Objective:
Primary Objective:
Linvoseltamab will be used as monotherapy in participants with NDMM who are eligible for high
dose chemotherapy (HDT) with ASCT or ineligible for ASCT.
For phase 1, the primary objective of the study is to assess the safety, tolerability, and to determine
a recommended phase 2 dose regimen (RP2DR) of linvoseltamab for phase 2 of the study.
For phase 2, the primary objectives of the study are:
- To assess the preliminary anti-tumor activity of linvoseltamab in participants with
NDMM who are eligible for HDT with ASCT (transplant-eligible)
- To assess the preliminary anti-tumor activity of linvoseltamab in participants with
NDMM who are ineligible for ASCT (transplant-ineligible)
Secondary Objectives:
The secondary objectives of the study are:
- For phases 1 and 2 (applicable to both cohorts [ie, transplant-eligible and transplant-ineligible]):
- To evaluate the pharmacokinetic (PK) properties of linvoseltamab
- To evaluate total soluble BCMA concentrations in serum at baseline and over time
- To assess the immunogenicity of linvoseltamab
For phase 1:
- To assess the preliminary anti-tumor activity of linvoseltamab
For phase 2 (applicable to both cohorts):
- To evaluate the safety and tolerability of linvoseltamab
- To evaluate the preliminary anti-tumor activity of linvoseltamab in participants who
are transplant-eligible and transplant-ineligible
- Transplant-eligible cohort only
- To evaluate duration of response (DOR), PFS, and rate of minimal residual disease
(MRD) negative status after ASCT
- To evaluate the impact of therapy with single-agent linvoseltamab on the ability to
collect stem cells in any participants who subsequently undergo stem cell
mobilization
- To evaluate the kinetics of engraftment
- To evaluate the overall PFS
- Transplant-ineligible cohort only
- To evaluate DOR, PFS, and rate of MRD-negative status