High-Risk Monoclonal Gammopathy of Undetermined Significance; Non-High-Risk Smoldering Multiple Myeloma
Conditions
Brief summary
Part 1: Frequency of adverse events of special interest (AESI) during the safety observation period, Part 1: Frequency of treatment-emergent adverse events (TEAEs) during the safety observation period, Part 1: Severity of TEAEs during the safety observation period, Part 2: Achievement of complete response (CR) as determined by the investigator
Detailed description
Frequency of TEAEs, Severity of TEAEs, Frequency of serious adverse events (SAEs), Severity of SAEs, Frequency of laboratory abnormalities, Severity of laboratory abnormalities, Minimal residual disease (MRD) negativity among participants that achieve a response of CR, Sustained MRD negativity on an annual basis, Overall response of partial response (PR) or better as determined by the investigator, Duration of response (DOR) as determined by the investigator, Biochemical progression-free survival (PFS) as determined by the investigator, Concentration of linvoseltamab in serum over time, Incidence of anti-drug antibodies (ADAs) to linvoseltamab over the study duration, Magnitude of ADAs to linvoseltamab over the study duration
Interventions
DRUGLinvoseltamab
DRUGRoActemra 20 mg/mL concentrate for solution for infusion
Sponsors
Regeneron Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Frequency of adverse events of special interest (AESI) during the safety observation period, Part 1: Frequency of treatment-emergent adverse events (TEAEs) during the safety observation period, Part 1: Severity of TEAEs during the safety observation period, Part 2: Achievement of complete response (CR) as determined by the investigator | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of TEAEs, Severity of TEAEs, Frequency of serious adverse events (SAEs), Severity of SAEs, Frequency of laboratory abnormalities, Severity of laboratory abnormalities, Minimal residual disease (MRD) negativity among participants that achieve a response of CR, Sustained MRD negativity on an annual basis, Overall response of partial response (PR) or better as determined by the investigator, Duration of response (DOR) as determined by the investigator, Biochemical progression-free survival (PFS) as determined by the investigator, Concentration of linvoseltamab in serum over time, Incidence of anti-drug antibodies (ADAs) to linvoseltamab over the study duration, Magnitude of ADAs to linvoseltamab over the study duration | — |
Countries
Belgium, France, Ireland, Italy, Poland, Spain
Outcome results
None listed