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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 4049979, Alabama 4829764 35294

Banner MD Anderson Cancer Center
Gilbert 5295903, Arizona 5551752 85234

Cancer Treatment Center of America Phoenix
Goodyear 5296266, Arizona 5551752 85338

HonorHealth Cancer Transplant Institute
Scottsdale 5313457, Arizona 5551752 85258

Mayo Clinic
Scottsdale 5313457, Arizona 5551752 85259

University of Arizona Cancer Center
Tucson 5318313, Arizona 5551752 85719

The University of Arkansas for Medical Sciences Myeloma Institute for Research and Therapy
Little Rock 4119403, Arkansas 4099753 72205

City of Hope
Duarte 5344147, California 5332921 91010

University of California at San Diego
La Jolla 5363943, California 5332921 92093

USC Norris Comprehensive Cancer Center
Los Angeles 5368361, California 5332921 90033

Samuel Oschin Comprehensive Cancer Center Cedars-Sinai Medical Center
Los Angeles 5368361, California 5332921 90048

University of California, Los Angeles UCLA
Los Angeles 5368361, California 5332921 90095

UCSF
San Francisco 5391959, California 5332921 94143

Stanford University Medical Center
Stanford 5398563, California 5332921 94305

UCHealth Cancer Care Anschutz Medical Campus University of Colorado Cancer Center
Aurora 5412347, Colorado 5417618 80045

Colorado Blood Cancer Institute
Denver 5419384, Colorado 5417618 80218

Yale New Haven Hospital
New Haven 4839366, Connecticut 4831725 06520

Christiana Care
Newark 4143861, Delaware 4142224 19713

MedStar Georgetown Hospital
Washington D.C. 4140963, District of Columbia 4138106 20007

University of Florida at Shands
Gainesville 4156404, Florida 4155751 32611

Mayo Clinic
Jacksonville 4160021, Florida 4155751 32224

University of Miami Sylvester Comprehensive Cancer Center
Miami 4164138, Florida 4155751 33136

Miami Cancer Institute at Baptist Health / Baptist Health Medical Group
Miami 4164138, Florida 4155751 33176

Advent Health Orlando
Orlando 4167147, Florida 4155751 32803

Memorial Healthcare System
Pembroke Pines 4168139, Florida 4155751 33028

H Lee Moffitt Cancer Center
Tampa 4174757, Florida 4155751 33612

Emory University
Atlanta 4180439, Georgia 4197000 30322

Northside Hospital Cancer Institute
Atlanta 4180439, Georgia 4197000 30342

City of Hope Cancer Center
Newnan 4212684, Georgia 4197000 30265

St. Luke's Mountain State Tumor Institute
Boise 5586437, Idaho 5596512 83712

Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion
Chicago 4887398, Illinois 4896861 60611

Rush University Medical Center
Chicago 4887398, Illinois 4896861 60612

University Of Illinois
Chicago 4887398, Illinois 4896861 60612

The University of Chicago Medical Center (UCMC)
Chicago 4887398, Illinois 4896861 60637

Loyola University Medical Center
Maywood 4901514, Illinois 4896861 60153

Advocate Lutheran General Hospital
Park Ridge 4905367, Illinois 4896861 60068

City of Hope Chicago
Zion 4917358, Illinois 4896861 60099

IU Health University Hospital
Indianapolis 4259418, Indiana 4921868 46202

St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation
Indianapolis 4259418, Indiana 4921868 46237 8601

University of Iowa Hospital and Clinics
Iowa City 4862034, Iowa 4862182 52242

University of Kansas Cancer Center
Fairway 4271358, Kansas 4273857 66205

University of Kentucky Chandler Medical Center
Lexington 4297983, Kentucky 6254925 40508

University of Louisville - James Graham Brown Cancer Center
Louisville 4299276, Kentucky 6254925 40202

Ochsner Clinic Foundation
New Orleans 4335045, Louisiana 4331987 70121

University of Maryland School of Medicine
Baltimore 4347778, Maryland 4361885 21201

Johns Hopkins University School of Medicine JHUSOM
Baltimore 4347778, Maryland 4361885 21205

Tufts New England Medical Center
Boston 4930956, Massachusetts 6254926 02111

Massachusetts General
Boston 4930956, Massachusetts 6254926 02114

Boston University Medical Center
Boston 4930956, Massachusetts 6254926 02118

Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215

Dana-Farber Brigham and Women's Cancer Center
Weymouth 4955336, Massachusetts 6254926 02190

University of Massachusetts Medical School
Worcester 4956184, Massachusetts 6254926 01655

University of Michigan Rogel Cancer Center
Ann Arbor 4984247, Michigan 5001836 48109

Barbara Ann Karmanos Cancer Institute - Lawrence and Idell Weisberg Cancer Treatment Center
Farmington Hills 4992523, Michigan 5001836 48334

William Beaumont Health System
Royal Oak 5007804, Michigan 5001836 48073

M Health Fairview University of Minnesota Medical Center East Bank
Minneapolis 5037649, Minnesota 5037779 55455

Mayo Clinic Rochester
Rochester 5043473, Minnesota 5037779 55905

University of Mississippi Medical Center
Jackson 4431410, Mississippi 4436296 39213

Saint Louis University
St Louis 4407066, Missouri 4398678 63110

Washington University School Of Medicine
St Louis 4407066, Missouri 4398678 63110

University of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 68198

John Theurer Cancer Center at Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760 07601

Rutgers, The State Univ of NJ-Robert Wood Johnson Medical School-The Cancer Institute of NJ (CINJ)
New Brunswick 5101717, New Jersey 5101760 08901-1914

University of New Mexico School of Medicine
Albuquerque 5454711, New Mexico 5481136 87106

Roswell Park Comprehensive Cancer Center
Buffalo 5110629, New York 5128638 14203

The Feinstein Institute for Medical Research (Northwell Health Inc.)
Manhasset 5125766, New York 5128638 11030

New York University Langone Medical Center
New York 5128581, New York 5128638 10010

Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg
New York 5128581, New York 5128638 10029

Columbia University Medical Center
New York 5128581, New York 5128638 10032

Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10065

Weill Cornell Medical Center
New York 5128581, New York 5128638 10065

University of Rochester Medical Center
Rochester 5134086, New York 5128638 14642

Montefiore Medical Center
The Bronx 5110266, New York 5128638 10467

University of North Carolina Hospital
Chapel Hill 4460162, North Carolina 4482348 27514

Atrium Health
Charlotte 4460243, North Carolina 4482348 28204

Novant Health
Charlotte 4460243, North Carolina 4482348 28204

Duke University
Durham 4464368, North Carolina 4482348 27710

Novant Health Forsyth Medical Center
Winston-Salem 4499612, North Carolina 4482348 27103

Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem 4499612, North Carolina 4482348 27157

Sanford Health
Fargo 5059163, North Dakota 5690763 58122

The Jewish Hospital - Mercy
Cincinnati 4508722, Ohio 5165418 45236

University Hospital of Cleveland
Cleveland 5150529, Ohio 5165418 44106

Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44145

The Ohio State University Wexner Medical Center - James Cancer Hospital
Columbus 4509177, Ohio 5165418 43210

OhioHealth Mansfield Hospital
Columbus 4509177, Ohio 5165418 43214

University of Oklahoma Stephenson Cancer Center
Oklahoma City 4544349, Oklahoma 4544379 73104

Oregon Health And Science University
Portland 5746545, Oregon 5744337 97239

Penn State Milton S Hershey Medical Ctr
Hershey 5193342, Pennsylvania 6254927 17033

University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine
Philadelphia 4560349, Pennsylvania 6254927 19104

Thomas Jefferson University
Philadelphia 4560349, Pennsylvania 6254927 19107

Fox Chase Cancer Center
Philadelphia 4560349, Pennsylvania 6254927 19111

University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
Pittsburgh 5206379, Pennsylvania 6254927 15323

Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425

Prisma Health
Greenville 4580543, South Carolina 4597040 29615

Avera McKennan Hospital
Sioux Falls 5231851, South Dakota 5769223 57105

University of Tennessee Medical Center
Knoxville 4634946, Tennessee 4662168 37920

Sarah Cannon Cancer Institute
Nashville 4644585, Tennessee 4662168 37203

Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232

St. David's South Austin Medical Center
Austin 4671654, Texas 4736286 78704

Texas Oncology-Medical City Dallas
Dallas 4684888, Texas 4736286 75230

Baylor University Medical Center
Dallas 4684888, Texas 4736286 75246

UT Southwestern Medical Center
Dallas 4684888, Texas 4736286 75390

Houston Methodist Hospital
Houston 4699066, Texas 4736286 77030

MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030

San Antonio Methodist TX Transplant Physicians Group
San Antonio 4726206, Texas 4736286 78229

Huntsman Cancer Institute
Salt Lake City 5780993, Utah 5549030 84112

Intermountain Healthcare
Salt Lake City 5780993, Utah 5549030 84143

Inova Schar Cancer Institute Dept of Fairfax Hospital
Fairfax 4758023, Virginia 6254928 22031

Virginia Oncology Associates
Norfolk 4776222, Virginia 6254928 23502

VCU Medical Center
Richmond 4781708, Virginia 6254928 23219

Swedish Cancer Institute First Hill
Seattle 5809844, Washington 5815135 98104

University of Washington School of Medicine
Seattle 5809844, Washington 5815135 98195

West Virginia University Medical Center
Morgantown 4815352, West Virginia 4826850 26506

University Of Wisconsin Hospital
Madison 5261457, Wisconsin 5279468 53792

Aurora Saint Lukes Medical Center
Milwaukee 5263045, Wisconsin 5279468 53215

Medical College Of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 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.