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Sponsored by: |
University of Arkansas |
Information provided by: | University of Arkansas |
ClinicalTrials.gov Identifier: | NCT00573391 |
This study is being done to find out if the combination of VelcadeTM with melphalan and dexamethasone (VMD) will be as effective, or even more effective as it is in combination with thalidomide and dexamethasone (VTD).
Condition | Intervention | Phase |
Multiple Myeloma |
Drug: Velcade, Thalidomide, and Dexamethasone Drug: Velcade, Melphalan, and Dexamethasone |
Phase III |
Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
MedlinePlus related topics: | Multiple Myeloma |
Drug Information available for: | Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Melphalan Thalidomide Bortezomib Melphalan hydrochloride Sarcolysin |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment |
Official Title: | A Phase III Study for Patients Relapsing or Progressing After Autologous Transplantation on Total Therapy 2 (TT2, UARK 98-026): Bortezomib, Thalidomide and Dexamethasone Versus Bortezomib, Melphalan, and Dexamethasone |
Estimated Enrollment: | 294 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Drug: Velcade, Thalidomide, and Dexamethasone
Velcade - Into vein (IV) Days 1, 4, 8, 11 Yr 1: Every 28-35 days-12 cycles Yr 2: Every 8-10 weeks- 6 cycles Thalidomide - By Mouth Days 1-28 Yr 1: Every 28-35 days-12 cycles Yr 2: Every 8-10 weeks- 6 cycles |
2: Experimental |
Drug: Velcade, Melphalan, and Dexamethasone
Velcade - Into vein (IV) Days 1, 4, 8, 11 Yr 1: Every 28-35 days-12 cycles Yr 2: Every 8-10 weeks- 6 cycles |
A new drug (bortezomib [VelcadeTM PS-341]) has been shown in recent studies to be effective in subjects with advanced multiple myeloma. There is also research that shows this drug may be even more effective when used in combination with other drugs that have been used to treat myeloma for many years (melphalan, thalidomide, and dexamethasone). This study is being done to find out if the combination of VelcadeTM with melphalan and dexamethasone (VMD) will be as effective, or even more effective as it is in combination with thalidomide and dexamethasone (VTD).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arkansas | |||||
University of Arkansas for Medical Sciences | Recruiting | ||||
Little Rock, Arkansas, United States, 72205 | |||||
Contact: Naveen Sanath, MD, MHSA 501-526-6990 ext 2454 nsanathkumar@uams.edu | |||||
Sub-Investigator: Bart Barlogie, MD, PhD | |||||
Sub-Investigator: Elias Anaissie, MD | |||||
Sub-Investigator: Monica Grazziutti, MD | |||||
Sub-Investigator: Mehmet Kocoglu, MD | |||||
Sub-Investigator: Mauricio Pineda, MD | |||||
Sub-Investigator: Frits van Rhee, MD, PhD | |||||
Sub-Investigator: Pooja Motwani, MD | |||||
Sub-Investigator: Sarah Waheed, MD | |||||
Sub-Investigator: Yazan Alsayed, MD | |||||
Sub-Investigator: Klaus Hollmig, MD | |||||
Sub-Investigator: Bijay Nair, MD | |||||
Sub-Investigator: Syed A Ali, MD | |||||
Sub-Investigator: Ali Javed, MD |
University of Arkansas |
Principal Investigator: | Bart Barlogie, MD, PhD | University of Arkansas |
Responsible Party: | University of Arkansas for Medical Sciences ( Bart Barlogie, MD, PhD ) |
Study ID Numbers: | 2006-05 |
First Received: | December 12, 2007 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00573391 |
Health Authority: | United States: Institutional Review Board |
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