NCT00253578

Sorafenib in Treating Patients With Relapsed or Refractory Multiple Myeloma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	sorafenib tosylate	Given PO
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2006-03-01
• Primary completion: 2007-11-01
• First posted: 2005-11-15
• Last updated: 2013-01-07

Locations

1 site across 1 country: United States