Sorafenib in Treating Patients With Relapsed or Refractory Multiple Myeloma

Refractory Multiple Myeloma Clinical Trial

Official title: A Phase II Trial of BAY 43-9006 (Sorafenib) (NSC-724772) in Patients With Relapsing or Resistant Multiple Myeloma

Status Completed

Clinical Trial Summary

This phase II trial is studying how well sorafenib works in treating patients with relapsed or refractory multiple myeloma. Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To assess the overall response rate (confirmed CR, R and PR) in patients with relapsed/refractory multiple myeloma treated with BAY 43-9006.

II. To evaluate qualitative and quantitative toxicities associated with this regimen.

III. To assess overall and progression-free survival in this group of patients treated with this regimen.

IV. To explore, in a preliminary manner, associations between gene expression signatures and response.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 3 years. ;

Study Design

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Refractory Multiple Myeloma

• NCT number: NCT00253578
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 2
• Start date: March 2006