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



Status:Completed
Conditions:Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:May 2008
End Date:May 2015

Use our guide to learn which trials are right for you!

A Phase II Trial of MRD (Melphalan, Lenalidomide and Dexamethasone) for Patients With AL Amyloidosis

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.

OBJECTIVES:

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.

Secondary

- 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
toxicity.

After completion of study therapy, patients are followed every 3 months until disease
progression and then annually thereafter.

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
We found this trial at
1
site
72 East Concord St.
Boston, Massachusetts 02118
617-638-4173
Boston University Cancer Research Center
?
mi
from
Boston, MA
Click here to add this to my saved trials