A Clinical Study on Minimal Residual Disease in Patients With Systemic Light Chain Amyloidosis (NCT07215494) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Clinical Study on Minimal Residual Disease in Patients With Systemic Light Chain Amyloidosis
China50 participantsStarted 2025-10
Plain-language summary
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) detection technologies in recent years has led to increasing attention to MRD in AL amyloidosis research. Therefore, in this era of advancing new drugs, MRD negativity may become a higher clinical treatment goal for AL amyloidosis, further improving long-term prognosis for patients.
Our department plans to conduct a single-center, prospective clinical study aimed at exploring the MRD status in patients who achieve hematologic CR after first-line induction chemotherapy (Dara-CyBorD), and further investigating whether autologous stem cell transplantation in MRD-positive CR patients who meet transplant criteria can further improve organ response, progression-free survival, and overall survival.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age range: 18-70 years (inclusive), no gender restriction;
. Newly diagnosed AL amyloidosis patients;
. Meet ASCT eligibility criteria and have a willingness to undergo ASCT;
. Achieved hematological complete response (CR) after 2-4 cycles of Dara-CyBorD induction chemotherapy.
Exclusion criteria
. Secondary to multiple myeloma or lymphoplasmacytic lymphoma, such as Waldenström's macroglobulinemia;
. Co-existing other active malignant tumors;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Co-existing other systemic diseases deemed unsuitable for inclusion by the investigator, such as newly developed severe cardiovascular and cerebrovascular diseases, or severe infections.