The purpose of this study is to evaluate the efficacy and safety of SCTC21C plus cyclophosphamide, bortezomib and dexamethasone (VCd) compared with VCd alone in treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.
Histopathological diagnosis of amyloidosis based on detection by immunohistochemistry and polarizing light microscopy of green bi-refringent material in congo red stained tissue specimens or characteristic electron microscopy appearance;
Measurable disease of amyloid light-chain (AL) amyloidosis;
One or more organs impacted by AL amyloidosis according to consensus guidelines
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2
Prior therapy for AL amyloidosis;
Other amyloidosis;
Uncontrolled infection.
Subjects with conditions that may affect safety or efficacy assessments include, but are not limited to, cardiovascular, respiratory, endocrine/metabolic, immune system, hepatic, gastrointestinal (such as gastrointestinal bleeding, perforation, ulcers, etc.), and malignant neoplasms, and are deemed clinically significant by the investigator.