NCT00679367

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	dexamethasone	40 mg once weekly
DRUG	lenalidomide	10 mg/day D1-21
DRUG	melphalan	5 mg/m2 D1-4

Timeline

• Start date: 2008-05-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2008-05-16
• Last updated: 2017-02-20
• Results posted: 2017-02-20

Locations

1 site across 1 country: United States