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

Boston Medical Center (BMC)

Status and phase

Completed

Phase 2

Conditions

Multiple Myeloma

Treatments

Drug: melphalan

Drug: lenalidomide

Drug: dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT00679367

RV-AMYL-PI-0219 (Other Grant/Funding Number)

BUMC-H-26320 (Other Identifier)

CDR0000595759

Details and patient eligibility

About

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.

Full description

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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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