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A Clinical Study on Minimal Residual Disease in Patients With Systemic Light Chain Amyloidosis

RecruitingNAAges 18 Years - 70 YearsAllPeking University First Hospital
NCT07215494 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Before effective treatment, the prognosis of patients with AL amyloidosis is very poor, with a median survival of approximately 12 months. In recent decades, with the development of new drugs, the treatment paradigm for AL amyloidosis has undergone significant changes, and the prognosis has improved dramatically. Achieving very good partial response (VGPR) or even complete response (CR) can lead to higher organ response and longer survival. However, not all patients who achieve ≥VGPR reach organ response, which may be related to the presence of small residual plasma cell clones in these patients. The ongoing production of monoclonal light chains deposits into tissues and organs, causing continuous damage, making organ response difficult. With the development of new drugs, the rate of hematologic CR has continuously increased, and the advancement of minimal residual disease (MRD) detectio

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age range: 18-70 years (inclusive), no gender restriction; 2. Newly diagnosed AL amyloidosis patients; 3. Meet ASCT eligibility criteria and have a willingness to undergo ASCT; 4. Achieved hematological complete response (CR) after 2-4 cycles of Dara-CyBorD induction chemotherapy. Exclusion Criteria: 1. Secondary to multiple myeloma or lymphoplasmacytic lymphoma, such as Waldenström's macroglobulinemia; 2. Co-existing other active malignant tumors; 3. Co-existing other systemic diseases deemed unsuitable for inclusion by the investigator, such as newly developed severe cardiovascular and cerebrovascular diseases, or severe infections.
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What it tests

  • First-Line Dara-BorCyD Treatment
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Where

1 site
Peking University First Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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