CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 89 enrolled
Drug / intervention
filgrastim +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00477971
NCT00477971Phase 3Completed

Phase III Trial of Stem Cell Transplantation Compared to Parenteral Melphalan and Oral Dexamethasone in the Treatment of Primary Systemic Amyloidosis (AL)

Mayo Clinic·interventional·Posted May 24, 2007·Updated May 17, 2016

In Brief

A Phase 3 clinical trial evaluating filgrastim, dexamethasone, and 2 other interventions for Multiple Myeloma and Plasma Cell Neoplasm. Completed, enrolled 89 participants across 1 site.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as melphalan and dexamethasone, work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing. Having an autologous 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. It is not yet known whether combination chemotherapy is more effective than chemotherapy followed by an autologous stem cell transplant in treating primary systemic amyloidosis. PURPOSE: This randomized phase III trial is studying the side effects and how well giving low-dose melphalan together with dexamethasone works compared with high-dose melphalan followed by an autologous stem cell transplant in treating patients with primary systemic amyloidosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 24, 2007
Enrollment StartOct 1, 2005
Primary CompletionJul 1, 2012
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 19.1 years ago

Interventions

filgrastimbiological

No administration information given

dexamethasonedrug

Given orally

melphalandrug

Given IV or orally

autologous hematopoietic stem cell transplantationprocedure

Given on day 0