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


Study First Submitted Date 2021-02-22
Study First Posted Date 2021-02-25
Last Update Posted Date 2023-01-23
Verification Month Year January 2023
Verification Date 2023-01-31
Last Update Posted Date 2023-01-23

Browse Interventions

Sequence: 95998481 Sequence: 95998482 Sequence: 95998483
Mesh Term Idecabtagene vicleucel Mesh Term Antineoplastic Agents, Immunological Mesh Term Antineoplastic Agents
Downcase Mesh Term idecabtagene vicleucel Downcase Mesh Term antineoplastic agents, immunological Downcase Mesh Term antineoplastic agents
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor


Sequence: 52139810
Name Multiple Myeloma
Downcase Name multiple myeloma

Id Information

Sequence: 40135636 Sequence: 40135637
Id Source org_study_id Id Source secondary_id
Id Value BB2121-EAP-001 Id Value U1111-1263-0642
Id Type Registry Identifier
Id Type Description WHO


Sequence: 42543435
Name United States
Removed True


Sequence: 52455726
Intervention Type Biological
Name Nonconforming idecabtagene vicleucel
Description Nonconforming idecabtagene vicleucel is to be administered to participants after lymphodepleting chemotherapy


Sequence: 79824108 Sequence: 79824109 Sequence: 79824110 Sequence: 79824111 Sequence: 79824112 Sequence: 79824113 Sequence: 79824114 Sequence: 79824115
Name BB2121 Name Multiple Myeloma Name Expanded Access Name idecabtagene vicleucel Name nonconforming Name CAR T Name EAP Name Pre-Approval Access
Downcase Name bb2121 Downcase Name multiple myeloma Downcase Name expanded access Downcase Name idecabtagene vicleucel Downcase Name nonconforming Downcase Name car t Downcase Name eap Downcase Name pre-approval access

Browse Conditions

Sequence: 193369678 Sequence: 193369679 Sequence: 193369680 Sequence: 193369681 Sequence: 193369682 Sequence: 193369683 Sequence: 193369684 Sequence: 193369685 Sequence: 193369686 Sequence: 193369687 Sequence: 193369688 Sequence: 193369689 Sequence: 193369690 Sequence: 193369691
Mesh Term Multiple Myeloma Mesh Term Neoplasms, Plasma Cell Mesh Term Neoplasms by Histologic Type Mesh Term Neoplasms Mesh Term Hemostatic Disorders Mesh Term Vascular Diseases Mesh Term Cardiovascular Diseases Mesh Term Paraproteinemias Mesh Term Blood Protein Disorders Mesh Term Hematologic Diseases Mesh Term Hemorrhagic Disorders Mesh Term Lymphoproliferative Disorders Mesh Term Immunoproliferative Disorders Mesh Term Immune System Diseases
Downcase Mesh Term multiple myeloma Downcase Mesh Term neoplasms, plasma cell Downcase Mesh Term neoplasms by histologic type Downcase Mesh Term neoplasms Downcase Mesh Term hemostatic disorders Downcase Mesh Term vascular diseases Downcase Mesh Term cardiovascular diseases Downcase Mesh Term paraproteinemias Downcase Mesh Term blood protein disorders Downcase Mesh Term hematologic diseases Downcase Mesh Term hemorrhagic disorders Downcase Mesh Term lymphoproliferative disorders Downcase Mesh Term immunoproliferative disorders Downcase Mesh Term immune system diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor


Sequence: 48291465
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Celgene

Overall Officials

Sequence: 29268937
Role Study Director
Name Bristol-Myers Squibb
Affiliation Bristol-Myers Squibb

Central Contacts

Sequence: 12000695 Sequence: 12000696
Contact Type primary Contact Type backup
Name Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, Name First line of the email MUST contain the NCT# and Site #.
Phone please email:
Email Clinical.Trials@bms.com
Role Contact Role Contact


Sequence: 30748210
Gender All
Minimum Age 18 Years
Maximum Age N/A
Criteria Inclusion Criteria: Had a participant-specific batch of Idecabtagene vicleucel (ide-cel) manufactured intended for commercial treatment; however, the final manufactured product was nonconforming and did not meet commercial release criteria Remanufacturing is deemed not feasible or clinically inappropriate per assessment of the treating physician in discussion with the participant Clinically stable 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 opinion of the treating physician, either increase the risk of Adverse Events associated with lymphodepleting chemotherapy, or exclude them from treatment with nonconforming Idecabtagene vicleucel (ide-cel) Has any condition and/or laboratory abnormality that places the participant at unacceptable risk if he/she were to participate in the Expanded Access Protocol based on the Investigator's judgement Other protocol-defined inclusion/exclusion criteria apply
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254125423
Registered In Calendar Year 2021
Were Results Reported False
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years

Intervention Other Names

Sequence: 26655793
Intervention Id 52455726
Name BB2121


Sequence: 4385478 Sequence: 4385479 Sequence: 4385480
Url https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html Url https://www.bmsstudyconnect.com/s/US/English/USenHome Url https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description BMS Clinical Trial Information Description BMS Clinical Trial Patient Recruiting Description FDA Safety Alerts and Recalls

Responsible Parties

Sequence: 28860767
Responsible Party Type Sponsor