UARK 2006-66, Total Therapy 3B: An Extension of UARK 2003-33 Total Therapy
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."
Drug: Bortezomib (Velcade)
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 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. [ Time Frame: 48 months ] [ Designated as safety issue: No ]
- To find out if outcomes and incidence of toxicities of participants in this study will be better when compared to individuals who participated in Total Therapy III. [ Time Frame: 48 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2006|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
VDTPACE Cycle 1 with Gene Array pre/post VEL. Drug administration dependent on different factors through study, i.e., stage, platelets, etc.
Drug: Bortezomib (Velcade)
Other Name: Velcade, PS-341Drug: Thalidomide
Other Name: ThalomidDrug: Dexamethasone
Other Name: Decadron, NSC-34521Drug: Melphalan
Other Name: Alkeran, NSC-8806Drug: Cisplatin
Other Name: Cis-diamminedichloroplatinum [CDDP], Platinol, NSC-119875Drug: Doxorubicin
Other Name: Adriamycin, NSC-123127Drug: Cyclophosphamide
Other Name: Cytoxan, NSC-26271Drug: Etoposide
Other Name: VP-16), Vepesid®, Ethylidene-Lignan P., NSC-141540Drug: Filgrastim
Other Name: G-CSF, r-metHuG-CSF, Neupogen, NSC 614629Drug: Lenalidomide
Other Name: CC-5013, IMiD-3, Revlimid,
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00572169
|United States, Arkansas|
|University of Arkansas for Medical Sciences/MIRT|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||Bart Barlogie, MD, PhD||UAMS Myeloma Institute for Research and Therapy|