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drugset / Trial / NCT00574080

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

NCT00574080 ↗

Phase 3 Terminated 20 enrolled University of Arkansas
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2006-07
Primary completion
2011-03
Completion
2011-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1 mg/m2 —
Subject Thalidomide Other / unclassified 200 mg —
Background Cisplatin Other / unclassified 10 mg/m2 Other
Background Cisplatin Other / unclassified 20 mg/m2 Other
Background Cyclophosphamide Other / unclassified 400 mg/m2 Other
Background Cyclophosphamide Other / unclassified 800 mg/m2 Other
Background Cytarabine Small molecule 400 mg/m2 —
Background Dexamethasone Small molecule 20 mg —
Background Dexamethasone Small molecule 40 mg —
Background Doxorubicin Other / unclassified 10 mg/m2 Other
Background Doxorubicin Other / unclassified 20 mg/m2 Other
Background Etoposide Small molecule 40 mg/m2 Other
Background Etoposide Small molecule 80 mg/m2 Other
Background Etoposide Small molecule 200 mg/m2 Other
Background Melphalan Small molecule 50 mg/m2 —
Background Melphalan Small molecule 140 mg/m2 —
Background Pegfilgrastim Protein / enzyme biologic 6 mg —
Background carmustine Small molecule 300 mg/m2 —

Indications

plasma cell myeloma