SCTC21C plus bortezomib, cyclophosphamide and dexamethasone for newly diagnosed systemic light-chain (AL) amyloidosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial includes a Part 1 safety run‑in followed by a Part 2 randomized, controlled, open‑label, multicenter comparison of SCTC21C plus VCd versus VCd alone. Each part has screening (up to 28 days), a treatment period of repeating 28‑day cycles beginning at Cycle 1 Day 1 that continues until disease progression or unacceptable toxicity, and a post‑intervention follow‑up period. Safety is monitored through adverse events, lab tests, vital signs, physical exams and ECGs. Efficacy endpoints include complete hematologic response, overall response rates, very good partial response or better, and overall survival.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.