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Udvidet adgangsprogram (EAP) for Ciltacabtagene Autoleucel (Cilta-Cel) uden for specifikationen (OOS) hos deltagere med myelomatose

12. februar 2026 opdateret af: Janssen Scientific Affairs, LLC

Intermediate-Size Population Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-cel) uden for specifikationen (OOS) hos patienter med myelomatose

Formålet med dette udvidede adgangsprogram (EAP) er at give ciltacabtagene autoleucel (cilta-cel), der ikke opfylder de kommercielle frigivelsesspecifikationer fra CARVYKTI og ikke er tilgængelig via det lokale sundhedssystem i det land, hvor behandlingen anmodes om.

Studieoversigt

Status

Ledig

Betingelser

Intervention / Behandling

Undersøgelsestype

Udvidet adgang

Udvidet adgangstype

  • Befolkning af middelstørrelse

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • Ledig
        • University of Alabama at Birmingham
    • Arizona
      • Gilbert, Arizona, Forenede Stater, 85234
        • Ledig
        • Banner MD Anderson Cancer Center
      • Goodyear, Arizona, Forenede Stater, 85338
        • Ledig
        • Cancer Treatment Center of America Phoenix
      • Scottsdale, Arizona, Forenede Stater, 85259
        • Ledig
        • Mayo Clinic
      • Scottsdale, Arizona, Forenede Stater, 85258
        • Ledig
        • HonorHealth Cancer Transplant Institute
      • Tucson, Arizona, Forenede Stater, 85719
        • Ledig
        • University of Arizona Cancer Center
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Ledig
        • The University of Arkansas for Medical Sciences Myeloma Institute for Research and Therapy
    • California
      • Berkeley, California, Forenede Stater, 94704
        • Ledig
        • Alta Bates Medical Center Cancer Center
      • Duarte, California, Forenede Stater, 91010
        • Ledig
        • City of Hope
      • La Jolla, California, Forenede Stater, 92093
        • Ledig
        • University of California at San Diego
      • Los Angeles, California, Forenede Stater, 90033
        • Ledig
        • USC Norris Comprehensive Cancer Center
      • Los Angeles, California, Forenede Stater, 90048
        • Ledig
        • Samuel Oschin Comprehensive Cancer Center Cedars-Sinai Medical Center
      • Los Angeles, California, Forenede Stater, 90095
        • Ledig
        • University of California, Los Angeles UCLA
      • Newport Beach, California, Forenede Stater, 92658
        • Ledig
        • Hoag Memorial Hospital
      • Sacramento, California, Forenede Stater, 95816
        • Ledig
        • Sutter Medical Foundation
      • Sacramento, California, Forenede Stater, 95817
        • Ledig
        • University of Calif Davis Medical Center
      • San Francisco, California, Forenede Stater, 94143
        • Ledig
        • UCSF
      • Stanford, California, Forenede Stater, 94305
        • Ledig
        • Stanford University Medical Center
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • Ledig
        • UCHealth Cancer Care Anschutz Medical Campus University of Colorado Cancer Center
      • Denver, Colorado, Forenede Stater, 80218
        • Ledig
        • Colorado Blood Cancer Institute
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06520
        • Ledig
        • Yale New Haven Hospital
    • Delaware
      • Newark, Delaware, Forenede Stater, 19713
        • Ledig
        • Christiana Care
    • District of Columbia
      • Washington D.C., District of Columbia, Forenede Stater, 20007
        • Ledig
        • MedStar Georgetown Hospital
    • Florida
      • Gainesville, Florida, Forenede Stater, 32611
        • Ledig
        • University of Florida at Shands
      • Jacksonville, Florida, Forenede Stater, 32224
        • Ledig
        • Mayo Clinic
      • Miami, Florida, Forenede Stater, 33136
        • Ledig
        • University of Miami Sylvester Comprehensive Cancer Center
      • Miami, Florida, Forenede Stater, 33176
        • Ledig
        • Miami Cancer Institute at Baptist Health / Baptist Health Medical Group
      • Orlando, Florida, Forenede Stater, 32803
        • Ledig
        • Advent Health Orlando
      • Orlando, Florida, Forenede Stater, 32806
        • Ledig
        • Orlando Health
      • Pembroke Pines, Florida, Forenede Stater, 33028
        • Ledig
        • Memorial Healthcare System
      • Tampa, Florida, Forenede Stater, 33612
        • Ledig
        • H Lee Moffitt Cancer Center
      • Tampa, Florida, Forenede Stater, 33606
        • Ledig
        • Tampa General Hospital
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Ledig
        • Emory University
      • Atlanta, Georgia, Forenede Stater, 30342
        • Ledig
        • Northside Hospital Cancer Institute
      • Newnan, Georgia, Forenede Stater, 30265
        • Ledig
        • City of Hope Cancer Center
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96826
        • Ledig
        • Kapi Olani Medical Center for Women and Children Hawaii Pacific
    • Idaho
      • Boise, Idaho, Forenede Stater, 83712
        • Ledig
        • St. Luke's Mountain State Tumor Institute
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Ledig
        • Rush University Medical Center
      • Chicago, Illinois, Forenede Stater, 60611
        • Ledig
        • Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion
      • Chicago, Illinois, Forenede Stater, 60612
        • Ledig
        • University of Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • Ledig
        • The University of Chicago Medical Center (UCMC)
      • Evanston, Illinois, Forenede Stater, 60201
        • Ledig
        • NorthShore University Health System, Evanston Hospital
      • Maywood, Illinois, Forenede Stater, 60153
        • Ledig
        • Loyola University Medical Center
      • Park Ridge, Illinois, Forenede Stater, 60068
        • Ledig
        • Advocate Lutheran General Hospital
      • Zion, Illinois, Forenede Stater, 60099
        • Ledig
        • City of Hope Chicago
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Ledig
        • IU Health University Hospital
      • Indianapolis, Indiana, Forenede Stater, 46237 8601
        • Ledig
        • St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation
      • Kokomo, Indiana, Forenede Stater, 46902
        • Ledig
        • Community Health Network MD Anderson Cancer Center
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
        • Ledig
        • University of Iowa Hospital and Clinics
    • Kansas
      • Fairway, Kansas, Forenede Stater, 66205
        • Ledig
        • University of Kansas Cancer Center
      • Wichita, Kansas, Forenede Stater, 67214
        • Ledig
        • Ascension Via Christi Research
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40508
        • Ledig
        • University of Kentucky Chandler Medical Center
      • Louisville, Kentucky, Forenede Stater, 40202
        • Ledig
        • University of Louisville - James Graham Brown Cancer Center
      • Louisville, Kentucky, Forenede Stater, 40207
        • Ledig
        • Norton Cancer Institute
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70121
        • Ledig
        • Ochsner Clinic Foundation
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • Ledig
        • University of Maryland School of Medicine
      • Baltimore, Maryland, Forenede Stater, 21205
        • Ledig
        • Johns Hopkins University School of Medicine JHUSOM
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Ledig
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, Forenede Stater, 02111
        • Ledig
        • Tufts New England Medical Center
      • Boston, Massachusetts, Forenede Stater, 02114
        • Ledig
        • Massachusetts General
      • Boston, Massachusetts, Forenede Stater, 02118
        • Ledig
        • Boston University Medical Center
      • Weymouth, Massachusetts, Forenede Stater, 02190
        • Ledig
        • Dana-Farber Brigham and Women's Cancer Center
      • Worcester, Massachusetts, Forenede Stater, 01655
        • Ledig
        • University of Massachusetts Medical School
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • Ledig
        • University of Michigan Rogel Cancer Center
      • Farmington Hills, Michigan, Forenede Stater, 48334
        • Ledig
        • Barbara Ann Karmanos Cancer Institute - Lawrence and Idell Weisberg Cancer Treatment Center
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Ledig
        • Corewell Health Grand Rapids Hospitals Butterworth
      • Royal Oak, Michigan, Forenede Stater, 48073
        • Ledig
        • William Beaumont Health System
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • Ledig
        • M Health Fairview University of Minnesota Medical Center East Bank
      • Rochester, Minnesota, Forenede Stater, 55905
        • Ledig
        • Mayo Clinic Rochester
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39213
        • Ledig
        • University of Mississippi Medical Center
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65201
        • Ledig
        • Ellis Fischel Cancer Center
      • St Louis, Missouri, Forenede Stater, 63110
        • Ledig
        • Saint Louis University
      • St Louis, Missouri, Forenede Stater, 63110
        • Ledig
        • Washington University School of Medicine
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68198
        • Ledig
        • University of Nebraska Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03756
        • Ledig
        • Dartmouth Hitchcock Medical Center
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Ledig
        • John Theurer Cancer Center at Hackensack University Medical Center
      • New Brunswick, New Jersey, Forenede Stater, 08901-1914
        • Ledig
        • Rutgers, The State Univ of NJ-Robert Wood Johnson Medical School-The Cancer Institute of NJ (CINJ)
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87106
        • Ledig
        • University of New Mexico School of Medicine
    • New York
      • Buffalo, New York, Forenede Stater, 14203
        • Ledig
        • Roswell Park Comprehensive Cancer Center
      • Manhasset, New York, Forenede Stater, 11030
        • Ledig
        • The Feinstein Institute for Medical Research (Northwell Health Inc.)
      • New York, New York, Forenede Stater, 10065
        • Ledig
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, Forenede Stater, 10065
        • Ledig
        • Weill Cornell Medical Center
      • New York, New York, Forenede Stater, 10010
        • Ledig
        • New York University Langone Medical Center
      • New York, New York, Forenede Stater, 10029
        • Ledig
        • Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg
      • New York, New York, Forenede Stater, 10032
        • Ledig
        • Columbia University Medical Center
      • Rochester, New York, Forenede Stater, 14642
        • Ledig
        • University of Rochester Medical Center
      • The Bronx, New York, Forenede Stater, 10467
        • Ledig
        • Montefiore Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27514
        • Ledig
        • University of North Carolina Hospital
      • Charlotte, North Carolina, Forenede Stater, 28204
        • Ledig
        • Atrium Health
      • Charlotte, North Carolina, Forenede Stater, 28204
        • Ledig
        • Novant Health
      • Durham, North Carolina, Forenede Stater, 27710
        • Ledig
        • Duke University
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Ledig
        • Novant Health Forsyth Medical Center
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Ledig
        • Atrium Health Wake Forest Baptist Comprehensive Cancer Center
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58122
        • Ledig
        • Sanford Health
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45236
        • Ledig
        • The Jewish Hospital - Mercy
      • Cincinnati, Ohio, Forenede Stater, 45220
        • Ledig
        • Good Samaritan Hospital
      • Cleveland, Ohio, Forenede Stater, 44106
        • Ledig
        • University Hospital of Cleveland
      • Cleveland, Ohio, Forenede Stater, 44145
        • Ledig
        • Cleveland Clinic
      • Columbus, Ohio, Forenede Stater, 43210
        • Ledig
        • The Ohio State University Wexner Medical Center - James Cancer Hospital
      • Columbus, Ohio, Forenede Stater, 43214
        • Ledig
        • OhioHealth Mansfield Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Ledig
        • University of Oklahoma Stephenson Cancer Center
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Ledig
        • Oregon Health and Science University
      • Portland, Oregon, Forenede Stater, 97213
        • Ledig
        • Providence Portland Medical Center
    • Pennsylvania
      • Danville, Pennsylvania, Forenede Stater, 17622
        • Ledig
        • Geisinger Medical Center
      • Hershey, Pennsylvania, Forenede Stater, 17033
        • Ledig
        • Penn State Milton S Hershey Medical Ctr
      • Philadelphia, Pennsylvania, Forenede Stater, 19111
        • Ledig
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Ledig
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Ledig
        • University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine
      • Pittsburgh, Pennsylvania, Forenede Stater, 15323
        • Ledig
        • University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02908
        • Ledig
        • Roger Williams Medical Center
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Ledig
        • Medical University of South Carolina
      • Greenville, South Carolina, Forenede Stater, 29615
        • Ledig
        • Prisma Health
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57105
        • Ledig
        • Avera McKennan Hospital
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater, 37920
        • Ledig
        • University of Tennessee Medical Center
      • Memphis, Tennessee, Forenede Stater, 38120
        • Ledig
        • Baptist Clinical Research Institute
      • Nashville, Tennessee, Forenede Stater, 37203
        • Ledig
        • Sarah Cannon Cancer Institute
      • Nashville, Tennessee, Forenede Stater, 37232
        • Ledig
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, Forenede Stater, 37212
        • Ledig
        • Tennessee Valley Healthcare System
    • Texas
      • Austin, Texas, Forenede Stater, 78704
        • Ledig
        • St. David's South Austin Medical Center
      • Dallas, Texas, Forenede Stater, 75246
        • Ledig
        • Baylor University Medical Center
      • Dallas, Texas, Forenede Stater, 75390
        • Ledig
        • UT Southwestern Medical Center
      • Dallas, Texas, Forenede Stater, 75230
        • Ledig
        • Texas Oncology-Medical City Dallas
      • Houston, Texas, Forenede Stater, 77030
        • Ledig
        • MD Anderson Cancer Center
      • Houston, Texas, Forenede Stater, 77030
        • Ledig
        • Houston Methodist Hospital
      • San Antonio, Texas, Forenede Stater, 78229
        • Ledig
        • San Antonio Methodist TX Transplant Physicians Group
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84112
        • Ledig
        • Huntsman Cancer Institute
      • Salt Lake City, Utah, Forenede Stater, 84143
        • Ledig
        • Intermountain Healthcare
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22903
        • Ledig
        • University of Virginia
      • Fairfax, Virginia, Forenede Stater, 22031
        • Ledig
        • Inova Schar Cancer Institute Dept of Fairfax Hospital
      • Norfolk, Virginia, Forenede Stater, 23502
        • Ledig
        • Virginia Oncology Associates
      • Richmond, Virginia, Forenede Stater, 23219
        • Ledig
        • VCU Medical Center
    • Washington
      • Seattle, Washington, Forenede Stater, 98104
        • Ledig
        • Swedish Cancer Institute First Hill
      • Seattle, Washington, Forenede Stater, 98195
        • Ledig
        • University of Washington School of Medicine
    • West Virginia
      • Morgantown, West Virginia, Forenede Stater, 26506
        • Ledig
        • West Virginia University Medical Center
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792
        • Ledig
        • University Of Wisconsin Hospital
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Ledig
        • Medical College of Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53215
        • Ledig
        • Aurora Saint Lukes Medical Center
  • Tyskland
      • Dummy, Tyskland, 99999
        • Ledig
        • DUMMY

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

N/A

Beskrivelse

Inklusionskriterier:

  • Berettiget til behandling med cilta-cel i henhold til United States Prescribing Information (USPI)
  • Har alvorlig eller livstruende myelomatose pr. USPI, og hvor re-aferese, genfremstilling eller anden anti-myelom rettet behandling ikke anses for mulig eller tilstrækkelig efter den behandlende læges skøn
  • Gunstig deltagerens fordele/risiko vurdering fastlagt af Janssen lægeundersøgelse
  • Den behandlende læge bekræfter den gunstige risiko-benefit-profil, og at det er i deltagerens interesse at fortsætte med denne behandling
  • I stand til at give informeret samtykke, der angiver, at de forstår formålet med dette udvidede adgangsprogram (EAP)
  • En kvinde i den fødedygtige alder skal have en negativ meget følsom serum (beta-humant choriongonadotropin [beta-hCG]) graviditetstest under screening og før den første dosis cyclophosphamid og fludarabin

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Samarbejdspartnere og efterforskere

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

Sponsor

Janssen Scientific Affairs, LLC

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.

Datoer for studieregistrering

Først indsendt

21. marts 2022

Først indsendt, der opfyldte QC-kriterier

25. april 2022

Først opslået (Faktiske)

26. april 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. februar 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. februar 2026

Sidst verificeret

1. februar 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CR108968
  • 68284528MMY4006 (Anden identifikator: Janssen Research & Development, LLC)

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 .

Kliniske forsøg med Myelomatose

Kliniske forsøg med Cilta-cel OOS Terapi

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Ireland

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner