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Tests treatment safety and results for Amyloidosis
Official title 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)
ClinicalTrials.gov ID: NCT07388602
What this study is testing
What is SCTC21C?
SCTC21C is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for amyloidosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histopathological diagnosis of amyloidosis based on detection by immunohistochemistry and polarizing light microscopy of green bi-refringent material...
- 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
You likely can't join if
- Prior therapy for AL amyloidosis;
- Other amyloidosis;
- Uncontrolled infection.
- people with conditions that may affect safety or how well it works assessments include, but are not limited to, cardiovascular, respiratory...
- people who have undergone major surgery or experienced significant trauma within 4 weeks prior to the first use of the investigational drug, or who...
- Received a live or attenuated vaccine within 30 days prior to the first dose; Female people who are currently breastfeeding.
See the full eligibility 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...
- 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.
- people with conditions that may affect safety or how well it works assessments include, but are not limited to, cardiovascular, respiratory, endocrine/metabolic, immune system, hepatic, gastrointestinal (such as...
- people 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 people who are currently breastfeeding.
- people with mental disorders or poor compliance, or other circumstances deemed unsuitable for participation in this study by other investigators.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.