Pomalidomide With Melphalan and Dexamethasone for Untreated Systemic AL Amyloidosis
Summary
The goal of this clinical research study is to find the highest tolerable dose of pomalidomide that can be given in combination with melphalan and dexamethasone that can be given to patients with AL amyloidosis. The safety of this drug combination will also be studied. Pomalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. This may decrease the growth of cancer cells. Melphalan is designed to damage the DNA (genetic material) of cells, which may cause cancer cells to die. Dexamethasone is a corticosteroid that is similar to a natural hormone made by your body. Dexamethasone is often given to Multiple Myeloma (MM) patients in combination with other chemotherapy to treat cancer. Planned Phase I/II Study terminated early during Phase I portion without continuation to Phase II.
Timeline
- Start
- 2014-01
- Primary completion
- 2016-02
- Completion
- 2016-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pomalidomide | Other / unclassified | 1 mg | Oral |
| Background | Dexamethasone | Small molecule | 40 mg | Oral |
| Background | Melphalan | Small molecule | 9 mg/m2 | Oral |