drugset / Trial / NCT00890552
A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis
NaSingle-groupOpen-labelTreatment
Summary
This open-label trial will evaluate the use of lenalidomide; melphalan; and dexamethasone (MDR) to treat newly diagnosed or relapsed AL amyloidosis, over the course of nine 28-day cycles.
Timeline
- Start
- 2009-04
- Primary completion
- 2012-08
- Completion
- 2012-10
Publications
- Background Palladini G, Dispenzieri A, Gertz MA, Kumar S, Wechalekar A, Hawkins PN, Schonland S, Hegenbart U, Comenzo R, Kastritis E, Dimopoulos MA, Jaccard A, Klersy C, Merlini G. New criteria for response to treatment in immunoglobulin light chain amyloidosis based on free light chain measurement and cardiac biomarkers: impact on survival outcomes. J Clin Oncol. 2012 Dec 20;30(36):4541-9. doi: 10.1200/JCO.2011.37.7614. Epub 2012 Oct 22.
- Results Dinner S, Witteles W, Afghahi A, Witteles R, Arai S, Lafayette R, Schrier SL, Liedtke M. Lenalidomide, melphalan and dexamethasone in a population of patients with immunoglobulin light chain amyloidosis with high rates of advanced cardiac involvement. Haematologica. 2013 Oct;98(10):1593-9. doi: 10.3324/haematol.2013.084574. Epub 2013 May 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 40 mg | Oral |
| Subject | Lenalidomide | Other / unclassified | 10 mg | Oral |
| Subject | Melphalan | Small molecule | 0.18 mg/kg | Oral |