RATIONALE: Drugs used in chemotherapy, such as melphalan and dexamethasone, work in
different ways to stop the growth of abnormal plasma cells, either by killing the cells or
by stopping them from dividing. Biological therapies, such as lenalidomide, may stimulate
the immune system in different ways and stop the abnormal plasma cells from growing. Giving
melphalan together with lenalidomide and dexamethasone may be an effective treatment for
primary systemic amyloidosis.
PURPOSE: This phase II trial is studying the side effects and how well giving melphalan
together with lenalidomide and dexamethasone works in treating patients with primary
- To determine the tolerability and safety of melphalan, lenalidomide, and dexamethasone,
in terms of toxicity, in patients with primary systemic amyloidosis.
- To determine the hematologic response rate in patients treated with this regimen.
- To assess organ response in patients treated with this regimen.
OUTLINE: Patients receive oral lenalidomide once daily on days 1-21, oral melphalan once
daily on days 1-4, and oral dexamethasone once on days 1, 8, 15, and 22. Treatment repeats
every 28 days for up to 12 months in the absence of disease progression or unacceptable
After completion of study therapy, patients are followed every 3 months until disease
progression and then annually thereafter.
- Diagnosis of primary systemic amyloidosis
- Not pregnant
- Negative pregnancy test
- Able to tolerate an anticoagulation regimen (e.g., 325 mg of aspirin per day,
therapeutic warfarin, or low molecular weight heparin)
PRIOR CONCURRENT THERAPY:
- Recovered from prior therapy
- Permanent or stable side effects/changes allowed
- Prior chemotherapy, thalidomide, lenalidomide, or steroids for amyloidosis allowed
- More than 4 weeks since prior and no other concurrent cytotoxic chemotherapy or
- No secondary or familial amyloidosis
- No multiple myeloma (≥ 30% plasma cells in bone marrow biopsy or lytic bone lesions)
- No prior cumulative doses of oral melphalan > 200 mg
- No more than one prior course of high-dose melphalan with stem cell transplant