Study on Linvoseltamab with Tocilizumab to Reduce Risk of Cytokine Release Syndrome in Adults with Relapsed or Refractory Multiple Myeloma
Sponsor: Regeneron Pharmaceuticals
ClinicalTrials ID:NCT07609940
This clinical trial is testing whether taking tocilizumab before linvoseltamab can lower the risk of Cytokine Release Syndrome (CRS) in adults with multiple myeloma that has returned or not responded to at least four previous treatments.
Patient Parameters
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Program Overview
The purpose of this study is to find out if using tocilizumab before the first dose of linvoseltamab can help reduce the risk of Cytokine Release Syndrome (CRS) in people with Relapsed or Refractory Multiple Myeloma (RRMM). Participants in this study have already tried at least four different treatments for their multiple myeloma, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody. The study will also look at how safe and effective linvoseltamab is when given after tocilizumab. Researchers will monitor for any side effects from taking tocilizumab before linvoseltamab and see if it affects the need for hospital care due to CRS. They will also track how often other medications are needed to support participants' care.
Eligibility Criteria
Inclusion Criteria
- Have multiple myeloma that has worsened after at least four previous treatments, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.
- Be in relatively good health with an ECOG performance status score of 2 or less, meaning fully active or able to carry out light work.
- Have confirmed disease progression according to specific medical criteria during or after the most recent treatment.
Exclusion Criteria
- Have been diagnosed with plasma cell leukemia, symptomatic amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome.
- Have known brain lesions or involvement of the brain's protective layers due to myeloma.
- Have a history of certain neurological conditions, such as Progressive Multifocal Leukoencephalopathy (PML) or movement disorders affecting the central nervous system.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mary Bird Perkins Cancer Center | 70809 | Baton Rouge | Louisiana |
| Northwest Medical Specialties, PLLC | 98405 | Tacoma | Washington |
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