Comparison of BTD and BCD Based Regimens in the Treatment of AL Amyloidosis

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Research Objective:At present, there is no standard therapeutic regimen for monoclonal immunoglobulin light chain (AL) amyloidosis in the world. To compare the efficacy and safety of the regimens between bortezomib-thalidomide-dexamethasone (BTD) and bortezomib-cyclophosphamide-dexamethasone (BCD) in the treatment of AL amyloidosis, so as to provide more clinical evidence for the standard treatment for the disease.

Research Design:This study was designed as a prospective, randomized and controlled clinical study. Patients who meet the inclusion criteria of this study will be randomized to the BTD scheme group or BCD scheme group.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangdong Provincial People's Hospital
• Treatments: Bortezomib; Cyclophosphamide; Thalidomide

Criteria

Inclusion Criteria:

1.Signed the written informed consent; 2.18 years old ≤ age ≤ 80 years old, no restriction on gender; 3.AL amyloidosis was confirmed by pathological biopsy in the accumulated system or organ (kidney, heart, liver, skin), and excluded other secondary factors; 4.The proliferation of monoclonal plasma cells was confirmed by fixed electrophoresis of bone marrow or blood/urine.

Exclusion Criteria:

1. Pathological biopsy showed non-AL amyloidosis;

2. Abnormal proliferation of plasma cells reached the standard of multiple myeloma；

3. Other hematological system tumors;

4. Cushing's syndrome;

5. Active hepatitis;

5.Pregnant or lactating women;