NCT00890552

A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This open-label trial will evaluate the use of lenalidomide; melphalan; and dexamethasone (MDR) to treat newly diagnosed or relapsed AL amyloidosis, over the course of nine 28-day cycles.

Detailed description

The study will evaluate the 3-drug combination of lenalidomide; melphalan; and dexamethasone (MDR) as the absence of disease progression or toxicity, patients will complete nine 28-day cycles of MDR therapy, with the option of continuing treatment with lenalidomide as single-agent. Patients received up to nine cycles of treatment, with the option to continue on lenalidomide as a single agent if they responded to treatment.

Conditions

• Leukemia
• Amyloidosis

Interventions

Type	Name	Description
DRUG	Lenalidomide	Lenalidomide is a a derivative of thalidomide. Orally-administered lenalidomide 10 mg will be taken daily on days 1 to 21 of 28-day cycle.
DRUG	Melphalan	Melphalan is a phenylalanine derivative of mechlorethamine. Orally-administered melphalan 0.18 mg/kg will be taken on days 1 to 4 of a 28-day cycle
DRUG	Dexamethasone	Dexamethasone is an anti-inflammatory and immunosuppressant steroid medication. Orally-administered dexamethasone 40 mg orally once weekly of a 28-day cycle

Timeline

• Start date: 2009-04-01
• Primary completion: 2012-08-01
• Completion: 2012-10-01
• First posted: 2009-04-30
• Last updated: 2017-03-22
• Results posted: 2017-03-22

Locations

1 site across 1 country: United States