PlatoHealth

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

Time Stamp: November 2, 2023 1:51 AM
Source Node: 247470

Studies

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

Conditions

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

Countries

Sequence:	42543435
Name	United States
Removed	True

Interventions

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

Keywords

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

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

Eligibilities

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

Links

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