Relapsed/Refractory Multiple Myeloma (RRMM)
Conditions
Keywords
Cytokine Release Syndrome (CRS), Linvoseltamab, Tocilizumab, Bispecific antibodies
Brief summary
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
Interventions
DRUGLinvoseltamab
Administered per the protocol
DRUGTocilizumab
Administered per the protocol
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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/
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | Up to 12 months | NCI CTCAE grade 1 to 5 version 5.0 |
| 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 | — |
Countries
United States
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed