NCT00079456

Temsirolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma

A Phase II Trial of CCI-779 in Patients With Relapsed or Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (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 temsirolimus works in treating patients with relapsed or refractory multiple myeloma. Drugs used in chemotherapy such as temsirolimus work in different ways to stop cancer cells from dividing so they stop growing or die.

Detailed description

PRIMARY OBJECTIVES: I. Determine the overall response rate in patients with relapsed or refractory multiple myeloma treated with CCI-779. SECONDARY OBJECTIVES: I. Determine the progression-free survival of patients treated with this drug. II. Determine the toxicity of this drug in these patients. III. Determine the presence of PTEN mutation in patients treated with this drug. IV. Correlate the pharmacokinetics of this drug with response in these patients. V. Correlate the pharmacodynamic effects of this drug with response in these patients. OUTLINE: This is an open-label study. Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Conditions

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

Interventions

Type	Name	Description
DRUG	temsirolimus	Given IV
OTHER	pharmacological study	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2004-02-01
• Primary completion: 2007-02-01
• First posted: 2004-03-10
• Last updated: 2013-10-11

Locations

2 sites across 1 country: United States