A Phase I/II, Open Label Study to Evaluate Safety, Tolera...

Primary Objective:

Secondary Objectives:

To assess safety and tolerability of elranatamab in patients with relapsed or refractory AL amyloidosis.
To assess best overall response (BOR), duration of response (DoR), progression free survival (PFS) and overall survival (OS).
To assess incidence and severity of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
To assess incidence of treatment emergent adverse events.
To assess major organ deterioration (MOD) progression free survival (PFS) for the duration of the study.

Exploratory Objectives:

To characterize change in peripheral blood/bone marrow plasma cytokines during the course of the study.
To determine relevant changes of cellular immune components in the bone marrow and peripheral blood during the course of the study.
To determine minimal residual disease status based on next generation sequencing (NGS, 10 -6, Clonoseq) in the bone marrow and liquid chromatography mass spectrometry (LC-MS) in the peripheral blood.
To determine cardiac and/or renal response in applicable patients during the course of the study.
To assess changes in quality of life via SF-36v2 Health Survey.

Clinical Trial Details