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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

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

Banner MD Anderson Cancer Center
Gilbert, Arizona 85234

Cancer Treatment Center of America Phoenix
Goodyear, Arizona 85338

HonorHealth Cancer Transplant Institute
Scottsdale, Arizona 85258

Mayo Clinic
Scottsdale, Arizona 85259

University of Arizona Cancer Center
Tucson, Arizona 85719

The University of Arkansas for Medical Sciences Myeloma Institute for Research and Therapy
Little Rock, Arkansas 72205

Alta Bates Medical Center Cancer Center
Berkeley, California 94704

City of Hope
Duarte, California 91010

University of California at San Diego
La Jolla, California 92093

USC Norris Comprehensive Cancer Center
Los Angeles, California 90033

Samuel Oschin Comprehensive Cancer Center Cedars-Sinai Medical Center
Los Angeles, California 90048

University of California, Los Angeles UCLA
Los Angeles, California 90095

Hoag Memorial Hospital
Newport Beach, California 92658

Sutter Medical Foundation
Sacramento, California 95816

University of Calif Davis Medical Center
Sacramento, California 95817

UCSF
San Francisco, California 94143

Stanford University Medical Center
Stanford, California 94305

UCHealth Cancer Care Anschutz Medical Campus University of Colorado Cancer Center
Aurora, Colorado 80045

Colorado Blood Cancer Institute
Denver, Colorado 80218

Yale New Haven Hospital
New Haven, Connecticut 06520

Christiana Care
Newark, Delaware 19713

MedStar Georgetown Hospital
Washington D.C., District of Columbia 20007

University of Florida at Shands
Gainesville, Florida 32611

Mayo Clinic
Jacksonville, Florida 32224

University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida 33136

Miami Cancer Institute at Baptist Health / Baptist Health Medical Group
Miami, Florida 33176

Advent Health Orlando
Orlando, Florida 32803

Orlando Health
Orlando, Florida 32806

Memorial Healthcare System
Pembroke Pines, Florida 33028

Tampa General Hospital
Tampa, Florida 33606

H Lee Moffitt Cancer Center
Tampa, Florida 33612

Emory University
Atlanta, Georgia 30322

Northside Hospital Cancer Institute
Atlanta, Georgia 30342

City of Hope Cancer Center
Newnan, Georgia 30265

Kapi Olani Medical Center for Women and Children Hawaii Pacific
Honolulu, Hawaii 96826

St. Luke's Mountain State Tumor Institute
Boise, Idaho 83712

Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion
Chicago, Illinois 60611

Rush University Medical Center
Chicago, Illinois 60612

University Of Illinois
Chicago, Illinois 60612

The University of Chicago Medical Center (UCMC)
Chicago, Illinois 60637

NorthShore University Health System, Evanston Hospital
Evanston, Illinois 60201

Loyola University Medical Center
Maywood, Illinois 60153

Advocate Lutheran General Hospital
Park Ridge, Illinois 60068

City of Hope Chicago
Zion, Illinois 60099

IU Health University Hospital
Indianapolis, Indiana 46202

St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation
Indianapolis, Indiana 46237 8601

Community Health Network MD Anderson Cancer Center
Kokomo, Indiana 46902

University of Iowa Hospital and Clinics
Iowa City, Iowa 52242

University of Kansas Cancer Center
Fairway, Kansas 66205

Ascension via Christi Research
Wichita, Kansas 67214

University of Kentucky Chandler Medical Center
Lexington, Kentucky 40508

University of Louisville - James Graham Brown Cancer Center
Louisville, Kentucky 40202

Norton Cancer Institute
Louisville, Kentucky 40207

Ochsner Clinic Foundation
New Orleans, Louisiana 70121

University of Maryland School of Medicine
Baltimore, Maryland 21201

Johns Hopkins University School of Medicine JHUSOM
Baltimore, Maryland 21205

Tufts New England Medical Center
Boston, Massachusetts 02111

Massachusetts General
Boston, Massachusetts 02114

Boston University Medical Center
Boston, Massachusetts 02118

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215

Dana-Farber Brigham and Women's Cancer Center
Weymouth, Massachusetts 02190

University of Massachusetts Medical School
Worcester, Massachusetts 01655

University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48109

Barbara Ann Karmanos Cancer Institute - Lawrence and Idell Weisberg Cancer Treatment Center
Farmington Hills, Michigan 48334

Corewell Health Grand Rapids Hospitals Butterworth
Grand Rapids, Michigan 49503

William Beaumont Health System
Royal Oak, Michigan 48073

M Health Fairview University of Minnesota Medical Center East Bank
Minneapolis, Minnesota 55455

Mayo Clinic Rochester
Rochester, Minnesota 55905

University of Mississippi Medical Center
Jackson, Mississippi 39213

Ellis Fischel Cancer Center
Columbia, Missouri 65201

Saint Louis University
St Louis, Missouri 63110

Washington University School Of Medicine
St Louis, Missouri 63110

University of Nebraska Medical Center
Omaha, Nebraska 68198

Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756

John Theurer Cancer Center at Hackensack University Medical Center
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

University of New Mexico School of Medicine
Albuquerque, New Mexico 87106

Roswell Park Comprehensive Cancer Center
Buffalo, New York 14203

The Feinstein Institute for Medical Research (Northwell Health Inc.)
Manhasset, New York 11030

New York University Langone Medical Center
New York, New York 10010

Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg
New York, New York 10029

Columbia University Medical Center
New York, New York 10032

Memorial Sloan Kettering Cancer Center
New York, New York 10065

Weill Cornell Medical Center
New York, New York 10065

University of Rochester Medical Center
Rochester, New York 14642

Montefiore Medical Center
The Bronx, New York 10467

University of North Carolina Hospital
Chapel Hill, North Carolina 27514

Atrium Health
Charlotte, North Carolina 28204

Novant Health
Charlotte, North Carolina 28204

Duke University
Durham, North Carolina 27710

Novant Health Forsyth Medical Center
Winston-Salem, North Carolina 27103

Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina 27157

Sanford Health
Fargo, North Dakota 58122

Good Samaritan Hospital
Cincinnati, Ohio 45220

The Jewish Hospital - Mercy
Cincinnati, Ohio 45236

University Hospital of Cleveland
Cleveland, Ohio 44106

Cleveland Clinic
Cleveland, Ohio 44145

The Ohio State University Wexner Medical Center - James Cancer Hospital
Columbus, Ohio 43210

OhioHealth Mansfield Hospital
Columbus, Ohio 43214

University of Oklahoma Stephenson Cancer Center
Oklahoma City, Oklahoma 73104

Providence Portland Medical Center
Portland, Oregon 97213

Oregon Health And Science University
Portland, Oregon 97239

Geisinger Medical Center
Danville, Pennsylvania 17622

Penn State Milton S Hershey Medical Ctr
Hershey, Pennsylvania 17033

University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania 19104

Thomas Jefferson University
Philadelphia, Pennsylvania 19107

Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111

University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15323

Roger Williams Medical Center
Providence, Rhode Island 02908

Medical University of South Carolina
Charleston, South Carolina 29425

Prisma Health
Greenville, South Carolina 29615

Avera McKennan Hospital
Sioux Falls, South Dakota 57105

University of Tennessee Medical Center
Knoxville, Tennessee 37920

Baptist Clinical Research Institute
Memphis, Tennessee 38120

Sarah Cannon Cancer Institute
Nashville, Tennessee 37203

Tennessee Valley Healthcare System
Nashville, Tennessee 37212

Vanderbilt University Medical Center
Nashville, Tennessee 37232

St. David's South Austin Medical Center
Austin, Texas 78704

Texas Oncology-Medical City Dallas
Dallas, Texas 75230

Baylor University Medical Center
Dallas, Texas 75246

UT Southwestern Medical Center
Dallas, Texas 75390

Houston Methodist Hospital
Houston, Texas 77030

MD Anderson Cancer Center
Houston, Texas 77030

San Antonio Methodist TX Transplant Physicians Group
San Antonio, Texas 78229

Huntsman Cancer Institute
Salt Lake City, Utah 84112

Intermountain Healthcare
Salt Lake City, Utah 84143

University of Virginia
Charlottesville, Virginia 22903

Inova Schar Cancer Institute Dept of Fairfax Hospital
Fairfax, Virginia 22031

Virginia Oncology Associates
Norfolk, Virginia 23502

VCU Medical Center
Richmond, Virginia 23219

Swedish Cancer Institute First Hill
Seattle, Washington 98104

University of Washington School of Medicine
Seattle, Washington 98195

West Virginia University Medical Center
Morgantown, West Virginia 26506

University Of Wisconsin Hospital
Madison, Wisconsin 53792

Aurora Saint Lukes Medical Center
Milwaukee, Wisconsin 53215

Medical College Of Wisconsin
Milwaukee, Wisconsin 53226

More Details

NCT ID
NCT05346835
Status
Available
Sponsor
Janssen Scientific Affairs, LLC

Study Contact

Study Contact
1-800-526-7736
Janssenmedinfo@its.jnj.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.