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.
Parallel
SCTC21C
DrugPharmaceutical form: Solution for infusion； Route of administration: Subcutaneous
Bortezomib
DrugPharmaceutical form: Lyophilized powder for injection； Route of administration: Subcutaneous
Dexamethasone
DrugPharmaceutical form: Tablets, ampoules or vials for injection； Route of administration: Oral/Intravenous
Cyclophosphamide
DrugPharmaceutical form: Tablets, ampoules or vials for injection； Route of administration: Oral/Intravenous
Percentage of Participants With Overall Complete Hematologic Response (CHR)
Overall CHR rate was defined as percentage of participants who achieved CHR, according to the International Amyloidosis Consensus Criteria.
Major Organ Deterioration Progression-Free Survival (MOD-PFS)
MOD-PFS was defined as duration from the date of randomization to either hematologic progression, or major organ deterioration (clinical manifestation of cardiac failure or renal failure), or death, whichever occurred first.
Percentage of Participants Who Achieved Complete Hematologic Response (CHR) at 6 Months
CHR rate was defined as percentage of participants who achieved CHR, according to the International Amyloidosis Consensus Criteria.
Duration of Complete Hematologic Response (CHR)
Duration of CHR was defined as the time between the date of initial documentation of CHR to the date of first documented evidence of hematologic progressive diseased.
Hematologic Very Good Partial Response (VGPR) or Better Rate
Hematologic VGPR or Better Rate was defined as percentage of participants who achieved hematologic Complete response (CR) or VGPR.
PRO: EQ-5D-5L
Health state utility and health status will be assessed using the European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L)
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