UARK 2008-01, Total Therapy 4 - A Phase III Trial for Low Risk Myeloma: A Randomized Trial Comparing Standard Total Therapy 3 (S-TT3) With TT3-LITE (L-TT3)
The major treatment-related toxicities in TT3 pertained to the high-dose melphalan 200mg/m2
(MEL200)-based tandem transplant approach, consisting of mucosal and other toxicities.
For the TT4 trial, we are proposing to compare standard TT3 (S-TT3) to TT3-Lite (L-TT3).
L-TT3 will employ various strategies aimed at improving the therapeutic Index of S-TT3 by
reducing toxicities while maintaining the superior results reported for S-TT3 in terms of
frequency and duration of CR, EFS, and. The following strategies will be utilized in L-TT3:
- Applying only 1 instead of 2 cycles of induction and consolidation therapy prior to and
after tandem transplant. This is supported by the well known association between prior
exposure to mucotoxic therapies4, 5 and worse post-transplant mucositis, particularly
when etoposide is used in the mobilizing regimen6 such as in VDTPACE.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine whether anti-myeloma efficacy can be preserved or even enhanced in L-TT3 v S-TT3, due to anticipated enhanced treatment compliance and synergy between MEL and VTD.
3 years
Yes
Sarah Waheed, MD
Principal Investigator
UAMS
United States: Institutional Review Board
UARK 2008-01
NCT00734877
July 2008
September 2013
Name | Location |
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University of Arkansas for Medical Sciences, Myeloma Institute for Research and Therapy | Little Rock, Arkansas 72205 |