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This study is researching whether the use of tocilizumab before the first dose of linvoseltamab will decrease the risk of Cytokine Release Syndrome (CRS) in participants who have Relapsed or Refractory Multiple Myeloma (RRMM) who have already been treated with at least four lines of treatment for their multiple myeloma, including medicines called a proteasome inhibitor, an immunomodulatory drug, and an anti-Cluster of Differentiation (CD) 38 antibody.
The aim of the study is to see how safe, tolerable and effective linvoseltamab is when given after tocilizumab.
The study is looking at several other research questions, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Linvoseltamab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linvoseltamab | Drug | Administered per the protocol |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of any grade CRS per American Society for Transplantation and Cellular Therapy (ASTCT) grading | Up to 28 days | |
| Severity of any grade CRS per ASTCT grading | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of CRS of any grade | Up to 12 months | |
| Occurrence of recurrent CRS of any grade | Up to 12 months | |
| Occurrence of grade ≥2 CRS per ASTCT grading |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined inclusion/exclusion criteria apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
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All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D000080424 | Cytokine Release Syndrome |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
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| Tocilizumab | Drug | Administered per the protocol |
|
|
| Up to 12 months |
| Occurrence of recurrent grade ≥2 CRS per ASTCT grading | Up to 12 months |
| Occurrence of any grade infections per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 | NCI CTCAE grade 1 to 5 version 5.0 | Up to 12 months |
| Occurrence of grade ≥3 infections per NCI-CTCAE version 5.0 | Up to 12 months |
| Occurrence of any grade Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) per ASTCT grading | Up to 12 months |
| Occurrence of grade ≥3 ICANS per ASTCT grading | Up to 12 months |
| Occurrence of any grade neurotoxicity per NCI-CTCAE version 5.0 grading | Up to 12 months |
| Occurrence of any grade neurotoxicity per ASTCT grading | Up to 12 months |
| Occurrence of grade ≥3 neurotoxicity per NCI-CTCAE version 5.0 grading | Up to 12 months |
| Occurrence of grade ≥3 neurotoxicity per ASTCT grading | Up to 12 months |
| Occurrence of any grade neutropenia per NCI-CTCAE version 5.0 grading | Up to 12 months |
| Occurrence of grade ≥3 neutropenia per NCI-CTCAE version 5.0 grading | Up to 12 months |
| Number of treatment doses of tocilizumab following at least 1 dose of linvoseltamab for the management CRS | Up to 12 months |
| Number of treatment doses of corticosteroid following at least 1 dose of linvoseltamab for the management CRS | Up to 12 months |
| Total duration of corticosteroid treatment following at least 1 dose of linvoseltamab for the management CRS | Up to 12 months |
| Number of hospitalizations per participant treated with at least 1 dose of linvoseltamab | Up to 12 months |
| Total length of each Adverse Event (AE)-related hospital stay | Up to 12 months |
| Occurrence of Treatment-Emergent Adverse Events (TEAEs) in participants treated with at least 1 dose of linvoseltamab | Up to 12 months |
| Severity of TEAEs in participants treated with at least 1 dose of linvoseltamab | Up to 12 months |
| Occurrence of Adverse Events of Special Interest (AESI) in participants treated with at least 1 dose of linvoseltamab | Up to 12 months |
| Severity of AESI in participants treated with at least 1 dose of linvoseltamab | Up to 12 months |
| Occurrence of Serious Adverse Events (SAEs) in participants treated with at least 1 dose of linvoseltamab | Up to 12 months |
| Severity of SAEs in participants treated with at least 1 dose of linvoseltamab | Up to 12 months |
| Achievement of Partial Response or better (≥PR) per International Myeloma Working Group (IMWG) criteria | Up to 12 months |
| Duration Of Response (DOR) | Up to 12 months |
| Progression-Free Survival (PFS) | Up to 12 months |
| Overall Survival | Up to 12 months |
| Time To Response (TTR) | Up to 12 months |
| 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 |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |