NCT00609167

Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

A Phase II Trial of Cyclophosphamide, Bortezomib and Dexamethasone (CYBOR-D) in Patients With Newly Diagnosed Active Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy such as cyclophosphamide and dexamethasone work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cyclophosphamide and dexamethasone together with bortezomib may kill more cancer cells. PURPOSE: This phase II trial is studying giving cyclophosphamide and dexamethasone together with bortezomib to see how well it works in treating patients with newly diagnosed multiple myeloma.

Detailed description

OBJECTIVES: Primary \* To evaluate the response rate (complete response \[CR\], near CR \[nCR\], and very good partial response) in patients with newly diagnosed multiple myeloma treated with bortezomib in combination with cyclophosphamide and dexamethasone . Secondary * Determine the overall response rate (partial response, PR, or better) in these patients after 4, 8, and 12 courses of this regimen. * Determine the duration of progression-free and overall survival of patients treated with this regimen. * To evaluate the toxicity of this regimen in these patients. * To evaluate the ability to successfully collect peripheral blood stem cells from these patients after 4 months of this regimen. * To evaluate the CR or nCR rate in these patients after 8 and 12 courses of this regimen. OUTLINE: This is a multicenter study. Patients receive oral cyclophosphamide on days 1, 8, 15, and 22; bortezomib IV on days 1, 4, 8 , and 11 OR days 1, 8, 15 and 22; and dexamethasone on days 1-4, 9-12, and 17-20 in courses 1 and 2 and days 1, 18, 15, and 22 in all subsequent courses. Courses repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Conditions

• Multiple Myeloma and Plasma Cell Neoplasm

Interventions

Type	Name	Description
DRUG	bortezomib	First 33 patients: 1.3 mg/m\^2 IV Days 1, 4, 8 \& 11 Remaining 30 patients: 1.5 mg/m\^2 IV Days 1, 8, 15 \& 22
DRUG	cyclophosphamide	300mg/m\^2 PO days 1, 8, 15 \& 22
DRUG	dexamethasone	First 33 patients: 40 mg PO Days 1-4, 9-12, 17-20 Remaining 30 patients: 40 mg PO Days 1-4, 9-12, 17-20 for cycles 1-2; Days 1, 8, 15, 22 for cycle 3+2 for cycle 3 and beyond

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-01-01
• Completion: 2010-11-01
• First posted: 2008-02-06
• Last updated: 2011-05-17
• Results posted: 2010-12-07

Locations

2 sites across 2 countries: United States, Canada