced Breast Care Center PLLC
Contact: Site Public Contact
Email: karen.forman@ascension.org

Great Lakes Cancer Management Specialists-Macomb Professional Building
Contact: Site Public Contact
Email: karen.forman@ascension.org

Macomb Hematology Oncology PC
Contact: Site Public Contact
Email: karen.forman@ascension.org

Michigan Breast Specialists-Warren
Contact: Site Public Contact
Email: karen.forman@ascension.org

Saint John Macomb-Oakland Hospital
Contact: Site Public Contact
Email: karen.forman@ascension.org

West Branch
Saint Mary's Oncology/Hematology Associates of West Branch
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Wyoming
University of Michigan Health - West
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Ypsilanti
Huron Gastroenterology PC
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

MN
Bemidji
Sanford Joe Lueken Cancer Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Burnsville
Fairview Ridges Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Minnesota Oncology - Burnsville
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Cambridge
Cambridge Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Coon Rapids
Mercy Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Edina
Fairview Southdale Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Fridley
Unity Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Maple Grove
Fairview Clinics and Surgery Center Maple Grove
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Maplewood
Minnesota Oncology Hematology PA-Maplewood
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Saint John's Hospital - Healtheast
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Minneapolis
Abbott-Northwestern Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Health Partners Inc
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Hennepin County Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Monticello
Monticello Cancer Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

New Ulm
New Ulm Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Princeton
Fairview Northland Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Robbinsdale
North Memorial Medical Health Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Rochester
Mayo Clinic in Rochester
Contact: Site Public Contact

Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Saint Paul
Regions Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

United Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Shakopee
Saint Francis Regional Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Stillwater
Lakeview Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Thief River Falls
Sanford Thief River Falls Medical Center
Contact: Site Public Contact

Waconia
Ridgeview Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Willmar
Rice Memorial Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Woodbury
Minnesota Oncology Hematology PA-Woodbury
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Wyoming
Fairview Lakes Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

MO
Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Contact: Site Public Contact

Bolivar
Central Care Cancer Center - Bolivar
Contact: Site Public Contact
Email: aroland@kccop.org

Branson
Cox Cancer Center Branson
Contact: Site Public Contact

Cape Girardeau
Saint Francis Medical Center
Contact: Site Public Contact
Email: sfmc@sfmc.net

Southeast Cancer Center
Contact: Site Public Contact

Chesterfield
Saint Luke's Hospital
Contact: Site Public Contact

Farmington
Parkland Health Center - Farmington
Contact: Site Public Contact

Jefferson City
Capital Region Southwest Campus
Contact: Site Public Contact
Email: swooden@mail.crmc.org

Joplin
Freeman Health System
Contact: Site Public Contact
Email: LJCrockett@freemanhealth.com

Mercy Hospital Joplin
Contact: Site Public Contact
Email: esmeralda.carrillo@mercy.net

Rolla
Delbert Day Cancer Institute at PCRMC
Contact: Site Public Contact
Email: research@phelpshealth.org

Mercy Clinic-Rolla-Cancer and Hematology
Contact: Site Public Contact

Saint Joseph
Heartland Regional Medical Center
Contact: Site Public Contact
Email: linda.schumacher@mymlc.com

Saint Louis
Mercy Hospital Saint Louis
Contact: Site Public Contact

Mercy Hospital South
Contact: Site Public Contact
Email: Danielle.Werle@mercy.net

Missouri Baptist Medical Center
Contact: Site Public Contact

Saint Louis Cancer and Breast Institute-South City
Contact: Site Public Contact

Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Contact: Site Public Contact

Springfield
CoxHealth South Hospital
Contact: Site Public Contact

Mercy Hospital Springfield
Contact: Site Public Contact

Sullivan
Missouri Baptist Sullivan Hospital
Contact: Site Public Contact

Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Contact: Site Public Contact

Washington
Mercy Hospital Washington
Contact: Site Public Contact

MT
Anaconda
Community Hospital of Anaconda
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Billings
Billings Clinic Cancer Center
Contact: Site Public Contact
Email: research@billingsclinic.org

Bozeman
Bozeman Deaconess Hospital
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Great Falls
Benefis Healthcare- Sletten Cancer Institute
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Great Falls Clinic
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Kalispell
Kalispell Regional Medical Center
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Missoula
Community Medical Hospital
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Saint Patrick Hospital - Community Hospital
Contact: Site Public Contact
Email: amy.hanneman@providence.org

NC
Clinton
Southeastern Medical Oncology Center-Clinton
Contact: Site Public Contact
Email: jfields@cancersmoc.com

Goldsboro
Southeastern Medical Oncology Center-Goldsboro
Contact: Site Public Contact
Email: jfields@cancersmoc.com

Greenville
East Carolina University
Contact: Site Public Contact
Email: eubankss@ecu.edu

Jacksonville
Southeastern Medical Oncology Center-Jacksonville
Contact: Site Public Contact
Email: jfields@cancersmoc.com

Kenansville
Vidant Oncology-Kenansville
Contact: Site Public Contact
Email: research@ecuhealth.org

Kinston
Vidant Oncology-Kinston
Contact: Site Public Contact
Email: research@ecuhealth.org

Richlands
Vidant Oncology-Richlands
Contact: Site Public Contact
Email: research@ecuhealth.org

ND
Bismarck
Sanford Bismarck Medical Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Fargo
Sanford Broadway Medical Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Medical Center Fargo
Contact: Site Public Contact

Sanford Roger Maris Cancer Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford South University Medical Center
Contact: Site Public Contact

Southpointe-Sanford Medical Center Fargo
Contact: Site Public Contact

NE
Grand Island
CHI Health Saint Francis
Contact: Site Public Contact

Kearney
CHI Health Good Samaritan
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Lincoln
Cancer Partners of Nebraska - Pine Lake
Contact: Site Public Contact
Email: research@cancerpartners.com

Saint Elizabeth Regional Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Southeast Nebraska Cancer Center - 68th Street Place
Contact: Site Public Contact
Email: research@cancerpartners.com

Omaha
Alegent Health Bergan Mercy Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Alegent Health Immanuel Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Alegent Health Lakeside Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Creighton University Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Papillion
Midlands Community Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

NJ
Morristown
Morristown Medical Center
Contact: Site Public Contact

Summit
Overlook Hospital
Contact: Site Public Contact

NM
Albuquerque
University of New Mexico Cancer Center
Contact: Site Public Contact
Email: HSC-ClinicalTrialInfo@salud.unm.edu

NY
Binghamton
Lourdes Hospital
Contact: Site Public Contact

Glens Falls
Glens Falls Hospital
Contact: Site Public Contact

Rochester
University of Rochester
Contact: Site Public Contact

Stony Brook
Stony Brook University Medical Center
Contact: Site Public Contact

Syracuse
State University of New York Upstate Medical University
Contact: Site Public Contact

West Islip
Good Samaritan Hospital Medical Center
Contact: Site Public Contact

OH
Beachwood
UHHS-Chagrin Highlands Medical Center
Contact: Site Public Contact
Email: CTUReferral@UHhospitals.org

Beavercreek
Indu and Raj Soin Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Belpre
Strecker Cancer Center-Belpre
Contact: Site Public Contact
Email: sheree@columbusccop.org

Boardman
Saint Elizabeth Boardman Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Centerville
Dayton Physicians LLC-Miami Valley South
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Miami Valley Hospital South
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Chardon
Geauga Hospital
Contact: Site Public Contact
Email: CTUReferral@UHhospitals.org

Chillicothe
Adena Regional Medical Center
Contact: Site Public Contact
Email: sheree@columbusccop.org

Cincinnati
Bethesda North Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Good Samaritan Hospital - Cincinnati
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Oncology Hematology Care Inc-Kenwood
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

TriHealth Cancer Institute-Anderson
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

TriHealth Cancer Institute-Westside
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

University of Cincinnati Cancer Center-UC Medical Center
Contact: Site Public Contact
Email: cancer@uchealth.com

Cleveland
Case Western Reserve University
Contact: Site Public Contact
Email: CTUReferral@UHhospitals.org

Louis Stokes Cleveland VA Medical Center
Contact: Site Public Contact
Email: holly.henry@va.gov

Columbus
Columbus Oncology and Hematology Associates Inc
Contact: Site Public Contact
Email: sheree@columbusccop.org

Doctors Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Grant Medical Center
Contact: Site Public Contact
Email: sheree@columbusccop.org

Mount Carmel East Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Mount Carmel Health Center West
Contact: Site Public Contact
Email: sheree@columbusccop.org

Riverside Methodist Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

The Mark H Zangmeister Center
Contact: Site Public Contact
Email: sheree@columbusccop.org

Dayton
Dayton Blood and Cancer Center
Contact: Site Public Contact

Dayton Physician LLC-Miami Valley Hospital North
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Miami Valley Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Miami Valley Hospital North
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Delaware
Delaware Health Center-Grady Cancer Center
Contact: Site Public Contact
Email: sheree@columbusccop.org

Grady Memorial Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Dublin
Columbus Oncology and Hematology Associates
Contact: Site Public Contact
Email: sheree@columbusccop.org

Dublin Methodist Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Findlay
Armes Family Cancer Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Blanchard Valley Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Orion Cancer Care
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Franklin
Atrium Medical Center-Middletown Regional Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Dayton Physicians LLC-Atrium
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Gahanna
Central Ohio Breast and Endocrine Surgery
Contact: Site Public Contact
Email: sheree@columbusccop.org

Greenville
Dayton Physicians LLC-Wayne
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Miami Valley Cancer Care and Infusion
Contact: Site Public Contact

Wayne Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Grove City
Mount Carmel Grove City Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Zangmeister Center Grove City
Contact: Site Public Contact
Email: sheree@columbusccop.org

Kettering
Greater Dayton Cancer Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Kettering Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Lancaster
Fairfield Medical Center
Contact: Site Public Contact
Email: sheree@columbusccop.org

Lima
Saint Rita's Medical Center
Contact: Site Public Contact

Mansfield
OhioHealth Mansfield Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Marietta
Marietta Memorial Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Marion
OhioHealth Marion General Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Maumee
Toledo Clinic Cancer Centers-Maumee
Contact: Site Public Contact
Email: pshoup@toledoclinic.com

Mayfield Heights
UH Seidman Cancer Center at Landerbrook Health Center
Contact: Site Public Contact
Email: CTUReferral@UHhospitals.org

Mount Vernon
Knox Community Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

New Albany
Mount Carmel New Albany Surgical Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Newark
Licking Memorial Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Newark Radiation Oncology
Contact: Site Public Contact
Email: sheree@columbusccop.org

Parma
University Hospitals Parma Medical Center
Contact: Site Public Contact
Email: CTUReferral@UHhospitals.org

Perrysburg
Mercy Health Perrysburg Cancer Center
Contact: Site Public Contact
Email: sheree@columbusccop.org

Portsmouth
Southern Ohio Medical Center
Contact: Site Public Contact
Email: sheree@columbusccop.org

Springfield
Springfield Regional Cancer Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Springfield Regional Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Toledo
Mercy Health - Saint Anne Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Saint Vincent Mercy Medical Center
Contact: Site Public Contact
Email: sheree@columbusccop.org

Toledo Clinic Cancer Centers-Toledo
Contact: Site Public Contact

Troy
Dayton Physicians LLC - Troy
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Upper Valley Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Wadsworth
University Hospitals Sharon Health Center
Contact: Site Public Contact
Email: CTUReferral@UHhospitals.org

Warren
Saint Joseph Warren Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

West Chester
University of Cincinnati Cancer Center-West Chester
Contact: Site Public Contact
Email: cancer@uchealth.com

Westerville
Saint Ann's Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Westlake
UH Seidman Cancer Center at Saint John Medical Center
Contact: Site Public Contact
Email: CTUReferral@UHhospitals.org

Youngstown
Saint Elizabeth Youngstown Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Zanesville
Genesis Healthcare System Cancer Care Center
Contact: Site Public Contact
Email: sheree@columbusccop.org

OK
Oklahoma City
Mercy Hospital Oklahoma City
Contact: Site Public Contact

OR
Baker City
Saint Alphonsus Medical Center-Baker City
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Bend
Saint Charles Health System
Contact: Site Public Contact
Email: nosall@stcharleshealthcare.org

Clackamas
Clackamas Radiation Oncology Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Providence Cancer Institute Clackamas Clinic
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Coos Bay
Bay Area Hospital
Contact: Site Public Contact
Email: cherie.cox@bayareahospital.org

Newberg
Providence Newberg Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Ontario
Saint Alphonsus Medical Center-Ontario
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Oregon City
Providence Willamette Falls Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Portland
Oregon Health and Science University
Contact: Site Public Contact
Email: trials@ohsu.edu

Providence Portland Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Providence Saint Vincent Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Redmond
Saint Charles Health System-Redmond
Contact: Site Public Contact

PA
Allentown
Lehigh Valley Hospital-Cedar Crest
Contact: Site Public Contact
Email: Morgan_M.Horton@lvhn.org

Bethlehem
Lehigh Valley Hospital - Muhlenberg
Contact: Site Public Contact
Email: Morgan_M.Horton@lvhn.org

Chadds Ford
Christiana Care Health System-Concord Health Center
Contact: Site Public Contact
Email: lbarone@christianacare.org

Danville
Geisinger Medical Center
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

East Stroudsburg
Pocono Medical Center
Contact: Site Public Contact
Email: Morgan_M.Horton@lvhn.org

Hazleton
Geisinger Medical Center-Cancer Center Hazleton
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

Lehigh Valley Hospital-Hazleton
Contact: Site Public Contact
Email: Morgan_M.Horton@lvhn.org

Lewisburg
Geisinger Medical Oncology-Lewisburg
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

Pottsville
Geisinger Cancer Services-Pottsville
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

Scranton
Community Medical Center
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

West Reading
Reading Hospital
Contact: Site Public Contact

Wilkes-Barre
Geisinger Wyoming Valley/Henry Cancer Center
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

RI
Westerly
Smilow Cancer Hospital Care Center - Westerly
Contact: Site Public Contact
Email: canceranswers@yale.edu

SC
Charleston
Medical University of South Carolina
Contact: Site Public Contact
Email: hcc-clinical-trials@musc.edu

Ralph H Johnson VA Medical Center
Contact: Site Public Contact
Email: ashley.salvo@va.gov

Greenville
Saint Francis Cancer Center
Contact: Site Public Contact
Email: melissa_beckman@bshsi.org

Saint Francis Hospital
Contact: Site Public Contact
Email: melissa_beckman@bshsi.org

SD
Sioux Falls
Avera Cancer Institute
Contact: Site Public Contact
Email: OncRegulatory@avera.org

TN
Nashville
Vanderbilt University/Ingram Cancer Center
Contact: Site Public Contact

TX
Bryan
Saint Joseph Regional Cancer Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

UT
Salt Lake City
Huntsman Cancer Institute/University of Utah
Contact: Site Public Contact
Email: cancerinfo@hci.utah.edu

VA
Charlottesville
University of Virginia Cancer Center
Contact: Site Public Contact
Email: uvacancertrials@hscmail.mcc.virginia.edu

Fairfax
Inova Schar Cancer Institute
Contact: Site Public Contact
Email: Stephanie.VanBebber@inova.org

Falls Church
Inova Fairfax Hospital
Contact: Site Public Contact
Email: Stephanie.VanBebber@inova.org

Lynchburg
Centra Lynchburg Hematology-Oncology Clinic Inc
Contact: Site Public Contact
Email: Kevin.Patel@centrahealth.com

Richmond
Virginia Cancer Institute
Contact: Site Public Contact
Email: smoore@vacancer.com

Virginia Commonwealth University/Massey Cancer Center
Contact: Site Public Contact
Email: CTOclinops@vcu.edu

South Hill
VCU Community Memorial Health Center
Contact: Site Public Contact
Email: nemer.elmouallem@vcuhealth.org

WI
Appleton
Ascension Saint Elizabeth Hospital
Contact: Site Public Contact
Email: AWRI.inquiry@ascension.org

ThedaCare Regional Cancer Center
Contact: Site Public Contact
Email: ResearchDept@thedacare.org

Baraboo
SSM Health Dean Medical Group - Baraboo
Contact: Site Public Contact

Brookfield
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Contact: Site Public Contact
Email: AWRI.Inquiry@Ascension.org

Burlington
Aurora Cancer Care-Southern Lakes VLCC
Contact: Site Public Contact
Email: ncorp@aurora.org

Chilton
Ascension Calumet Hospital
Contact: Site Public Contact
Email: AWRI.inquiry@ascension.org

Chippewa Falls
Marshfield Clinic-Chippewa Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Cudahy
Aurora Saint Luke's South Shore
Contact: Site Public Contact
Email: ncorp@aurora.org

Eau Claire
HSHS Sacred Heart Hospital
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

Marshfield Medical Center-EC Cancer Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Franklin
Ascension Saint Francis - Reiman Cancer Center
Contact: Site Public Contact
Email: AWRI.Inquiry@Ascension.org

Ascension Southeast Wisconsin Hospital - Franklin
Contact: Site Public Contact
Email: AWRI.Inquiry@Ascension.org

Germantown
Aurora Health Care Germantown Health Center
Contact: Site Public Contact
Email: ncorp@aurora.org

Grafton
Aurora Cancer Care-Grafton
Contact: Site Public Contact
Email: ncorp@aurora.org

Green Bay
Aurora BayCare Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org

Saint Vincent Hospital Cancer Center Green Bay
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

Saint Vincent Hospital Cancer Center at Saint Mary's
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

Janesville
SSM Health Dean Medical Group - Janesville
Contact: Site Public Contact

Kenosha
Aurora Cancer Care-Kenosha South
Contact: Site Public Contact
Email: ncorp@aurora.org

La Crosse
Gundersen Lutheran Medical Center
Contact: Site Public Contact
Email: cancerctr@gundersenhealth.org

Mayo Clinic Health System-Franciscan Healthcare
Contact: Site Public Contact

Ladysmith
Marshfield Clinic - Ladysmith Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Madison
Dean Hematology and Oncology Clinic
Contact: Site Public Contact

University of Wisconsin Carbone Cancer Center
Contact: Site Public Contact

William S Middleton VA Medical Center
Contact: Site Public Contact

Marinette
Aurora Bay Area Medical Group-Marinette
Contact: Site Public Contact
Email: ncorp@aurora.org

Marshfield
Marshfield Medical Center-Marshfield
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Mequon
Ascension Columbia Saint Mary's Hospital Ozaukee
Contact: Site Public Contact
Email: AWRI.Inquiry@Ascension.org

Milwaukee
Ascension Columbia Saint Mary's Hospital - Milwaukee
Contact: Site Public Contact
Email: AWRI.Inquiry@Ascension.org

Ascension Saint Francis Hospital
Contact: Site Public Contact
Email: AWRI.Inquiry@Ascension.org

Ascension Southeast Wisconsin Hospital - Saint Joseph Campus
Contact: Site Public Contact
Email: AWRI.Inquiry@Ascension.org

Aurora Cancer Care-Milwaukee
Contact: Site Public Contact
Email: ncorp@aurora.org

Aurora Saint Luke's Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org

Aurora Sinai Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org

Minocqua
Marshfield Clinic-Minocqua Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Mukwonago
ProHealth D N Greenwald Center
Contact: Site Public Contact
Email: research.institute@phci.org

Neenah
ThedaCare Regional Medical Center - Neenah
Contact: Site Public Contact
Email: ResearchDept@thedacare.org

Neillsville
Marshfield Medical Center - Neillsville
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

New Richmond
Cancer Center of Western Wisconsin
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Oconomowoc
ProHealth Oconomowoc Memorial Hospital
Contact: Site Public Contact

Oconto Falls
Saint Vincent Hospital Cancer Center at Oconto Falls
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

Oshkosh
Ascension Mercy Hospital
Contact: Site Public Contact
Email: AWRI.inquiry@ascension.org

Vince Lombardi Cancer Clinic - Oshkosh
Contact: Site Public Contact
Email: ncorp@aurora.org

Racine
Ascension All Saints Hospital
Contact: Site Public Contact
Email: AWRI.Inquiry@Ascension.org

Aurora Cancer Care-Racine
Contact: Site Public Contact
Email: ncorp@aurora.org

Rice Lake
Marshfield Medical Center-Rice Lake
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Contact: Site Public Contact
Email: ncorp@aurora.org

Stevens Point
Marshfield Medical Center-River Region at Stevens Point
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Sturgeon Bay
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

Summit
Aurora Medical Center in Summit
Contact: Site Public Contact
Email: ncorp@aurora.org

Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Contact: Site Public Contact
Email: ncorp@aurora.org

Waukesha
ProHealth Waukesha Memorial Hospital
Contact: Site Public Contact

UW Cancer Center at ProHealth Care
Contact: Site Public Contact
Email: Chanda.miller@phci.org

Wausau
Marshfield Clinic-Wausau Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Wauwatosa
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Contact: Site Public Contact
Email: AWRI.Inquiry@Ascension.org

Aurora Cancer Care-Milwaukee West
Contact: Site Public Contact
Email: ncorp@aurora.org

West Allis
Aurora West Allis Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org

Weston
Marshfield Medical Center - Weston
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Wisconsin Rapids
Marshfield Clinic - Wisconsin Rapids Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

WV
Charleston
West Virginia University Charleston Division
Contact: Site Public Contact

WY
Cody
Billings Clinic-Cody
Contact: Site Public Contact
Email: research@billingsclinic.org

Sheridan
Welch Cancer Center
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

PRIMARY OBJECTIVE:
I. To determine if bortezomib, daratumumab and hyaluronidase-fihj (daratumumab-hyaluronidase) subcutaneous (SC), lenalidomide and dexamethasone (Btz-DRd) consolidation followed by daratumumab-hyaluronidase SC and lenalidomide (DR) maintenance after standard induction therapy with daratumumab-hyaluronidase SC, lenalidomide and dexamethasone (DRd) results in superior overall survival compared to DRd consolidation followed by DR maintenance, in minimal residual disease (MRD) positive patients.

SECONDARY OBJECTIVES:
I. To determine if Btz-DRd consolidation followed by DR maintenance after standard induction therapy with DRd results in superior overall survival compared to DRd consolidation followed by DR maintenance in MRD negative patients.
II. To determine if Btz-DRd consolidation followed by DR maintenance after standard induction therapy with DRd results in superior progression-free survival compared to DRd consolidation followed by DR maintenance in both MRD positive and MRD negative patients.
III. To describe and compare the incidence of toxicities during consolidation between Btz-DRd and DRd arms.
IV. To assess the improvement in MRD negative rate with consolidation among patients who are MRD positive after induction.
V. To assess the sustained MRD negative rate among patients who are MRD negative after induction.
VI. To evaluate best response on induction, consolidation, and maintenance.

PATIENT REPORTED OUTCOMES (PRO) OBJECTIVES:
I. To quantify the extent to which the addition of bortezomib to DRd over consolidation treatment contributes to neuropathy and associated physical and functional impairments. (Primary PRO Objective)
II. To evaluate the rate of resolution of neurotoxicity and associated physical and functional impairments following completion of consolidation therapy. (Secondary PRO Objective)
III. To investigate the relationship between MRD status and patient reported health-related quality of life outcomes. (Exploratory PRO Objective)
IV. To evaluate attributes of select patient reported treatment-emergent symptomatic adverse events (PRO- Common Terminology Criteria for Adverse Events [CTCAE]) longitudinally and compare responses with provider-reported adverse events. (Exploratory PRO Objective)
V. To tabulate PRO compliance and completion rates. (Exploratory PRO Objective)

IMAGING OBJECTIVES:
I. To evaluate the association between post-induction fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)/computed tomography (CT) and patient outcomes (overall survival [OS] and progression-free survival [PFS]). (Primary Imaging Objective)
II. To evaluate the association between baseline 18F-FDG PET/CT and patient outcomes (PFS and OS). (Secondary Imaging Objective)
III. To compare overall survival with the addition of Bortezomib to consolidation DRd therapy among 18F-FDG PET/CT-positive and 18F-FDG PET/CT-negative subgroups. (Secondary Imaging Objective)
IV. To evaluate the ability of baseline 18F-FDG PET/CT to predict post-induction depth of response as measured by MRD assessment. (Secondary Imaging Objective)
V. To evaluate the ability of post-induction 18F-FDG PET/CT to predict MRD conversion post-consolidation. (Secondary Imaging Objective)
VI. To utilize 18F-FDG PET/CT, standard risk factors and clinical data to identify distinct subgroups with differing patient outcomes (PFS and OS). (Exploratory Imaging Objective)
VII. To compare the various qualitative 18F-FDG PET/CT criteria to determine which criteria yields superior risk stratification. (Exploratory Imaging Objective)

OUTLINE:
ARM A (INDUCTION): All patients receive standard induction therapy comprising the following: daratumumab-hyaluronidase subcutaneously (SC) on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide orally (PO) daily on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 9 cycles in the absence of disease progression or unacceptable toxicity.

After completion of standard induction therapy, patients are randomized to 1 of 2 arms.

ARM B:
CONSOLIDATION: Patients receive bortezomib SC on days 1, 8, and 15, daratumumab SC on day 1, lenalidomide PO daily on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 9 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Patients receive lenalidomide PO daily on days 1-21 and daratumumab-hyaluronidase SC on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM C: 
CONSOLIDATION: Patients receive daratumumab-hyaluronidase SC on day 1, lenalidomide PO daily on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 9 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Patients receive lenalidomide PO daily on days 1-21, and daratumumab-hyaluronidase SC on day 1. Cycles repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months if less than 2 years from study entry, every 6 months if 2-5 years from study entry, then annually for up to 15 years from study entry.

Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.


The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its National Clinical Trials Network.


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