Official Title
Expanded Access Protocol (EAP) for Patients Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release
Brief Summary

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.

Available
Intermediate-size Population
Multiple Myeloma

Biological: Nonconforming idecabtagene vicleucel
Nonconforming idecabtagene vicleucel is to be administered to subjects after lymphodepleting chemotherapy.
Other Name: BB2121

Eligibility 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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
United States
Locations

University of Alabama
Birmingham, Alabama, 35205

Available

City of Hope Cancer Center
Duarte, California, 91010-3000

Available

University of California San Diego Moores Cancer Center
La Jolla, California, 92093

Available

Cedars-Sinai Medical Center
Los Angeles, California, 90048

Available

UCLA School of Medicine
Los Angeles, California, 90095

Available

University of California San Francisco Medical Center
San Francisco, California, 94142

Available

Stanford University
Stanford, California, 94305

Available

Colorado Blood Cancer Institute
Denver, Colorado, 80218

Available

Yale Cancer Center
New Haven, Connecticut, 06510

Available

Medstar Georgetown University Hospital
Washington, District of Columbia, 20007

Available

Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224

Available

University of Miami Sylvester Cancer Center
Miami, Florida, 33136

Available

H Lee Moffitt Cancer Center
Tampa, Florida, 32207

Available

Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322

Available

Northside Hospital, Inc
Atlanta, Georgia, 30342

Available

Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, 60611

Available

Rush University Medical Center
Chicago, Illinois, 60612

Available

University of Illinois Medical Center
Chicago, Illinois, 60612

Available

University of Chicago
Chicago, Illinois, 60637

Available

Cancer Treatment Centers of America, Chicago
Zion, Illinois, 60099

Available

Indiana University Cancer Center
Indianapolis, Indiana, 46202-528

Available

University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242

Available

University of Kansas Medical Center
Westwood, Kansas, 66205

Available

Cancer Center of Kansas
Wichita, Kansas, 67214

Available

University of Kentucky
Lexington, Kentucky, 40536

Available

University of Maryland - Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201

Available

Massachusetts General Hospital / Dana-Farber Cancer Institute
Boston, Massachusetts, 02114

Available

Dana Farber Cancer Institute
Boston, Massachusetts, 02115

Available

Boston Medical Center
Boston, Massachusetts, 02118

Available

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215

Available

University of Massachusetts
Worcester, Massachusetts, 01655

Available

University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109

Available

Karmanos Cancer Institute
Detroit, Michigan, 48201

Available

Henry Ford Hospital
Detroit, Michigan, 48202

Available

Spectrum Health
Grand Rapids, Michigan, 49503

Available

University of Minnesota
Minneapolis, Minnesota, 55455

Available

Mayo Clinic
Rochester, Minnesota, 55905

Available

Washington Univ School of Medicine Siteman Cancer Center
Saint Louis, Missouri, 63110

Available

University of Nebraska Medical Center
Omaha, Nebraska, 68105

Available

Darthmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756

Available

Hackensack University Medical Center
Hackensack, New Jersey, 07601

Available

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903

Available

Roswell Park Cancer Institute
Buffalo, New York, 14263

Available

New York Presbyterian Cornell University
New York, New York, 10021

Available

Mount Sinai Hospital
New York, New York, 10029

Available

Columbia-Presbyterian Medical Center
New York, New York, 10032

Available

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

Available

University of Rochester Cancer Center
Rochester, New York, 14642

Available

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514

Available

University of Cincinnati
Cincinnati, Ohio, 45267-0501

Available

Cleveland Clinic
Cleveland, Ohio, 44106

Available

University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106

Available

Ohio State University Wexner Medical Center
Columbus, Ohio, 43210

Available

Providence Portland Medical Center
Portland, Oregon, 97213

Available

Oregon Health and Science University OHSU
Portland, Oregon, 97239

Available

University Of Pennsylvania
Philadelphia, Pennsylvania, 19104

Available

Thomas Jefferson University
Philadelphia, Pennsylvania, 19107

Available

Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111

Available

Allegheny Health Network
Pittsburgh, Pennsylvania, 15224

Available

Medical University of South Carolina Hollings Cancer Center
Charleston, South Carolina, 29425

Available

Greenville Health System
Greenville, South Carolina, 29615

Available

Avera McKennan Hospital & University Health Center
Sioux Falls, South Dakota, 57105

Available

Sarah Cannon Research Institute
Nashville, Tennessee, 37203

Available

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

Available

Medical City Dallas Hospital
Dallas, Texas, 75230

Available

UT Southwestern Medical Center Simmons Comprehensive Cancer Center
Dallas, Texas, 75390-8852

Available

Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75426

Available

Texas Medical Center
Houston, Texas, 77030

Available

The University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030

Available

Methodist Hospital - Texas Transplant Institute
San Antonio, Texas, 78229

Available

University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, 84112

Available

Intermountain Healthcare - LDS Hospital
Salt Lake City, Utah, 84143

Available

University of Virginia
Charlottesville, Virginia, 22908

Available

VCU Massey Cancer Center
Richmond, Virginia, 23298-0037

Available

Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109

Available

West Virginia University - Berkeley Medical Center - Cancer and Infusion Center
Morgantown, West Virginia, 26506

Available

University of Wisconsin Medical School
Madison, Wisconsin, 53792

Available

Froedtert Hospital BMT Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3522

Available

Contacts

Associate Director Clinical Trial Disclosure
1-888-260-1599
clinicaltrialdisclosure@bms.com

Amit Agarwal, MD
Study Director
Bristol-Myers Squibb

NCT Number
Keywords
BB2121
Multiple myeloma
Expanded Access
idecabtagene vicleucel
nonconforming
CAR T
EAP
MeSH Terms
Multiple Myeloma
Intervention Name
Nonconforming idecabtagene vicleucel