382
Participants
Start Date
July 31, 2008
Primary Completion Date
September 30, 2026
Study Completion Date
September 30, 2027
M-VTD-PACE
2 cycles of induction therapy with M-VTD-PACE and PBSC collection after the 1st cycle. MEL-based tandem transplant will be administered 6 weeks to 3 months apart, applying single dose MEL 200 mg/m2 with adjustments for age and renal function. Consolidation will consist of 2 cycles of dose-reduced VTD-PACE. Maintenance treatment will employ VRD for 3 years.
TT3-LITE Regimen (L-TT3)
The TT3-LITE Regimen (L-TT3) will employ only 1 cycle of induction therapy with MVTD-PACE and, as in S-TT3, PBSC collection following recovery from this one and only induction treatment. MEL-based tandem transplant will be administered 6 weeks to 3 months apart, applying fractionated MEL200mg/m2 in 4 successive daily fractions of 50mg/m2 (MEL50 x 4) with addition of VTD with adjustments for age and renal function. Consolidation will consist of only 1 cycle of dose-reduced VTD-PACE. Maintenance treatment will employ VRD for 3 years.
University of Arkansas for Medical Sciences, Myeloma Institute for Research and Therapy, Little Rock
Collaborators (1)
Millennium Pharmaceuticals, Inc.
INDUSTRY
University of Arkansas
OTHER