UARK 2013-13, Total Therapy 4B - Formerly 2008-01 - A Phase III Trial for Low Risk Myeloma

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

382

Participants

Timeline

Start Date

July 31, 2008

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2027

Conditions
Multiple Myeloma
Interventions
DRUG

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.

DRUG

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.

Trial Locations (1)

72205

University of Arkansas for Medical Sciences, Myeloma Institute for Research and Therapy, Little Rock

Sponsors
All Listed Sponsors
collaborator

Millennium Pharmaceuticals, Inc.

INDUSTRY

lead

University of Arkansas

OTHER

NCT00734877 - UARK 2013-13, Total Therapy 4B - Formerly 2008-01 - A Phase III Trial for Low Risk Myeloma | Biotech Hunter | Biotech Hunter