Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-Cel) Out-of-Specification (OOS) in Participants With Multiple Myeloma

February 12, 2026 updated by: Janssen Scientific Affairs, LLC

Intermediate-Size Population Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) in Patients With Multiple Myeloma

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Available

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Expanded Access Type

Expanded Access Type

Describes the category of expanded access under U.S. Food and Drug Administration (FDA) regulations. There are three types of expanded access:
  • Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation.
  • Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA.
  • Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use.
  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Scientific Affairs, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108968
  • 68284528MMY4006 (Other Identifier: Janssen Research & Development, LLC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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