NCT00514137

Sunitinib in Treating Patients With Relapsed Multiple Myeloma

A Phase II Trial of Sunitinib (SU11248) in Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well sunitinib works in treating patients with relapsed multiple myeloma. Sunitinib 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 number of responses in patients with relapsed multiple myeloma treated with sunitinib (sunitinib malate). SECONDARY OBJECTIVES: I. To assess the toxicity of sunitinib malate in patients with relapsed multiple myeloma. II. To assess time to progression after initial response to sunitinib malate. OUTLINE: Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3-6 months for up to 3 years.

Conditions

• Refractory Multiple Myeloma
• Stage I Multiple Myeloma
• Stage II Multiple Myeloma
• Stage III Multiple Myeloma

Interventions

Type	Name	Description
DRUG	sunitinib malate	Oral 37.5 mg each day of the 6-week cycle (continuous dosing).

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-03-01
• Completion: 2010-08-01
• First posted: 2007-08-09
• Last updated: 2014-05-28
• Results posted: 2013-03-06

Locations

1 site across 1 country: United States