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Brief Title: UARK 2003-33, Total Therapy III
Official Title: A Phase 2 Study Incorporating Bone Marrow Microenvironment (ME) Co-Targeting Bortezomib Into Tandem Melphalan-Based Autotransplants With DT PACE for Induction/Consolidation and Thalidomide + Dexamethasone for Maintenance
Study ID: NCT00081939
Brief Summary: There have been two previous Total Therapy studies for multiple myeloma (MM) at the Myeloma Institute for Research and Therapy (MIRT): Total Therapy I (from 1989 through 1994) and Total Therapy II (from 1996 to 2004). Results have shown that patients treated on these studies had better outcomes (meaning patients have lived longer and had better responses to treatment) when compared to patients treated with standard chemotherapy. With this new study, Total Therapy III, researchers will take what they have learned from the first two studies and add new treatment strategies to try to improve the outcomes even more, especially for patients with chromosome abnormalities.
Detailed Description: 1.1 To determine, in a historical comparison with TT II (Thalidomide arm), whether two cycles of VDTPACE induction (instead of four induction cycles in TT II) followed by more timely MEL 200-based transplant with DEX + THAL between transplants can: 1.1.1 Increase the CR frequency from 50% to 60% at 18 months from initiation of therapy; 1.1.2 Increase \> n-CR rate pre-transplant #1 from 20% to 40%; 1.1.3 Raise 2-year EFS rates from 55% to 75% in patients with CA and from 80% to 95%, in patients without CA.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Arkansas for Medical Sciences/MIRT, Little Rock, Arkansas, United States
Name: Bart Barlogie, MD, PhD
Affiliation: UAMS
Role: PRINCIPAL_INVESTIGATOR