Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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 systemic amyloidosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Medical Center
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide; Melphalan; Thalidomide

Criteria

Inclusion Criteria:

DISEASE CHARACTERISTICS:

• Diagnosis of primary systemic amyloidosis

PATIENT CHARACTERISTICS:

• 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 radiotherapy

Exclusion Criteria:

• 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