NCT00871013

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

* To find out if giving multi-agent chemotherapy in lower and more frequent doses to make the timely delivery of chemotherapy cycles possible, will result in better myeloma responses * To find out if changing the way the drugs are given during the transplant phase will also result in fewer side effects, while still being effective * To find out if giving treatment between transplants (called "inter-therapy") will prevent the myeloma from re-growing between transplants * To find out if long-term maintenance therapy will result in longer remissions * To find out what the effects (good and bad) of this overall treatment will be * To learn more about the biology and genetics of multiple myeloma by performing imaging tests and collecting blood, bone marrow aspirate and biopsies, and biopsies of lesions seen on MRI or PET scans. Bone marrow aspirates and biopsies are tissue sample collected from the bone cavity.

Conditions

• Myeloma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-03-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2009-03-30
• Last updated: 2025-07-01

Locations

1 site across 1 country: United States