Rapid DFLC Response Predict Complete Hematologica Response in Systemic AL Amyloidosis Patients Treated with Daratumumab-based Regimen

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY

Light chain amyloidosis (AL amyloidosis) is a rare plasma cell dyscrasia characterized by the deposition of insoluble amyloid fibrils in multiple organ systems. The treatment of amyloidosis primarily relies on anti-plasma cell therapy and supportive care. The application of anti-plasma cell therapy has significantly improved outcomes in patients with AL amyloidosis. Standard first-line therapy typically includes daratumumab, bortezomib, cyclophosphamide, and dexamethasone (Dara-BCD), achieving a complete hematologic response in nearly 60% of patients.The depth and speed of the hematologic response are strongly correlated with organ response and overall survival. An early achievement of a complete hematologic response is particularly crucial in cases of AL amyloidosis characterized by significant organ involvement. The median time to a hematologic response for the daratumumab based treatment is only 7-9 days. The retrospective data showed that the hematologic response in Day 7 in Cycle 1 (C1D7) may predict the complete hematologic response rate. In order to validate the conclusion, the investigator design this prospective study.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• Diagnosis of systemic AL amyloidosis;

• Daratumumab, bortezomib, dexamethasone used in treatment;

• Informed consent explained to, understood by and signed by the patient;

• dFLC ≥ 50 mg/L;

Locations
Other Locations
China
Fuxing Hospital affiliated to Capital Medical University
RECRUITING
Beijing
Peking University People's Hospital
RECRUITING
Beijing
Contact Information
Primary
Yang Liu, M.D.
pkuphliuyang@bjmu.edu.cn
+86-13716926210
Time Frame
Start Date: 2024-10-26
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 50
Treatments
Group 1
All patients in this cohort receive daratumumab, bortezomib and dexamethasone as treatment.~All patients receive additional sFLC examination in C1D7, C1D14.
Related Therapeutic Areas
Sponsors
Leads: Peking University People's Hospital

This content was sourced from clinicaltrials.gov