A Study to Evaluate the Safety and Efficacy of SCTC21C in Combination With Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Newly Diagnosed Systemic Light-Chain Amyloidosis (NDSLCA)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SCTC21C, Bortezomib, Dexamethasone, Cyclophosphamide.
- Who it may be relevant to
- Registry conditions: Amyloidosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase 3 Randomized, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of SCTC21C in Combination With Bortezomib, Cyclophosphamide, and Dexamethasone Versus Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Newly Diagnosed Systemic Light-Chain Amyloidosis
Overview
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.
Detailed description
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).
Interventions
- Drug SCTC21C
Pharmaceutical form: Solution for infusion； Route of administration: Subcutaneous - Drug Bortezomib
Pharmaceutical form: Lyophilized powder for injection； Route of administration: Subcutaneous - Drug Dexamethasone
Pharmaceutical form: Tablets, ampoules or vials for injection； Route of administration: Oral/Intravenous - Drug Cyclophosphamide
Pharmaceutical form: Tablets, ampoules or vials for injection； Route of administration: Oral/Intravenous
Primary outcome measures
- Percentage of Participants With Overall Complete Hematologic Response (CHR) [Time frame: Up to approximately 50 months after the First Participant In (FPI)]
Secondary outcome measures (6)
- Major Organ Deterioration Progression-Free Survival (MOD-PFS) [Time frame: Up to approximately 50 months after the FPI]
- Percentage of Participants Who Achieved Complete Hematologic Response (CHR) at 6 Months [Time frame: Month 6]
- Duration of Complete Hematologic Response (CHR) [Time frame: Up to approximately 50 months after the FPI]
- Hematologic Very Good Partial Response (VGPR) or Better Rate [Time frame: Up to approximately 50 months after the FPI]
- Overall Survival (OS) [Time frame: Up to approximately 50 months after the FPI]
- Adverse Events [Time frame: Up to approximately 50 months after the FPI]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
- Subjects who have undergone major surgery or experienced significant trauma within 4 weeks prior to the first use of the investigational drug, or who require elective surgery during the trial period.
- Received a live or attenuated vaccine within 30 days prior to the first dose; Female subjects who are currently breastfeeding.
- Subjects with mental disorders or poor compliance, or other circumstances deemed unsuitable for participation in this study by other investigators.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking Union Medical College Hospital — Beijing
Identifiers
NCT: NCT07388602 · SCTC21C-B301