Bortezomib and Vorinostat in Treating Patients With Multiple Myeloma Who Have Undergone Autologous Stem Cell Transplant

DS Stage II Plasma Cell Myeloma Clinical Trial

Official title: Bortezomib and Vorinostat as Maintenance Therapy After Autologous Stem Cell Transplant for Multiple Myeloma

Status Active, not recruiting

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

• DS Stage I Plasma Cell Myeloma
• DS Stage II Plasma Cell Myeloma
• DS Stage III Plasma Cell Myeloma
• Multiple Myeloma
• Neoplasms, Plasma Cell

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