Plasma Cell MyelomaPhase 3NCT04566328
Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE Trial
A Phase 3 study testing Bortezomib, Daratumumab and Hyaluronidase-fihj and Dexamethasone in people with Plasma Cell Myeloma and RISS Stage I Plasma Cell Myeloma, run by ECOG-ACRIN Cancer Research Group at 647 sites in 2 countries.
Trial summary
This phase III trial compares the combination of four drugs (daratumumab, bortezomib, lenalidomide and dexamethasone) to the use of a three drug combination (daratumumab, lenalidomide and dexamethasone). Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plasma Cell Myeloma, RISS Stage I Plasma Cell Myeloma, RISS Stage II Plasma Cell Myeloma
- What is being tested?
- Bortezomib, Daratumumab and Hyaluronidase-fihj and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,450 participants
- Where
- 647 sitesin 2 countries
- Study dates
- 24 Feb 2021to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- 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 newly diagnosed multiple myeloma (MM) by International Myeloma Working Group (IMWG) criteria
- STEP 0 - Patient must agree to register to the mandatory REVLIMID Risk Evaluation and Mitigation Strategy (RevREMS) program and be willing and able to comply with the requirements of RevREMS
- STEP 0 - Patient must be able to undergo diagnostic bone marrow aspirate following preregistration.
- NOTE: Bone marrow aspirate specimen 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
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- STEP 1 - Patient must meet all eligibility criteria in STEP 0 with exception of allergy requirement
- STEP 1 - Institution must have received the Clonality (ID) test results from Adaptive Biotechnologies and dominant sequences were identified
- STEP 1 - Patient must have standard risk MM as defined by the Revised International Staging System (RISS) 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
- 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 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 - Patients must have a serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), and serum free light chain (FLC) assay performed within 28 days prior to 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
- STEP 1 - Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization 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 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 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 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)
Who cannot join
- 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 1 - Women 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 females 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. Females of childbearing potential must also agree to ongoing pregnancy testing while on protocol treatment. A female of childbearing potential is defined as any woman, 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 - Women 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 days 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). Men 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 female 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. Men must also agree to abstain from donating sperm while on study treatment and for 3 months 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
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- 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 investigator's opinion, potentially interfere with the completion of treatment according to this protocol
- 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 - Patient must not have received any non-protocol therapy outside of the assigned Step 1 Induction treatment including stem cell transplant
- STEP 2 - Women 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 females 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. Females of childbearing potential must also agree to ongoing pregnancy testing while on protocol treatment. A female of childbearing potential is defined as any woman, 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 - Women 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 days 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).
- Men 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 female 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. Men must also agree to abstain from donating sperm while on study treatment and for 3 months 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
Trial locations and contacts
647 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
307 sites in 2 countries
United States300 sites, 147 recruiting
- Suspended
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520
- Suspended
Hickman Cancer Center
Adrian, Michigan, 49221
- Suspended
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
- Recruiting
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Elie G. Dib
- Recruiting
MyMichigan Medical Center Gratiot
Alma, Michigan, 48801
Site Public Contact, 989-631-2469, CVResearch@mymichigan.org
Elie G. Dib
- Recruiting
MyMichigan Medical Center Alpena
Alpena, Michigan, 49707
Site Public Contact, 989-631-2469, CVResearch@mymichigan.org
Elie G. Dib
- Recruiting
OSF Saint Anthony's Health Center
Alton, Illinois, 62002
Site Public Contact, 618-463-5623
Jay W. Carlson
- Recruiting
Mary Greeley Medical Center
Ames, Iowa, 50010
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
McFarland Clinic - Ames
Ames, Iowa, 50010
Site Public Contact, 515-239-4734, ksoder@mcfarlandclinic.com
Joseph J. Merchant
- Suspended
Community Hospital of Anaconda
Anaconda, Montana, 59711
- Suspended
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
- Suspended
Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504
- Suspended
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
- Suspended
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
- Suspended
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
- Suspended
Anchorage Oncology Centre
Anchorage, Alaska, 99508
- Suspended
Katmai Oncology Group
Anchorage, Alaska, 99508
- Suspended
Providence Alaska Medical Center
Anchorage, Alaska, 99508
- Recruiting
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
Site Public Contact, 920-364-3604, ResearchDept@thedacare.org
Yazhini Vallatharasu
- Recruiting
Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton
Appleton, Wisconsin, 54915
Site Public Contact, AWRI.inquiry@ascension.org
Jonathan S. Treisman
- Recruiting
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, 93420
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
OhioHealth O'Bleness Hospital
Athens, Ohio, 45701
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Yvonne A. Efebera
- Suspended
Sutter Auburn Faith Hospital
Auburn, California, 95602
- Suspended
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, 95603
- Suspended
Hematology Oncology Associates of Central New York-Auburn
Auburn, New York, 13021
- Suspended
Rush-Copley Medical Center
Aurora, Illinois, 60504
- 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
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
Elie G. Dib
- Recruiting
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, 63011
Site Public Contact, 888-446-3729
Jay W. Carlson
- Active, not recruiting
SSM Health Dean Medical Group - Baraboo
Baraboo, Wisconsin, 53913
- Recruiting
CommonSpirit Saint Joseph Hospital - Bardstown
Bardstown, Kentucky, 40004
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010
Site Public Contact, 847-842-4847
Thomas J. Saphner
- Suspended
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, 70805
- Suspended
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, 70808
- Suspended
Bronson Battle Creek
Battle Creek, Michigan, 49017
- Active, not recruiting
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122
- Suspended
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431
- Suspended
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
- Suspended
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714
- Suspended
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
- Suspended
Saint Charles Health System
Bend, Oregon, 97701
- Suspended
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704
- Recruiting
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Elie G. Dib
- Suspended
Billings Clinic Cancer Center
Billings, Montana, 59101
- Suspended
Lourdes Hospital
Binghamton, New York, 13905
- Suspended
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
- Recruiting
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Suspended
Saint Elizabeth Boardman Hospital
Boardman, Ohio, 44512
- Recruiting
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
Elie G. Dib
- Suspended
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
- Recruiting
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
Site Public Contact, 913-948-5588, aroland@kccop.org
Jay W. Carlson
- Suspended
McFarland Clinic - Boone
Boone, Iowa, 50036
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Site Public Contact, 617-636-5000, ContactUsCancerCenter@TuftsMedicalCenter.org
Raymond L. Comenzo
- Suspended
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
- Recruiting
Cox Cancer Center Branson
Branson, Missouri, 65616
Site Public Contact, 417-269-4520
Jay W. Carlson
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield
Brookfield, Wisconsin, 53045
Site Public Contact, AWRI.Inquiry@Ascension.org
Jonathan S. Treisman
- Suspended
Saint Joseph Regional Cancer Center
Bryan, Texas, 77802
- Suspended
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
- Suspended
Highline Medical Center-Main Campus
Burien, Washington, 98166
- Suspended
Mills-Peninsula Medical Center
Burlingame, California, 94010
- Recruiting
University of Vermont Medical Center
Burlington, Vermont, 05401
Site Public Contact, 802-656-4101, rpo@uvm.edu
Mansour Gergi
- Recruiting
University of Vermont and State Agricultural College
Burlington, Vermont, 05405
Site Public Contact, 802-656-8990, rpo@uvm.edu
Mansour Gergi
- Recruiting
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Suspended
Fairview Ridges Hospital
Burnsville, Minnesota, 55337
- Recruiting
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Suspended
Loyola Center for Health at Burr Ridge
Burr Ridge, Illinois, 60527
- Recruiting
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
Elie G. Dib
- Recruiting
Cambridge Medical Center
Cambridge, Minnesota, 55008
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Suspended
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, 95682
- Suspended
Hematology Oncology Associates of CNY at Camillus
Camillus, New York, 13031
- 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
Elie G. Dib
- Recruiting
Trinity Health Medical Center - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- 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
- Not yet recruiting
IU Health North Hospital
Carmel, Indiana, 46032
Chelsea Young, 317-278-5621, youngchs@iu.edu
Rafat Abonour
- 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
- Suspended
Caro Cancer Center
Caro, Michigan, 48723
- Recruiting
Saint Anthony Regional Hospital
Carroll, Iowa, 51401
Site Public Contact, 515-689-7658, sbenson@iora.org
Seema Harichand-Herdt
- Recruiting
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
- Suspended
Eden Hospital Medical Center
Castro Valley, California, 94546
- Recruiting
Mercy Hospital
Cedar Rapids, Iowa, 52403
Site Public Contact, 319-365-4673
Deborah W. Wilbur
- Recruiting
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Site Public Contact, 319-363-2690
Deborah W. Wilbur
- Suspended
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459
- Suspended
Miami Valley Hospital South
Centerville, Ohio, 45459
- Recruiting
Centralia Oncology Clinic
Centralia, Illinois, 62801
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Suspended
Saint Mary's Hospital
Centralia, Illinois, 62801
- Suspended
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
- Active, not recruiting
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
- Suspended
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720
- Active, not recruiting
Geauga Hospital
Chardon, Ohio, 44024
- Recruiting
Ralph H Johnson VA Medical Center
Charleston, South Carolina, 29401
Site Public Contact, 843-789-7020, ashley.salvo@va.gov
Oleksandra Lupak
- Suspended
Medical University of South Carolina
Charleston, South Carolina, 29425
- Active, not recruiting
West Virginia University Charleston Division
Charleston, West Virginia, 25304
- Suspended
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
- 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
Elie G. Dib
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Jefferson Cherry Hill Hospital
Cherry Hill, New Jersey, 08002
Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu
Adam F. Binder
- Suspended
Saint Luke's Hospital
Chesterfield, Missouri, 63017
- Suspended
Memorial Hospital of Laramie County
Cheyenne, Wyoming, 82001
- Suspended
Mount Sinai Hospital Medical Center
Chicago, Illinois, 60608
- Suspended
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
- Active, not recruiting
University of Illinois
Chicago, Illinois, 60612
- Recruiting
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
Site Public Contact, 773-296-5360
Thomas J. Saphner
- Suspended
Adena Regional Medical Center
Chillicothe, Ohio, 45601
- Recruiting
Ascension Calumet Hospital-Chilton
Chilton, Wisconsin, 53014
Site Public Contact, AWRI.inquiry@ascension.org
Jonathan S. Treisman
- Recruiting
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Adedayo A. Onitilo
- Suspended
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
- Recruiting
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Suspended
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236
- Recruiting
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
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, 45255
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Suspended
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
- Suspended
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015
- Recruiting
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, 48346
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Suspended
Newland Medical Associates-Clarkston
Clarkston, Michigan, 48346
- Active, not recruiting
Case Western Reserve University
Cleveland, Ohio, 44106
- Suspended
Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio, 44106
- Recruiting
MetroHealth Medical Center
Cleveland, Ohio, 44109
Site Public Contact, 216-778-7559, ababal@metrohealth.org
Tamila L. Kindwall-Keller
- Recruiting
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328
Site Public Contact, 919-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- 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
- Suspended
Billings Clinic-Cody
Cody, Wyoming, 82414
- Suspended
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
- 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
- Suspended
Mount Carmel East Hospital
Columbus, Ohio, 43213
- Recruiting
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Yvonne A. Efebera
- Recruiting
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
- Suspended
The Mark H Zangmeister Center
Columbus, Ohio, 43219
- Suspended
Mount Carmel Health Center West
Columbus, Ohio, 43222
- Recruiting
Doctors Hospital
Columbus, Ohio, 43228
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Yvonne A. Efebera
- 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
- Suspended
Bay Area Hospital
Coos Bay, Oregon, 97420
- Recruiting
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, 40701
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Suspended
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503
- Recruiting
Greater Regional Medical Center
Creston, Iowa, 50801
Site Public Contact, 515-241-3305
Richard L. Deming
- 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
- Suspended
Carle at The Riverfront
Danville, Illinois, 61832
- Suspended
Geisinger Medical Center
Danville, Pennsylvania, 17822
- Suspended
Sutter Davis Hospital
Davis, California, 95616
- Suspended
Miami Valley Hospital
Dayton, Ohio, 45409
- Suspended
Premier Blood and Cancer Center
Dayton, Ohio, 45409
- Suspended
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415
- Suspended
Miami Valley Hospital North
Dayton, Ohio, 45415
- 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
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Renee Cheng
- Recruiting
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
- Suspended
AdventHealth Porter
Denver, Colorado, 80210
- Recruiting
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, 06418
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Sabrina Browning
- 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
- Suspended
Henry Ford Hospital
Detroit, Michigan, 48202
- Recruiting
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236
Site Public Contact, 313-343-3166, Kkeenan1@hfhs.org
Elie G. Dib
- Suspended
Geisinger Cancer Center Dickson City
Dickson City, Pennsylvania, 18519
- Recruiting
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
Site Public Contact, 815-285-7800
Bryan A. Faller
- Suspended
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801
- Recruiting
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
Site Public Contact, 630-275-1270, Barbara.barhamand@advocatehealth.com
Thomas J. Saphner
- Recruiting
Columbus Oncology and Hematology Associates
Dublin, Ohio, 43016
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Yvonne A. Efebera
- Recruiting
Dublin Methodist Hospital
Dublin, Ohio, 43016
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Yvonne A. Efebera
- Suspended
CommonSpirit Cancer Center Mercy
Durango, Colorado, 81301
- Suspended
Mercy Medical Center
Durango, Colorado, 81301
- Recruiting
Henry Ford River District Hospital
East China Township, Michigan, 48054
Site Public Contact, 313-343-3166, kforman1@hfhs.org
Elie G. Dib
- Recruiting
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Elie G. Dib
- Suspended
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, 13057
- Active, not recruiting
HSHS Sacred Heart Hospital
Eau Claire, Wisconsin, 54701
- Recruiting
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Adedayo A. Onitilo
- Recruiting
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
- Suspended
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
- Suspended
Carle Physician Group-Effingham
Effingham, Illinois, 62401
- Recruiting
Crossroads Cancer Center
Effingham, Illinois, 62401
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Suspended
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042
- 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
- Active, not recruiting
Christiana Care - Union Hospital
Elkton, Maryland, 21921
- Suspended
Walter Knox Memorial Hospital
Emmett, Idaho, 83617
- Suspended
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631
- Suspended
Saint Elizabeth Hospital
Enumclaw, Washington, 98022
- Recruiting
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, 49829
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Brian L. Burnette
- Recruiting
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Suspended
Providence Regional Cancer Partnership
Everett, Washington, 98201
- Active, not recruiting
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
- Recruiting
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, 06824
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Sabrina Browning
- Active, not recruiting
Inova Fairfax Hospital
Falls Church, Virginia, 22042
- Suspended
Sanford South University Medical Center
Fargo, North Dakota, 58103
- Suspended
Southpointe-Sanford Medical Center Fargo
Fargo, North Dakota, 58103
- Suspended
Sanford Medical Center Fargo
Fargo, North Dakota, 58104
- Suspended
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
- Suspended
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
- Recruiting
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Site Public Contact, 314-996-5569
Bryan A. Faller
- Suspended
Saint Francis Hospital
Federal Way, Washington, 98003
- Suspended
Armes Family Cancer Center
Findlay, Ohio, 45840
- Suspended
Blanchard Valley Hospital
Findlay, Ohio, 45840
- Suspended
Orion Cancer Care
Findlay, Ohio, 45840
- Recruiting
Cancer Hematology Centers - Flint
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Recruiting
Genesee Hematology Oncology PC
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Recruiting
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Recruiting
Hurley Medical Center
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Recruiting
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa, 50501
Site Public Contact, 515-282-2921, trials@missioncancer.com
Seema Harichand-Herdt
- Recruiting
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Site Public Contact, eileen.georgi@holy-cross.com
Elie G. Dib
- Recruiting
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
Site Public Contact, 800-378-9373
Jay W. Carlson
- Suspended
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
- Suspended
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005
- Recruiting
Ascension Southeast Wisconsin Hospital - Franklin
Franklin, Wisconsin, 53132
Site Public Contact, AWRI.Inquiry@Ascension.org
Jonathan S. Treisman
- Recruiting
Reiman Cancer Center-Ascension Wisconsin Health Center-Rawson
Franklin, Wisconsin, 53132
Site Public Contact, AWRI.Inquiry@Ascension.org
Jonathan S. Treisman
- Active, not recruiting
Frederick Memorial Hospital
Frederick, Maryland, 21701
- Active, not recruiting
FMH James M Stockman Cancer Institute
Frederick, Maryland, 21702
- Suspended
Palo Alto Medical Foundation-Fremont
Fremont, California, 94538
- Recruiting
Washington Health
Fremont, California, 94538
Site Public Contact, 510-248-1600
Matthew E. Tenold
- Active, not recruiting
Unity Hospital
Fridley, Minnesota, 55432
- Suspended
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
- Suspended
Central Ohio Breast and Endocrine Surgery
Gahanna, Ohio, 43230
- Recruiting
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Suspended
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401
- Recruiting
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
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Renee Cheng
- Recruiting
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
MyMichigan Medical Center Gladwin
Gladwin, Michigan, 48624
Site Public Contact, 989-631-2469, CVResearch@mymichigan.org
Elie G. Dib
- Recruiting
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, 06033
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Sabrina Browning
- Suspended
Glens Falls Hospital
Glens Falls, New York, 12801
- Recruiting
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, 27534
Site Public Contact, 919-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- Recruiting
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
CHI Health Saint Francis
Grand Island, Nebraska, 68803
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Suspended
Nebraska Cancer Specialists/Oncology Hematology West PC
Grand Island, Nebraska, 68803
- Suspended
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
- Suspended
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
- Suspended
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
- Recruiting
Central Care Cancer Center - Great Bend
Great Bend, Kansas, 67530
Site Public Contact, 913-948-5588, aroland@kccop.org
Jay W. Carlson
- Suspended
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
- Suspended
Great Falls Clinic
Great Falls, Montana, 59405
- Recruiting
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
- Suspended
East Carolina University
Greenville, North Carolina, 27834
- Suspended
Dayton Physicians LLC-Wayne
Greenville, Ohio, 45331
- Suspended
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331
- Suspended
Wayne Hospital
Greenville, Ohio, 45331
- Active, not recruiting
Saint Francis Hospital
Greenville, South Carolina, 29601
- Active, not recruiting
Saint Francis Cancer Center
Greenville, South Carolina, 29607
- Recruiting
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, 06830
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Sabrina Browning
- Recruiting
Henry Ford Saint John Hospital - Academic
Grosse Pointe Woods, Michigan, 48236
Site Public Contact, 313-343-3166, kforman1@hfhs.org
Elie G. Dib
- Recruiting
Henry Ford Saint John Hospital - Breast
Grosse Pointe Woods, Michigan, 48236
Site Public Contact, 313-343-3166, karen.forman@ascension.org
Elie G. Dib
- Recruiting
Henry Ford Saint John Hospital - Van Elslander
Grosse Pointe Woods, Michigan, 48236
Site Public Contact, 313-343-3166, kforman1@hfhs.org
Elie G. Dib
- Suspended
Mount Carmel Grove City Hospital
Grove City, Ohio, 43123
- Suspended
Zangmeister Center Grove City
Grove City, Ohio, 43123
- Recruiting
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, 06437
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Sabrina Browning
- Recruiting
Gulfport Memorial Hospital
Gulfport, Mississippi, 39502
Site Public Contact, 504-210-3539, emede1@lsuhsc.edu
Augusto C. Ochoa
- Recruiting
Penn State Health Medical Group - Andrews Patel Hematology/Oncology East
Harrisburg, Pennsylvania, 17111
Site Public Contact, 717-526-1030
Shin Mineishi
- Suspended
Hartford Hospital
Hartford, Connecticut, 06102
- Recruiting
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Sabrina Browning
- Suspended
Hi-Line Sletten Cancer Center
Havre, Montana, 59501
- Recruiting
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429
Site Public Contact, 708-799-9995
Thomas J. Saphner
- Suspended
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201
- Recruiting
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania, 18201
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Elie G. Dib
- Suspended
Benefis Helena Specialty Center
Helena, Montana, 59601
- Suspended
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
- Suspended
Loyola Medicine Homer Glen
Homer Glen, Illinois, 60491
- Suspended
Providence Hood River Memorial Hospital
Hood River, Oregon, 97031
- Suspended
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas, 71913
- Suspended
Cancer Center of Kansas-Independence
Independence, Kansas, 67301
- Recruiting
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Chelsea Young, 317-278-5621, youngchs@iu.edu
Rafat Abonour
- Not yet recruiting
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
Chelsea Young, 317-278-5621, youngchs@iu.edu
Rafat Abonour
- Suspended
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
- Suspended
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, 32209
- Recruiting
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, 28546
Site Public Contact, 910-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- Active, not recruiting
SSM Health Dean Medical Group - Janesville
Janesville, Wisconsin, 53546
- Suspended
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129
- Suspended
MU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri, 65109
- Suspended
University of Wisconsin Carbone Cancer Center - Johnson Creek
Johnson Creek, Wisconsin, 53038
- Recruiting
Freeman Health System
Joplin, Missouri, 64804
Site Public Contact, 417-347-4030, LJCrockett@freemanhealth.com
Jay W. Carlson
- Recruiting
Mercy Hospital Joplin
Joplin, Missouri, 64804
Site Public Contact, 417-556-3074, esmeralda.carrillo@mercy.net
Jay W. Carlson
- Suspended
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
- Suspended
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
- Suspended
Beacon Kalamazoo Cancer Center
Kalamazoo, Michigan, 49009
- Suspended
Beacon Kalamazoo
Kalamazoo, Michigan, 49048
- Suspended
Logan Health Medical Center
Kalispell, Montana, 59901
- Recruiting
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, 64128
Site Public Contact, 800-525-1483
Suman Kambhampati
- Recruiting
CHI Health Good Samaritan
Kearney, Nebraska, 68847
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Active, not recruiting
ECU Health Oncology Kenansville
Kenansville, North Carolina, 28349
Puerto Rico7 sites
- Suspended
Cancer Center-Metro Medical Center Bayamon
Bayamón, 00959-5060
- Suspended
Puerto Rico Hematology Oncology Group
Bayamón, 00961
- Suspended
Doctors Cancer Center
Manati, 00674
- Suspended
San Juan Community Oncology Group
San Juan, 00917
- Suspended
Centro Comprensivo de Cancer de UPR
San Juan, 00927
- Suspended
PROncology
San Juan, 00927
- Suspended
San Juan City Hospital
San Juan, 00936
About this study
Official title: Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation
This phase III trial compares the combination of four drugs (daratumumab, bortezomib, lenalidomide and dexamethasone) to the use of a three drug combination (daratumumab, lenalidomide and dexamethasone). 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 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 body's immune response and are used with other drugs in the treatment of some types of cancer. Adding bortezomib to daratumumab, lenalidomide, and dexamethasone may be more effective in shrinking the cancer or preventing it from returning, compared to continuing on daratumumab, lenalidomide, and dexamethasone.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine if bortezomib, daratumumab and hyaluronidase-fihj (daratumumab), lenalidomide and dexamethasone (Btz-DRd) consolidation followed by daratumumab and lenalidomide (DR) maintenance after standard induction therapy with daratumumab, 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:
- 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.
- To assess the sustained MRD negative rate among patients who are MRD negative after induction.
PATIENT REPORTED OUTCOMES (PRO) OBJECTIVES:
- 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:
- 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 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 SC on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM C:
CONSOLIDATION: Patients receive 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 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.
- Being tested
- Bortezomib, Daratumumab and Hyaluronidase-fihj, Dexamethasone, Lenalidomide, Quality-of-Life Assessment
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
Also called [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid, LDP 341, MLN341, PS-341
Given SC
Daratumumab and Hyaluronidase-fihjBiological
Also called DARA Co-formulated with rHuPH20, DARA/rHuPH20, Daratumumab + rHuPH20, Daratumumab with rHuPH20
Given SC
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
| Study group | Role | What they receive |
|---|---|---|
| Arm A (daratumumab, lenalidomide, dexamethasone) | Active comparator | INDUCTION: All patients receive standard induction therapy comprising the following: daratumumab 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. Receives: Biological: Daratumumab and Hyaluronidase-fihj; Drug: Dexamethasone; Drug: Lenalidomide; Other: Quality-of-Life Assessment |
| Arm B (bortezomib, daratumumab, lenalidomide, dexamethasone) | Experimental | 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 SC on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Bortezomib; Biological: Daratumumab and Hyaluronidase-fihj; Drug: Dexamethasone; Drug: Lenalidomide; Other: Quality-of-Life Assessment |
| Arm C (daratumumab, lenalidomide, dexamethasone) | Active comparator | CONSOLIDATION: Patients receive 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 SC on day 1. Cycles repeats every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Biological: Daratumumab and Hyaluronidase-fihj; Drug: Dexamethasone; Drug: Lenalidomide; Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consolidation overall survival
Will be estimated using the Kaplan-Meier (KM) method and compared using a stratified log-rank test. Stratified cox proportional hazards regression will produce treatment hazard ratio (bortezomib, daratumumab and hyaluronidase-fihj (daratumumab), lenalidomide and dexamethasone [Btz-DRd] then daratumumab, lenalidomide and dexamethasone [DRd] then daratumumab and lenalidomide [DR]).
Measured: Time from Step 2 randomization at the start of consolidation to death or to the date last known alive, assessed up to 15 years
Secondary outcomes (6)
Consolidation progression-free survival
Patients alive without disease progression will be censored at date of last disease evaluation. Only deaths that occur within 3 months of the last disease evaluation are considered events.
Measured: Time from Step 2 randomization at the start of consolidation until the earlier of progression or death due to any cause, assessed up to 15 years
Incidence of adverse events
Measured: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance).
Incidence of grade 3 or higher non-hematologic adverse events
Measured: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance).
Incidence of grade 3 or higher adverse events
Measured: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance).
Best response
Measured: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance).
FACT-Ntx TOI recovery rate (Patient reported outcome [PRO])
Defined as the proportion of patients with the FACT-Ntx TOI score returning to baseline level reached at consolidation randomization after experiencing a MID decrease while on up to 1 year of maintenance.
Measured: From end of induction through consolidation up to 1 year of maintenance, up to 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start24 Feb 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasma Cell MyelomaStudies of the same condition, open and under way.
- More trials run by ECOG-ACRIN Cancer Research GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Sequential
- Masking
- None (open label)
- Enrolment
- 1,450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Shaji K Kumar, Principal investigator, ECOG-ACRIN Cancer Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566328
- Sponsor's protocol ID
- EAA181
- Other IDs
- NCI-2020-06647, EAA181, EAA181, U10CA180820
- Status last verified
- Jun 2026
- First submitted
- 16 Sep 2020
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation
- ClinicalTrials.gov ID
- NCT04566328
- Acronym / sponsor ID
- EAA181
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,450 participants (estimated)
- Lead sponsor
- ECOG-ACRIN Cancer Research GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase III trial compares the combination of four drugs (daratumumab, bortezomib, lenalidomide and dexamethasone) to the use of a three drug combination (daratumumab, lenalidomide and dexamethasone). 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 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 body's immune response and are used with other drugs in the treatment of some types of cancer. Adding bortezomib to daratumumab, lenalidomide, and dexamethasone may be more effective in shrinking the cancer or preventing it from returning, compared to continuing on daratumumab, lenalidomide, and dexamethasone.
Detailed description
PRIMARY OBJECTIVE:
- To determine if bortezomib, daratumumab and hyaluronidase-fihj (daratumumab), lenalidomide and dexamethasone (Btz-DRd) consolidation followed by daratumumab and lenalidomide (DR) maintenance after standard induction therapy with daratumumab, 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:
- 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.
- To assess the sustained MRD negative rate among patients who are MRD negative after induction.
PATIENT REPORTED OUTCOMES (PRO) OBJECTIVES:
- 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:
- 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 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 SC on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM C:
CONSOLIDATION: Patients receive 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A (daratumumab, lenalidomide, dexamethasone) | Active comparator | Biological: Daratumumab and Hyaluronidase-fihj, Drug: Dexamethasone, Drug: Lenalidomide, Other: Quality-of-Life AssessmentINDUCTION: All patients receive standard induction therapy comprising the following: daratumumab 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. |
| Arm B (bortezomib, daratumumab, lenalidomide, dexamethasone) | Experimental | Drug: Bortezomib, Biological: Daratumumab and Hyaluronidase-fihj, Drug: Dexamethasone, Drug: Lenalidomide, Other: Quality-of-Life AssessmentCONSOLIDATION: 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 SC on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Arm C (daratumumab, lenalidomide, dexamethasone) | Active comparator | Biological: Daratumumab and Hyaluronidase-fihj, Drug: Dexamethasone, Drug: Lenalidomide, Other: Quality-of-Life AssessmentCONSOLIDATION: Patients receive 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 SC on day 1. Cycles repeats every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (47 listed)
- 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 newly diagnosed multiple myeloma (MM) by International Myeloma Working Group (IMWG) criteria
- STEP 0 - Patient must agree to register to the mandatory REVLIMID Risk Evaluation and Mitigation Strategy (RevREMS) program and be willing and able to comply with the requirements of RevREMS
- STEP 0 - Patient must be able to undergo diagnostic bone marrow aspirate following preregistration.
- STEP 1 - Patient must meet all eligibility criteria in STEP 0 with exception of allergy requirement
Key exclusion criteria (19 listed)
- 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 1 - Women 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 females 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. Females of childbearing potential must also agree to ongoing pregnancy testing while on protocol treatment. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
- STEP 1 - Women 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 days 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). Men 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 female 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. Men must also agree to abstain from donating sperm while on study treatment and for 3 months 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
- 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 investigator's opinion, potentially interfere with the completion of treatment according to this protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BortezomibAlso: [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid, LDP 341, MLN341, PS-341Given SC | Drug | Arm B (bortezomib, daratumumab, lenalidomide, dexamethasone) |
| Daratumumab and Hyaluronidase-fihjAlso: DARA Co-formulated with rHuPH20, DARA/rHuPH20, Daratumumab + rHuPH20, Daratumumab with rHuPH20Given SC | Biological | Arm A (daratumumab, lenalidomide, dexamethasone), Arm B (bortezomib, daratumumab, lenalidomide, dexamethasone), Arm C (daratumumab, lenalidomide, dexamethasone) |
| DexamethasoneAlso: Aacidexam, Adexone, Aknichthol Dexa, Alba-DexGiven PO | Drug | Arm A (daratumumab, lenalidomide, dexamethasone), Arm B (bortezomib, daratumumab, lenalidomide, dexamethasone), Arm C (daratumumab, lenalidomide, dexamethasone) |
| LenalidomideAlso: CC-5013, CC5013, CDC 501, RevlimidGiven PO | Drug | Arm A (daratumumab, lenalidomide, dexamethasone), Arm B (bortezomib, daratumumab, lenalidomide, dexamethasone), Arm C (daratumumab, lenalidomide, dexamethasone) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm A (daratumumab, lenalidomide, dexamethasone), Arm B (bortezomib, daratumumab, lenalidomide, dexamethasone), Arm C (daratumumab, lenalidomide, dexamethasone) |
Primary outcome
Consolidation overall survival
Time frame: Time from Step 2 randomization at the start of consolidation to death or to the date last known alive, assessed up to 15 years
Will be estimated using the Kaplan-Meier (KM) method and compared using a stratified log-rank test. Stratified cox proportional hazards regression will produce treatment hazard ratio (bortezomib, daratumumab and hyaluronidase-fihj (daratumumab), lenalidomide and dexamethasone [Btz-DRd] then daratumumab, lenalidomide and dexamethasone [DRd] then daratumumab and lenalidomide [DR]).
6 secondary outcomes
Consolidation progression-free survival
Time frame: Time from Step 2 randomization at the start of consolidation until the earlier of progression or death due to any cause, assessed up to 15 years
Incidence of adverse events
Time frame: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance).
Incidence of grade 3 or higher non-hematologic adverse events
Time frame: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance).
Incidence of grade 3 or higher adverse events
Time frame: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance).
Best response
Time frame: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance).
FACT-Ntx TOI recovery rate (Patient reported outcome [PRO])
Time frame: From end of induction through consolidation up to 1 year of maintenance, up to 21 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cancer Center at Saint Joseph's
Phoenix, United States
Shaji K Kumar principal investigator
ECOG-ACRIN Cancer Research Group
647 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bortezomib, Daratumumab and Hyaluronidase-fihj and Dexamethasone in people with Plasma Cell Myeloma and RISS Stage I Plasma Cell Myeloma, run by ECOG-ACRIN Cancer Research Group at 647 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 47 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 647 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consolidation overall survival (time frame: Time from Step 2 randomization at the start of consolidation to death or to the date last known alive, assessed up to 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.