NCT01072773

Bortezomib, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Light Chain Amyloidosis

Phase II Study of Bortezomib, Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Light Chain Amyloidosis

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

Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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. Giving bortezomib together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bortezomib, cyclophosphamide, and dexamethasone together works in treating patients with primary systemic light chain amyloidosis.

Detailed description

PRIMARY OBJECTIVE: I. To assess the confirmed hematologic response rate of the combination of bortezomib, cyclophosphamide and dexamethasone in patients with primary systemic amyloidosis. SECONDARY OBJECTIVES: I. Organ response rate of the bortezomib, cyclophosphamide and dexamethasone combination. II. Severity and frequency of adverse events associated with bortezomib, cyclophosphamide and dexamethasone treatment in patients with primary systemic amyloidosis. III. Time to progression. IV. Survival. OUTLINE: Patients receive bortezomib IV on days 1, 8, and 15 and oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years.

Conditions

• Primary Systemic Amyloidosis

Interventions

Type	Name	Description
DRUG	bortezomib	1.3 mg/m\^2, by IV on days 1, 8 and 15 every 28 days
DRUG	cyclophosphamide	300 mg/m\^2, orally, on days 1, 8, 15 \& 22 every 28 days.
DRUG	dexamethasone	40 mg, orally, on days 1, 8, 15 \& 22 every 28 days

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-03-01
• Completion: 2012-06-01
• First posted: 2010-02-22
• Last updated: 2014-04-02
• Results posted: 2012-12-05

Locations

1 site across 1 country: United States