Clinical Research Directory
Browse clinical research sites, groups, and studies.
Trial for Patients Not Qualifying for TT4 and TT5 Protocols Because of Prior Therapy
Sponsor: University of Arkansas
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
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
Velcade
Given by vein, Days 1, 5, 8, 11
Thalidomide
Given by mouth at bedtime, Days 5-8
Dexamethasone
Given by mouth, once per day Days 5-8
Cisplatin
Given by vein, Days 5-8 continuous infusion
Adriamycin
Given by vein, days 5-8 continuous infusion
Cyclophosphamide
Given by vein days 5-8 continuous infusion
Etoposide
Given by vein days 5-8 continuous infusion
Locations (1)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States