NCT00693433

Temsirolimus and Dexamethasone in Treating Patients With Recurrent or Refractory Multiple Myeloma

A Phase 1 Study of CCI-779 in Combination With Dexamethasone in Multiple Myeloma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial is studying the side effects and best dose of temsirolimus when given together with dexamethasone in treating patients with recurrent or refractory multiple myeloma. Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving temsirolimus together with dexamethasone may kill more cancer cells.

Detailed description

PRIMARY OBJECTIVES: I. To assess the toxicity and safety of temsirolimus in combination with dexamethasone in patients with recurrent or refractory multiple myeloma. II. To assess a dose of temsirolimus that is capable of inhibiting the mammalian target of rapamycin (mTOR) in myeloma tumor cells. SECONDARY OBJECTIVES: I. To assess the efficacy of temsirolimus in combination with dexamethasone in these patients. II. To correlate the efficacy of this regimen with molecular characteristics of the individual tumor clones. OUTLINE: This is a multicenter, dose-escalation study of temsirolimus. Patients receive temsirolimus intravenously (IV) over 30 minutes once weekly on days 1, 8, 15, and 22 and oral dexamethasone once on days 1, 2, 8, 9, 15, 16, 22, and 23. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow aspiration and blood sample collection periodically for correlative studies. Correlative studies include analysis of p70S6 kinase activity in peripheral blood mononuclear cells and in multiple myeloma cells; analysis of the degree of AKT phosphorylation and degree of PTEN expression in multiple myeloma cells by immunohistochemistry; Ras mutational analysis; and Myc 5'UTR mutational analysis. After completion of study treatment, patients are followed for 4 weeks.

Conditions

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

Interventions

Type	Name	Description
DRUG	dexamethasone	Given orally
DRUG	temsirolimus	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-08-01
• First posted: 2008-06-09
• Last updated: 2015-12-04

Locations

1 site across 1 country: United States