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RECRUITINGPhase 3INTERVENTIONAL

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)

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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

Locations (1)

Peking Union Medical College Hospital
Beijing, Beijing Municipality, China