NCT00572169

UARK 2006-66, Total Therapy 3B: An Extension of UARK 2003-33 Total Therapy

A Phase II Study Incorporating Bone Marrow Microenvironment (ME) - Co-Targeting Bortezomib Into Tandem Melphalan-Based Autotransplants With DTPACE for Induction/Consolidation and Thalidomide + Dexamethasone for Maintenance

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 177 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

With this study - Total Therapy IIIB - researchers are extending the findings of Total Therapy III based what they have learned from the first two studies (Total Therapy I and II), with new research strategies designed to explore why chromosome abnormalities found in persons with multiple myeloma affect the outcome of drug therapy used in this disease."

Detailed description

It is well known that myeloma patients with chromosome abnormalities are at higher risk because their disease tends to be more aggressive and does not respond to treatment as well as patients without chromosome abnormalities. When researchers at the Myeloma Institute looked at the results of Total Therapy II, they found that although research subjects with chromosome abnormalities had better outcomes (how many responded, and how long they survived) than those treated with standard chemotherapy; still their outcomes did not improve significantly with Total Therapy II, when compared to Total Therapy I. The research in this new study is designed to target this high-risk group of individuals with chromosomal abnormalities. However, it is hoped that both groups of research participants - those with and without chromosome abnormalities - will derive benefit from changes made in this new research study.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Velcade	Will be given in central venous catheter
DRUG	Thalidomide	Capsule taken by mouth
DRUG	Dexamethasone	A pill taken by mouth
DRUG	Adriamycin	Given into the vein (IV) by a continuous infusion through a central catheter
DRUG	Cisplatin	Given into the vein (IV) by a continuous infusion through a central catheter
DRUG	Cyclophosphamide	Given into the vein (IV) by a continuous infusion through a central catheter
DRUG	Etoposide	Given into the vein (IV) by a continuous infusion through a central catheter

Timeline

• Start date: 2006-11-01
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2007-12-12
• Last updated: 2026-02-05

Locations

1 site across 1 country: United States