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Bortezomib, Melphalan, and Dexamethasone in Treating Patients With Primary Amyloidosis or Light Chain Deposition Disease

NCT00520767 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2023-12-22

Study results available
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Summary

RATIONALE: Giving bortezomib together with melphalan and dexamethasone may be an effective treatment for primary amyloidosis and light chain deposition disease.

PURPOSE: This phase II trial is studying how well giving bortezomib together with melphalan and dexamethasone works in treating patients with primary amyloidosis or light chain deposition disease.

Conditions

  • Primary Systemic Amyloidosis
  • Light Chain Deposition Disease

Interventions

DRUG

bortezomib

Bortezomib 1.3 mg/m2 days 1, 8, 15, 22

DRUG

dexamethasone

Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23

DRUG

melphalan

Melphalan 9 mg/m2/day days 1-4

GENETIC

microarray analysis

≤28 days prior to enrollment

OTHER

flow cytometry

Day 1 of cycles 6, 12, 18 and at end of study.

OTHER

laboratory biomarker analysis

≤28 days prior to enrollment

PROCEDURE

quality-of-life assessment

Start of each cycle

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Barbara Ann Karmanos Cancer Institute

    lead OTHER

Principal Investigators

  • Jeffrey A. Zonder, MD · Barbara Ann Karmanos Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2010-10-31
Completion
2019-06-06

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00520767 on ClinicalTrials.gov