Clinical trial · Interventional
Comparison of BTD and BCD Based Regimens in the Treatment of AL Amyloidosis
A Comparative Study of Bortezomib-Thalidomide-Dexamethason and Bortezomib-Cyclophosphamide-Dexamethason in the Treatment of Monoclonal Immunoglobulin Light Chain Amyloidosis: A Prospective Randomized Controlled Trial（BTD-CHINA-TRIAL）
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Immunoglobulin Light-Chain Amyloidosis | AL Amyloidosis | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group1
- description
- Group1 is the AL amyloidosis patients who have bortezomib-thalidomide-dexamethason-based regimens for their treatment.
- interventionNames
- Drug: Thalidomide
- type
- EXPERIMENTAL
- label
- Group2
- description
- Group2 is the AL amyloidosis patients who have bortezomib-cyclophosphamide-dexamethason-based regimens for their treatment.
- interventionNames
- Drug: Cyclophosphamide
Primary outcomes (1)
- measure
- Hematologic Response
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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;
References
Publications (14)
- BACKGROUNDHuang XH, Liu ZH. The Clinical Presentation and Management of Systemic Light-Chain Amyloidosis in China. Kidney Dis (Basel). 2016 Apr;2(1):1-9. doi: 10.1159/000444287. Epub 2016 Feb 25. PMID 27536686
- BACKGROUNDMerlini G, Bellotti V. Molecular mechanisms of amyloidosis. N Engl J Med. 2003 Aug 7;349(6):583-96. doi: 10.1056/NEJMra023144. No abstract available. PMID 12904524
- BACKGROUNDWechalekar AD, Gillmore JD, Hawkins PN. Systemic amyloidosis. Lancet. 2016 Jun 25;387(10038):2641-2654. doi: 10.1016/S0140-6736(15)01274-X. Epub 2015 Dec 21. PMID 26719234
- BACKGROUNDPerfetto F, Moggi-Pignone A, Livi R, Tempestini A, Bergesio F, Matucci-Cerinic M. Systemic amyloidosis: a challenge for the rheumatologist. Nat Rev Rheumatol. 2010 Jul;6(7):417-29. doi: 10.1038/nrrheum.2010.84. Epub 2010 Jun 8. PMID 20531382
- BACKGROUNDGertz MA. Immunoglobulin light chain amyloidosis: 2016 update on diagnosis, prognosis, and treatment. Am J Hematol. 2016 Sep;91(9):947-56. doi: 10.1002/ajh.24433. PMID 27527836
- BACKGROUNDDingli D, Tan TS, Kumar SK, Buadi FK, Dispenzieri A, Hayman SR, Lacy MQ, Gastineau DA, Hogan WJ, Gertz MA. Stem cell transplantation in patients with autonomic neuropathy due to primary (AL) amyloidosis. Neurology. 2010 Mar 16;74(11):913-8. doi: 10.1212/WNL.0b013e3181d55f4d. PMID 20231668
- BACKGROUNDKumar S, Dispenzieri A, Lacy MQ, Hayman SR, Buadi FK, Colby C, Laumann K, Zeldenrust SR, Leung N, Dingli D, Greipp PR, Lust JA, Russell SJ, Kyle RA, Rajkumar SV, Gertz MA. Revised prognostic staging system for light chain amyloidosis incorporating cardiac biomarkers and serum free light chain measurements. J Clin Oncol. 2012 Mar 20;30(9):989-95. doi: 10.1200/JCO.2011.38.5724. Epub 2012 Feb 13. PMID 22331953