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
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To find out if outcomes of participants in this study will be better when compared to individuals who participated in Total Therapy II, especially those with chromosome abnormalities.
Bart Barlogie, MD, PhD
UAMS Myeloma Institute for Research and Therapy
United States: Institutional Review Board
|University of Arkansas for Medical Sciences/MIRT||Little Rock, Arkansas 72205|