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Lenalidomid og dexamethason med eller uden bortezomib til behandling af patienter med tidligere ubehandlet myelomatose

7. juli 2026 opdateret af: National Cancer Institute (NCI)

Et randomiseret fase III-forsøg med CC-5013 (lenalidomid, NSC-703813) og lavdosis dexamethason (LLD) versus Bortezomib (PS-341, NSC-681239), lenalidomid og lavdosis dexamethason (BLLD) til induktion, hos patienter Ubehandlet myelomatose uden hensigt om øjeblikkelig autolog stamcelletransplantation

Dette randomiserede fase III-studie undersøger lenalidomid, dexamethason og bortezomib for at se, hvor godt det virker sammenlignet med dexamethason og lenalidomid alene til behandling af patienter med tidligere ubehandlet myelomatose. Biologiske terapier, såsom lenalidomid, kan stimulere immunsystemet på forskellige måder og stoppe kræftceller i at vokse. Lægemidler, der bruges i kemoterapi, såsom dexamethason, virker på forskellige måder for at stoppe væksten af ​​kræftceller, enten ved at dræbe cellerne, ved at stoppe dem i at dele sig eller ved at stoppe dem i at sprede sig. Bortezomib kan stoppe væksten af ​​kræftceller ved at blokere nogle af de enzymer, der er nødvendige for cellevækst, eller ved at blokere blodtilførslen til kræften. Det vides endnu ikke, om lenalidomid og dexamethason er mere effektive med eller uden bortezomib til behandling af myelomatose.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

PRIMÆRE MÅL:

I. At sammenligne progressionsfri overlevelse (PFS) hos patienter med nyligt diagnosticeret myelom behandlet med lenalidomid plus lavdosis dexamethason versus bortezomib plus lenalidomid og lavdosis dexamethason.

SEKUNDÆRE MÅL:

I. Vurder svar ved hjælp af de nye internationale svarkriterier. II. At banke prøver til fremtidig translationel medicinsk forskning. III. Følg patienterne for at vurdere den samlede overlevelse og andre langsigtede resultater stratificeret efter hensigten om transplantation ved progression.

TERTIÆRE MÅL:

I. At evaluere tilpassede og genomomfattende enkeltnukleotidpolymorfier i sammenhæng med biologi, prognose og resultat for begge behandlingsregimer kombineret; at verificere de resultater, der for nylig er opnået med den brugerdefinerede Bank on a Cure program (BOAC) single nucleotide polymorphism (SNP) chip på Total Therapy 2 (TT2) data med hensyn til knoglesygdom i den kooperative gruppe.

II. At bruge baseline genekspressionsprofilering som et værktøj til at evaluere biologi, prognostiske og risikofaktorer og respons på terapi for begge behandlingsregimer kombineret. For at validere John Shaughnessys 70-geners risikomodel udviklet til Total Therapy 2 (TT2) i den kooperative gruppe.

OMRIDS:

INDUKTIONSTERAPI: Patienterne randomiseres til 1 ud af 2 behandlingsarme.

ARM I: Patienter får dexamethason oralt (PO) én gang dagligt (QD) på dag 1, 8, 15 og 22 og lenalidomid PO QD på dag 1-21. Behandlingen gentages hver 28. dag i 6 forløb i fravær af sygdomsprogression eller uacceptabel toksicitet.

ARM II: Patienter modtager dexamethason PO QD på dag 1, 2, 4, 5, 8, 9, 11 og 12; lenalidomid PO QD på dag 1-14; og bortezomib intravenøst ​​(IV) over 3-5 sekunder på dag 1, 4, 8 og 11. Behandlingen gentages hver 21. dag i 8 forløb i fravær af sygdomsprogression eller uacceptabel toksicitet.

I begge arme gennemgår patienter, der har til hensigt at gennemgå transplantation ved tilbagefald, perifer blodstamcelleindsamling, helst efter forløb 2.

VEDLIGEHOLDELSESTERAPI: Efter afslutning af mindst 4 forløb (arm I) eller mindst 6 forløb (arm II) induktionsterapi, modtager patienter vedligeholdelsesterapi omfattende dexamethason PO QD på dag 1, 8, 15 og 22 og lenalidomid PO QD på dagene 1-21. Kurser gentages hver 28. dag i fravær af sygdomsprogression eller uacceptabel toksicitet.

Efter afsluttet undersøgelsesbehandling følges patienterne periodisk i op til 6 år.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

525

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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    • Alaska
      • Anchorage, Alaska, Forenede Stater, 99508
        • Providence Alaska Medical Center
    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85259
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        • Desert Regional Medical Center
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        • Queen's Medical Center
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        • Hawaii Cancer Care Inc - Waterfront Plaza
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        • Straub Clinic and Hospital
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        • University of Hawaii Cancer Center
      • Honolulu, Hawaii, Forenede Stater, 96817
        • Queen's Cancer Center - Kuakini
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        • Kapiolani Medical Center for Women and Children
      • Honolulu, Hawaii, Forenede Stater, 96819
        • Kaiser Permanente Moanalua Medical Center
      • Kailua, Hawaii, Forenede Stater, 96734
        • Castle Medical Center
      • Lihue, Hawaii, Forenede Stater, 96766
        • Wilcox Memorial Hospital and Kauai Medical Clinic
      • Wailuku, Hawaii, Forenede Stater, 96793
        • Maui Memorial Medical Center
      • Wailuku, Hawaii, Forenede Stater, 96793
        • Pacific Cancer Institute of Maui
      • ‘Aiea, Hawaii, Forenede Stater, 96701
        • Pali Momi Medical Center
    • Illinois
      • Alton, Illinois, Forenede Stater, 62002
        • OSF Saint Anthony's Health Center
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        • Rush-Copley Medical Center
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        • MacNeal Hospital and Cancer Center
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        • Illinois CancerCare-Bloomington
      • Bloomington, Illinois, Forenede Stater, 61701
        • OSF Saint Joseph Medical Center
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        • Illinois CancerCare-Canton
      • Canton, Illinois, Forenede Stater, 61520
        • Graham Hospital Association
      • Carthage, Illinois, Forenede Stater, 62321
        • Illinois CancerCare-Carthage
      • Carthage, Illinois, Forenede Stater, 62321
        • Memorial Hospital
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University
      • Chicago, Illinois, Forenede Stater, 60612
        • University of Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Hematology and Oncology Associates
      • Decatur, Illinois, Forenede Stater, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, Forenede Stater, 62526
        • Heartland Cancer Research NCORP
      • Downers Grove, Illinois, Forenede Stater, 60515
        • Advocate Good Samaritan Hospital
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        • Illinois CancerCare-Eureka
      • Eureka, Illinois, Forenede Stater, 61530
        • Eureka Hospital
      • Evanston, Illinois, Forenede Stater, 60201
        • NorthShore University HealthSystem-Evanston Hospital
      • Galesburg, Illinois, Forenede Stater, 61401
        • Illinois CancerCare-Galesburg
      • Galesburg, Illinois, Forenede Stater, 61401
        • Galesburg Cottage Hospital
      • Havana, Illinois, Forenede Stater, 62644
        • Mason District Hospital
      • Havana, Illinois, Forenede Stater, 62644
        • Illinois CancerCare-Havana
      • Highland Park, Illinois, Forenede Stater, 60035
        • Hematology Oncology Associates of Illinois-Highland Park
      • Hopedale, Illinois, Forenede Stater, 61747
        • Hopedale Medical Complex - Hospital
      • Joliet, Illinois, Forenede Stater, 60435
        • Duly Health and Care Joliet
      • Joliet, Illinois, Forenede Stater, 60432
        • Midwest Center for Hematology Oncology
      • Kankakee, Illinois, Forenede Stater, 60901
        • Presence Saint Mary's Hospital
      • Kewanee, Illinois, Forenede Stater, 61443
        • Illinois CancerCare-Kewanee Clinic
      • Libertyville, Illinois, Forenede Stater, 60048
        • AMG Libertyville - Oncology
      • Macomb, Illinois, Forenede Stater, 61455
        • Illinois CancerCare-Macomb
      • Macomb, Illinois, Forenede Stater, 61455
        • Mcdonough District Hospital
      • Maywood, Illinois, Forenede Stater, 60153
        • Loyola University Medical Center
      • Monmouth, Illinois, Forenede Stater, 61462
        • Illinois CancerCare-Monmouth
      • Monmouth, Illinois, Forenede Stater, 61462
        • Holy Family Medical Center
      • Mount Vernon, Illinois, Forenede Stater, 62864
        • SSM Health Good Samaritan
      • Naperville, Illinois, Forenede Stater, 60563
        • DuPage Medical Group-Ogden
      • Niles, Illinois, Forenede Stater, 60714
        • Illinois Cancer Specialists-Niles
      • Normal, Illinois, Forenede Stater, 61761
        • Carle Cancer Institute Normal
      • Normal, Illinois, Forenede Stater, 61761
        • Illinois CancerCare-Community Cancer Center
      • Normal, Illinois, Forenede Stater, 61761
        • Carle BroMenn Medical Center
      • Ottawa, Illinois, Forenede Stater, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Ottawa, Illinois, Forenede Stater, 61350
        • Ottawa Regional Hospital and Healthcare Center
      • Pekin, Illinois, Forenede Stater, 61554
        • Illinois CancerCare-Pekin
      • Pekin, Illinois, Forenede Stater, 61554
        • Pekin Hospital
      • Pekin, Illinois, Forenede Stater, 61554
        • OSF Saint Francis Radiation Oncology at Pekin
      • Peoria, Illinois, Forenede Stater, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, Forenede Stater, 61637
        • OSF Saint Francis Medical Center
      • Peoria, Illinois, Forenede Stater, 61615
        • Illinois CancerCare-Peoria
      • Peoria, Illinois, Forenede Stater, 61614
        • Proctor Hospital
      • Peru, Illinois, Forenede Stater, 61354
        • Illinois CancerCare-Peru
      • Peru, Illinois, Forenede Stater, 61354
        • Illinois Valley Hospital
      • Princeton, Illinois, Forenede Stater, 61356
        • Illinois CancerCare-Princeton
      • Princeton, Illinois, Forenede Stater, 61356
        • Perry Memorial Hospital
      • Skokie, Illinois, Forenede Stater, 60076
        • Hematology Oncology Associates of Illinois - Skokie
      • Spring Valley, Illinois, Forenede Stater, 61362
        • Saint Margaret's Hospital
      • Spring Valley, Illinois, Forenede Stater, 61362
        • Illinois CancerCare-Spring Valley
      • Springfield, Illinois, Forenede Stater, 62781
        • Springfield Memorial Hospital
      • Urbana, Illinois, Forenede Stater, 61801
        • Carle Cancer Center
      • Warrenville, Illinois, Forenede Stater, 60555
        • Northwestern Medicine Cancer Center Warrenville
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        • Northwestern Medicine Central DuPage Hospital
    • Indiana
      • Beech Grove, Indiana, Forenede Stater, 46107
        • Franciscan Saint Francis Health-Beech Grove
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        • Elkhart General Hospital
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        • Michiana Hematology Oncology PC-Elkhart
      • Elkhart, Indiana, Forenede Stater, 46514-2098
        • Elkhart Clinic
      • Fort Wayne, Indiana, Forenede Stater, 46845
        • Fort Wayne Medical Oncology and Hematology Inc-Parkview
      • Goshen, Indiana, Forenede Stater, 46526
        • Goshen Center for Cancer Care
      • Kokomo, Indiana, Forenede Stater, 46904
        • Community Howard Regional Health
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        • IU Health La Porte Hospital
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        • Franciscan Saint Anthony Health-Michigan City
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        • Michiana Hematology Oncology PC-Mishawaka
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        • Saint Joseph Regional Medical Center-Mishawaka
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        • Sinai Hospital of Baltimore
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        • Beth Israel Deaconess Medical Center
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        • Boston Medical Center
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        • Commonwealth Hematology Oncology PC-Concord
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        • Dana Farber Community Cancer Care-Haverhill
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        • Bronson Battle Creek
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        • Corewell Health Dearborn Hospital
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        • OSF Saint Francis Hospital and Medical Group
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        • Genesys Regional Medical Center-West Flint Campus
      • Flint, Michigan, Forenede Stater, 48503
        • Hurley Medical Center
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        • Cancer Research Consortium of West Michigan NCORP
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Trinity Health Grand Rapids Hospital
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
      • Holland, Michigan, Forenede Stater, 49423
        • Holland Community Hospital
      • Jackson, Michigan, Forenede Stater, 49201
        • Allegiance Health
      • Kalamazoo, Michigan, Forenede Stater, 49007
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, Forenede Stater, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, Forenede Stater, 49048
        • Beacon Kalamazoo
      • Lansing, Michigan, Forenede Stater, 48912
        • University of Michigan Health - Sparrow Lansing
      • Livonia, Michigan, Forenede Stater, 48154
        • Trinity Health Saint Mary Mercy Livonia Hospital
      • Marquette, Michigan, Forenede Stater, 49855
        • UP Health System Marquette
      • Monroe, Michigan, Forenede Stater, 48162
        • Mercy Memorial Hospital
      • Monroe, Michigan, Forenede Stater, 48162
        • Toledo Clinic Cancer Centers-Monroe
      • Mount Clemens, Michigan, Forenede Stater, 48043
        • McLaren Cancer Institute-Macomb
      • Muskegon, Michigan, Forenede Stater, 49442
        • Mercy Health Partners-Hackley Campus
      • Muskegon, Michigan, Forenede Stater, 49444
        • Trinity Health Muskegon Hospital
      • Niles, Michigan, Forenede Stater, 49120
        • Corewell Health Lakeland Hospitals - Niles Hospital
      • Pontiac, Michigan, Forenede Stater, 48341
        • Trinity Health Saint Joseph Mercy Oakland Hospital
      • Port Huron, Michigan, Forenede Stater, 48060
        • Lake Huron Medical Center
      • Royal Oak, Michigan, Forenede Stater, 48073
        • Corewell Health William Beaumont University Hospital
      • Saginaw, Michigan, Forenede Stater, 48601
        • MyMichigan Medical Center Saginaw
      • Saint Joseph, Michigan, Forenede Stater, 49085
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
      • Saint Joseph, Michigan, Forenede Stater, 49085
        • Corewell Health Lakeland Hospitals - Saint Joseph Hospital
      • Southfield, Michigan, Forenede Stater, 48075
        • Henry Ford Health Providence Southfield Hospital
      • Traverse City, Michigan, Forenede Stater, 49684
        • Munson Medical Center
      • Warren, Michigan, Forenede Stater, 48093
        • Henry Ford Health Warren Hospital
      • Wyoming, Michigan, Forenede Stater, 49519
        • University of Michigan Health - West
    • Minnesota
      • Alexandria, Minnesota, Forenede Stater, 56308
        • Medini, Eitan MD (UIA Investigator)
      • Brainerd, Minnesota, Forenede Stater, 56401
        • Essentia Health Saint Joseph's Medical Center
      • Burnsville, Minnesota, Forenede Stater, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, Forenede Stater, 55433
        • Mercy Hospital
      • Duluth, Minnesota, Forenede Stater, 55805
        • Essentia Health Cancer Center
      • Duluth, Minnesota, Forenede Stater, 55805
        • Essentia Health Saint Mary's Medical Center
      • Duluth, Minnesota, Forenede Stater, 55805
        • Miller-Dwan Hospital
      • Edina, Minnesota, Forenede Stater, 55435
        • Fairview Southdale Hospital
      • Fergus Falls, Minnesota, Forenede Stater, 56537
        • Etzell, Paul S MD (UIA Investigator)
      • Fergus Falls, Minnesota, Forenede Stater, 56537
        • Swenson, Wade II, MD (UIA Investigator)
      • Fridley, Minnesota, Forenede Stater, 55432
        • Unity Hospital
      • Hutchinson, Minnesota, Forenede Stater, 55350
        • Hutchinson Area Health Care
      • Litchfield, Minnesota, Forenede Stater, 55355
        • Meeker County Memorial Hospital
      • Maplewood, Minnesota, Forenede Stater, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, Forenede Stater, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, Forenede Stater, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, Forenede Stater, 55407
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, Forenede Stater, 55407
        • Virginia Piper Cancer Institute
      • Robbinsdale, Minnesota, Forenede Stater, 55422
        • North Memorial Medical Health Center
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic in Rochester
      • Saint Cloud, Minnesota, Forenede Stater, 56303
        • Coborn Cancer Center at Saint Cloud Hospital
      • Saint Cloud, Minnesota, Forenede Stater, 56303
        • Saint Cloud Hospital
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • Metro Minnesota Community Oncology Research Consortium
      • Saint Paul, Minnesota, Forenede Stater, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, Forenede Stater, 55102
        • United Hospital
      • Saint Paul, Minnesota, Forenede Stater, 55102
        • Saint Joseph's Hospital - Healtheast
      • Shakopee, Minnesota, Forenede Stater, 55379
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, Forenede Stater, 55082
        • Lakeview Hospital
      • Waconia, Minnesota, Forenede Stater, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, Forenede Stater, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, Forenede Stater, 55125
        • Minnesota Oncology Hematology PA-Woodbury
      • Woodbury, Minnesota, Forenede Stater, 55125
        • Fairview Cancer Center - Woodbury
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39216
        • University of Mississippi Medical Center
      • Keesler Air Force Base, Mississippi, Forenede Stater, 39534
        • Keesler Medical Center
      • Pascagoula, Mississippi, Forenede Stater, 39581
        • Singing River Hospital
    • Missouri
      • Cape Girardeau, Missouri, Forenede Stater, 63703
        • Saint Francis Medical Center
      • Cape Girardeau, Missouri, Forenede Stater, 63701
        • Southeast Missouri Hospital
      • Joplin, Missouri, Forenede Stater, 64804
        • Freeman Health System
      • Kansas City, Missouri, Forenede Stater, 64116
        • North Kansas City Hospital
      • Kansas City, Missouri, Forenede Stater, 64111
        • Saint Luke's Hospital of Kansas City
      • Kansas City, Missouri, Forenede Stater, 64132
        • Research Medical Center
      • Kansas City, Missouri, Forenede Stater, 64118
        • Heartland Hematology and Oncology Associates Incorporated
      • Kansas City, Missouri, Forenede Stater, 64114
        • Saint Joseph Health Center
      • Kansas City, Missouri, Forenede Stater, 64108
        • University Health Truman Medical Center
      • Lee's Summit, Missouri, Forenede Stater, 64086
        • Saint Luke's East - Lee's Summit
      • Liberty, Missouri, Forenede Stater, 64068
        • Liberty Hospital
      • Saint Joseph, Missouri, Forenede Stater, 64506
        • Heartland Regional Medical Center
      • St Louis, Missouri, Forenede Stater, 63109
        • Mercy Infusion Center - Chippewa
      • St Louis, Missouri, Forenede Stater, 63141
        • Mercy Hospital Saint Louis
      • St Louis, Missouri, Forenede Stater, 63141
        • Saint Louis-Cape Girardeau CCOP
    • Montana
      • Billings, Montana, Forenede Stater, 59101
        • Billings Clinic Cancer Center
      • Billings, Montana, Forenede Stater, 59101
        • Saint Vincent Healthcare
      • Billings, Montana, Forenede Stater, 59102
        • Montana Cancer Consortium NCORP
      • Billings, Montana, Forenede Stater, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, Forenede Stater, 59102
        • Saint Vincent Frontier Cancer Center
      • Bozeman, Montana, Forenede Stater, 59715
        • Bozeman Health Deaconess Hospital
      • Butte, Montana, Forenede Stater, 59701
        • Saint James Community Hospital and Cancer Treatment Center
      • Great Falls, Montana, Forenede Stater, 59405
        • Great Falls Clinic
      • Great Falls, Montana, Forenede Stater, 59405
        • Berdeaux, Donald MD (UIA Investigator)
      • Great Falls, Montana, Forenede Stater, 59405
        • Benefis Sletten Cancer Institute
      • Havre, Montana, Forenede Stater, 59501
        • Northern Montana Hospital
      • Helena, Montana, Forenede Stater, 59601
        • Saint Peter's Community Hospital
      • Kalispell, Montana, Forenede Stater, 59901
        • Glacier Oncology PLLC
      • Kalispell, Montana, Forenede Stater, 59901
        • Kalispell Medical Oncology
      • Kalispell, Montana, Forenede Stater, 59901
        • Logan Health Medical Center
      • Missoula, Montana, Forenede Stater, 59802
        • Saint Patrick Hospital - Community Hospital
      • Missoula, Montana, Forenede Stater, 59804
        • Guardian Oncology and Center for Wellness
      • Missoula, Montana, Forenede Stater, 59802
        • Montana Cancer Specialists
      • Missoula, Montana, Forenede Stater, 59804
        • Community Medical Center
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89102
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, Forenede Stater, 89120
        • Nevada Cancer Research Foundation NCORP
    • New Jersey
      • Camden, New Jersey, Forenede Stater, 08103
        • Cooper Hospital University Medical Center
      • Freehold, New Jersey, Forenede Stater, 07728
        • CentraState Medical Center
      • New Brunswick, New Jersey, Forenede Stater, 08903
        • Rutgers Cancer Institute of New Jersey
      • New Brunswick, New Jersey, Forenede Stater, 08903
        • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
      • Newark, New Jersey, Forenede Stater, 07101
        • Rutgers New Jersey Medical School
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87102
        • Lovelace Medical Center-Saint Joseph Square
      • Albuquerque, New Mexico, Forenede Stater, 87106
        • University of New Mexico Cancer Center
      • Las Cruces, New Mexico, Forenede Stater, 88011
        • Memorial Medical Center-Las Cruces
      • San Juan, New Mexico, Forenede Stater, 87401
        • San Juan Regional Medical Center
    • New York
      • Glens Falls, New York, Forenede Stater, 12801
        • Adirondack Cancer Center
      • Middletown, New York, Forenede Stater, 10940
        • Garnet Health Medical Center
      • Mineola, New York, Forenede Stater, 11501
        • NYU Langone Hospital - Long Island
      • New York, New York, Forenede Stater, 10019
        • Mount Sinai West
      • New York, New York, Forenede Stater, 10003
        • Mount Sinai Union Square
      • Rochester, New York, Forenede Stater, 14642
        • University of Rochester
      • Rochester, New York, Forenede Stater, 14620
        • Highland Hospital
      • The Bronx, New York, Forenede Stater, 10466
        • Montefiore Medical Center-Wakefield Campus
    • North Carolina
      • Asheville, North Carolina, Forenede Stater, 28801
        • Mission Hospital
      • Charlotte, North Carolina, Forenede Stater, 28204
        • Novant Health Presbyterian Medical Center
      • Goldsboro, North Carolina, Forenede Stater, 27534
        • Wayne Memorial Hospital
      • Hendersonville, North Carolina, Forenede Stater, 28791
        • Margaret R Pardee Memorial Hospital
      • Kinston, North Carolina, Forenede Stater, 28501
        • ECU Health Oncology Kinston
      • Rutherfordton, North Carolina, Forenede Stater, 28139
        • Rutherford Hospital
      • Winston-Salem, North Carolina, Forenede Stater, 27104
        • Southeast Clinical Oncology Research Consortium NCORP
    • North Dakota
      • Bismarck, North Dakota, Forenede Stater, 58501
        • Sanford Bismarck Medical Center
      • Bismarck, North Dakota, Forenede Stater, 58501
        • Mid Dakota Clinic
      • Bismarck, North Dakota, Forenede Stater, 58501
        • Saint Alexius Medical Center
    • Ohio
      • Beachwood, Ohio, Forenede Stater, 44122
        • Cleveland Clinic Cancer Center Beachwood
      • Bowling Green, Ohio, Forenede Stater, 43402
        • Toledo Clinic Cancer Centers-Bowling Green
      • Cleveland, Ohio, Forenede Stater, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, Forenede Stater, 44109
        • MetroHealth Medical Center
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, Forenede Stater, 44111
        • Cleveland Clinic Cancer Center/Fairview Hospital
      • Clyde, Ohio, Forenede Stater, 43410
        • North Coast Cancer Care-Clyde
      • Dayton, Ohio, Forenede Stater, 45406
        • Good Samaritan Hospital - Dayton
      • Dayton, Ohio, Forenede Stater, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, Forenede Stater, 45415
        • Miami Valley Hospital North
      • Dayton, Ohio, Forenede Stater, 45405
        • Grandview Hospital
      • Dayton, Ohio, Forenede Stater, 45459
        • Dayton NCI Community Oncology Research Program
      • Dayton, Ohio, Forenede Stater, 45428
        • Dayton Veterans Affairs Medical Center
      • Elyria, Ohio, Forenede Stater, 44035
        • Mercy Cancer Center-Elyria
      • Elyria, Ohio, Forenede Stater, 44035
        • Hematology Oncology Center Incorporated
      • Findlay, Ohio, Forenede Stater, 45840
        • Blanchard Valley Hospital
      • Franklin, Ohio, Forenede Stater, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Greenville, Ohio, Forenede Stater, 45331
        • Wayne Hospital
      • Independence, Ohio, Forenede Stater, 44131
        • Cleveland Clinic Cancer Center Independence
      • Kettering, Ohio, Forenede Stater, 45429
        • Kettering Medical Center
      • Lima, Ohio, Forenede Stater, 45801
        • Saint Rita's Medical Center
      • Lima, Ohio, Forenede Stater, 45804
        • Lima Memorial Hospital
      • Maumee, Ohio, Forenede Stater, 43537
        • Toledo Clinic Cancer Centers-Maumee
      • Maumee, Ohio, Forenede Stater, 43537
        • Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
      • Maumee, Ohio, Forenede Stater, 43537
        • Saint Luke's Hospital
      • Mayfield Heights, Ohio, Forenede Stater, 44124
        • Hillcrest Hospital Cancer Center
      • Norwalk, Ohio, Forenede Stater, 44857
        • Fisher-Titus Medical Center
      • Oregon, Ohio, Forenede Stater, 43616
        • Saint Charles Hospital
      • Oregon, Ohio, Forenede Stater, 43616
        • Toledo Clinic Cancer Centers-Oregon
      • Parma, Ohio, Forenede Stater, 44129
        • University Hospitals Parma Medical Center
      • Sandusky, Ohio, Forenede Stater, 44870
        • North Coast Cancer Care
      • Sylvania, Ohio, Forenede Stater, 43560
        • ProMedica Flower Hospital
      • Tiffin, Ohio, Forenede Stater, 44883
        • Mercy Hospital of Tiffin
      • Toledo, Ohio, Forenede Stater, 43606
        • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
      • Toledo, Ohio, Forenede Stater, 43623
        • Mercy Health - Saint Anne Hospital
      • Toledo, Ohio, Forenede Stater, 43623
        • Toledo Clinic Cancer Centers-Toledo
      • Toledo, Ohio, Forenede Stater, 43614
        • University of Toledo
      • Toledo, Ohio, Forenede Stater, 43617
        • Toledo Community Hospital Oncology Program CCOP
      • Toledo, Ohio, Forenede Stater, 43608
        • Mercy Health - Saint Vincent Hospital
      • Troy, Ohio, Forenede Stater, 45373
        • Upper Valley Medical Center
      • Wauseon, Ohio, Forenede Stater, 43567
        • Fulton County Health Center
      • Wilmington, Ohio, Forenede Stater, 45177
        • Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center
      • Wooster, Ohio, Forenede Stater, 44691
        • Cleveland Clinic Wooster Family Health and Surgery Center
      • Xenia, Ohio, Forenede Stater, 45385
        • Greene Memorial Hospital
    • Oregon
      • Clackamas, Oregon, Forenede Stater, 97015
        • Clackamas Radiation Oncology Center
      • Gresham, Oregon, Forenede Stater, 97030
        • Legacy Mount Hood Medical Center
      • Milwaukie, Oregon, Forenede Stater, 97222
        • Providence Milwaukie Hospital
      • Newberg, Oregon, Forenede Stater, 97132
        • Providence Newberg Medical Center
      • Oregon City, Oregon, Forenede Stater, 97045
        • Providence Willamette Falls Medical Center
      • Portland, Oregon, Forenede Stater, 97210
        • Legacy Good Samaritan Hospital and Medical Center
      • Portland, Oregon, Forenede Stater, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, Forenede Stater, 97225
        • Providence Saint Vincent Medical Center
      • Portland, Oregon, Forenede Stater, 97227
        • Legacy Emanuel Hospital and Health Center
      • Portland, Oregon, Forenede Stater, 97216
        • Adventist Medical Center
      • Portland, Oregon, Forenede Stater, 97227
        • Compass Oncology Rose Quarter
      • Tualatin, Oregon, Forenede Stater, 97062
        • Legacy Meridian Park Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, Forenede Stater, 18103
        • Lehigh Valley Hospital-Cedar Crest
      • Butler, Pennsylvania, Forenede Stater, 16001
        • Butler Memorial Hospital
      • Danville, Pennsylvania, Forenede Stater, 17822
        • Geisinger Medical Center
      • DuBois, Pennsylvania, Forenede Stater, 15801
        • Oncology Hematology Associates of Northern Pennsylvania
      • Hazleton, Pennsylvania, Forenede Stater, 18201
        • Geisinger Medical Center-Cancer Center Hazleton
      • Hershey, Pennsylvania, Forenede Stater, 17033-0850
        • Penn State Milton S Hershey Medical Center
      • Lancaster, Pennsylvania, Forenede Stater, 17602
        • Lancaster General Hospital
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Pennsylvania Hospital
      • State College, Pennsylvania, Forenede Stater, 16801
        • Geisinger Medical Group
      • State College, Pennsylvania, Forenede Stater, 16803
        • Mount Nittany Medical Center
      • Upland, Pennsylvania, Forenede Stater, 19013
        • Associates In Hematology Oncology PC-Upland
      • West Grove, Pennsylvania, Forenede Stater, 19390
        • Jennersville Regional Hospital
      • West Reading, Pennsylvania, Forenede Stater, 19611
        • Reading Hospital
      • Wilkes-Barre, Pennsylvania, Forenede Stater, 18711
        • Geisinger Wyoming Valley/Henry Cancer Center
      • Wilkes-Barre, Pennsylvania, Forenede Stater, 18765
        • Geisinger South Wilkes-Barre
    • Rhode Island
      • Cranston, Rhode Island, Forenede Stater, 02920
        • Hematology and Oncology Associates of Rhode Island Inc
      • Pawtucket, Rhode Island, Forenede Stater, 02860
        • Memorial Hospital of Rhode Island
      • Warwick, Rhode Island, Forenede Stater, 02886
        • Kent Hospital
    • South Carolina
      • Anderson, South Carolina, Forenede Stater, 29621
        • AnMed Health Hospital
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • Spartanburg Medical Center
    • South Dakota
      • Rapid City, South Dakota, Forenede Stater, 57701
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, Forenede Stater, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, Forenede Stater, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
      • Sioux Falls, South Dakota, Forenede Stater, 57104
        • Sanford Cancer Center Oncology Clinic
      • Sioux Falls, South Dakota, Forenede Stater, 57105
        • Medical X-Ray Center
      • Sioux Falls, South Dakota, Forenede Stater, 57117-5045
        • Avera McKennan Hospital and University Health Center
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37403
        • Erlanger Medical Center
      • Jackson, Tennessee, Forenede Stater, 38301
        • Jackson-Madison County General Hospital
      • Jackson, Tennessee, Forenede Stater, 38301
        • The Jackson Clinic PA
      • Kingsport, Tennessee, Forenede Stater, 37660
        • Wellmont Holston Valley Hospital and Medical Center
      • Memphis, Tennessee, Forenede Stater, 38163
        • University of Tennessee Health Science Center
    • Texas
      • Amarillo, Texas, Forenede Stater, 79106
        • The Don and Sybil Harrington Cancer Center
      • Fort Sam Houston, Texas, Forenede Stater, 78234
        • Brooke Army Medical Center
      • Houston, Texas, Forenede Stater, 77030
        • UT MD Anderson Cancer Center
      • Houston, Texas, Forenede Stater, 77030
        • Houston Methodist Hospital
      • Houston, Texas, Forenede Stater, 77030
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
      • Houston, Texas, Forenede Stater, 77030
        • Michael E DeBakey VA Medical Center
      • Houston, Texas, Forenede Stater, 77030
        • Ben Taub General Hospital
      • Houston, Texas, Forenede Stater, 77030
        • Baylor Saint Luke's Medical Center
      • Lackland Air Force Base, Texas, Forenede Stater, 78236
        • Wilford Hall Medical Center
    • Virginia
      • Danville, Virginia, Forenede Stater, 24541
        • Danville Regional Medical Center
      • Fredericksburg, Virginia, Forenede Stater, 22401
        • Fredericksburg Oncology Inc
      • Martinsville, Virginia, Forenede Stater, 24112
        • Sovah Health Martinsville
      • Norton, Virginia, Forenede Stater, 24273
        • Ballad Health Cancer Care - Norton
    • Washington
      • Seattle, Washington, Forenede Stater, 98101
        • Virginia Mason Medical Center
      • Vancouver, Washington, Forenede Stater, 98686
        • Legacy Salmon Creek Hospital
      • Vancouver, Washington, Forenede Stater, 98664
        • PeaceHealth Southwest Medical Center
      • Vancouver, Washington, Forenede Stater, 98684
        • Compass Oncology Vancouver
    • West Virginia
      • Wheeling, West Virginia, Forenede Stater, 26003
        • Wheeling Hospital/Schiffler Cancer Center
    • Wisconsin
      • Burlington, Wisconsin, Forenede Stater, 53105
        • Aurora Cancer Care-Southern Lakes VLCC
      • Chippewa Falls, Wisconsin, Forenede Stater, 54729
        • Marshfield Clinic-Chippewa Center
      • Eau Claire, Wisconsin, Forenede Stater, 54701
        • HSHS Sacred Heart Hospital
      • Eau Claire, Wisconsin, Forenede Stater, 54701
        • Marshfield Clinic Cancer Center at Sacred Heart
      • Green Bay, Wisconsin, Forenede Stater, 54311
        • Aurora BayCare Medical Center
      • Green Bay, Wisconsin, Forenede Stater, 54301
        • Saint Vincent Hospital Cancer Center Green Bay
      • Green Bay, Wisconsin, Forenede Stater, 54303
        • Saint Vincent Hospital Cancer Center at Saint Mary's
      • Green Bay, Wisconsin, Forenede Stater, 54301-3526
        • Green Bay Oncology at Saint Vincent Hospital
      • Johnson Creek, Wisconsin, Forenede Stater, 53038
        • University of Wisconsin Carbone Cancer Center - Johnson Creek
      • La Crosse, Wisconsin, Forenede Stater, 54601
        • Gundersen Lutheran Medical Center
      • La Crosse, Wisconsin, Forenede Stater, 54601
        • Mayo Clinic Health System-Franciscan Healthcare
      • Ladysmith, Wisconsin, Forenede Stater, 54848
        • Marshfield Medical Center - Ladysmith
      • Madison, Wisconsin, Forenede Stater, 53792
        • University of Wisconsin Carbone Cancer Center - University Hospital
      • Manitowoc, Wisconsin, Forenede Stater, 54221
        • Holy Family Memorial Hospital
      • Marinette, Wisconsin, Forenede Stater, 54143
        • Aurora Bay Area Medical Group-Marinette
      • Marinette, Wisconsin, Forenede Stater, 54143
        • Bay Area Medical Center
      • Marshfield, Wisconsin, Forenede Stater, 54449
        • Marshfield Medical Center-Marshfield
      • Marshfield, Wisconsin, Forenede Stater, 54449
        • Marshfield Medical Center
      • Milwaukee, Wisconsin, Forenede Stater, 53210
        • Ascension Southeast Wisconsin Hospital-Saint Joseph-Milwaukee
      • Minocqua, Wisconsin, Forenede Stater, 54548
        • Marshfield Medical Center - Minocqua
      • Oconto Falls, Wisconsin, Forenede Stater, 54154
        • Saint Vincent Hospital Cancer Center at Oconto Falls
      • Rhinelander, Wisconsin, Forenede Stater, 54501
        • Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
      • Rice Lake, Wisconsin, Forenede Stater, 54868
        • Marshfield Medical Center-Rice Lake
      • Sheboygan, Wisconsin, Forenede Stater, 53081
        • Vince Lombardi Cancer Clinic-Sheboygan
      • Sheboygan, Wisconsin, Forenede Stater, 53081
        • HSHS Saint Nicholas Hospital
      • Stevens Point, Wisconsin, Forenede Stater, 54481
        • Aspirus Cancer Care - Stevens Point
      • Sturgeon Bay, Wisconsin, Forenede Stater, 54235-1495
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
      • Summit, Wisconsin, Forenede Stater, 53066
        • Aurora Medical Center in Summit
      • Two Rivers, Wisconsin, Forenede Stater, 54241
        • Vince Lombardi Cancer Clinic-Two Rivers
      • Weston, Wisconsin, Forenede Stater, 54476
        • Marshfield Medical Center - Weston
      • Wisconsin Rapids, Wisconsin, Forenede Stater, 54494
        • Marshfield Clinic - Wisconsin Rapids Center
    • Wyoming
      • Casper, Wyoming, Forenede Stater, 82609
        • Rocky Mountain Oncology
      • Sheridan, Wyoming, Forenede Stater, 82801
        • Welch Cancer Center
  • Puerto Rico
      • San Juan, Puerto Rico, 00936
        • San Juan City Hospital
  • Saudi Arabien
      • Riyadh, Saudi Arabien, 11211
        • King Faisal Specialist Hospital and Research Centre

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Patienter skal have nydiagnosticeret myelomatose med målbar sygdom; patienter med ikke-sekretorisk myelomatose (MM) baseret på standard M-komponent kriterier (dvs. målbar serum/urin M-komponent) er ikke kvalificerede til denne undersøgelse; undtagelse: patienter med ikke-sekretorisk MM vil kun være kvalificerede, hvis baseline serum Freelite er forhøjet (Bemærk, at serum Freelite skal tegnes; serum lette kæder er ikke acceptable); alle test for at fastslå baseline sygdomsstatus skal være afsluttet inden for 28 dage før registrering og dokumenteret på baseline og opfølgende tumorvurderingsskema for myelomatose
  • Patienter må ikke have modtaget tidligere kemoterapi for denne sygdom; patienter må ikke have modtaget tidligere strålebehandling til et stort område af bækkenet (mere end halvdelen af ​​bækkenet); forudgående steroidbehandling er tilladt, forudsat at behandlingen ikke var af mere end 2 ugers varighed; patienter må ikke have modtaget nogen tidligere behandling med bortezomib eller lenalidomid
  • Patienter skal have en Zubrod præstationsstatus (PS) på 0 - 3; BEMÆRK: Patienter med PS 3 er kun berettigede, hvis det er dokumenteret af den behandlende læge, at patientens myelomatose er den centrale årsag til hans/hendes handicap; patienter, der har en PS på 3 på grund af andre samtidige medicinske tilstande, er ikke kvalificerede til dette forsøg
  • Blodpladetal >= 80 x 10^3/mcL; skal indhentes inden for 28 dage før registrering; undtagelse: patienter med biopsipåvist involvering af tungmarv, som defineret ved at have mindst 30 % marvcellularitet, hvor > 50 % af cellerne er maligne plasmaceller (dokumenterede marvresultater kræves); i dette tilfælde, selv om der ikke er nogen påkrævede nedre normalgrænser for blodtallene, skal den behandlende læge bruge sin medicinske vurdering med hensyn til passendeheden af ​​denne undersøgelsesterapi for disse patienter
  • Absolut neutrofiltal (ANC) >= 1 x 10^3/mcL; skal indhentes inden for 28 dage før registrering; undtagelse: patienter med biopsipåvist involvering af tungmarv, som defineret ved at have mindst 30 % marvcellularitet, hvor > 50 % af cellerne er maligne plasmaceller (dokumenterede marvresultater kræves); i dette tilfælde, selv om der ikke er nogen påkrævede nedre normalgrænser for blodtallene, skal den behandlende læge bruge sin medicinske vurdering med hensyn til passendeheden af ​​denne undersøgelsesterapi for disse patienter
  • Hæmoglobin (inklusive patienter, som enten er blevet transfunderet eller behandlet med erythropoietin [EPO]) >= 9 g/dL; skal indhentes inden for 28 dage før registrering; undtagelse: patienter med biopsipåvist involvering af tungmarv, som defineret ved at have mindst 30 % marvcellularitet, hvor > 50 % af cellerne er maligne plasmaceller (dokumenterede marvresultater kræves); i dette tilfælde, selv om der ikke er nogen påkrævede nedre normalgrænser for blodtallene, skal den behandlende læge bruge sin medicinske vurdering med hensyn til passendeheden af ​​denne undersøgelsesterapi for disse patienter
  • Patienter skal tilbydes deltagelse i Myelom-prøvelageret til bankvirksomhed og fremtidig forskning; med patientens samtykke vil knoglemarvsaspirater og serumprøver blive sendt til Myelom-prøvelageret til yderligere testning og banking (inklusive SNP-testning); patientens samtykke skal indhentes, før prøver kan indsendes
  • Patienter skal have baseline skeletundersøgelse for at inkludere lateral kranium, anterior-posterior (AP) bækken og posterior-anterior (PA) bryst inden for 28 dage før registrering
  • Institutioner skal indsende en lokal cytogenetisk rapport og fluorescens in situ hybridisering (FISH) analyserapport opnået før tilmelding til S0777; til FISH-analyse vil to prober blive brugt: LSI 13 (RBI) 13q14 SpectrumOrange Probe til påvisning af kromosom 13 deletion og LSI p53 (17p13.1) SpectrumOrange probe til påvisning af tumorprotein (p)53 locus på kromosom 17; hvis disse nøjagtige prober ikke er tilgængelige lokalt, er det acceptabelt at indsende resultater ved hjælp af lokal protokol; dette skal noteres på præstudieskemaet; BEMÆRK: det kræves ikke, at resultaterne af FISH-analysen kendes før registrering, kun at præregistreringsprøver tegnes og sendes til analyse før registrering, og FISH-analyserapporten indsendes
  • Patienter med patologiske frakturer, lungebetændelse ved diagnose eller symptomatisk hyperviskositet skal have behandlet disse tilstande før registrering (dvs. intramedullær stang, intramedullær stang, I.V. antibiotika, plasmaferese)
  • Patienterne skal have en beregnet eller målt kreatininclearance > 30 cc/min; målt kreatininclearance eller serumkreatinin anvendt i beregningen skal opnås inden for 28 dage før registrering
  • Patienter må ikke have ukontrolleret, aktiv infektion, der kræver intravenøs antibiotika, New York Heart Association (NYHA) klasse III eller klasse IV hjertesvigt, myokardieinfarkt inden for de sidste 6 måneder, historie med behandling for klinisk signifikante ventrikulære hjertearytmier, dårligt kontrolleret hypertension eller dårligt kontrolleret diabetes mellitus; patienter skal have gennemgået et elektrokardiogram (EKG) inden for 28 dage før registrering
  • Patienter må ikke have nogen psykiatrisk sygdom, der potentielt kan forstyrre afslutningen af ​​behandlingen i henhold til denne protokol
  • Patienter må ikke være positive for hepatitis B, hepatitis C eller humant immundefektvirus (HIV). patienter skal have en negativ hepatitis B- og HIV-test udført inden for 28 dage før registrering; undtagelse: behandlingsfølsomme HIV-infektionspatienter vil være berettigede, forudsat at immunologiske og virologiske indekser indikerer gunstige langsigtede overlevelsesudsigter på grundlag af HIV-infektion, men hvis forventede levetid er begrænset overvejende af myelomatose snarere end HIV-infektion i bedømmelsen af den behandlende læge
  • Patienter må ikke have en historie med cerebral vaskulær ulykke med vedvarende neurologiske mangler
  • Patienter skal være i stand til at tage aspirin 325 mg dagligt (eller enoxaparin 40 mg subkutant [SQ] dagligt, hvis patienten ikke er i stand til at tage aspirin) som profylaktisk antikoagulering; undtagelse: patienter, der får antikoaguleringsbehandling såsom Coumadin eller heparin, vil IKKE modtage aspirin og behøver derfor ikke at være i stand til at tage det
  • Kvinder i den fødedygtige alder (FCBP) skal have en negativ serum- eller uringraviditetstest med en følsomhed på mindst 25 mIU/ml inden for 10 - 14 dage og igen inden for 24 timer før påbegyndelse af cyklus 1 med lenalidomid; desuden skal de enten forpligte sig til fortsat afholdenhed fra heteroseksuelt samleje eller påbegynde TO acceptable metoder til prævention: én yderst effektiv metode og én yderligere effektiv metode SAMTIDIG, mindst 28 dage før start med lenalidomid; FCBP skal også acceptere igangværende graviditetstest; mænd skal acceptere at bruge et latexkondom under seksuel kontakt med en FCBP, selvom de har fået en vellykket vasektomi; en FCBP er en seksuelt moden kvinde, der: ikke har gennemgået en hysterektomi eller bilateral ooforektomi; eller ikke har været naturligt postmenopausal i mindst 24 på hinanden følgende måneder (dvs. har haft menstruation på noget tidspunkt i de foregående 24 på hinanden følgende måneder); alle patienter skal rådgives af en uddannet rådgiver hver 28. dag om graviditetsforholdsregler og risici for fostereksponering
  • Ingen tidligere malignitet er tilladt undtagen for tilstrækkeligt behandlet basalcelle- (eller pladecelle-) hudkræft, in situ livmoderhalskræft eller anden cancer, for hvilken patienten har været sygdomsfri i fem år
  • Patienter skal tilbydes deltagelse i genekspressionsprofilering (GEP) molekylære undersøgelser til evaluering af genetiske polymorfismer
  • Alle patienter skal informeres om undersøgelsens karakter af denne undersøgelse og skal underskrive og give skriftligt samtykke i overensstemmelse med institutionelle føderale retningslinjer
  • På tidspunktet for patientregistrering skal den behandlende institutions navn og identifikationsnummer (ID) oplyses til det statistiske center for at sikre, at den aktuelle (inden for 365 dage) dato for institutionens bedømmelsesnævns godkendelse af denne undersøgelse er blevet indtastet i database

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Arm I (dexamethason og lenalidomid)
Patienterne får dexamethason PO QD på dag 1, 8, 15 og 22 og lenalidomid PO QD på dag 1-21. Behandlingen gentages hver 28. dag i 6 forløb i fravær af sygdomsprogression eller uacceptabel toksicitet.
Medicin: Lenalidomid
Givet PO
Andre navne:
  • CC-5013
  • Revlimid
  • CC5013
  • CDC 501
  • CC 5013
Medicin: Dexamethason
Givet PO
Andre navne:
  • Dekadron
  • Hemady
  • Aacideksamen
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron DP
  • Decalix
  • Decameth
  • Decason R.p.
  • Dectancyl
  • Dekacort
  • Deltafluoren
  • Deronil
  • Desamethason
  • Desameton
  • Dexa-Mamallet
  • Dexa-næsehorn
  • Dexa-Scheroson
  • Dexa-sinus
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluoren
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethason Intensol
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Dxevo
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolon
  • Millicorten
  • Mymethason
  • Orgadrone
  • Spersadex
  • TaperDex
  • Visumetazon
  • ZoDex
  • LenaDex
Andet: Laboratoriebiomarkøranalyse
Valgfri korrelative undersøgelser
Eksperimentel: Arm II (dexamethason, lenalidomid, bortezomib)
Patienter modtager dexamethason PO QD på dag 1, 2, 4, 5, 8, 9, 11 og 12; lenalidomid PO QD på dag 1-14; og bortezomib IV over 3-5 sekunder på dag 1, 4, 8 og 11. Behandlingen gentages hver 21. dag i 8 forløb i fravær af sygdomsprogression eller uacceptabel toksicitet.
Medicin: Lenalidomid
Givet PO
Andre navne:
  • CC-5013
  • Revlimid
  • CC5013
  • CDC 501
  • CC 5013
Medicin: Dexamethason
Givet PO
Andre navne:
  • Dekadron
  • Hemady
  • Aacideksamen
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron DP
  • Decalix
  • Decameth
  • Decason R.p.
  • Dectancyl
  • Dekacort
  • Deltafluoren
  • Deronil
  • Desamethason
  • Desameton
  • Dexa-Mamallet
  • Dexa-næsehorn
  • Dexa-Scheroson
  • Dexa-sinus
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluoren
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethason Intensol
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Dxevo
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolon
  • Millicorten
  • Mymethason
  • Orgadrone
  • Spersadex
  • TaperDex
  • Visumetazon
  • ZoDex
  • LenaDex
Andet: Laboratoriebiomarkøranalyse
Valgfri korrelative undersøgelser
Medicin: Bortezomib
Givet IV
Andre navne:
  • Velcade
  • MLN341
  • PS-341
  • LDP 341
  • [(1R)-3-methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]borsyre
  • PS341
  • LDP-341
  • MLN-341
  • LDP341
  • MLN 341
  • PS 341
  • Boruzu

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progressionsfri overlevelse
Tidsramme: Fra registreringsdatoen til datoen for første dokumentation for progression eller symptomatisk forværring eller død på grund af en hvilken som helst årsag, vurderet op til 6 år
Ustratificeret median progressionsfri overlevelse i måneder.
Fra registreringsdatoen til datoen for første dokumentation for progression eller symptomatisk forværring eller død på grund af en hvilken som helst årsag, vurderet op til 6 år

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Samlet overlevelse
Tidsramme: Op til 6 år
Ustratificeret median samlet overlevelse i måneder.
Op til 6 år
Svarprocenter ()
Tidsramme: Op til 6 år
Responsraten blev beregnet som antallet af patienter med dokumenteret bekræftet partiel respons (PR) eller bedre, hvilket inkluderer bekræftet/ubekræftet stringent komplet respons (sCR), bekræftet/ubekræftet komplet respons (CR), bekræftet/ubekræftet meget god delvis respons ( VGPR), eller bekræftet partiel respons (PR), som bedste respons divideret med det samlede antal evaluerbare patienter i hver arm. Patienter med målbar sygdom, som defineret i protokollen, er evaluerbare. Responsrater blev sammenlignet mellem de to behandlingsarme ved hjælp af en stratificeret Cochran-Mantel-Haenszel-test. Responsbetegnelser var baseret på International Uniform Response Criteria for Myelom. På grund af disse kriteriers kompleksitet er detaljerne i disse kriterier udeladt.
Op til 6 år

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Brian M Durie, SWOG Cancer Research Network

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. juli 2008

Primær færdiggørelse (Faktiske)

5. november 2015

Studieafslutning (Anslået)

10. juni 2027

Datoer for studieregistrering

Først indsendt

22. marts 2008

Først indsendt, der opfyldte QC-kriterier

22. marts 2008

Først opslået (Anslået)

26. marts 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NCI-2009-00798 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U10CA032102 (U.S. NIH-bevilling/kontrakt)
  • U10CA180888 (U.S. NIH-bevilling/kontrakt)
  • SWOG-S0777
  • S0777 (Anden identifikator: CTEP)
  • CDR0000590321

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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