An Open-label Phase I/II Trial of Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Systemic Light-Chain Amyloidosis

The purpose of this study is assess safety, safest dose, and effectiveness of venetoclax in combination with dexamethasone in subjects with t(11;14) positive relapsed (comes back) or refractory (did not get better) light chain amyloidosis. Furthermore, the purpose of phase 2 part of this study is to compare the effectiveness of venetoclax and dexamethasone versus investigator’s choice treatment in this condition.

Are you Eligible? (Inclusion Criteria)

• Are you 18 years of age or older?
• Can you comply with the procedures in this study, which include taking the study
• drug and extra clinic visits and procedures?
• Do you have an Eastern Cooperative Oncology Group Performance Status (ECOG
• PS) of 0 to 2? ECOG PS describes a patient's level of functioning in terms of
• ability to care for oneself, daily activities and physical ability.