NCT00052884|TerminatedPhase 1

Study Stopped

Slow accrual and changes in clinical practice

Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell Transplantation

A Phase I Study of Amifostine Followed by High-Dose Escalation of Melphalan With Stem Cell Reconstitution for Patients With Primary Systemic Amyloidosis

Eastern Cooperative Oncology Group ClinicalTrials.gov

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3 other identifiers

CDR0000258785U10CA021115ECOG-E2A01

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJan 2003

StartedJan 2004

CompletionMar 2011

Brief 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 peripheral stem cell transplant to replace the blood-forming cells destroyed by chemotherapy, allows higher dose of chemotherapy to be given so that more plasma cells are killed. Giving a chemoprotective drug such as amifostine may protect kidney cells from the side effects of chemotherapy. PURPOSE: This phase I trial is studying the side effects and best dose of melphalan given together with amifostine in treating patients who are undergoing peripheral stem cell transplant for primary systemic amyloidosis.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_1

Timeline

Completed

Started Jan 2004

Longer than P75 for phase_1

Geographic Reach

1 country

16 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

7.1 years study duration

First Submitted

Initial submission to the registry

January 24, 2003

Completed

3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

12 months until next milestone

Study Start

First participant enrolled

January 22, 2004

Completed

3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed

3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed

Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

3.6 years

First QC Date

January 24, 2003

Last Update Submit

June 14, 2023

Conditions

Drug/Agent Toxicity by Tissue/Organ Multiple Myeloma and Plasma Cell Neoplasm

Keywords

drug/agent toxicity by tissue/organprimary systemic amyloidosis

Outcome Measures

Primary Outcomes (1)

Maximum Tolerated Dose
The maximum tolerated dose is the highest dose level at which fewer than 1 of 3 or 2 of 6 patients experience dose-limiting toxicity, defined as any grade 3 or higher toxicity of any of the following: renal failure, alkaline phosphatase elevation, GI bleeding, and cardiac rhythm disturbances, assessed using NCI Common Toxicity Criteria, version 2.0.
Assessed over 30 days

Study Arms (1)

Amifostine, Melphalan, and Stem Cell Reconstitution

EXPERIMENTAL

Amifostine, Melphalan, and Stem Cell Reconstitution. Doses of Melphalan tested included 100 mg/m2 and 120 mg/m2

Biological: filgrastimDrug: amifostine trihydrateDrug: melphalanProcedure: bone marrow ablation with stem cell supportProcedure: peripheral blood stem cell transplantation