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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1263-0642 | Registry Identifier | WHO |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nonconforming idecabtagene vicleucel | Biological | Nonconforming idecabtagene vicleucel is to be administered to participants after lymphodepleting chemotherapy |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, | Contact | please email: | Clinical.Trials@bms.com | |
| First line of the email MUST contain the NCT# and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41894689 | Derived | Sidana S, Lin Y, Cowan AJ, Rodriguez-Otero P, Scheid C, Mueller PJ, Broussard C, Krengel P, Li Y, Piault R, Corrao A, Ho C, Patel K. Idecabtagene vicleucel manufacturing and clinical value of out-of-specification products in relapsed and refractory MM. Blood Adv. 2026 Jun 9;10(11):3769-3776. doi: 10.1182/bloodadvances.2025017186. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C000715380 | idecabtagene vicleucel |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |