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

NCT07215494 | Not Yet Recruiting DMC

• 1 other identifier: PKUFH202510
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Light Chain (AL) Amyloidosis; MRD

Keywords

light chain amyloidosis; MRD; ASCT

Outcome Measures

Primary Outcomes (3)

• Organ Response Rates

  2 years

• Progression-Free Survival

  2 years

• Overall Survival

  2 years

Study Arms (1)

First-Line Treatment for MRD-Positive Patients Undergoing ASCT

EXPERIMENTAL

First-Line treatment with Dara-CyBorD achieves CR, but MRD-Positive patients are recommended to undergo ASCT.

Drug: First-Line Dara-BorCyD Treatment

Interventions

First-Line Dara-BorCyD Treatment DRUG

First-Line Dara-BorCyD Treatment Achieves CR, but ASCT is Recommended for MRD-Positive Patients

First-Line Treatment for MRD-Positive Patients Undergoing ASCT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Secondary to multiple myeloma or lymphoplasmacytic lymphoma, such as Waldenström's macroglobulinemia;
• Co-existing other active malignant tumors;

Sponsors & Collaborators

• Peking University First Hospital: lead
• Beijing Chao Yang Hospital: collaborator
• Beijing Anzhen Hospital: collaborator

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

MeSH Terms

Conditions

Amyloidosis; Immunoglobulin Light-chain Amyloidosis

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Paraproteinemias

Central Study Contacts

Yujun Dong

CONTACT

008618210264969; dongy@hsc.pku.edu.cn

Weiwei Xie

CONTACT

008617801203152; xieweiwei1227@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief of department of hematology

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: October 10, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: October 10, 2025

Record last verified: 2025-10

Locations

CN (1)