S1211 Bortezomib, Dexamethasone, and Lenalidomide With or Without Elotuzumab in Treating Patients With Newly Diagnosed High-Risk Multiple Myeloma
NCT ID: NCT01668719
Last Updated: 2025-06-10
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
142 participants
INTERVENTIONAL
2012-11-30
2025-12-31
Brief Summary
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Detailed Description
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I. To determine the appropriate Phase II dose of elotuzumab to use in combination with lenalidomide, bortezomib, and dexamethasone for patients with multiple myeloma. (Phase I) II. To assess whether incorporation of the novel agent elotuzumab into the treatment algorithm of high-risk multiple myeloma (HRMM) will improve progression-free survival (PFS). (Phase II) III. To estimate the frequency and severity of toxicities of this treatment strategy in this patient population. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of elotuzumab, followed by a phase II, randomized study.
PHASE I:
INDUCTION: Patients receive bortezomib subcutaneously (SC) or intravenously (IV) on days 1, 4, 8, and 11; lenalidomide orally (PO) once daily (QD) on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12 (and on day 15 of courses 1 and 2 only). Patients also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; dexamethasone PO on days 1, 8, and 15; and elotuzumab IV on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients are randomized to 1 of 2 treatment arms.
ARM I:
INDUCTION: Patients receive bortezomib SC or IV on days 1, 4, 8, and 11; lenalidomide PO QD on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity (patients who received a course of chemotherapy prior to registration will begin protocol treatment with course 2 and receive a total of 7 courses of protocol therapy).
MAINTENANCE: Patients receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; and dexamethasone PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM II:
INDUCTION: Patients receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Patients also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Patients also receive elotuzumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for up to 6 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I (bortezomib, lenalidomide, dexamethasone)
INDUCTION: Patients receive bortezomib SC or IV on days 1, 4, 8, and 11; lenalidomide PO QD on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity (patients who received a course of chemotherapy prior to registration will begin protocol treatment with course 2 and receive a total of 7 courses of protocol therapy).
MAINTENANCE: Patients receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; and dexamethasone PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Bortezomib
Given SC or IV
Dexamethasone
Given PO or IV
Laboratory Biomarker Analysis
Correlative studies
Lenalidomide
Given PO
Arm II (bortezomib, lenalidomide, dexamethasone, elotuzumab)
INDUCTION: Patients receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Patients also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Patients also receive elotuzumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Bortezomib
Given SC or IV
Dexamethasone
Given PO or IV
Elotuzumab
Given IV
Laboratory Biomarker Analysis
Correlative studies
Lenalidomide
Given PO
Interventions
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Bortezomib
Given SC or IV
Dexamethasone
Given PO or IV
Elotuzumab
Given IV
Laboratory Biomarker Analysis
Correlative studies
Lenalidomide
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* For the Phase II portion only, patients must have high-risk MM based on one or more of the following criteria at the time of initial diagnosis (prior to any chemotherapy):
* Poor-risk genomic signature according to the University of Arkansas 70-gene model (available clinically as myeloma prognostic risk score \[MyPRS\] score, Signal Genetics, Inc) AND/OR
* Translocation (14;16), and/or translocation (14;20), and/or deletion (17p) by fluorescence in-situ hybridization (FISH) or cytogenetics AND/OR
* Primary plasma cell leukemia (defined by either \>= 2,000 plasma cells/mL of peripheral blood, or 20% on a manual differential count) AND/OR
* Serum lactate dehydrogenase (LDH) \>= 2 x institutional upper limit of normal (IULN) AND/OR
* 1q21 amplification by FISH analysis AND/OR
* High risk by the SKY92 signature
* Patients with non-secretory MM or known amyloidosis are not eligible
* Patients must have measurable disease within 28 days prior to registration (or prior to initiation of first induction course for patients with prior therapy)
* Patients on the Phase I portion may not have received ANY prior chemotherapy; patients on the Phase II portion may have received one prior cycle of any non-investigational chemotherapy; prior chemotherapy must have been completed within 56 days prior to registration and all toxicities must have resolved to =\< grade 1; patients on either portion may have received prior treatment with dexamethasone, providing total number of days of treatment was =\< 14 days and total treatment dose was =\< 360 mg
* Patients may have received prior radiotherapy for symptomatic localized bone lesions or impending spinal cord compression only; radiotherapy must be completed at least 14 days prior to registration and all toxicities must have resolved to =\< grade 1
* Absolute neutrophil count (ANC) \>= 1,000 cells/mm\^3 without growth factor support
* Platelet count \>= 70,000 cells/mm\^3 for patients who have bone marrow plasmacytosis \< 50%; or \>= 50,000 cells/mm\^3 for patients who have bone marrow plasmacytosis of \>= 50%
* Total bilirubin =\< 1.5 x institutional upper limit of normal (IULN)
* Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) and serum glutamate pyruvate transaminase (SGPT)/alanine aminotransferase (ALT) =\< 2.5 x IULN
* Creatinine clearance (CrCL) \>= 30 mL/min, measured by a 24-hour urine collection or estimated by the Cockcroft and Gault formula within 14 days prior to registration
* Patients must not have active involvement of the central nervous system (CNS) with MM (by clinical evaluation); patients with documentation of, or clinical signs or symptoms consistent with, CNS involvement of MM must have a lumbar puncture that is negative for CNS involvement of MM; the lumbar puncture must be completed within 14 days prior to registration; patients with no previous history of documented CNS involvement and with no clinical signs or symptoms consistent with CNS involvement are not required to have completed a lumbar puncture prior to registration; note that monitoring of CNS involvement and treatment with intrathecal therapy is recommended during protocol treatment
* Patients who are known to be human immunodeficiency virus positive (HIV+) are eligible providing they meet all of the following additional criteria within 28 days prior to registration:
* Cluster of differentiation (CD)4 cells \>= 500/mm\^3
* Viral load of \< 50 copies HIV messenger ribonucleic acid (mRNA)/mm\^3 if on combination antiretroviral therapy (cART) or \< 25,000 copies HIV mRNA if not on cART
* No zidovudine or stavudine as part of cART
* Patients who are HIV+ and do not meet all of these criteria are not eligible for this study
* Patients must have baseline skeletal survey (whole body x-ray) to document lytic lesions, osteopenia or compression fracture
* Patients must have Zubrod performance status =\< 2
* Patients with known hepatitis B or hepatitis C infection may be eligible providing they have viral load \< 800,000 IU/L within 28 days prior to registration
* Patients must not have POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
* Patients must not have clinically significant illness including uncontrolled, active infection requiring intravenous antibiotics, New York Heart Association (NYHA) class III or class IV heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled \>= grade 3 cardiac arrhythmias, uncontrolled hypertension, or uncontrolled diabetes mellitus; patients must have undergone an electrocardiogram (EKG) within 28 days prior to registration
* Uncontrolled diabetes: a glycated hemoglobin (Hg A1C) \> 7% within 14 days prior to registration; the same criterion will be used in patients with confirmed diagnosis of diabetes mellitus who have been on a stable dietary or therapeutic regimen for this condition in the last three months
* Uncontrolled blood pressure and hypertension: systolic blood pressure (SBP) \> 140 mm Hg or diastolic blood pressure (DBP) \> 90 mm Hg within 14 days prior to registration; patients are permitted to be receiving multiple anti-hypertensive medications (unless otherwise indicated in the study); all blood pressure measurements within the 14 days prior to registration and on day 1 of cycle 1 must be SBP =\< 140 and DBP =\< 90; an exception can be made by a healthcare provider for a patient with a single blood pressure elevation who upon rechecking has a normal blood pressure
* Patients must have history and physical examination within 28 days prior to registration
* Patients must not have any psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
* Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to registration; (Note: that pregnancy testing is also required within 24 hours prior to treatment on cycle 1, day 1); furthermore, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy; a FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
* No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years
* Patients must be offered participation in banking of specimens for future research; with the patient's consent, specimens (serum and bone marrow biopsy core) must be submitted to the repository; patient consent must be obtained before specimens are submitted
* Patients must be registered to the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS)™ program and must be willing and able to comply with the requirements of the Revlimid REMS™ program
* Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
* As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Saad Usmani
Role: PRINCIPAL_INVESTIGATOR
SWOG Cancer Research Network
Locations
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Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States
Alaska Women's Cancer Care
Anchorage, Alaska, United States
Anchorage Oncology Centre
Anchorage, Alaska, United States
Katmai Oncology Group
Anchorage, Alaska, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Los Angeles County-USC Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, United States
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, United States
Medical Oncology and Hematology Group PC-Guilford
Guilford, Connecticut, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, United States
Smilow Cancer Hospital-Orange Care Center
Orange, Connecticut, United States
Charlotte Hungerford Hospital Center for Cancer Care
Torrington, Connecticut, United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, United States
Beebe Medical Center
Lewes, Delaware, United States
Christiana Gynecologic Oncology LLC
Newark, Delaware, United States
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
Regional Hematology and Oncology PA
Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Beebe Health Campus
Rehoboth Beach, Delaware, United States
Nanticoke Memorial Hospital
Seaford, Delaware, United States
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Hawaii Cancer Care Inc-POB II
Honolulu, Hawaii, United States
Queen's Medical Center
Honolulu, Hawaii, United States
Straub Clinic and Hospital
Honolulu, Hawaii, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Hawaii Cancer Care Inc-Liliha
Honolulu, Hawaii, United States
Hawaii Oncology Inc-Kuakini
Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Castle Medical Center
Kailua, Hawaii, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States
Hawaii Oncology Inc-Pali Momi
‘Aiea, Hawaii, United States
Pali Momi Medical Center
‘Aiea, Hawaii, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Saint Joseph Medical Center
Bloomington, Illinois, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States
Illinois CancerCare-Canton
Canton, Illinois, United States
Memorial Hospital of Carbondale
Carbondale, Illinois, United States
Illinois CancerCare-Carthage
Carthage, Illinois, United States
Centralia Oncology Clinic
Centralia, Illinois, United States
Cancer Care Center of Decatur
Decatur, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Crossroads Cancer Center
Effingham, Illinois, United States
Illinois CancerCare-Eureka
Eureka, Illinois, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, United States
Ingalls Memorial Hospital
Harvey, Illinois, United States
Hines Veterans Administration Hospital
Hines, Illinois, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States
Illinois CancerCare-Macomb
Macomb, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Garneau, Stewart C MD (UIA Investigator)
Moline, Illinois, United States
Porubcin, Michael MD (UIA Investigator)
Moline, Illinois, United States
Spector, David MD (UIA Investigator)
Moline, Illinois, United States
Trinity Medical Center
Moline, Illinois, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States
Radiation Oncology of Northern Illinois
Ottawa, Illinois, United States
Illinois CancerCare-Pekin
Pekin, Illinois, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Illinois CancerCare-Peru
Peru, Illinois, United States
Valley Radiation Oncology
Peru, Illinois, United States
Illinois CancerCare-Princeton
Princeton, Illinois, United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
Memorial Medical Center
Springfield, Illinois, United States
Cancer Care Specialists of Illinois-Swansea
Swansea, Illinois, United States
Reid Health
Richmond, Indiana, United States
Mary Greeley Medical Center
Ames, Iowa, United States
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States
Constantinou, Costas L MD (UIA Investigator)
Bettendorf, Iowa, United States
McFarland Clinic PC-Boone
Boone, Iowa, United States
McFarland Clinic PC-Trinity Cancer Center
Fort Dodge, Iowa, United States
McFarland Clinic PC-Jefferson
Jefferson, Iowa, United States
McFarland Clinic PC-Marshalltown
Marshalltown, Iowa, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, United States
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States
Newman Regional Health
Emporia, Kansas, United States
Saint Catherine Hospital
Garden City, Kansas, United States
Saint Rose Ambulatory and Surgery Center
Great Bend, Kansas, United States
Hays Medical Center
Hays, Kansas, United States
Providence Medical Center
Kansas City, Kansas, United States
University of Kansas Cancer Center-West
Kansas City, Kansas, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
Kansas Institute of Medicine Cancer and Blood Center
Lenexa, Kansas, United States
Minimally Invasive Surgery Hospital
Lenexa, Kansas, United States
Olathe Medical Center
Olathe, Kansas, United States
Menorah Medical Center
Overland Park, Kansas, United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States
Saint Luke's South Hospital
Overland Park, Kansas, United States
Via Christi Hospital-Pittsburg
Pittsburg, Kansas, United States
Kansas City NCI Community Oncology Research Program
Prairie Village, Kansas, United States
Salina Regional Health Center
Salina, Kansas, United States
Cotton O'Neil Cancer Center / Stormont Vail Health
Topeka, Kansas, United States
Saint Francis Hospital and Medical Center - Topeka
Topeka, Kansas, United States
Wesley Medical Center
Wichita, Kansas, United States
Oncology Hematology Care Inc-Crestview
Crestview Hills, Kentucky, United States
Hematology/Oncology Clinic LLP
Baton Rouge, Louisiana, United States
West Jefferson Medical Center
Marrero, Louisiana, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Bixby Medical Center
Adrian, Michigan, United States
Hickman Cancer Center
Adrian, Michigan, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, United States
Bronson Battle Creek
Battle Creek, Michigan, United States
Beaumont Hospital-Dearborn
Dearborn, Michigan, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Saint John Hospital and Medical Center
Detroit, Michigan, United States
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, United States
Allegiance Health
Jackson, Michigan, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Sparrow Hospital
Lansing, Michigan, United States
Saint Mary Mercy Hospital
Livonia, Michigan, United States
Mercy Memorial Hospital
Monroe, Michigan, United States
Toledo Clinic Cancer Centers-Monroe
Monroe, Michigan, United States
Mercy Health Mercy Campus
Muskegon, Michigan, United States
Lakeland Community Hospital
Niles, Michigan, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States
Lake Huron Medical Center
Port Huron, Michigan, United States
Spectrum Health Reed City Hospital
Reed City, Michigan, United States
Saint Mary's of Michigan
Saginaw, Michigan, United States
Lakeland Hospital
Saint Joseph, Michigan, United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States
Providence Hospital-Southfield Cancer Center
Southfield, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Essentia Health Cancer Center
Duluth, Minnesota, United States
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, United States
Miller-Dwan Hospital
Duluth, Minnesota, United States
Fairview-Southdale Hospital
Edina, Minnesota, United States
Lake Region Healthcare Corporation-Cancer Care
Fergus Falls, Minnesota, United States
Unity Hospital
Fridley, Minnesota, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Health Partners Inc
Minneapolis, Minnesota, United States
New Ulm Medical Center
New Ulm, Minnesota, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States
Lakeview Hospital
Stillwater, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Rice Memorial Hospital
Willmar, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Central Care Cancer Center-Carrie J Babb Cancer Center
Bolivar, Missouri, United States
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, United States
CoxHealth Cancer Center
Branson, Missouri, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Southeast Cancer Center
Cape Girardeau, Missouri, United States
Centerpoint Medical Center LLC
Independence, Missouri, United States
Capital Region Medical Center-Goldschmidt Cancer Center
Jefferson City, Missouri, United States
Truman Medical Center
Kansas City, Missouri, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
North Kansas City Hospital
Kansas City, Missouri, United States
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, United States
The University of Kansas Cancer Center-South
Kansas City, Missouri, United States
Research Medical Center
Kansas City, Missouri, United States
The University of Kansas Cancer Center-North
Kansas City, Missouri, United States
The University of Kansas Cancer Center-Lee's Summit
Lee's Summit, Missouri, United States
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States
Liberty Radiation Oncology Center
Liberty, Missouri, United States
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, United States
Saint John's Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Saint Joseph Oncology Inc
Saint Joseph, Missouri, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, United States
Cancer Research for the Ozarks NCORP
Springfield, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, United States
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri, United States
Nebraska Hematology and Oncology
Lincoln, Nebraska, United States
Nebraska Cancer Research Center
Lincoln, Nebraska, United States
Southeast Nebraska Cancer Center
Lincoln, Nebraska, United States
Faith Regional Medical Offices West
Norfolk, Nebraska, United States
Great Plains Regional Medical Center
North Platte, Nebraska, United States
Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Alegent Health Immanuel Medical Center
Omaha, Nebraska, United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, United States
Oncology Hematology West
Omaha, Nebraska, United States
Alegent Health Lakeside Hospital
Omaha, Nebraska, United States
Oncology Hematology West PC
Omaha, Nebraska, United States
Urology Cancer Center PC
Omaha, Nebraska, United States
Creighton University Medical Center
Omaha, Nebraska, United States
Regional West Medical Center
Scottsbluff, Nebraska, United States
Cancer and Blood Specialists-Henderson
Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, United States
Las Vegas Cancer Center-Henderson
Henderson, Nevada, United States
21st Century Oncology - Henderson
Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Cancer and Blood Specialists-Shadow
Las Vegas, Nevada, United States
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, United States
21st Century Oncology
Las Vegas, Nevada, United States
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Las Vegas, Nevada, United States
HealthCare Partners Medical Group Oncology/Hematology-San Martin
Las Vegas, Nevada, United States
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, United States
Cancer Therapy and Integrative Medicine
Las Vegas, Nevada, United States
Cancer and Blood Specialists-Tenaya
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, United States
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, United States
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada, United States
21st Century Oncology - Fort Apache
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Nevada Cancer Specialists-Fort Apache
Las Vegas, Nevada, United States
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, United States
21st Century Oncology - Vegas Tenaya
Las Vegas, Nevada, United States
Orange Regional Medical Center
Middletown, New York, United States
University of Rochester
Rochester, New York, United States
Staten Island University Hospital
Staten Island, New York, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, United States
Carolinas HealthCare System NorthEast
Concord, North Carolina, United States
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, United States
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, United States
Kinston Medical Specialists PA
Kinston, North Carolina, United States
Carolinas HealthCare System Union
Monroe, North Carolina, United States
FirstHealth of the Carolinas-Moore Regional Hosiptal
Pinehurst, North Carolina, United States
Iredell Memorial Hospital
Statesville, North Carolina, United States
Southeastern Medical Oncology Center-Wilson
Wilson, North Carolina, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States
Roger Maris Cancer Center
Fargo, North Dakota, United States
Sanford Clinic North-Fargo
Fargo, North Dakota, United States
Sanford Medical Center-Fargo
Fargo, North Dakota, United States
Cleveland Clinic Cancer Center Beachwood
Beachwood, Ohio, United States
Strecker Cancer Center-Belpre
Belpre, Ohio, United States
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, United States
Miami Valley Hospital South
Centerville, Ohio, United States
Geaugra Hospital
Chardon, Ohio, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
Oncology Hematology Care Inc-Eden Park
Cincinnati, Ohio, United States
Oncology Hematology Care Inc-Mercy West
Cincinnati, Ohio, United States
Oncology Hematology Care Inc - Anderson
Cincinnati, Ohio, United States
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, United States
Oncology Hematology Care Inc-Blue Ash
Cincinnati, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Mount Carmel East Hospital
Columbus, Ohio, United States
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Columbus NCI Community Oncology Research Program
Columbus, Ohio, United States
Grant Medical Center
Columbus, Ohio, United States
The Mark H Zangmeister Center
Columbus, Ohio, United States
Mount Carmel Health Center West
Columbus, Ohio, United States
Doctors Hospital
Columbus, Ohio, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Samaritan North Health Center
Dayton, Ohio, United States
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, United States
Delaware Radiation Oncology
Delaware, Ohio, United States
Grady Memorial Hospital
Delaware, Ohio, United States
Mercy Cancer Center-Elyria
Elyria, Ohio, United States
Oncology Hematology Care Inc-Healthplex
Fairfield, Ohio, United States
Blanchard Valley Hospital
Findlay, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States
Wayne Hospital
Greenville, Ohio, United States
Cleveland Clinic Cancer Center Independence
Independence, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Fairfield Medical Center
Lancaster, Ohio, United States
Lancaster Radiation Oncology
Lancaster, Ohio, United States
Lima Memorial Hospital
Lima, Ohio, United States
OhioHealth Mansfield Hospital
Mansfield, Ohio, United States
Cleveland Clinic Cancer Center Mansfield
Mansfield, Ohio, United States
Marietta Memorial Hospital
Marietta, Ohio, United States
OneHealth Marion General Hospital
Marion, Ohio, United States
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, United States
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States
Ireland Cancer Center Landerbrook Health Center
Mayfield Heights, Ohio, United States
Lake University Ireland Cancer Center
Mentor, Ohio, United States
Knox Community Hospital
Mount Vernon, Ohio, United States
Licking Memorial Hospital
Newark, Ohio, United States
Newark Radiation Oncology
Newark, Ohio, United States
Saint Charles Hospital
Oregon, Ohio, United States
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, United States
University Hospitals Parma Medical Center
Parma, Ohio, United States
Southern Ohio Medical Center
Portsmouth, Ohio, United States
Ireland Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio, United States
North Coast Cancer Care
Sandusky, Ohio, United States
Springfield Regional Cancer Center
Springfield, Ohio, United States
Springfield Regional Medical Center
Springfield, Ohio, United States
Cleveland Clinic Cancer Center Strongsville
Strongsville, Ohio, United States
Flower Hospital
Sylvania, Ohio, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, United States
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States
Saint Vincent Mercy Medical Center
Toledo, Ohio, United States
University of Toledo
Toledo, Ohio, United States
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, United States
Mercy Saint Anne Hospital
Toledo, Ohio, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States
Upper Valley Medical Center
Troy, Ohio, United States
South Pointe Hospital
Warrensville Heights, Ohio, United States
Fulton County Health Center
Wauseon, Ohio, United States
Saint Ann's Hospital
Westerville, Ohio, United States
UH-Seidman Cancer Center at Saint John Medical Center
Westlake, Ohio, United States
Cleveland Clinic Wooster Family Health and Surgery Center
Wooster, Ohio, United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States
Providence Oncology and Hematology Care Southeast
Clackamas, Oregon, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, United States
Providence Newberg Medical Center
Newberg, Oregon, United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, United States
Lewistown Hospital
Lewistown, Pennsylvania, United States
Geisinger Medical Oncology-Pottsville
Pottsville, Pennsylvania, United States
Geisinger Medical Group
State College, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
McLeod Regional Medical Center
Florence, South Carolina, United States
Self Regional Healthcare
Greenwood, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
M D Anderson Cancer Center
Houston, Texas, United States
Fredericksburg Oncology Inc
Fredericksburg, Virginia, United States
Memorial Hospital Of Martinsville
Martinsville, Virginia, United States
PeaceHealth Saint John Medical Center
Longview, Washington, United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States
Compass Oncology Vancouver
Vancouver, Washington, United States
Legacy Salmon Creek Hospital
Vancouver, Washington, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, United States
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, United States
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, United States
Aurora Health Center-Fond du Lac
Fond du Lac, Wisconsin, United States
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States
Bay Area Medical Center
Marinette, Wisconsin, United States
Vince Lombardi Cancer Clinic-Marinette
Marinette, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States
Aurora Cancer Care-Racine
Racine, Wisconsin, United States
Marshfield Clinic at James Beck Cancer Center
Rhinelander, Wisconsin, United States
Lakeview Medical Center-Marshfield Clinic
Rice Lake, Wisconsin, United States
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, United States
HSHS Saint Nicholas Hospital
Sheboygan, Wisconsin, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, United States
Marshfield Clinic Cancer Care at Saint Michael's Hospital
Stevens Point, Wisconsin, United States
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
Aurora Medical Center in Summit
Summit, Wisconsin, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, United States
Aurora Cancer Care-Waukesha
Waukesha, Wisconsin, United States
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, United States
Diagnostic and Treatment Center
Weston, Wisconsin, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States
Countries
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References
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Banerjee R, Sexton R, Cowan AJ, Rosenberg AS, Ailawadhi S, Rajkumar SV, Kumar S, Dispenzieri A, Lonial S, Durie BGM, Richardson PG, Usmani SZ, Hoering A, Orlowski RZ. Dexamethasone dose intensity does not impact outcomes in newly diagnosed multiple myeloma: a secondary SWOG analysis. Blood. 2025 Jan 2;145(1):75-84. doi: 10.1182/blood.2024025939.
Usmani SZ, Hoering A, Ailawadhi S, Sexton R, Lipe B, Hita SF, Valent J, Rosenzweig M, Zonder JA, Dhodapkar M, Callander N, Zimmerman T, Voorhees PM, Durie B, Rajkumar SV, Richardson PG, Orlowski RZ; SWOG1211 Trial Investigators. Bortezomib, lenalidomide, and dexamethasone with or without elotuzumab in patients with untreated, high-risk multiple myeloma (SWOG-1211): primary analysis of a randomised, phase 2 trial. Lancet Haematol. 2021 Jan;8(1):e45-e54. doi: 10.1016/S2352-3026(20)30354-9. Epub 2020 Dec 22.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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NCI-2012-01998
Identifier Type: REGISTRY
Identifier Source: secondary_id
PS1211_A12PAMDREVW01
Identifier Type: -
Identifier Source: secondary_id
CDR0000738512
Identifier Type: -
Identifier Source: secondary_id
S1211
Identifier Type: OTHER
Identifier Source: secondary_id
S1211
Identifier Type: OTHER
Identifier Source: secondary_id
S1211
Identifier Type: -
Identifier Source: org_study_id
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