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

NCT07215494 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-10-10

No results posted yet for this study

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

Interventions

DRUG

First-Line Dara-BorCyD Treatment

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

Sponsors & Collaborators

  • Beijing Chao Yang Hospital

    collaborator OTHER

  • Beijing Anzhen Hospital

    collaborator OTHER

  • Peking University First Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2029-09-30
Completion
2029-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07215494 on ClinicalTrials.gov