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
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.
Induction
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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:
Participants/data will be followed and assessed for an expected average of 3 years
No
Bart Barlogie, MD, PhD
Principal Investigator
UAMS
United States: Food and Drug Administration
UARK 2003-33
NCT00081939
January 2004
January 2014
Name | Location |
---|---|
University of Arkansas for Medical Sciences/MIRT | Little Rock, Arkansas 72205 |