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

Study Purpose

This study is designed to evaluate the safety and efficacy of nonconforming idecabtagene vicleucel (ide-cel) in subjects 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Expanded Access
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Subject has multiple myeloma, 18 years of age or older and subject or legally authorized representative is able to sign the informed consent form. 2. Subject had a subject-specific batch of idecabtagene vicluecel manufactured intended for commercial treatment; however, the final manufactured product was nonconforming and did not meet commercial release criteria. The Sponsor has determined that the nonconforming idecabtagene vicleucel may be released for use under the Expanded Access Protocol. 3. Remanufacturing is deemed not feasible or clinically inappropriate per assessment of the treating physician in discussion with the subject. 4. Subject is clinically stable, has recovered from any prior toxicities prior to receiving lymphodepleting chemotherapy, and has adequate bone marrow function to receive lymphodepleting chemotherapy. 5. Females of childbearing potential must: 1. Have a negative pregnancy test as verified by the treating physician within 7 days prior to the first dose of lymphodepleting chemotherapy following institutional testing methodology practices. This applies even if the subject practices true abstinence from heterosexual contact. 2. Either commit to true abstinence from heterosexual contact or agree to use, and be able to comply with, effective contraception without interruption. Contraception methods must include 1 highly effective method from screening until at least 12 months after the lymphodepleting chemotherapy. 3. Agree to abstain from breastfeeding during study participation and for at least 12 months following lymphodepleting chemotherapy. 4. There are insufficient exposure data to provide any recommendation concerning the duration of contraception and the abstaining from breastfeeding following treatment with nonconforming idecabtagene vicluecel. Any decision regarding contraception and breastfeeding after infusion should be discussed with the treating physician. 6. Male subjects must: 1. Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential for at least 12 months after lymphodepleting chemotherapy even if the subject has undergone a successful vasectomy. 2. There are insufficient exposure data to provide any recommendation concerning the duration of contraception following treatment with nonconforming idecabtagene vicluecel. Any decision regarding contraception after infusion should be discussed with the treating physician. Subject must agree to not donate blood, organs, tissue, sperm or semen and egg cells for usage in other individuals for at least 1 year following lymphodepleting chemotherapy. There are insufficient exposure data to provide any recommendation concerning the duration of refraining from tissue donation following treatment with nonconforming idecabtagene vicluecel. Therefore, participants treated with nonconforming idecabtagene vicluecel should not donate blood, organs, tissues, and cells for transplantation.

Exclusion Criteria:

1. Subject has a hypersensitivity to the active substance or to any of the excipients. 2. Subject should not experience a significant worsening in clinical status that would, in the opinion of the treating physician, either increase the risk of AEs associated with lymphodepleting chemotherapy or exclude them from treatment with nonconforming idecabtagene vicluecel. 3. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness, sociologic or geographic condition that would prevent the subject from participating in the Expanded Access Protocol, complying with protocol requirements or confound the ability to interpret the data in the Investigator's judgement. 4. Subject has any condition and/or laboratory abnormality that places the subject at unacceptable risk if he/she were to participate in the Expanded Access Protocol based on the Investigator's judgement. 5. Pregnant or nursing women or has intention of becoming pregnant during the study.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04771078
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Celgene
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Amit Agarwal, MD
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Available
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama, Birmingham, Alabama

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Available

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University of Alabama

Birmingham, Alabama, 35205

City of Hope Cancer Center, Duarte, California

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Available

Address

City of Hope Cancer Center

Duarte, California, 91010-3000

La Jolla, California

Status

Available

Address

University of California San Diego Moores Cancer Center

La Jolla, California, 92093

Cedars-Sinai Medical Center, Los Angeles, California

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Available

Address

Cedars-Sinai Medical Center

Los Angeles, California, 90048

UCLA School of Medicine, Los Angeles, California

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Available

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UCLA School of Medicine

Los Angeles, California, 90095

San Francisco, California

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Available

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University of California San Francisco Medical Center

San Francisco, California, 94142

Stanford University, Stanford, California

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Available

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Stanford University

Stanford, California, 94305

University of Colorado, Aurora, Colorado

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Available

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University of Colorado

Aurora, Colorado, 80045

Colorado Blood Cancer Institute, Denver, Colorado

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Available

Address

Colorado Blood Cancer Institute

Denver, Colorado, 80218

Yale Cancer Center, New Haven, Connecticut

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Available

Address

Yale Cancer Center

New Haven, Connecticut, 06510

Medstar Georgetown University Hospital, Washington, District of Columbia

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Available

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Medstar Georgetown University Hospital

Washington, District of Columbia, 20007

Mayo Clinic - Jacksonville, Jacksonville, Florida

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Available

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Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224

Miami, Florida

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Available

Address

University of Miami Sylvester Cancer Center

Miami, Florida, 33136

H Lee Moffitt Cancer Center, Tampa, Florida

Status

Available

Address

H Lee Moffitt Cancer Center

Tampa, Florida, 32207

Atlanta, Georgia

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Available

Address

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322

Northside Hospital, Inc, Atlanta, Georgia

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Available

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Northside Hospital, Inc

Atlanta, Georgia, 30342

Chicago, Illinois

Status

Available

Address

Robert H. Lurie Comprehensive Cancer Center

Chicago, Illinois, 60611

University of Illinois Medical Center, Chicago, Illinois

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Available

Address

University of Illinois Medical Center

Chicago, Illinois, 60612

University of Chicago, Chicago, Illinois

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Available

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University of Chicago

Chicago, Illinois, 60637

Zion, Illinois

Status

Available

Address

Cancer Treatment Centers of America, Chicago

Zion, Illinois, 60099

Indiana University Cancer Center, Indianapolis, Indiana

Status

Available

Address

Indiana University Cancer Center

Indianapolis, Indiana, 46202-528

University of Iowa Hospitals and Clinics, Iowa City, Iowa

Status

Available

Address

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242

University of Kansas Medical Center, Westwood, Kansas

Status

Available

Address

University of Kansas Medical Center

Westwood, Kansas, 66205

Cancer Center of Kansas, Wichita, Kansas

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Available

Address

Cancer Center of Kansas

Wichita, Kansas, 67214

University of Kentucky, Lexington, Kentucky

Status

Available

Address

University of Kentucky

Lexington, Kentucky, 40536

Baltimore, Maryland

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Available

Address

University of Maryland - Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201

Boston, Massachusetts

Status

Available

Address

Massachusetts General Hospital / Dana-Farber Cancer Institute

Boston, Massachusetts, 02114

Dana Farber Cancer Institute, Boston, Massachusetts

Status

Available

Address

Dana Farber Cancer Institute

Boston, Massachusetts, 02115

Beth Israel Deaconess Medical Center, Boston, Massachusetts

Status

Available

Address

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

Ann Arbor, Michigan

Status

Available

Address

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109

Karmanos Cancer Institute, Detroit, Michigan

Status

Available

Address

Karmanos Cancer Institute

Detroit, Michigan, 48201

University of Minnesota, Minneapolis, Minnesota

Status

Available

Address

University of Minnesota

Minneapolis, Minnesota, 55455

Mayo Clinic, Rochester, Minnesota

Status

Available

Address

Mayo Clinic

Rochester, Minnesota, 55905

Saint Louis, Missouri

Status

Available

Address

Washington Univ School of Medicine Siteman Cancer Center

Saint Louis, Missouri, 63110

University of Nebraska Medical Center, Omaha, Nebraska

Status

Available

Address

University of Nebraska Medical Center

Omaha, Nebraska, 68105

Darthmouth Hitchcock Medical Center, Lebanon, New Hampshire

Status

Available

Address

Darthmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756

Hackensack University Medical Center, Hackensack, New Jersey

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Available

Address

Hackensack University Medical Center

Hackensack, New Jersey, 07601

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey

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Available

Address

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903

Roswell Park Cancer Institute, Buffalo, New York

Status

Available

Address

Roswell Park Cancer Institute

Buffalo, New York, 14263

New York Presbyterian Cornell University, New York, New York

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Available

Address

New York Presbyterian Cornell University

New York, New York, 10021

Mount Sinai Hospital, New York, New York

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Available

Address

Mount Sinai Hospital

New York, New York, 10029

Columbia-Presbyterian Medical Center, New York, New York

Status

Available

Address

Columbia-Presbyterian Medical Center

New York, New York, 10032

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Available

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

University of Rochester Cancer Center, Rochester, New York

Status

Available

Address

University of Rochester Cancer Center

Rochester, New York, 14642

Chapel Hill, North Carolina

Status

Available

Address

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514

Oncology Hematology Care, Inc., Cincinnati, Ohio

Status

Available

Address

Oncology Hematology Care, Inc.

Cincinnati, Ohio, 45236

Cleveland Clinic, Cleveland, Ohio

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Available

Address

Cleveland Clinic

Cleveland, Ohio, 44106

Cleveland, Ohio

Status

Available

Address

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

Columbus, Ohio

Status

Available

Address

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210

Providence Portland Medical Center, Portland, Oregon

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Available

Address

Providence Portland Medical Center

Portland, Oregon, 97213

Portland, Oregon

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Available

Address

Oregon Health and Science University OHSU

Portland, Oregon, 97239

University Of Pennsylvania, Philadelphia, Pennsylvania

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Available

Address

University Of Pennsylvania

Philadelphia, Pennsylvania, 19104

Thomas Jefferson University, Philadelphia, Pennsylvania

Status

Available

Address

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

Fox Chase Cancer Center, Philadelphia, Pennsylvania

Status

Available

Address

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

Allegheny Health Network, Pittsburgh, Pennsylvania

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Available

Address

Allegheny Health Network

Pittsburgh, Pennsylvania, 15224

Pittsburgh, Pennsylvania

Status

Available

Address

University of Pittsburgh Medical Center Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

Charleston, South Carolina

Status

Available

Address

Medical University of South Carolina Hollings Cancer Center

Charleston, South Carolina, 29425

Greenville Health System, Greenville, South Carolina

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Available

Address

Greenville Health System

Greenville, South Carolina, 29615

Sioux Falls, South Dakota

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Available

Address

Avera McKennan Hospital & University Health Center

Sioux Falls, South Dakota, 57105

Sarah Cannon Research Institute, Nashville, Tennessee

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Available

Address

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

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

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Available

Address

St. David's South Austin Medical Center

Austin, Texas, 78704

Medical City Dallas Hospital, Dallas, Texas

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Available

Address

Medical City Dallas Hospital

Dallas, Texas, 75230

Dallas, Texas

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Available

Address

UT Southwestern Medical Center Simmons Comprehensive Cancer Center

Dallas, Texas, 75390-8852

Dallas, Texas

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Available

Address

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75426

Texas Medical Center, Houston, Texas

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Available

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Texas Medical Center

Houston, Texas, 77030

Houston, Texas

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Available

Address

The University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030

San Antonio, Texas

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Available

Address

Methodist Hospital - Texas Transplant Institute

San Antonio, Texas, 78229

Salt Lake City, Utah

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Available

Address

University of Utah - Huntsman Cancer Institute

Salt Lake City, Utah, 84112

Intermountain Healthcare - LDS Hospital, Salt Lake City, Utah

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Available

Address

Intermountain Healthcare - LDS Hospital

Salt Lake City, Utah, 84143

VCU Massey Cancer Center, Richmond, Virginia

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Available

Address

VCU Massey Cancer Center

Richmond, Virginia, 23298-0037

Fred Hutchinson Cancer Research Center, Seattle, Washington

Status

Available

Address

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109

Morgantown, West Virginia

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Available

Address

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

Morgantown, West Virginia, 26506

University of Wisconsin Medical School, Madison, Wisconsin

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Available

Address

University of Wisconsin Medical School

Madison, Wisconsin, 53792

Milwaukee, Wisconsin

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Available

Address

Froedtert Hospital BMT Medical College of Wisconsin

Milwaukee, Wisconsin, 53226-3522