AzTrials
AzTrials

Smoldering Plasma Cell MyelomaPhase 3NCT03937635

Lenalidomide, and Dexamethasone With or Without Daratumumab in Treating Patients With High-Risk Smoldering Myeloma

A Phase 3 study testing Daratumumab, Dexamethasone and Lenalidomide in people with Smoldering Plasma Cell Myeloma, run by ECOG-ACRIN Cancer Research Group at 748 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

This phase III trial studies how well lenalidomide and dexamethasone works with or without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Smoldering Plasma Cell Myeloma
What is being tested?
Daratumumab, Dexamethasone and Lenalidomide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
288 participants
Where
748 sitesin 2 countries
Study dates
16 Sep 2019to 31 Dec 2029
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 12 months. High-risk is defined by the presence of 2 or more of the following factors:
  • Abnormal serum free light chain ratio of involved to uninvolved >20, but less than 100 if the involved FLC is >= 10 mg/dL by serum free light chain (FLC) assay
  • Serum M-protein level >= 2 gm/dL
  • Presence of t(4;14) or del 17p, del 13q or 1q gain by conventional cytogenetics or fluorescence in situ hybridization (FISH) studies.
  • >20% plasma cells on biopsy or aspirate
  • Bone marrow aspirate and/or biopsy is required to be performed within 42 days prior to randomization and must demonstrate 10-59% clonal plasma cells.
Show all 37Show fewer
  • >= 1 g/dL on serum protein electrophoresis (within 28 days prior to randomization).
  • >= 200 mg of monoclonal protein on a 24 hour urine protein electrophoresis (within 28 days prior to randomization).
  • NOTE: In the rare situation where the serum protein electrophoresis (SPEP) is felt to be unreliable, then quantitative immunoglobulin levels on nephelometry or turbidometry can be accepted.
  • SPEP, urine protein electrophoresis (UPEP), and serum FLC are required to be performed within 28 days prior to randomization.
  • 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 hour (hr), and urine in addition to serum must be followed in order to confirm a very good partial response (VGPR) or higher response.
  • Patients must have no lytic lesions, no known plasmacytoma, and no unexplained hypercalcemia (i.e., > 11 mg/dL or 1mg/dL above upper limit of normal [ULN]).
  • Hemoglobin >= 11 g/dL (within 28 days prior to randomization).
  • Platelet count >= 100,000 cells/mm^3 (within 28 days prior to randomization).
  • Absolute neutrophil count >= 1500 cells/mm^3 (within 28 days prior to randomization).
  • Calculated creatinine clearance >= 30 mL/min (within 28 days prior to randomization).
  • Bilirubin =< 1.5 mg/dL (within 28 days prior to randomization).
  • 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 (within 28 days prior to randomization).
  • Patients must not have any prior or concurrent systemic or radiation therapy for the treatment of myeloma. Patients must also not have contraindication to deep vein thrombosis (DVT) prophylaxis/aspirin.
  • Patients must not have more than one focal marrow lesion on magnetic resonance imaging (MRI) of either pelvis or spine. Patients with indwelling pacemakers and/or ICD (implantable cardioverter-defibrillator) that is known or suspected to be MRI incompatible will be excused from this test.
  • Concurrent use of erythropoietin is not allowed while on study therapy.
  • Prior or glucocorticosteroid therapy for the treatment of multiple myeloma is not permitted. Prior systemic glucocorticosteroid use for the treatment of non-malignant disorders is permitted; concurrent use after registration on the study should be restricted to the equivalent of prednisone 10 mg per day. Prior or concurrent topical or localized glucocorticosteroid therapy to treat non-malignant comorbid disorders is permitted.
  • Patients must not have active, uncontrolled seizure disorder. Patients must not have had a seizure in the last 6 months.
  • Patients must not have uncontrolled intercurrent illness including uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or social situation that would limit compliance with the study, or a prior history of Stevens Johnson syndrome.
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
  • Patients with monoclonal gammopathy of undetermined significance are not eligible.
  • Patients must not have grade 2 or higher peripheral neuropathy per CTCAE.
  • Patients must not have active, uncontrolled infection.
  • Patients may have a history of current or previous deep vein thrombosis or pulmonary embolism but are required to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation.
  • Patients should not have New York Heart Association classification III or IV heart failure at baseline.
  • Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for the time period considered appropriate for cure of the specific cancer. For most diseases this time frame is 5 years.
  • Patients must agree to register into the mandatory Risk Evaluation and Mitigation Strategy (REMS) program and be willing and able to comply with the requirements of REMS.
  • Women must not be pregnant due to potential harm to the fetus from daratumumab and lenalidomide. All females of childbearing potential (FCBP) must have a blood test or urine study with a sensitivity of at least 25 mIU/mL within 10-14 days prior to the first dose of lenalidomide and again within 24 hours prior to the first dose of lenalidomide. FCBP must also agree to ongoing pregnancy testing while on treatment. 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 achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) 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).
  • Females of childbearing potential (FCBP) must either abstain from sexual intercourse for the duration of their participation in the study or agree to use 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 study treatment; 2) while participating in the study; 3) during dose interruptions; and 4) for at least 28 days after the last dose of protocol treatment (FCBP who are assigned to Arm A and receive daratumumab must extend this contraception requirement to 3 months after the last dose of protocol treatment). Women must also agree to not breastfeed during this same time period. Men must agree to either abstain from sexual intercourse for the duration of their participation in the study or use a latex condom during sexual contact with a FCBP while participating in the study and for 28 days after the last dose of protocol treatment even if they have had a successful vasectomy. Men must also agree to abstain from donating sperm while on study treatment and for 28 days after the last dose of protocol treatment even if they have had a successful vasectomy. Both women and men must both agree to abstain from donating blood during study participation and for at least 28 days after the last dose of protocol treatment.
  • Human immunodeficiency virus (HIV)+ patients with undetectable HIV viral loads tested within 6 months are eligible.
  • Patients should not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to daratumumab, lenalidomide, or dexamethasone.
  • Patients must not have known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal or known moderate or severe persistent asthma within 2 years prior to randomization

Who cannot join

None listed.

Trial locations and contacts

748 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

306 sites in 2 countries

United States300 sites, 200 recruiting

  • Providence Regional Cancer System-Aberdeen

    Aberdeen, Washington, 98520

    Site Public Contact, 360-412-8958, deidre.dillon@providence.org

    Alison K. Conlin

    Recruiting

  • Hickman Cancer Center

    Adrian, Michigan, 49221

    Suspended

  • Riverwood Healthcare Center

    Aitkin, Minnesota, 56431

    Suspended

  • Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

    Site Public Contact, 229-312-0405, ga_cares@augusta.edu

    Anand P. Jillella

    Recruiting

  • Mayo Clinic Health System in Albert Lea

    Albert Lea, Minnesota, 56007

    Withdrawn

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    Christopher M. Reynolds

    Recruiting

  • MyMichigan Medical Center Gratiot

    Alma, Michigan, 48801

    Site Public Contact, 989-631-2469, CVResearch@mymichigan.org

    Christopher M. Reynolds

    Recruiting

  • OSF Saint Anthony's Health Center

    Alton, Illinois, 62002

    Site Public Contact, 618-463-5623

    Jay W. Carlson

    Recruiting

  • American Fork Hospital / Huntsman Intermountain Cancer Center

    American Fork, Utah, 84003

    Suspended

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

    Active, not recruiting

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

    Active, not recruiting

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

    Suspended

  • Anchorage Associates in Radiation Medicine

    Anchorage, Alaska, 98508

    Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Alison K. Conlin

    Recruiting

  • Anchorage Radiation Therapy Center

    Anchorage, Alaska, 99504

    Suspended

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

    Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Alison K. Conlin

    Recruiting

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508

    Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Alison K. Conlin

    Recruiting

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

    Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Alison K. Conlin

    Recruiting

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

    Suspended

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

    Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Alison K. Conlin

    Recruiting

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

    Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Alison K. Conlin

    Recruiting

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    Ankeny, Iowa, 50023

    Site Public Contact, 515-241-3305

    Richard L. Deming

    Recruiting

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

    Site Public Contact, 800-865-1125, CancerAnswerLine@med.umich.edu

    Erica L. Campagnaro

    Recruiting

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

    Site Public Contact, 920-364-3604, ResearchDept@thedacare.org

    Yazhini Vallatharasu

    Recruiting

  • Mission Hope Medical Oncology - Arroyo Grande

    Arroyo Grande, California, 93420

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • PCR Oncology

    Arroyo Grande, California, 93420

    Site Public Contact, 702-384-0013, research@sncrf.org

    John A. Ellerton

    Recruiting

  • Duluth Clinic Ashland

    Ashland, Wisconsin, 54806

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Northwest Wisconsin Cancer Center

    Ashland, Wisconsin, 54806

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Site Public Contact, 888-946-7447

    Nisha S. Joseph

    Recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Site Public Contact, 404-778-1868

    Nisha S. Joseph

    Recruiting

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

    Site Public Contact, 404-851-7115

    Nisha S. Joseph

    Recruiting

  • MultiCare Auburn Medical Center

    Auburn, Washington, 98001

    Suspended

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, 80012

    Site Public Contact, 303-777-2663, info@westernstatesncorp.org

    Nicholas J. DiBella

    Recruiting

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

    Suspended

  • Rush-Copley Medical Center

    Aurora, Illinois, 60504

    Site Public Contact, 630-978-6212, RCMC_Cancer_Research@rush.edu

    Suparna Mantha

    Recruiting

  • Advocate Outpatient Center - Aurora

    Aurora, Illinois, 60506

    Site Public Contact, ncorp@aah.org

    Thomas J. Saphner

    Recruiting

  • Saint Alphonsus Cancer Care Center-Baker City

    Baker City, Oregon, 97814

    Suspended

  • Mercy Oncology and Hematology - Clayton-Clarkson

    Ballwin, Missouri, 63011

    Suspended

  • Saint Agnes Hospital

    Baltimore, Maryland, 21229

    Site Public Contact, 410-368-2910

    Carole B. Miller

    Recruiting

  • CommonSpirit Saint Joseph Hospital - Bardstown

    Bardstown, Kentucky, 40004

    Suspended

  • Advocate Good Shepherd Hospital

    Barrington, Illinois, 60010

    Site Public Contact, 847-842-4847

    Thomas J. Saphner

    Recruiting

  • LSU Health Baton Rouge-North Clinic

    Baton Rouge, Louisiana, 70805

    Site Public Contact, 225-765-7659, research@ololrmc.com

    Marshall P. Stagg

    Recruiting

  • Our Lady of the Lake Physician Group

    Baton Rouge, Louisiana, 70808

    Site Public Contact, 225-765-7659, research@ololrmc.com

    Marshall P. Stagg

    Recruiting

  • Our Lady of The Lake

    Baton Rouge, Louisiana, 70808

    Site Public Contact, 225-765-7659

    Marshall P. Stagg

    Recruiting

  • Hematology/Oncology Clinic PLLC

    Baton Rouge, Louisiana, 70809

    Suspended

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Houston Methodist San Jacinto Hospital

    Baytown, Texas, 77521

    Site Public Contact, 888-823-5923, ctsucontact@westat.com

    Siddhartha Ganguly

    Recruiting

  • Indu and Raj Soin Medical Center

    Beavercreek, Ohio, 45431

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Overlake Medical Center

    Bellevue, Washington, 98004

    Suspended

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

    Site Public Contact, 360-788-8223, achapman1@peacehealth.org

    Alison K. Conlin

    Recruiting

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

    Suspended

  • Saint Charles Health System

    Bend, Oregon, 97701

    Site Public Contact, 541-706-2909, nosall@stcharleshealthcare.org

    Alison K. Conlin

    Recruiting

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    Christopher M. Reynolds

    Recruiting

  • University of Iowa Healthcare Cancer Services Quad Cities

    Bettendorf, Iowa, 52722

    Site Public Contact, 563-355-7733, katherine-daprile@uiowa.edu

    Christopher Strouse

    Recruiting

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

    Site Public Contact, 800-996-2663, research@billingsclinic.org

    John M. Schallenkamp

    Recruiting

  • Saint Vincent Healthcare

    Billings, Montana, 59101

    Suspended

  • Saint Vincent Frontier Cancer Center

    Billings, Montana, 59102

    Suspended

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

    Site Public Contact, gingerreeves@uabmc.edu

    Kelly N. Godby

    Recruiting

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Saint Elizabeth Boardman Hospital

    Boardman, Ohio, 44512

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

    Suspended

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

    Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

    Site Public Contact, 208-381-2774, eslinget@slhs.org

    Alison K. Conlin

    Recruiting

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

    Site Public Contact, 913-948-5588, aroland@kccop.org

    Jay W. Carlson

    Recruiting

  • McFarland Clinic - Boone

    Boone, Iowa, 50036

    Active, not recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Site Public Contact, 617-636-5000, ContactUsCancerCenter@TuftsMedicalCenter.org

    Raymond L. Comenzo

    Recruiting

  • Boulder Community Foothills Hospital

    Boulder, Colorado, 80303

    Site Public Contact, 303-777-2663, jbloomfield@co-cancerresearch.org

    Nicholas J. DiBella

    Recruiting

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

    Site Public Contact, 303-777-2663, info@westernstatesncorp.org

    Nicholas J. DiBella

    Recruiting

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Cox Cancer Center Branson

    Branson, Missouri, 65616

    Suspended

  • United Hospital Center

    Bridgeport, West Virginia, 26330

    Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu

    Lauren W. Veltri

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Henry Ford Cancer Institute-Downriver

    Brownstown, Michigan, 48183

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Haythem Y. Ali

    Recruiting

  • Saint Joseph Regional Cancer Center

    Bryan, Texas, 77802

    Suspended

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

    Site Public Contact, 818-847-4793, Najee.Boucher@providence.org

    Alison K. Conlin

    Recruiting

  • Highline Medical Center-Main Campus

    Burien, Washington, 98166

    Suspended

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

    Suspended

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Loyola Center for Health at Burr Ridge

    Burr Ridge, Illinois, 60527

    Suspended

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

    Suspended

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

    Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Cambridge Medical Center

    Cambridge, Minnesota, 55008

    Suspended

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

    Site Public Contact, 856-325-6757

    Sushil Ghimire

    Recruiting

  • Hematology Oncology Associates of CNY at Camillus

    Camillus, New York, 13031

    Site Public Contact, 315-472-7504

    Steven M. Duffy

    Recruiting

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Aultman Health Foundation

    Canton, Ohio, 44710

    Site Public Contact, 330-363-7274, ClinicalReserachDept@aultman.com

    Aarthi Rajkumar

    Recruiting

  • Mercy Cancer Center - Cape Girardeau

    Cape Girardeau, Missouri, 63703

    Site Public Contact, 888-446-3729

    Jay W. Carlson

    Recruiting

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

    Site Public Contact, 573-334-2230, sfmc@sfmc.net

    Bryan A. Faller

    Recruiting

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

    Site Public Contact, 618-457-5200, clinical.research@sih.net

    Bryan A. Faller

    Recruiting

  • IU Health North Hospital

    Carmel, Indiana, 46032

    Active, not recruiting

  • Mercy Cancer Center - Carmichael

    Carmichael, California, 95608

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Mercy San Juan Medical Center

    Carmichael, California, 95608

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@commonspirit.org

    Shahzad Siddique

    Recruiting

  • Caro Cancer Center

    Caro, Michigan, 48723

    Suspended

  • Saint Anthony Regional Hospital

    Carroll, Iowa, 51401

    Site Public Contact, 515-689-7658, sbenson@iora.org

    Seema Harichand-Herdt

    Recruiting

  • Carson Tahoe Regional Medical Center

    Carson City, Nevada, 89703

    Suspended

  • SIH Cancer Institute

    Carterville, Illinois, 62918

    Site Public Contact, 618-985-3333, clinical.research@sih.net

    Bryan A. Faller

    Recruiting

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Sandra L Maxwell Cancer Center

    Cedar City, Utah, 84720

    Suspended

  • Rocky Mountain Cancer Centers - Centennial

    Centennial, Colorado, 80112

    Suspended

  • Dayton Physicians LLC-Miami Valley South

    Centerville, Ohio, 45459

    Suspended

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Saint Mary's Hospital

    Centralia, Illinois, 62801

    Suspended

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

    Site Public Contact, 360-412-8958, deidre.dillon@providence.org

    Alison K. Conlin

    Recruiting

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

    Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu

    Sascha A. Tuchman

    Recruiting

  • Geauga Hospital

    Chardon, Ohio, 44024

    Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org

    Brenda W. Cooper

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Suspended

  • West Virginia University Charleston Division

    Charleston, West Virginia, 25304

    Site Public Contact, 304-388-9944

    Ahmed A. Khalid

    Recruiting

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

    Active, not recruiting

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

    Site Public Contact, 434-243-6303, uvacancertrials@hscmail.mcc.virginia.edu

    Craig A. Portell

    Recruiting

  • Minnesota Oncology Hematology PA-Chaska

    Chaska, Minnesota, 55318

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Saint Luke's Hospital

    Chesterfield, Missouri, 63017

    Site Public Contact, 314-205-6936

    Mark J. Fesler

    Recruiting

  • Cheyenne Regional Medical Center-West

    Cheyenne, Wyoming, 82001

    Suspended

  • Memorial Hospital of Laramie County

    Cheyenne, Wyoming, 82001

    Site Public Contact, ecog.rss@jimmy.harvard.edu

    John M. Schallenkamp

    Recruiting

  • Swedish Covenant Hospital

    Chicago, Illinois, 60625

    Site Public Contact, 773-878-8200

    David L. Grinblatt

    Recruiting

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

    Site Public Contact, 773-296-5360

    Thomas J. Saphner

    Recruiting

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

    Site Public Contact, 877-779-7585, Jeffh@columbusccop.org

    Aruna C. Gowda

    Recruiting

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Oncology Hematology Care Inc-Kenwood

    Cincinnati, Ohio, 45236

    Suspended

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • TriHealth Cancer Institute-Westside

    Cincinnati, Ohio, 45247

    Suspended

  • TriHealth Cancer Institute-Anderson

    Cincinnati, Ohio, 45255

    Suspended

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Keith E. Stockerl-Goldstein

    Recruiting

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Alison K. Conlin

    Recruiting

  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

    Suspended

  • Hematology Oncology Consultants-Clarkston

    Clarkston, Michigan, 48346

    Suspended

  • Newland Medical Associates-Clarkston

    Clarkston, Michigan, 48346

    Suspended

  • Case Western Reserve University

    Cleveland, Ohio, 44106

    Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org

    Brenda W. Cooper

    Recruiting

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

    Site Public Contact, 216-778-7559, ababal@metrohealth.org

    Tamila L. Kindwall-Keller

    Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Site Public Contact, 866-223-8100, TaussigResearch@ccf.org

    Jack Khouri

    Recruiting

  • Henry Ford Macomb Hospital-Clinton Township

    Clinton Township, Michigan, 48038

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Haythem Y. Ali

    Recruiting

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

    Site Public Contact, 515-241-3305

    Richard L. Deming

    Recruiting

  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic

    Clive, Iowa, 50325

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

    Suspended

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Saint Francis Cancer Center

    Colorado Springs, Colorado, 80923

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • John B Amos Cancer Center

    Columbus, Georgia, 31904

    Site Public Contact, 706-478-7968, cdean@iacthealth.com

    Andrew W. Pippas

    Recruiting

  • Mount Carmel East Hospital

    Columbus, Ohio, 43213

    Site Public Contact, 614-488-2745, Jeffh@columbusccop.org

    Aruna C. Gowda

    Recruiting

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

    Suspended

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Yvonne A. Efebera

    Recruiting

  • Grant Medical Center

    Columbus, Ohio, 43215

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Yvonne A. Efebera

    Recruiting

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

    Site Public Contact, 614-488-2745, Jeffh@columbusccop.org

    Aruna C. Gowda

    Recruiting

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

    Site Public Contact, 614-488-2745, Jeffh@columbusccop.org

    Aruna C. Gowda

    Recruiting

  • Doctors Hospital

    Columbus, Ohio, 43228

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Yvonne A. Efebera

    Recruiting

  • UT MD Anderson - The Woodlands

    Conroe, Texas, 77384

    Site Public Contact, 866-632-6789, askmdanderson@mdanderson.org

    Mahmoud Gaballa

    Recruiting

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Minnesota Oncology - Coon Rapids

    Coon Rapids, Minnesota, 55433

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

    Site Public Contact, 541-269-8392, cherie.cox@bayareahospital.org

    Alison K. Conlin

    Recruiting

  • Commonwealth Cancer Center-Corbin

    Corbin, Kentucky, 40701

    Suspended

  • Alegent Health Mercy Hospital

    Council Bluffs, Iowa, 51503

    Suspended

  • Greater Regional Medical Center

    Creston, Iowa, 50801

    Site Public Contact, 515-241-3305

    Richard L. Deming

    Recruiting

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Keith E. Stockerl-Goldstein

    Recruiting

  • AMG Crystal Lake - Oncology

    Crystal Lake, Illinois, 60014

    Site Public Contact, 630-929-6129, advocateresearch@advocate.com

    Thomas J. Saphner

    Recruiting

  • Aurora Saint Luke's South Shore

    Cudahy, Wisconsin, 53110

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • UT Southwestern Simmons Cancer Center - RedBird

    Dallas, Texas, 75237

    Site Public Contact, 214-648-7097, canceranswerline@utsouthwestern.edu

    Aimaz Afrough

    Recruiting

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

    Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu

    Aimaz Afrough

    Recruiting

  • Carle at The Riverfront

    Danville, Illinois, 61832

    Site Public Contact, 800-446-5532, Research@Carle.com

    Suparna Mantha

    Recruiting

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

    Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu

    Joseph P. Lynch

    Recruiting

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

    Suspended

  • Miami Valley Hospital

    Dayton, Ohio, 45409

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Premier Blood and Cancer Center

    Dayton, Ohio, 45409

    Site Public Contact, 937-276-8320

    Tarek M. Sabagh

    Recruiting

  • Dayton Physician LLC - Englewood

    Dayton, Ohio, 45415

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Dayton Veterans Affairs Medical Center

    Dayton, Ohio, 45428

    Active, not recruiting

  • Henry Ford Medical Center-Fairlane

    Dearborn, Michigan, 48126

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Haythem Y. Ali

    Recruiting

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Essentia Health - Deer River Clinic

    Deer River, Minnesota, 56636

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

    Withdrawn

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Yvonne A. Efebera

    Recruiting

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Yvonne A. Efebera

    Recruiting

  • Cancer Center of Colorado at Sloan's Lake

    Denver, Colorado, 80204

    Suspended

  • National Jewish Health-Main Campus

    Denver, Colorado, 80206

    Suspended

  • The Women's Imaging Center

    Denver, Colorado, 80209

    Suspended

  • AdventHealth Porter

    Denver, Colorado, 80210

    Suspended

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

    Suspended

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

    Site Public Contact, 303-777-2663, info@westernstatesncorp.org

    Nicholas J. DiBella

    Recruiting

  • Rocky Mountain Cancer Centers-Midtown

    Denver, Colorado, 80218

    Suspended

  • Saint Joseph Hospital - Cancer Centers of Colorado

    Denver, Colorado, 80218

    Suspended

  • Rocky Mountain Cancer Centers-Rose

    Denver, Colorado, 80220

    Suspended

  • Rose Medical Center

    Denver, Colorado, 80220

    Suspended

  • Western Surgical Care

    Denver, Colorado, 80220

    Suspended

  • Smilow Cancer Hospital-Derby Care Center

    Derby, Connecticut, 06418

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Noffar Bar

    Recruiting

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-6727

    Seema Harichand-Herdt

    Recruiting

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Broadlawns Medical Center

    Des Moines, Iowa, 50314

    Site Public Contact, 515-282-2200

    Seema Harichand-Herdt

    Recruiting

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

    Site Public Contact, 515-241-3305

    Richard L. Deming

    Recruiting

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

    Site Public Contact, 515-241-8704

    Seema Harichand-Herdt

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Haythem Y. Ali

    Recruiting

  • Henry Ford Health Saint John Hospital

    Detroit, Michigan, 48236

    Site Public Contact, 313-343-3166, Kkeenan1@hfhs.org

    Christopher M. Reynolds

    Recruiting

  • Essentia Health Saint Mary's - Detroit Lakes Clinic

    Detroit Lakes, Minnesota, 56501

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

    Suspended

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinois, 60515

    Site Public Contact, 630-275-1270, Barbara.barhamand@advocatehealth.com

    Thomas J. Saphner

    Recruiting

  • Epic Care-Dublin

    Dublin, California, 94568

    Active, not recruiting

  • Dublin Methodist Hospital

    Dublin, Ohio, 43016

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Yvonne A. Efebera

    Recruiting

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • CommonSpirit Cancer Center Mercy

    Durango, Colorado, 81301

    Suspended

  • Mercy Medical Center

    Durango, Colorado, 81301

    Suspended

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

    Suspended

  • Henry Ford River District Hospital

    East China Township, Michigan, 48054

    Suspended

  • Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    Christopher M. Reynolds

    Recruiting

  • Hematology Oncology Associates of Central New York-East Syracuse

    East Syracuse, New York, 13057

    Site Public Contact, 315-472-7504

    Steven M. Duffy

    Recruiting

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Seth O. Fagbemi

    Recruiting

  • Mayo Clinic Health System-Eau Claire Clinic

    Eau Claire, Wisconsin, 54701

    Withdrawn

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Minnesota Oncology - Edina

    Edina, Minnesota, 55435

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026

    Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org

    Alison K. Conlin

    Recruiting

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

    Site Public Contact, 800-446-5532, Research@carle.com

    Suparna Mantha

    Recruiting

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Advocate Sherman Hospital

    Elgin, Illinois, 60123

    Site Public Contact, 847-429-2907

    Thomas J. Saphner

    Recruiting

  • Mercy Cancer Center - Elk Grove

    Elk Grove, California, 95758

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Bay Area Breast Surgeons Inc

    Emeryville, California, 94608

    Active, not recruiting

  • Epic Care Partners in Cancer Care

    Emeryville, California, 94608

    Active, not recruiting

  • Walter Knox Memorial Hospital

    Emmett, Idaho, 83617

    Suspended

  • Mountain Blue Cancer Care Center - Swedish

    Englewood, Colorado, 80113

    Suspended

  • Swedish Medical Center

    Englewood, Colorado, 80113

    Suspended

  • The Melanoma and Skin Cancer Institute

    Englewood, Colorado, 80113

    Site Public Contact, 720-316-8091, ryan.weight@theskincancerinstitute.com

    Nicholas J. DiBella

    Recruiting

  • Saint Elizabeth Hospital

    Enumclaw, Washington, 98022

    Suspended

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

    Site Public Contact, 847-570-2109

    David L. Grinblatt

    Recruiting

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

    Site Public Contact, 425-261-3529, marilyn.birchman@providence.org

    Alison K. Conlin

    Recruiting

  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

    Suspended

  • Smilow Cancer Hospital Care Center-Fairfield

    Fairfield, Connecticut, 06824

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Noffar Bar

    Recruiting

  • Essentia Health Cancer Center-South University Clinic

    Fargo, North Dakota, 58103

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • Saint Francis Hospital

    Federal Way, Washington, 98003

    Suspended

  • Lake Region Healthcare Corporation-Cancer Care

    Fergus Falls, Minnesota, 56537

    Suspended

  • Armes Family Cancer Center

    Findlay, Ohio, 45840

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Orion Cancer Care

    Findlay, Ohio, 45840

    Suspended

  • Cancer Hematology Centers - Flint

    Flint, Michigan, 48503

    Suspended

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

    Suspended

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Christopher M. Reynolds

    Recruiting

  • Hurley Medical Center

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Christopher M. Reynolds

    Recruiting

  • Aurora Health Center-Fond du Lac

    Fond du Lac, Wisconsin, 54937

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • McFarland Clinic - Trinity Cancer Center

    Fort Dodge, Iowa, 50501

    Active, not recruiting

  • UI Healthcare Mission Cancer and Blood - Fort Dodge

    Fort Dodge, Iowa, 50501

    Suspended

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

    Site Public Contact, eileen.georgi@holy-cross.com

    Christopher M. Reynolds

    Recruiting

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas, 72903

    Site Public Contact, 800-378-9373

    Jay W. Carlson

    Recruiting

  • UT Southwestern/Simmons Cancer Center-Fort Worth

    Fort Worth, Texas, 76104

    Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu

    Aimaz Afrough

    Recruiting

  • Essentia Health - Fosston

    Fosston, Minnesota, 56542

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Dayton Physicians LLC-Atrium

    Franklin, Ohio, 45005

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Unity Hospital

    Fridley, Minnesota, 55432

    Active, not recruiting

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

    Site Public Contact, 208-381-2774, eslinget@slhs.org

    Alison K. Conlin

    Recruiting

  • Central Ohio Breast and Endocrine Surgery

    Gahanna, Ohio, 43230

    Suspended

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

    Suspended

  • Central Care Cancer Center - Garden City

    Garden City, Kansas, 67846

    Site Public Contact, 913-948-5588, aroland@kccop.org

    Jay W. Carlson

    Recruiting

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

    Withdrawn

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • MultiCare Gig Harbor Medical Park

    Gig Harbor, Washington, 98335

    Suspended

  • Smilow Cancer Hospital Care Center at Glastonbury

    Glastonbury, Connecticut, 06033

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Noffar Bar

    Recruiting

  • Glens Falls Hospital

    Glens Falls, New York, 12801

    Active, not recruiting

  • NorthShore University HealthSystem-Glenbrook Hospital

    Glenview, Illinois, 60026

    Site Public Contact, 847-570-2109

    David L. Grinblatt

    Recruiting

  • National Jewish Health-Western Hematology Oncology

    Golden, Colorado, 80401

    Suspended

  • CTCA at Western Regional Medical Center

    Goodyear, Arizona, 85338

    Site Public Contact, 623-207-3000

    Misam Zawit

    Recruiting

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Nebraska Cancer Specialists/Oncology Hematology West PC

    Grand Island, Nebraska, 68803

    Suspended

  • Saint Mary's Hospital and Regional Medical Center

    Grand Junction, Colorado, 81501

    Suspended

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

    Grand Rapids, Michigan, 49503

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503

    Suspended

  • Central Care Cancer Center - Great Bend

    Great Bend, Kansas, 67530

    Suspended

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Great Falls Clinic

    Great Falls, Montana, 59405

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Banner North Colorado Medical Center

    Greeley, Colorado, 80631

    Suspended

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

    Site Public Contact, 920-433-8889, WI_research_admin@hshs.org

    Brian L. Burnette

    Recruiting

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

    Site Public Contact, 920-433-8889, wi_research_admin@hshs.org

    Brian L. Burnette

    Recruiting

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • East Carolina University

    Greenville, North Carolina, 27834

    Site Public Contact, 252-744-1015, eubankss@ecu.edu

    Darla K. Liles

    Recruiting

  • Dayton Physicians LLC-Wayne

    Greenville, Ohio, 45331

    Suspended

  • Miami Valley Cancer Care and Infusion

    Greenville, Ohio, 45331

    Site Public Contact, 937-569-7515

    Tarek M. Sabagh

    Recruiting

  • Wayne Hospital

    Greenville, Ohio, 45331

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

    Suspended

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Ki Y. Chung

    Recruiting

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Ki Y. Chung

    Recruiting

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Ki Y. Chung

    Recruiting

  • Smilow Cancer Hospital Care Center at Greenwich

    Greenwich, Connecticut, 06830

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Noffar Bar

    Recruiting

  • Self Regional Healthcare

    Greenwood, South Carolina, 29646

    Active, not recruiting

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Ki Y. Chung

    Recruiting

  • Henry Ford Saint John Hospital - Academic

    Grosse Pointe Woods, Michigan, 48236

    Suspended

  • Henry Ford Saint John Hospital - Breast

    Grosse Pointe Woods, Michigan, 48236

    Suspended

  • Henry Ford Saint John Hospital - Van Elslander

    Grosse Pointe Woods, Michigan, 48236

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Christopher M. Reynolds

    Recruiting

  • Mount Carmel Grove City Hospital

    Grove City, Ohio, 43123

    Site Public Contact, 614-488-2745, Jeffh@columbusccop.org

    Aruna C. Gowda

    Recruiting

  • Smilow Cancer Hospital Care Center - Guilford

    Guilford, Connecticut, 06437

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Noffar Bar

    Recruiting

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Noffar Bar

    Recruiting

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

    Active, not recruiting

Other trials in United States

Puerto Rico6 sites, 5 recruiting

  • Cancer Center-Metro Medical Center Bayamon

    Bayamón, 00959-5060

    Site Public Contact, 787-395-7085

    Luis J. Santos Reyes

    Recruiting

  • HIMA San Pablo Oncologic Hospital

    Caguas, 00726

    Suspended

  • Doctors Cancer Center

    Manati, 00674

    Site Public Contact, 787-621-4397

    Luis J. Santos Reyes

    Recruiting

  • San Juan Community Oncology Group

    San Juan, 00917

    Site Public Contact, 787-274-3387

    Luis J. Santos Reyes

    Recruiting

  • Centro Comprensivo de Cancer de UPR

    San Juan, 00927

    Site Public Contact, ecog.rss@jimmy.harvard.edu

    Luis J. Santos Reyes

    Recruiting

  • San Juan City Hospital

    San Juan, 00936

    Site Public Contact, 787-763-1296

    Luis J. Santos Reyes

    Recruiting

Other trials in Puerto Rico

About this study

Official title: Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM)

This phase III trial studies how well lenalidomide and dexamethasone works with or without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as daratumumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and dexamethasone with daratumumab may work better in treating patients with smoldering myeloma.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To compare overall survival in patients with high-risk smoldering multiple myeloma randomized to daratumumab-lenalidomide (revlimid)-dexamethasone or revlimid-dexamethasone.

SECONDARY OBJECTIVES:

  1. To compare progression-free survival and response rates between arms. II. To evaluate safety and compare toxicity rates between arms. III. To monitor incidence of infusion-related reactions over the first cycle of daratumumab.

IV. To evaluate stem cell mobilization failure and early stem cell mobilization feasibility.

EXPLORATORY OBJECTIVES:

  1. To measure treatment exposure and adherence. II. To estimate treatment duration and time to progression.

PATIENT-REPORTED OUTCOMES OBJECTIVES:

  1. To compare change in health-related quality of life (Functional Assessment of Cancer Therapy [FACT]- General [G]]) from baseline to end of study therapy between arms.

II. To compare change in FACT-G scores from treatment end to 6-months post-treatment end between arms.

III. To describe changes in FACT-G scores over study therapy and shortly after treatment discontinuation and evaluate correlation with survival.

IV. To evaluate attributes of select patient reported treatment-emergent symptomatic adverse events (Patient Reported Outcomes [PRO]-Common Terminology Criteria for Adverse Events [CTCAE]) longitudinally.

  1. To derive an overall PRO-CTCAE score at each assessment time point. VI. To measure the likelihood of medication adherence (ASK-12) at 6 month intervals throughout treatment.

VII. To assess the association of overall PRO-CTCAE score with FACT-G score. VIII. To compare select PRO-CTCAE items and related provider-reported CTCAEs. IX. To evaluate association between treatment adherence and Adherence Starts with Knowledge 12 (ASK-12) score.

  1. To assess correlation of treatment adherence and ASK-12 score with FACT-G score.

XI. To tabulate PRO compliance and completion rates.

LABORATORY OBJECTIVES:

  1. To compare minimal residual disease negative rate after 12 cycles of study therapy between arms.

II. To compare minimal residual disease (MRD) positive to negative conversion rates from 12 cycles to end of treatment between arms.

III. To examine patterns of change in minimal residual disease levels during study therapy.

IV. To evaluate agreement and discordance between methods determining disease-free status.

  1. To assess the prognostic value of minimal residual disease status at 12 cycles for overall and progression-free survival.

IMAGING OBJECTIVES:

  1. To evaluate the association of baseline fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) imaging with progression-free survival.

II. To assess the ability of baseline FDG-PET/CT to predict minimal residual disease status after 12 cycles of study therapy and at the end of study therapy.

III. To describe the results of subsequent FDG-PET/CT imaging studies in the subset of patients with baseline abnormal FDG-PET/CT, and to associate these results with progression-free survival (PFS).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive daratumumab intravenously (IV) on days 1, 8, 15, and 22 of courses 1-2, days 1 and 15 of courses 3-6, and day 1 of courses 7-24. Patients also receive lenalidomide orally (PO) daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22 in courses 1-12. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22 of courses 1-12. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

After completion of study, patients will be followed up every 3, 6 or 12 months for up to 15 years from study entry.

Being tested
Daratumumab, Dexamethasone, Lenalidomide, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
Smoldering Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DaratumumabBiological

    Also called Anti-CD38 Monoclonal Antibody, Darzalex, HuMax-CD38, JNJ-54767414

    Given IV

  • DexamethasoneDrug

    Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex

    Given PO

  • LenalidomideDrug

    Also called CC-5013, CC5013, CDC 501, Revlimid

    Given PO

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT03937635
Study groupRoleWhat they receive
Arm I (daratumumab, lenalidomide, dexamethasone)ExperimentalPatients receive daratumumab IV on days 1, 8, 15, and 22 of courses 1-2, days 1 and 15 of courses 3-6, and day 1 of courses 7-24. Patients also receive lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22 in courses 1-12. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Daratumumab; Drug: Dexamethasone; Drug: Lenalidomide; Other: Questionnaire Administration
Arm II (lenalidomide, dexamethasone)ExperimentalPatients receive lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22 of courses 1-12. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Dexamethasone; Drug: Lenalidomide; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS)

    Will be estimated using the Kaplan-Meier (KM) method and compared using a stratified log-rank test. Stratified cox proportional hazards regression will produce a treatment hazard ratio estimate.

    Measured: From randomization to death due to any cause, or censored at date last known alive, assessed up to 15 years

  2. Functional Assessment of Cancer Therapy-General (FACT-G) score

    A general effect size measure of half standard deviation will be used to establish the minimally important difference. Descriptive statistics (mean, standard deviation [SD], median, range) will be used to evaluate the distribution of levels and changes for the set of health-related quality of life (QOL) evaluations. Levels and changes will also be assessed graphically. Changes from baseline will be analyzed using linear mixed models based on restricted maximum likelihood estimation with covariance matrix maximizing Akaike information criteria. Models with treatment, assessment time, and treatment by assessment time interaction with and without other predictors will be fit. If there is substantial missingness, will analyze the data according to the methods described in Schluchter and Schluchter, Greene and Beck.

    Measured: Baseline to 24 cycles of treatment (each cycle is 28 days)

Secondary outcomes (10)

  1. Progression-free survival (PFS)

    Will be estimated using the KM method and compared using a stratified log-rank test. Stratified cox proportional hazards regression will produce a treatment hazard ratio estimate.

    Measured: From randomization until disease progression or death due to any cause, or censored at date of last disease evaluation, assessed up to 15 years

  2. Best response on treatment based on International Myeloma Working Group (IMWG) criteria

    Response will be tabulated by category. Response rates of very good partial response (VGPR) or better and partial response (PR) or better will be compared using the Fisher's exact test. Ineligible patients are excluded from the analysis and unevaluable patients are counted in the denominator.

    Measured: At 12 and 24 months

  3. Incidence of adverse events by worst grade and type for treated patients determined using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

    Will monitor the toxicities experienced by all treated patients. Will compare rates of worst grade 3 or higher non-hematologic treatment-related events using the Fisher's exact test.

    Measured: Up to 28 days post-treatment

  4. Incidence of grade 3 or higher infusion-related reactions over course 1 determined based on CTCAE

    Will monitor the toxicities experienced by all treated patients. Will compare rates of worst grade 3 or higher non-hematologic treatment-related events using the Fisher's exact test.

    Measured: During cycle 1 of treatment (each cycle is 28 days)

  5. Stem cell (SC) mobilization failure

    Defined as not collecting a minimum of 5x10^6 CD34 cells per kilogram weight. SC mobilization and type of growth factor support will be summarized overall and by treatment arm with descriptive statistics.

    Measured: After 4 to 6 cycles of treatment (each cycle is 28 days)

  6. Early SC mobilization feasibility

    Defined as the proportion of patients less than 65 years of age treated for 6 courses who opt for SC mobilization. SC mobilization and type of growth factor support will be summarized overall and by treatment arm with descriptive statistics.

    Measured: Up to 6 cycles of treatment (each cycle is 28 days)

  7. Type of growth factor support

    SC mobilization and type of growth factor support will be summarized overall and by treatment arm with descriptive statistics.

    Measured: During 4 to 6 cycles of treatment (each cycle is 28 days)

  8. Change in FACT-G score

    A general effect size measure of half standard deviation will be used to establish the minimally important difference. Descriptive statistics (mean, SD, median, range) will be used to evaluate the distribution of levels and changes for the set of health-related QOL evaluations. Levels and changes will also be assessed graphically. Changes from baseline will be analyzed using linear mixed models based on restricted maximum likelihood estimation with covariance matrix maximizing Akaike information criteria. Models with treatment, assessment time, and treatment by assessment time interaction with and without other predictors will be fit. If there is substantial missingness, will analyze the data according to the methods described in Schluchter and Schluchter, Greene and Beck.

    Measured: From treatment end to 6 months post-treatment

  9. Levels of FACT-G score at each assessment time point

    A general effect size measure of half standard deviation will be used to establish the minimally important difference. Descriptive statistics (mean, SD, median, range) will be used to evaluate the distribution of levels and changes for the set of health-related QOL evaluations. Levels and changes will also be assessed graphically. Changes from baseline will be analyzed using linear mixed models based on restricted maximum likelihood estimation with covariance matrix maximizing Akaike information criteria. Models with treatment, assessment time, and treatment by assessment time interaction with and without other predictors will be fit. If there is substantial missingness, will analyze the data according to the methods described in Schluchter and Schluchter, Greene and Beck.

    Measured: From baseline, at 3, f7, 13, 19 cycles of treatment, and early discontinuation of treatment, assessed up to 24 cycles of treatment (each cycle is 28 days)

  10. Time to worsening of FACT-G

    Will be analyzed with Kaplan-Meier methods and Cox regression with the related treatment arm as the only factor. Correlation between time to worsening of symptoms with PFS and OS will be assessed with Kendall's Tau adjusted for censored observations.

    Measured: From baseline until a decrease of 9 points, or censored at date of last assessment, assessed up to 6 months post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2019
  2. Study start16 Sep 2019
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
288 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03937635
Sponsor's protocol ID
EAA173
Other IDs
NCI-2018-02611, EAA173, EAA173, U10CA180820
Status last verified
Jun 2026
First submitted
24 Apr 2019
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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