How well minimal residual disease is cleared in AL amyloidosis after first-line Dara-BorCyD

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

This interventional study targets adults newly diagnosed with AL amyloidosis who are eligible for autologous stem cell transplant and have achieved complete hematologic response after 2-4 induction cycles of Dara-CyBorD. It focuses on detecting minimal residual disease to understand if small remaining plasma cell clones influence organ recovery despite VGPR/CR. The trial uses first-line Dara-BorCyD treatment followed by ASCT, with MRD assessment guiding interpretation of response and potential clinical outcomes. Recruitment is limited to affiliated centers in Beijing, led by Peking University First Hospital, with collaboration from two partner hospitals. The goal is to clarify whether MRD status correlates with organ improvement and longer survival in this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Yujun Dong
• Email: dongy@hsc.pku.edu.cn
• Phone: 008618210264969

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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.