NCT00574080

UARK 2006-15: A Study of Tandem Transplants With or Without Bortezomib and Thalidomide

UARK 2006-15: A Phase III Randomized Study of Tandem Transplants With or Without Bortezomib (Velcade) and Thalidomide (Thalomid) to Evaluate Its Effect on Response Rate and Durability of Response in Multiple Myeloma Patients

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Add three drugs, bortezomib, thalidomide, and dexamethasone (VTD) to the high dose chemotherapy regimen immediately before transplant (DPACE/Melphalan) to try to improve myeloma response and acquire longer survival for participants.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Interim/Maintenance Dexamethasone	20 mg Days 1-4 every 3 weeks in the interim between treatment phases and during maintenance
DRUG	Induction/Consolidation Dexamethasone	40 mg Days 1-4
DRUG	Induction/Consolidation Cisplatin	10 mg/m2 by continuous infusion Days 1-4
DRUG	Induction/Consolidation Adriamycin	10 mg/m2 by continuous infusion Days 1-4
DRUG	InductionConsolidation Cyclophosphamide	400 mg/m2 by continuous infusion Days 1-4
DRUG	Induction/Consolidation Etoposide	40 mg/m2 by continuous infusion Days 1-4
DRUG	Induction Pegfilgrastim	6 mg Days 6 and 13
DRUG	Transplant 1 Dexamethasone	20 mg Days -4, -3, -2, -1 and +4, +5, +6, and +7
DRUG	Transplant 1 Cisplatin	20 mg/m2 by continuous infusion Days -3 and -2
DRUG	Transplant 1 Adriamycin	20 mg/m2 by continuous infusion Days -3 and -2
DRUG	Transplant 1 Cyclophosphamide	800 mg/m2 by continuous infusion Days -3 and -2
DRUG	Transplant 1 Etoposide	80 mg/m2 by continuous infusion Days -3 and -2
DRUG	Transplant 1 Melphalan	50 mg/m2 Days -2 and -1
DRUG	Transplant 1 and 2 Pegfilgrastim	6 mg Day +6
PROCEDURE	Autologous Peripheral Blood Stem Cell Transplant (ASCT)	Day 0
DRUG	Transplant 2 Carmustine	300 mg/m2 Day -5
DRUG	Transplant 2 Etoposide	200 mg/m2 Days -5, -4, -3, -2
DRUG	Transplant 2 Cytarabine	400 mg/m2 Days -5, -4, -3, -2
DRUG	Transplant 2 Melphalan	140 mg/m2 Day -1
DRUG	Transplant 2 Dexamethasone	20 mg Days -5, -4, -3, -2, +4, +5, +6, +7
DRUG	Transplant 1 and 2 Bortezomib	1 mg/m2 Days -4, -1, +3, +7
DRUG	Transplant 1 and 2 Thalidomide	200 mg Days -4 to +5

Timeline

• Start date: 2006-07-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2007-12-14
• Last updated: 2017-11-20
• Results posted: 2011-06-30

Locations

1 site across 1 country: United States