Adult Outpatient Linvoseltamab With Tocilizumab Prophylaxis to Mitigate the Risk of Cytokine Release Syndrome (CRS)

Phase 4RecruitingNCT07609940

Regeneron Pharmaceuticals30 enrolled

Overview

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: * What side effects may happen from taking tocilizumab before the first dose of linvoseltamab * Whether tocilizumab has an impact on CRS, including whether participants require hospital care and, if so, how many hospital visits occur and how long they last * How frequently other medications (for example, corticosteroids or additional doses of tocilizumab) are used to support participants' care if needed

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Relapsed/Refractory Multiple Myeloma (RRMM)

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: 1. Disease progression on or after at least 4 prior lines of therapy including a(n) Protease Inhibitor (PI), Immunomodulatory imide Drug (IMiD), and anti-CD 38 antibody 2. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2 3. Confirmed progressive disease according to IMWG criteria during or after the most recent line of therapy Key Exclusion Criteria: 1. Diagnosis of plasma cell leukemia, symptomatic amyloidosis (including myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes (POEMS) syndrome 2. Known myeloma brain lesions or meningeal involvement 3. History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy \[PML\], or Central Nervous System (CNS) movement disorder NOTE: Other protocol defined inclusion/exclusion criteria apply

Locations (4)

Berenson Cancer Center

Los Angeles, California, United States

RECRUITING

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

RECRUITING

American Oncology Partners, PA dba The Center for Cancer and Blood Disorders

Bethesda, Maryland, United States

RECRUITING

Northwest Medical Specialties, PLLC

Tacoma, Washington, United States

RECRUITING

Outcomes

Primary Outcomes

Occurrence of any grade CRS per American Society for Transplantation and Cellular Therapy (ASTCT) grading

Time frame: Up to 28 days

Severity of any grade CRS per ASTCT grading

Time frame: Up to 28 days

Secondary Outcomes

Occurrence of CRS of any grade

Time frame: Up to 12 months

Occurrence of recurrent CRS of any grade

Time frame: Up to 12 months

Occurrence of grade ≥2 CRS per ASTCT grading

Time frame: Up to 12 months

Occurrence of recurrent grade ≥2 CRS per ASTCT grading

Time frame: 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

Time frame: Up to 12 months

Occurrence of grade ≥3 infections per NCI-CTCAE version 5.0

Time frame: Up to 12 months

Occurrence of any grade Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) per ASTCT grading

Time frame: Up to 12 months

Occurrence of grade ≥3 ICANS per ASTCT grading

Time frame: Up to 12 months

Occurrence of any grade neurotoxicity per NCI-CTCAE version 5.0 grading

Time frame: Up to 12 months

Occurrence of any grade neurotoxicity per ASTCT grading

Time frame: Up to 12 months

Occurrence of grade ≥3 neurotoxicity per NCI-CTCAE version 5.0 grading

Time frame: Up to 12 months

Occurrence of grade ≥3 neurotoxicity per ASTCT grading

Time frame: Up to 12 months

Occurrence of any grade neutropenia per NCI-CTCAE version 5.0 grading

Time frame: Up to 12 months

Occurrence of grade ≥3 neutropenia per NCI-CTCAE version 5.0 grading

Time frame: Up to 12 months

Number of treatment doses of tocilizumab following at least 1 dose of linvoseltamab for the management CRS

Time frame: Up to 12 months

Number of treatment doses of corticosteroid following at least 1 dose of linvoseltamab for the management CRS

Time frame: Up to 12 months

Total duration of corticosteroid treatment following at least 1 dose of linvoseltamab for the management CRS

Time frame: Up to 12 months

Number of hospitalizations per participant treated with at least 1 dose of linvoseltamab

Time frame: Up to 12 months

Total length of each Adverse Event (AE)-related hospital stay

Time frame: Up to 12 months

Occurrence of Treatment-Emergent Adverse Events (TEAEs) in participants treated with at least 1 dose of linvoseltamab

Time frame: Up to 12 months

Severity of TEAEs in participants treated with at least 1 dose of linvoseltamab

Time frame: Up to 12 months

Occurrence of Adverse Events of Special Interest (AESI) in participants treated with at least 1 dose of linvoseltamab

Time frame: Up to 12 months

Severity of AESI in participants treated with at least 1 dose of linvoseltamab

Time frame: Up to 12 months

Occurrence of Serious Adverse Events (SAEs) in participants treated with at least 1 dose of linvoseltamab

Time frame: Up to 12 months

Severity of SAEs in participants treated with at least 1 dose of linvoseltamab

Time frame: Up to 12 months

Achievement of Partial Response or better (≥PR) per International Myeloma Working Group (IMWG) criteria

Time frame: Up to 12 months

Duration Of Response (DOR)

Time frame: Up to 12 months

Progression-Free Survival (PFS)

Time frame: Up to 12 months

Overall Survival

Time frame: Up to 12 months

Time To Response (TTR)

Time frame: Up to 12 months

Adult Outpatient Linvoseltamab With Tocilizumab Prophylaxis to Mitigate the Risk of Cytokine Release Syndrome (CRS)

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts