MedTrace Logo

Melphalan, Bortezomib, and Stem Cell Transplant in Treating Patients With Primary Systemic Amyloidosis

NCT00790647 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-02-06

Study results available
· View outcomes & findings →

Summary

RATIONALE: Giving melphalan and bortezomib before and after a stem cell transplant stops the growth of abnormal cells by stopping them from dividing or killing them. Giving colony-stimulating factors and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy and monoclonal antibody therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

PURPOSE: This phase II trial is studying how well giving melphalan together with bortezomib followed by stem cell transplant works in treating patients with primary systemic amyloidosis.

Conditions

Interventions

BIOLOGICAL

filgrastim

16 mcg/kg daily beginning 3 days before stem cell collection through day before final stem cell collection

DRUG

bortezomib

1.0 mg/m2/dose D -6, D-3, D +1, D + 4

DRUG

melphalan

100 mg/m2/dose D -2, D -1

PROCEDURE

Stem Cell Infusion

infusion of previously collected autologous stem cells

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
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2012-12-31
Completion
2014-11-30

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 NCT00790647 on ClinicalTrials.gov