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

NCT00679367 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-02-20

Study results available
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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.

Conditions

Interventions

DRUG

dexamethasone

40 mg once weekly

DRUG

lenalidomide

10 mg/day D1-21

DRUG

melphalan

5 mg/m2 D1-4

Sponsors & Collaborators

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Vaishali Sanchorawala, MD · Boston Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT00679367 on ClinicalTrials.gov