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Clinical Trial Summary

This phase II trial studies the side effects of giving bortezomib together with vorinostat and to see how well it works in treating patients with multiple myeloma who have undergone autologous stem cell transplant. Bortezomib and vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with vorinostat after an autologous stem cell transplant may stop the growth of any cancer cells that remain after transplant.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. Evaluate the toxicity of the use of vorinostat and bortezomib as maintenance therapy after autologous transplant.

SECONDARY OBJECTIVES:

I. Evaluate the median time to disease progression.

II. Evaluate survival.

OUTLINE: Patients receive bortezomib intravenously (IV) on days 2 and 5 and vorinostat orally (PO) once daily (QD) on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically. ;


Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00839956
Study type Interventional
Source Fred Hutchinson Cancer Research Center
Contact
Status Active, not recruiting
Phase Phase 2
Start date February 2009

See also
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Completed NCT01842308 - Carfilzomib and Melphalan Before Stem Cell Transplant in Treating Patients With Multiple Myeloma Phase 1/Phase 2
Completed NCT00066638 - FR901228 in Treating Patients With Relapsed or Refractory Multiple Myeloma Phase 2
Completed NCT00088855 - Bortezomib and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Previously Untreated Symptomatic Multiple Myeloma Phase 2
Completed NCT00445692 - Lenalidomide, Dexamethasone, and Clarithromycin in Treating Patients Who Have Undergone Stem Cell Transplant for Multiple Myeloma Phase 2
Completed NCT01605032 - Busulfan, Melphalan, and Bortezomib Before First-Line Stem Cell Transplant in Treating Patients With Multiple Myeloma Phase 2
Completed NCT01330173 - Vismodegib After Stem Cell Transplant in Treating Patients With High-Risk First Remission or Relapsed Multiple Myeloma Phase 1
Withdrawn NCT01251172 - RO4929097 After Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma Phase 2
Completed NCT01936090 - Bortezomib, Melphalan, and Total-Body Irradiation Before Stem Cell Transplant in Treating Patients With Multiple Myeloma Phase 1