Expanded Access Protocol (EAP) for Participants Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release

Last updated: January 19, 2023
Sponsor: Celgene
Overall Status: Planned

Phase

N/A

Condition

Multiple Myeloma

Leukemia

Lymphoproliferative Disorders

Treatment

N/A

Clinical Study ID

NCT04771078
BB2121-EAP-001
U1111-1263-0642
  • Ages > 18
  • All Genders

Study Summary

This study is designed to evaluate the safety and efficacy of nonconforming idecabtagene vicleucel (ide-cel) in participants with multiple myeloma per the approved prescribing information. This is an expanded access protocol (EAP) to be conducted at Risk Evaluation and Mitigation Strategies (REMS) qualified sites approved for commercial administration of idecabtagene vicleucel and where the EAP is authorized to be conducted for use of nonconforming idecabtagene vicleucel.

Non-conforming idecabtagene vicluecel is idecabtagene vicleucel that does not meet commercial release specifications but may be acceptable for use as an investigational product in the Expanded Access Protocol setting.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Had a participant-specific batch of Idecabtagene vicleucel (ide-cel) manufacturedintended for commercial treatment; however, the final manufactured product wasnonconforming and did not meet commercial release criteria
  • Remanufacturing is deemed not feasible or clinically inappropriate per assessment ofthe treating physician in discussion with the participant
  • Clinically stable

Exclusion

Exclusion Criteria:

  • Has a hypersensitivity to the active substance or to any of the excipients
  • No experience of a significant worsening in clinical status that would, in the opinionof the treating physician, either increase the risk of Adverse Events associated withlymphodepleting chemotherapy, or exclude them from treatment with nonconformingIdecabtagene vicleucel (ide-cel)
  • Has any condition and/or laboratory abnormality that places the participant atunacceptable risk if he/she were to participate in the Expanded Access Protocol basedon the Investigator's judgement Other protocol-defined inclusion/exclusion criteria apply

Study Design

Study Start date:
Estimated Completion Date:

Connect with a study center

  • University of Alabama

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • Univ of AR for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • City of Hope Cancer Center

    Duarte, California 91010-3000
    United States

    Site Not Available

  • University of California San Diego Moores Cancer Center

    La Jolla, California 92093
    United States

    Site Not Available

  • UCLA School of Medicine

    Los Angeles, California 90095
    United States

    Site Not Available

  • University of California San Francisco Medical Center

    San Francisco, California 94142
    United States

    Site Not Available

  • Stanford University

    Stanford, California 94305
    United States

    Site Not Available

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Colorado Blood Cancer Institute

    Denver, Colorado 80218
    United States

    Site Not Available

  • Yale Cancer Center

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Medstar Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • University of Miami Sylvester Cancer Center

    Miami, Florida 33136
    United States

    Site Not Available

  • H Lee Moffitt Cancer Center

    Tampa, Florida 32207
    United States

    Site Not Available

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Cancer Treatment Centers of America, Chicago

    Zion, Illinois 60099
    United States

    Site Not Available

  • Indiana University Cancer Center

    Indianapolis, Indiana 46202-528
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Kansas Medical Center

    Westwood, Kansas 66205
    United States

    Site Not Available

  • Cancer Center of Kansas

    Wichita, Kansas 67214
    United States

    Site Not Available

  • University of Kentucky

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • University of Maryland - Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • University of Massachusetts

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Spectrum Health

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Washington Univ School of Medicine Siteman Cancer Center

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • University of Nebraska Medical Center

    Omaha, Nebraska 68105
    United States

    Site Not Available

  • Darthmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08903
    United States

    Site Not Available

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Site Not Available

  • New York Presbyterian Cornell University

    New York, New York 10021
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • University of Cincinnati

    Cincinnati, Ohio 45267-0501
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Providence Portland Medical Center

    Portland, Oregon 97213
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Allegheny Health Network

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Medical University of South Carolina Hollings Cancer Center

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Greenville Health System

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Avera McKennan Hospital & University Health Center

    Sioux Falls, South Dakota 57105
    United States

    Site Not Available

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • St. David's South Austin Medical Center

    Austin, Texas 78704
    United States

    Site Not Available

  • UT Southwestern Medical Center Simmons Comprehensive Cancer Center

    Dallas, Texas 75390-8852
    United States

    Site Not Available

  • Texas Medical Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Methodist Hospital - Texas Transplant Institute

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Intermountain Healthcare - LDS Hospital

    Salt Lake City, Utah 84143
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • VCU Massey Cancer Center

    Richmond, Virginia 23298-0037
    United States

    Site Not Available

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington 98109
    United States

    Site Not Available

  • West Virginia University - Berkeley Medical Center - Cancer and Infusion Center

    Morgantown, West Virginia 26506
    United States

    Site Not Available

  • University of Wisconsin Medical School

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • Froedtert Hospital BMT Medical College of Wisconsin

    Milwaukee, Wisconsin 53226-3522
    United States

    Site Not Available

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