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Bortezomib, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Light Chain Amyloidosis

NCT01072773 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2014-04-02

Study results available
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Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with combination chemotherapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving bortezomib, cyclophosphamide, and dexamethasone together works in treating patients with primary systemic light chain amyloidosis.

Conditions

  • Primary Systemic Amyloidosis

Interventions

DRUG

bortezomib

1.3 mg/m\^2, by IV on days 1, 8 and 15 every 28 days

DRUG

cyclophosphamide

300 mg/m\^2, orally, on days 1, 8, 15 \& 22 every 28 days.

DRUG

dexamethasone

40 mg, orally, on days 1, 8, 15 \& 22 every 28 days

Sponsors & Collaborators

Principal Investigators

  • Shaji Kumar, M.D. · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-03-31
Completion
2012-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT01072773 on ClinicalTrials.gov