drugset / Trial / NCT01548573

Tandem Auto Transplantation in Myeloma Patients With <12 Months of Prior Treatment

NCT01548573 ↗

NaSingle-groupOpen-labelTreatment

Summary

This study is designed to decrease toxicity associated with prior tandem transplant protocols by reducing the intensity of induction, consolidation and maintenance therapy, while increasing event-free survival by adding bortezomib (Velcade®), thalidomide, gemcitabine and carmustine to the transplant regimens to down-regulate the rescue of myeloma cells by the micro-environment and to prevent DNA repair post high-dose alkylating agent therapy. By reducing drug resistance, it is hoped that 3-year event-free survival will be increased significantly when compared to Total Therapy II. Additionally, participants will have the option of providing biospecimens for a sub-study evaluating gene expression profiling at specific timepoints to better understand drug-resistance in myeloma, and to determine whether there are genes or gene products in the resistant population that can be targeted by novel therapies.

Timeline

Start
2012-05
Primary completion
2013-07
Completion
2014-08

Outcome

Outcome not reported

Stopped: “Met study stopping rules”

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule — Intravenous
Subject Cisplatin Other / unclassified — Intravenous
Subject Cyclophosphamide Other / unclassified — Intravenous
Subject Dexamethasone Small molecule — Oral
Subject Doxorubicin Other / unclassified — Intravenous
Subject Etoposide Small molecule — Intravenous
Subject Melphalan Small molecule — Intravenous
Subject Thalidomide Other / unclassified — Oral

Indications