Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01668719
Other study ID # S1211
Secondary ID NCI-2012-01998PS
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date November 2012
Est. completion date June 2024

Study information

Verified date May 2023
Source SWOG Cancer Research Network
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This partially randomized phase I/II trial studies the side effects and best dose of elotuzumab and to see how well it works when given together with lenalidomide, bortezomib, and dexamethasone in treating patients with newly diagnosed multiple myeloma that is likely to recur (come back), or spread (high-risk). Lenalidomide and bortezomib may stop the growth of multiple myeloma by blocking blood flow to the tumor. Also, bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, also work in different ways to kill cancer cells, by stopping them from dividing, or by stopping them from spreading. Giving elotuzumab together with lenalidomide, bortezomib, and dexamethasone may be a better way to block cancer growth.


Description:

PRIMARY OBJECTIVES: 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 142
Est. completion date June 2024
Est. primary completion date February 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients must have newly diagnosed active multiple myeloma (MM) - 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

Study Design


Intervention

Drug:
Bortezomib
Given SC or IV
Dexamethasone
Given PO or IV
Biological:
Elotuzumab
Given IV
Other:
Laboratory Biomarker Analysis
Correlative studies
Drug:
Lenalidomide
Given PO

Locations

Country Name City State
United States Hawaii Oncology Inc-Pali Momi 'Aiea Hawaii
United States Pali Momi Medical Center 'Aiea Hawaii
United States Bixby Medical Center Adrian Michigan
United States Hickman Cancer Center Adrian Michigan
United States Mary Greeley Medical Center Ames Iowa
United States McFarland Clinic PC-William R Bliss Cancer Center Ames Iowa
United States 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 Michigan Cancer Research Consortium NCORP Ann Arbor Michigan
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States Sinai Hospital of Baltimore Baltimore Maryland
United States Hematology/Oncology Clinic LLP Baton Rouge Louisiana
United States Bronson Battle Creek Battle Creek Michigan
United States Cleveland Clinic Cancer Center Beachwood Beachwood Ohio
United States Strecker Cancer Center-Belpre Belpre Ohio
United States Sanford Clinic North-Bemidgi Bemidji Minnesota
United States Walter Reed National Military Medical Center Bethesda Maryland
United States Constantinou, Costas L MD (UIA Investigator) Bettendorf Iowa
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Joseph Medical Center Bloomington Illinois
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
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 McFarland Clinic PC-Boone Boone Iowa
United States Toledo Clinic Cancer Centers-Bowling Green Bowling Green Ohio
United States CoxHealth Cancer Center Branson Missouri
United States Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
United States Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin
United States Fairview Ridges Hospital Burnsville Minnesota
United States Illinois CancerCare-Canton Canton Illinois
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States Memorial Hospital of Carbondale Carbondale Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
United States Miami Valley Hospital South Centerville Ohio
United States Centralia Oncology Clinic Centralia Illinois
United States Geaugra Hospital Chardon Ohio
United States Medical University of South Carolina Charleston South Carolina
United States Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina
United States Adena Regional Medical Center Chillicothe Ohio
United States Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin
United States Oncology Hematology Care Inc - Anderson Cincinnati Ohio
United States Oncology Hematology Care Inc-Blue Ash Cincinnati Ohio
United States Oncology Hematology Care Inc-Eden Park Cincinnati Ohio
United States Oncology Hematology Care Inc-Kenwood Cincinnati Ohio
United States Oncology Hematology Care Inc-Mercy West Cincinnati Ohio
United States Clackamas Radiation Oncology Center Clackamas Oregon
United States Providence Oncology and Hematology Care Southeast Clackamas Oregon
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 Southeastern Medical Oncology Center-Clinton Clinton North Carolina
United States Columbus NCI Community Oncology Research Program Columbus Ohio
United States Columbus Oncology and Hematology Associates Inc Columbus Ohio
United States Doctors Hospital Columbus Ohio
United States Grant Medical Center Columbus Ohio
United States Mount Carmel East Hospital Columbus Ohio
United States Mount Carmel Health Center West Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States The Mark H Zangmeister Center Columbus Ohio
United States Carolinas HealthCare System NorthEast Concord North Carolina
United States Mercy Hospital Coon Rapids Minnesota
United States Oncology Hematology Care Inc-Crestview Crestview Hills Kentucky
United States Geisinger Medical Center Danville Pennsylvania
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 Beaumont Hospital-Dearborn Dearborn Michigan
United States Cancer Care Center of Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
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 Smilow Cancer Hospital-Derby Care Center Derby Connecticut
United States Saint John Hospital and Medical Center Detroit Michigan
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States City of Hope Comprehensive Cancer Center Duarte California
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 Marshfield Clinic Cancer Center at Sacred Heart Eau Claire Wisconsin
United States Fairview-Southdale Hospital Edina Minnesota
United States Crossroads Cancer Center Effingham Illinois
United States Mercy Cancer Center-Elyria Elyria Ohio
United States Newman Regional Health Emporia Kansas
United States Green Bay Oncology - Escanaba Escanaba Michigan
United States Illinois CancerCare-Eureka Eureka Illinois
United States Oncology Hematology Care Inc-Healthplex Fairfield Ohio
United States Smilow Cancer Hospital Care Center-Fairfield Fairfield Connecticut
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 Weisberg Cancer Treatment Center Farmington Hills Michigan
United States Lake Region Healthcare Corporation-Cancer Care Fergus Falls Minnesota
United States Blanchard Valley Hospital Findlay Ohio
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States McLeod Regional Medical Center Florence South Carolina
United States Aurora Health Center-Fond du Lac Fond Du Lac Wisconsin
United States McFarland Clinic PC-Trinity Cancer Center Fort Dodge Iowa
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Fredericksburg Oncology Inc Fredericksburg Virginia
United States Unity Hospital Fridley Minnesota
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States Saint Catherine Hospital Garden City Kansas
United States Aurora Health Care Germantown Health Center Germantown Wisconsin
United States Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina
United States Wayne Memorial Hospital Goldsboro North Carolina
United States Aurora Cancer Care-Grafton Grafton Wisconsin
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 Saint Rose Ambulatory and Surgery Center Great Bend Kansas
United States Aurora BayCare Medical Center Green Bay Wisconsin
United States Green Bay Oncology at Saint Vincent Hospital 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 Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin
United States Wayne Hospital Greenville Ohio
United States Self Regional Healthcare Greenwood South Carolina
United States Legacy Mount Hood Medical Center Gresham Oregon
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 Ingalls Memorial Hospital Harvey Illinois
United States Hays Medical Center Hays Kansas
United States Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania
United States 21st Century Oncology - Henderson Henderson Nevada
United States Cancer and Blood Specialists-Henderson Henderson Nevada
United States Comprehensive Cancer Centers of Nevada - Henderson Henderson Nevada
United States Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson Nevada
United States Las Vegas Cancer Center-Henderson Henderson Nevada
United States Hines Veterans Administration Hospital Hines Illinois
United States Hawaii Cancer Care Inc-Liliha Honolulu Hawaii
United States Hawaii Cancer Care Inc-POB II Honolulu Hawaii
United States Hawaii Oncology Inc-Kuakini Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children 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 M D Anderson Cancer Center Houston Texas
United States Hutchinson Area Health Care Hutchinson Minnesota
United States Centerpoint Medical Center LLC Independence Missouri
United States Cleveland Clinic Cancer Center Independence Independence Ohio
United States Green Bay Oncology - Iron Mountain Iron Mountain Michigan
United States Allegiance Health Jackson Michigan
United States University of Mississippi Medical Center Jackson Mississippi
United States Mayo Clinic in Florida Jacksonville Florida
United States Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina
United States McFarland Clinic PC-Jefferson Jefferson Iowa
United States Capital Region Medical Center-Goldschmidt Cancer Center Jefferson City Missouri
United States Castle Medical Center Kailua Hawaii
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Heartland Hematology and Oncology Associates Incorporated Kansas City Missouri
United States North Kansas City Hospital Kansas City Missouri
United States Providence Medical Center Kansas City Kansas
United States Research Medical Center Kansas City Missouri
United States Saint Luke's Hospital of Kansas City Kansas City Missouri
United States The University of Kansas Cancer Center-North Kansas City Missouri
United States The University of Kansas Cancer Center-South Kansas City Missouri
United States Truman Medical Center Kansas City Missouri
United States University of Kansas Cancer Center Kansas City Kansas
United States University of Kansas Cancer Center-West Kansas City Kansas
United States Aurora Cancer Care-Kenosha South Kenosha Wisconsin
United States Kettering Medical Center Kettering Ohio
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Kinston Medical Specialists PA Kinston North Carolina
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States Fairfield Medical Center Lancaster Ohio
United States Lancaster Radiation Oncology Lancaster Ohio
United States Sparrow Hospital Lansing Michigan
United States 21st Century Oncology Las Vegas Nevada
United States 21st Century Oncology - Fort Apache Las Vegas Nevada
United States 21st Century Oncology - Vegas Tenaya Las Vegas Nevada
United States Cancer and Blood Specialists-Shadow Las Vegas Nevada
United States Cancer and Blood Specialists-Tenaya Las Vegas Nevada
United States Cancer Therapy and Integrative Medicine Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Northwest Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills 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 HealthCare Partners Medical Group Oncology/Hematology-Tenaya Las Vegas Nevada
United States Las Vegas Cancer Center-Medical Center Las Vegas Nevada
United States Nevada Cancer Research Foundation CCOP Las Vegas Nevada
United States Nevada Cancer Specialists-Fort Apache Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Central Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Southeast Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Saint Luke's East - Lee's Summit Lee's Summit Missouri
United States The University of Kansas Cancer Center-Lee's Summit Lee's Summit Missouri
United States Kansas Institute of Medicine Cancer and Blood Center Lenexa Kansas
United States Minimally Invasive Surgery Hospital Lenexa Kansas
United States Beebe Medical Center Lewes Delaware
United States Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania
United States Lewistown Hospital Lewistown Pennsylvania
United States Liberty Radiation Oncology Center Liberty Missouri
United States Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii
United States Lima Memorial Hospital Lima Ohio
United States Nebraska Cancer Research Center Lincoln Nebraska
United States Nebraska Hematology and Oncology Lincoln Nebraska
United States Southeast Nebraska Cancer Center Lincoln Nebraska
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Saint Mary Mercy Hospital Livonia Michigan
United States PeaceHealth Saint John Medical Center Longview Washington
United States Los Angeles County-USC Medical Center Los Angeles California
United States USC / Norris Comprehensive Cancer Center Los Angeles California
United States Illinois CancerCare-Macomb Macomb Illinois
United States University of Wisconsin Hospital and Clinics Madison Wisconsin
United States Holy Family Memorial Hospital Manitowoc Wisconsin
United States Cleveland Clinic Cancer Center Mansfield Mansfield Ohio
United States OhioHealth Mansfield Hospital Mansfield Ohio
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Saint John's Hospital - Healtheast Maplewood Minnesota
United States Marietta Memorial Hospital Marietta Ohio
United States Bay Area Medical Center Marinette Wisconsin
United States Vince Lombardi Cancer Clinic-Marinette Marinette Wisconsin
United States OneHealth Marion General Hospital Marion Ohio
United States West Jefferson Medical Center Marrero Louisiana
United States McFarland Clinic PC-Marshalltown Marshalltown Iowa
United States Marshfield Clinic Marshfield Wisconsin
United States Memorial Hospital Of Martinsville Martinsville Virginia
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 Loyola University Medical Center Maywood Illinois
United States Lake University Ireland Cancer Center Mentor Ohio
United States Orange Regional Medical Center Middletown New York
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 Providence Milwaukie Hospital Milwaukie Oregon
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Health Partners Inc Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
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 Carolinas HealthCare System Union Monroe North Carolina
United States Mercy Memorial Hospital Monroe Michigan
United States Toledo Clinic Cancer Centers-Monroe Monroe Michigan
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Knox Community Hospital Mount Vernon Ohio
United States Mercy Health Mercy Campus Muskegon Michigan
United States The Hospital of Central Connecticut New Britain Connecticut
United States Yale University New Haven Connecticut
United States Tulane University Health Sciences Center New Orleans Louisiana
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States New Ulm Medical Center New Ulm Minnesota
United States Christiana Care Health System-Christiana Hospital Newark 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 Licking Memorial Hospital Newark Ohio
United States Medical Oncology Hematology Consultants PA Newark Delaware
United States Newark Radiation Oncology Newark Ohio
United States Regional Hematology and Oncology PA Newark Delaware
United States Providence Newberg Medical Center Newberg Oregon
United States Lakeland Community Hospital Niles Michigan
United States Faith Regional Medical Offices West Norfolk Nebraska
United States Yale-New Haven Hospital North Haven Medical Center North Haven Connecticut
United States Great Plains Regional Medical Center North Platte Nebraska
United States Green Bay Oncology - Oconto Falls Oconto Falls Wisconsin
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Olathe Medical Center Olathe Kansas
United States Alegent Health Bergan Mercy Medical Center Omaha Nebraska
United States Alegent Health Immanuel Medical Center Omaha Nebraska
United States Alegent Health Lakeside Hospital Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Missouri Valley Cancer Consortium Omaha Nebraska
United States Oncology Hematology West Omaha Nebraska
United States Oncology Hematology West PC Omaha Nebraska
United States Urology Cancer Center PC Omaha Nebraska
United States Smilow Cancer Hospital-Orange Care Center Orange Connecticut
United States UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
United States Saint Charles Hospital Oregon Ohio
United States Toledo Clinic Cancer Centers-Oregon Oregon Ohio
United States Providence Willamette Falls Medical Center Oregon City Oregon
United States Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Radiation Oncology of Northern Illinois Ottawa Illinois
United States Menorah Medical Center Overland Park Kansas
United States Saint Luke's South Hospital Overland Park Kansas
United States University of Kansas Cancer Center-Overland Park Overland Park Kansas
United States University Hospitals Parma Medical Center Parma Ohio
United States Illinois CancerCare-Pekin Pekin Illinois
United States OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States FirstHealth of the Carolinas-Moore Regional Hosiptal Pinehurst North Carolina
United States Via Christi Hospital-Pittsburg Pittsburg Kansas
United States Saint Joseph Mercy Oakland Pontiac Michigan
United States Lake Huron Medical Center Port Huron Michigan
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 Southern Ohio Medical Center Portsmouth Ohio
United States Geisinger Medical Oncology-Pottsville Pottsville Pennsylvania
United States Kansas City NCI Community Oncology Research Program Prairie Village Kansas
United States Illinois CancerCare-Princeton Princeton Illinois
United States Aurora Cancer Care-Racine Racine Wisconsin
United States Rapid City Regional Hospital Rapid City South Dakota
United States Spectrum Health Reed City Hospital Reed City Michigan
United States Beebe Health Campus Rehoboth Beach Delaware
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 Reid Health Richmond Indiana
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Mayo Clinic Rochester Minnesota
United States University of Rochester Rochester New York
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Saint John's Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States Saint Mary's of Michigan Saginaw Michigan
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Lakeland Hospital Saint Joseph Michigan
United States Marie Yeager Cancer Center Saint Joseph Michigan
United States Saint Joseph Oncology Inc Saint Joseph Missouri
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri
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 Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States Salina Regional Health Center Salina Kansas
United States Ireland Cancer Center at Firelands Regional Medical Center Sandusky Ohio
United States North Coast Cancer Care Sandusky Ohio
United States Regional West Medical Center Scottsbluff Nebraska
United States Nanticoke Memorial Hospital Seaford Delaware
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States HSHS Saint Nicholas Hospital Sheboygan Wisconsin
United States Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin
United States Mercy Medical Center-Sioux City Sioux City Iowa
United States Saint Luke's Regional Medical Center Sioux City Iowa
United States Siouxland Regional Cancer Center Sioux City Iowa
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 Providence Hospital-Southfield Cancer Center Southfield Michigan
United States Cancer Research for the Ozarks NCORP Springfield Missouri
United States Central Illinois Hematology Oncology Center Springfield Illinois
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Springfield Regional Cancer Center Springfield Ohio
United States Springfield Regional Medical Center Springfield Ohio
United States Geisinger Medical Group State College Pennsylvania
United States Staten Island University Hospital Staten Island New York
United States Iredell Memorial Hospital Statesville North Carolina
United States Marshfield Clinic Cancer Care at Saint Michael's Hospital Stevens Point Wisconsin
United States Lakeview Hospital Stillwater Minnesota
United States Cleveland Clinic Cancer Center Strongsville Strongsville Ohio
United States Green Bay Oncology - Sturgeon Bay Sturgeon Bay Wisconsin
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States Aurora Medical Center in Summit Summit Wisconsin
United States Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri
United States Cancer Care Specialists of Illinois-Swansea Swansea Illinois
United States Flower Hospital Sylvania Ohio
United States Mercy Hospital of Tiffin Tiffin Ohio
United States Mercy Saint Anne Hospital Toledo Ohio
United States Saint Vincent Mercy Medical Center Toledo Ohio
United States The Toledo Hospital/Toledo Children's Hospital Toledo Ohio
United States Toledo Clinic Cancer Centers-Toledo Toledo Ohio
United States Toledo Community Hospital Oncology Program CCOP Toledo Ohio
United States University of Toledo Toledo Ohio
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 Charlotte Hungerford Hospital Center for Cancer Care Torrington Connecticut
United States Munson Medical Center Traverse City Michigan
United States Upper Valley Medical Center Troy Ohio
United States Smilow Cancer Hospital Care Center-Trumbull Trumbull Connecticut
United States Legacy Meridian Park Hospital Tualatin Oregon
United States Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin
United States Compass Oncology Vancouver Vancouver Washington
United States Legacy Salmon Creek Hospital Vancouver Washington
United States PeaceHealth Southwest Medical Center Vancouver Washington
United States Ridgeview Medical Center Waconia Minnesota
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States South Pointe Hospital Warrensville Heights Ohio
United States Smilow Cancer Hospital-Waterbury Care Center Waterbury Connecticut
United States Aurora Cancer Care-Waukesha Waukesha Wisconsin
United States Marshfield Clinic-Wausau Center Wausau Wisconsin
United States Fulton County Health Center Wauseon Ohio
United States Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin
United States Aurora West Allis Medical Center West Allis Wisconsin
United States Saint Ann's Hospital Westerville Ohio
United States UH-Seidman Cancer Center at Saint John Medical Center Westlake Ohio
United States Diagnostic and Treatment Center Weston Wisconsin
United States Marshfield Clinic - Weston Center Weston Wisconsin
United States Wesley Medical Center Wichita Kansas
United States Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania
United States Rice Memorial Hospital Willmar Minnesota
United States Christiana Care Health System-Wilmington Hospital Wilmington Delaware
United States Southeastern Medical Oncology Center-Wilson Wilson North Carolina
United States Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Cleveland Clinic Wooster Family Health and Surgery Center Wooster Ohio
United States Genesis Healthcare System Cancer Care Center Zanesville Ohio

Sponsors (2)

Lead Sponsor Collaborator
SWOG Cancer Research Network National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Phase I: Maximum Tolerated Dose (MTD) of Elotuzumab in Combination With Bortezomib, Lenalidomide and Dexamethasone Assess safety of elotuzumab in combination with bortezomib, lenalidomide and dexamethasone and select the optimal dose of elotuzumab for the Phase II portion from 10mg/kg on each cycle, to 5mg/kg on each cycle MTD reflects the highest dose that had a dose-limiting toxicity (DLT) rate of = 1/6 participants. DLTs were defined as treatment regimen related: grade = 3 non-hematologic toxicity; grade 3 nausea or diarrhea despite anti-emetic and anti-diarrheal therapy; grade 3 hyperglycemia if symptomatic or glucose level > 300mg/ml despite insulin and/or oral diabetic therapy; grade 4 neutropenia = 7 days or grade 3/4 neutropenia with fever (= 38.5 oC); grade 4 thrombocytopenia = 7 days or associated with hemorrhage; delay of treatment with any agent by > 2 weeks due to drug related toxicity.
DLT were graded using the NCI CTCAE version 4.0
Note:
i) the second, lower dose level was not tested as the first dose level was deemed safe ii) 6 participants were evaluable at phase I analysis
time from first participants randomized until at least 6 patients were evaluable for DLTs. DLTs were assessed only during Cycle 1 (21 days)
Primary Progression-free Survival From date of registration to date of first documentation of progression or death due to any cause.
Per the International Uniform Response Criteria for Multiple Myeloma, progression is defined as >=1 of Serum M protein increase >= 25% from lowest response level, with an absolute increase of >= 0.5g/dL; Urine M protein increase >= 25% from lowest response level, with an absolute increase of >= 200 mg/24 hrs; If participant had serum M protein <1 g/dL, urine M protein <200 mg/24 hrs, and an involved serum free light chain level >= 10mg/dL at baseline: >= 25% increase in the difference between involved and uninvolved serum free light chain level with an absolute increase of >= 10 mg/dL; Bone marrow plasma cell % increase =25% from baseline with the absolute plasma cell % >=10%; New bone lesions or soft tissue plasmocytomas, or definite increase in size of existing bone lesions or soft tissue plasmocytomas; Development of hypercalcemia that can be attributed solely to multiple myeloma
Up to 6 years post registration
Secondary Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. Duration of treatment and follow up until death or 6 years post registration, whichever occurs first.
Secondary Overall Survival From date of registration to date of death due to any cause Up to 6 years post registration
Secondary Response (Partial Response [PR] or Better) Rate Percentage of participants with PR or better to treatment per the International Uniform Response Criteria for Multiple Myeloma stringent Complete Response- CR criteria + normal serum free light chain (FLC) ratio + absence of clonal cells in bone marrow (BM) by immunohistochemistry or immunofluorescence CR- Negative immunofixation (IFX) on serum & urine M proteins + <5% plasma cells in BM + disappearance of soft tissue plasmocytomas (STP) very good PR- PR criteria + serum & urine M proteins detectable by IFX but not on electrophoresis or >=90% reduction (RED) in serum M protein & urine M protein <100 g/24 hrs PR- >=50% RED in size of STP, if present at baseline & >=50% RED in plasma cells, if >=30% plasma cells in BM at baseline: & RED in serum M protein of >=50% & in urine M protein of >= 90% or to 200 mg/24hr OR if serum M protein <1 g/dL, urine M protein <200 mg/24 hrs, & involved serum FLC level >= 10 mg/dl at baseline: >= 50% RED in (involved-uninvolved) serum FLC levels Up to 6 years post registration
See also
  Status Clinical Trial Phase
Terminated NCT01899326 - Desipramine Hydrochloride and Filgrastim For Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant N/A
Active, not recruiting NCT01619761 - NK Cells in Cord Blood Transplantation Phase 1
Terminated NCT01028716 - Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies Phase 2
Completed NCT00869206 - Zoledronic Acid in Treating Patients With Metastatic Breast Cancer, Metastatic Prostate Cancer, or Multiple Myeloma With Bone Involvement Phase 3
Completed NCT01842308 - Carfilzomib and Melphalan Before Stem Cell Transplant in Treating Patients With Multiple Myeloma Phase 1/Phase 2
Completed NCT00066638 - FR901228 in Treating Patients With Relapsed or Refractory Multiple Myeloma Phase 2
Completed NCT00088855 - Bortezomib and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Previously Untreated Symptomatic Multiple Myeloma Phase 2
Completed NCT00445692 - Lenalidomide, Dexamethasone, and Clarithromycin in Treating Patients Who Have Undergone Stem Cell Transplant for Multiple Myeloma Phase 2
Completed NCT01605032 - Busulfan, Melphalan, and Bortezomib Before First-Line Stem Cell Transplant in Treating Patients With Multiple Myeloma Phase 2
Active, not recruiting NCT00839956 - Bortezomib and Vorinostat in Treating Patients With Multiple Myeloma Who Have Undergone Autologous Stem Cell Transplant Phase 2
Withdrawn NCT01251172 - RO4929097 After Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma Phase 2
Completed NCT01330173 - Vismodegib After Stem Cell Transplant in Treating Patients With High-Risk First Remission or Relapsed Multiple Myeloma Phase 1
Completed NCT01936090 - Bortezomib, Melphalan, and Total-Body Irradiation Before Stem Cell Transplant in Treating Patients With Multiple Myeloma Phase 1