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ACTIVE NOT RECRUITING
NCT00871013
PHASE2

Trial for Patients Not Qualifying for TT4 and TT5 Protocols Because of Prior Therapy

Sponsor: University of Arkansas

View on ClinicalTrials.gov

Summary

There have been four previous Total Therapy (TT1 through IIIB) studies for multiple myeloma at the MIRT from 1989 to present. Results have shown that participants treated on these studies had better outcomes (meaning they have lived longer and had better responses to treatment) when compared to individuals treated with standard chemotherapy. Past studies conducted at the MIRT have shown that participants presenting to MIRT who have already received treatment for myeloma tend to have shorter remissions (disappearance of signs and symptoms of myeloma) and do not survive as long as participants who come to MIRT with untreated myeloma. Researchers at MIRT think that one reason for this is may be that the myeloma cells re-grow in the time when participants are not receiving treatment because they are recovering from high-dose chemotherapy. In this study, participants will receive several chemotherapy drugs previously shown to be effective in myeloma, but in lower doses and in shorter cycles. It is hoped that by giving the drugs in this way, myeloma cells will not have time to re-grow between cycles, therefore resulting in longer remissions. This study is being done in an attempt to improve the remission rate and the survival time for participants with high-risk myeloma.

Official title: UARK 2008-03 Phase II Trial for Patients Not Qualifying for TT4 and TT5 Protocols Because of Prior Therapy (No Prior Transplant)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2009-03

Completion Date

2026-12

Last Updated

2025-07-01

Healthy Volunteers

No

Conditions

Interventions

DRUG

Melphalan

Given by vein, Day 3 First Inter-Therapy Treatment Bortezomib (Velcade) By vein Days 1 and 4 Second Inter-Therapy Treatment Bortezomib (Velcade) By vein Days 1 and 4 Second Transplant Bortezomib (Velcade) By vein Day -5 and Day -2 Year 1 Maintenance Velcade (bortezomib) By vein Days 1, 8, 15, 22(weekly) Every 28 days Years 2 \& 3 Maintenance Velcade (bortezomib) By vein Days 1, 8, 15, 22(weekly) Every 56 days

DRUG

Velcade

Given by vein, Days 1, 5, 8, 11

DRUG

Thalidomide

Given by mouth at bedtime, Days 5-8

DRUG

Dexamethasone

Given by mouth, once per day Days 5-8

DRUG

Cisplatin

Given by vein, Days 5-8 continuous infusion

DRUG

Adriamycin

Given by vein, days 5-8 continuous infusion

DRUG

Cyclophosphamide

Given by vein days 5-8 continuous infusion

DRUG

Etoposide

Given by vein days 5-8 continuous infusion

Locations (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States