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

NCT00890552 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-03-22

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Stanley L Schrier, MD · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2012-08-31
Completion
2012-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00890552 on ClinicalTrials.gov