Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-Cel) Out-of-Specification (OOS) in Participants With Multiple Myeloma
Purpose
The purpose of this expanded access program (EAP) is to provide ciltacabtagene autoleucel (cilta-cel) that does not meet the commercial release specifications of CARVYKTI and is not available via the local health care system in the country where the treatment is requested.
Condition
- Multiple Myeloma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Criteria
Inclusion Criteria:
- Eligible for treatment with cilta-cel per United States Prescribing Information
(USPI)
- Has serious or life-threatening multiple myeloma per USPI, and where re-apheresis,
re-manufacturing, or other anti-myeloma directed therapy is not considered feasible
or adequate per treating physician discretion
- Favorable participant benefit/risk assessment determined by Janssen medical review
- Treating physician confirms the favorable risk benefit profile, and that proceeding
with this treatment is in the best interest of the participant
- Able to provide informed consent indicating they understand the purpose of this
expanded access program (EAP)
- A woman of childbearing potential must have a negative highly sensitive serum
(beta-human chorionic gonadotropin [beta-hCG]) pregnancy test during screening and
prior to the first dose of cyclophosphamide and fludarabine
Study Design
- Phase
- Study Type
- Expanded Access
Recruiting Locations
University of Alabama at Birmingham
Birmingham, Alabama 35294
Birmingham, Alabama 35294
Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
Gilbert, Arizona 85234
Cancer Treatment Center of America Phoenix
Goodyear, Arizona 85338
Goodyear, Arizona 85338
HonorHealth Cancer Transplant Institute
Scottsdale, Arizona 85258
Scottsdale, Arizona 85258
Mayo Clinic
Scottsdale, Arizona 85259
Scottsdale, Arizona 85259
University of Arizona Cancer Center
Tucson, Arizona 85719
Tucson, Arizona 85719
The University of Arkansas for Medical Sciences Myeloma Institute for Research and Therapy
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Alta Bates Medical Center Cancer Center
Berkeley, California 94704
Berkeley, California 94704
City of Hope
Duarte, California 91010
Duarte, California 91010
University of California at San Diego
La Jolla, California 92093
La Jolla, California 92093
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
Los Angeles, California 90033
Samuel Oschin Comprehensive Cancer Center Cedars-Sinai Medical Center
Los Angeles, California 90048
Los Angeles, California 90048
University of California, Los Angeles UCLA
Los Angeles, California 90095
Los Angeles, California 90095
Hoag Memorial Hospital
Newport Beach, California 92658
Newport Beach, California 92658
Sutter Medical Foundation
Sacramento, California 95816
Sacramento, California 95816
University of Calif Davis Medical Center
Sacramento, California 95817
Sacramento, California 95817
UCSF
San Francisco, California 94143
San Francisco, California 94143
Stanford University Medical Center
Stanford, California 94305
Stanford, California 94305
UCHealth Cancer Care Anschutz Medical Campus University of Colorado Cancer Center
Aurora, Colorado 80045
Aurora, Colorado 80045
Colorado Blood Cancer Institute
Denver, Colorado 80218
Denver, Colorado 80218
Yale New Haven Hospital
New Haven, Connecticut 06520
New Haven, Connecticut 06520
Christiana Care
Newark, Delaware 19713
Newark, Delaware 19713
MedStar Georgetown Hospital
Washington D.C., District of Columbia 20007
Washington D.C., District of Columbia 20007
University of Florida at Shands
Gainesville, Florida 32611
Gainesville, Florida 32611
Mayo Clinic
Jacksonville, Florida 32224
Jacksonville, Florida 32224
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida 33136
Miami, Florida 33136
Miami Cancer Institute at Baptist Health / Baptist Health Medical Group
Miami, Florida 33176
Miami, Florida 33176
Advent Health Orlando
Orlando, Florida 32803
Orlando, Florida 32803
Orlando Health
Orlando, Florida 32806
Orlando, Florida 32806
Memorial Healthcare System
Pembroke Pines, Florida 33028
Pembroke Pines, Florida 33028
Tampa General Hospital
Tampa, Florida 33606
Tampa, Florida 33606
H Lee Moffitt Cancer Center
Tampa, Florida 33612
Tampa, Florida 33612
Emory University
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Northside Hospital Cancer Institute
Atlanta, Georgia 30342
Atlanta, Georgia 30342
City of Hope Cancer Center
Newnan, Georgia 30265
Newnan, Georgia 30265
Kapi Olani Medical Center for Women and Children Hawaii Pacific
Honolulu, Hawaii 96826
Honolulu, Hawaii 96826
St. Luke's Mountain State Tumor Institute
Boise, Idaho 83712
Boise, Idaho 83712
Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion
Chicago, Illinois 60611
Chicago, Illinois 60611
Rush University Medical Center
Chicago, Illinois 60612
Chicago, Illinois 60612
University Of Illinois
Chicago, Illinois 60612
Chicago, Illinois 60612
The University of Chicago Medical Center (UCMC)
Chicago, Illinois 60637
Chicago, Illinois 60637
NorthShore University Health System, Evanston Hospital
Evanston, Illinois 60201
Evanston, Illinois 60201
Loyola University Medical Center
Maywood, Illinois 60153
Maywood, Illinois 60153
Advocate Lutheran General Hospital
Park Ridge, Illinois 60068
Park Ridge, Illinois 60068
City of Hope Chicago
Zion, Illinois 60099
Zion, Illinois 60099
IU Health University Hospital
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation
Indianapolis, Indiana 46237 8601
Indianapolis, Indiana 46237 8601
Community Health Network MD Anderson Cancer Center
Kokomo, Indiana 46902
Kokomo, Indiana 46902
University of Iowa Hospital and Clinics
Iowa City, Iowa 52242
Iowa City, Iowa 52242
University of Kansas Cancer Center
Fairway, Kansas 66205
Fairway, Kansas 66205
Ascension via Christi Research
Wichita, Kansas 67214
Wichita, Kansas 67214
University of Kentucky Chandler Medical Center
Lexington, Kentucky 40508
Lexington, Kentucky 40508
University of Louisville - James Graham Brown Cancer Center
Louisville, Kentucky 40202
Louisville, Kentucky 40202
Norton Cancer Institute
Louisville, Kentucky 40207
Louisville, Kentucky 40207
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
New Orleans, Louisiana 70121
University of Maryland School of Medicine
Baltimore, Maryland 21201
Baltimore, Maryland 21201
Johns Hopkins University School of Medicine JHUSOM
Baltimore, Maryland 21205
Baltimore, Maryland 21205
Tufts New England Medical Center
Boston, Massachusetts 02111
Boston, Massachusetts 02111
Massachusetts General
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Boston University Medical Center
Boston, Massachusetts 02118
Boston, Massachusetts 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Dana-Farber Brigham and Women's Cancer Center
Weymouth, Massachusetts 02190
Weymouth, Massachusetts 02190
University of Massachusetts Medical School
Worcester, Massachusetts 01655
Worcester, Massachusetts 01655
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Barbara Ann Karmanos Cancer Institute - Lawrence and Idell Weisberg Cancer Treatment Center
Farmington Hills, Michigan 48334
Farmington Hills, Michigan 48334
Corewell Health Grand Rapids Hospitals Butterworth
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
William Beaumont Health System
Royal Oak, Michigan 48073
Royal Oak, Michigan 48073
M Health Fairview University of Minnesota Medical Center East Bank
Minneapolis, Minnesota 55455
Minneapolis, Minnesota 55455
Mayo Clinic Rochester
Rochester, Minnesota 55905
Rochester, Minnesota 55905
University of Mississippi Medical Center
Jackson, Mississippi 39213
Jackson, Mississippi 39213
Ellis Fischel Cancer Center
Columbia, Missouri 65201
Columbia, Missouri 65201
Saint Louis University
St Louis, Missouri 63110
St Louis, Missouri 63110
Washington University School Of Medicine
St Louis, Missouri 63110
St Louis, Missouri 63110
University of Nebraska Medical Center
Omaha, Nebraska 68198
Omaha, Nebraska 68198
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
Rutgers, The State Univ of NJ-Robert Wood Johnson Medical School-The Cancer Institute of NJ (CINJ)
New Brunswick, New Jersey 08901-1914
New Brunswick, New Jersey 08901-1914
University of New Mexico School of Medicine
Albuquerque, New Mexico 87106
Albuquerque, New Mexico 87106
Roswell Park Comprehensive Cancer Center
Buffalo, New York 14203
Buffalo, New York 14203
The Feinstein Institute for Medical Research (Northwell Health Inc.)
Manhasset, New York 11030
Manhasset, New York 11030
New York University Langone Medical Center
New York, New York 10010
New York, New York 10010
Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg
New York, New York 10029
New York, New York 10029
Columbia University Medical Center
New York, New York 10032
New York, New York 10032
Memorial Sloan Kettering Cancer Center
New York, New York 10065
New York, New York 10065
Weill Cornell Medical Center
New York, New York 10065
New York, New York 10065
University of Rochester Medical Center
Rochester, New York 14642
Rochester, New York 14642
Montefiore Medical Center
The Bronx, New York 10467
The Bronx, New York 10467
University of North Carolina Hospital
Chapel Hill, North Carolina 27514
Chapel Hill, North Carolina 27514
Atrium Health
Charlotte, North Carolina 28204
Charlotte, North Carolina 28204
Novant Health
Charlotte, North Carolina 28204
Charlotte, North Carolina 28204
Duke University
Durham, North Carolina 27710
Durham, North Carolina 27710
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
Sanford Health
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Good Samaritan Hospital
Cincinnati, Ohio 45220
Cincinnati, Ohio 45220
The Jewish Hospital - Mercy
Cincinnati, Ohio 45236
Cincinnati, Ohio 45236
University Hospital of Cleveland
Cleveland, Ohio 44106
Cleveland, Ohio 44106
Cleveland Clinic
Cleveland, Ohio 44145
Cleveland, Ohio 44145
The Ohio State University Wexner Medical Center - James Cancer Hospital
Columbus, Ohio 43210
Columbus, Ohio 43210
OhioHealth Mansfield Hospital
Columbus, Ohio 43214
Columbus, Ohio 43214
University of Oklahoma Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
Providence Portland Medical Center
Portland, Oregon 97213
Portland, Oregon 97213
Oregon Health And Science University
Portland, Oregon 97239
Portland, Oregon 97239
Geisinger Medical Center
Danville, Pennsylvania 17622
Danville, Pennsylvania 17622
Penn State Milton S Hershey Medical Ctr
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
Philadelphia, Pennsylvania 19111
University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15323
Pittsburgh, Pennsylvania 15323
Roger Williams Medical Center
Providence, Rhode Island 02908
Providence, Rhode Island 02908
Medical University of South Carolina
Charleston, South Carolina 29425
Charleston, South Carolina 29425
Prisma Health
Greenville, South Carolina 29615
Greenville, South Carolina 29615
Avera McKennan Hospital
Sioux Falls, South Dakota 57105
Sioux Falls, South Dakota 57105
University of Tennessee Medical Center
Knoxville, Tennessee 37920
Knoxville, Tennessee 37920
Baptist Clinical Research Institute
Memphis, Tennessee 38120
Memphis, Tennessee 38120
Sarah Cannon Cancer Institute
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Tennessee Valley Healthcare System
Nashville, Tennessee 37212
Nashville, Tennessee 37212
Vanderbilt University Medical Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
St. David's South Austin Medical Center
Austin, Texas 78704
Austin, Texas 78704
Texas Oncology-Medical City Dallas
Dallas, Texas 75230
Dallas, Texas 75230
Baylor University Medical Center
Dallas, Texas 75246
Dallas, Texas 75246
UT Southwestern Medical Center
Dallas, Texas 75390
Dallas, Texas 75390
Houston Methodist Hospital
Houston, Texas 77030
Houston, Texas 77030
MD Anderson Cancer Center
Houston, Texas 77030
Houston, Texas 77030
San Antonio Methodist TX Transplant Physicians Group
San Antonio, Texas 78229
San Antonio, Texas 78229
Huntsman Cancer Institute
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
Intermountain Healthcare
Salt Lake City, Utah 84143
Salt Lake City, Utah 84143
University of Virginia
Charlottesville, Virginia 22903
Charlottesville, Virginia 22903
Inova Schar Cancer Institute Dept of Fairfax Hospital
Fairfax, Virginia 22031
Fairfax, Virginia 22031
Virginia Oncology Associates
Norfolk, Virginia 23502
Norfolk, Virginia 23502
VCU Medical Center
Richmond, Virginia 23219
Richmond, Virginia 23219
Swedish Cancer Institute First Hill
Seattle, Washington 98104
Seattle, Washington 98104
University of Washington School of Medicine
Seattle, Washington 98195
Seattle, Washington 98195
West Virginia University Medical Center
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
University Of Wisconsin Hospital
Madison, Wisconsin 53792
Madison, Wisconsin 53792
Aurora Saint Lukes Medical Center
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53215
Medical College Of Wisconsin
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
More Details
- NCT ID
- NCT05346835
- Status
- Available
- Sponsor
- Janssen Scientific Affairs, LLC