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2nd Autologous Stem Cell Transplant in Patients With Persistent/Recurrent (AL) Amyloidosis

NCT00075608 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-01-27

Study results available
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Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing. Having a stem cell transplant to replace the blood-forming cells destroyed by chemotherapy, allows higher doses of chemotherapy to be given so that more plasma cells are killed. By reducing the number of plasma cells, the disease may progress more slowly.

PURPOSE: This phase II trial is studying how well autologous stem cell transplant works in treating patients with persistent or recurrent primary systemic (AL) amyloidosis.

Conditions

Interventions

BIOLOGICAL

filgrastim

16mcg/kg IV daily beginning three days prior to stem cell collection through last day of stem cell collection

DRUG

melphalan

140-200 mcg/kg IV over two days

PROCEDURE

autologous stem cell transplantation

infusion of previously collected stem cells on Day 0

PROCEDURE

stem cell infusion

infusion of previously collected stem cells on Day 0

Sponsors & Collaborators

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Karen Quillen, MD · Boston Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2001-08-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00075608 on ClinicalTrials.gov