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.
This study comprises two phases: Part 1 is the safety run in, while Part 2 is a randomized, controlled, open-label, multicenter study. Both parts are divided into three stages: the screening period (up to 28 days before first dose/randomization), the treatment period (from Cycle 1 \[28 days\] Day 1 and continues until disease progression or unacceptable toxicity), and the follow-up period (Postintervention). Safety endpoints include treatment-emergent adverse events , treatment-related adverse events, serious adverse events, clinical laboratory tests, vital signs, physical examinations, electrocardiograms , etc. Efficacy endpoints include Overall Complete Hematologic Response (CHR)，objective response rate (ORR), Hematologic Very Good Partial Response (VGPR) or Better Rate, Overall Survival (OS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Pharmaceutical form: Solution for infusion； Route of administration: Subcutaneous
Pharmaceutical form: Lyophilized powder for injection； Route of administration: Subcutaneous
Pharmaceutical form: Tablets, ampoules or vials for injection； Route of administration: Oral/Intravenous
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGPercentage 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.
Time frame: Up to approximately 50 months after the First Participant In (FPI)
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.
Time frame: Up to approximately 50 months after the FPI
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.
Time frame: Month 6
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.
Time frame: Up to approximately 50 months after the FPI
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.
Time frame: Up to approximately 50 months after the FPI
Overall Survival (OS)
Overall survival (OS) was measured from the date of randomization to the date of the participant's death.
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Pharmaceutical form: Tablets, ampoules or vials for injection； Route of administration: Oral/Intravenous
Time frame: Up to approximately 50 months after the FPI
Adverse Events
Treatment-emergent adverse events/serious adverse events
Time frame: Up to approximately 50 months after the FPI